Publications by authors named "Roberto Da Cas"

42 Publications

[Medicines use in Italy. 2020 OsMed National Report.]

Recenti Prog Med 2021 Oct;112(10):659-667

Agenzia Italiana del Farmaco, Roma.

The 2020 National Report "Medicines use in Italy", produced by the National Observatory on the Use of Medicines (OsMed) of the Italian Medicines Agency (AIFA), describes the Italian pharmaceutical assistance through different available information flows that allow to recompose pharmaceutical territorial and hospital assistance, concerning both the national health service and private citizens. In the Report the results of numerous analyzes, both general and focused on specific therapeutic categories and classes, relating to pharmaceutical expenditure and consumption, are reported, but it is also present an in-depth analysis about monitoring registries and conditional reimbursement agreements, and a comparison between the most relevant Italian data and those of nine other European countries.
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http://dx.doi.org/10.1701/3679.36657DOI Listing
October 2021

Risk of SARS-CoV-2 infection and subsequent hospital admission and death at different time intervals since first dose of COVID-19 vaccine administration, Italy, 27 December 2020 to mid-April 2021.

Euro Surveill 2021 Jun;26(25)

The members have been listed at the end of this article.

To assess the real-world impact of vaccines on COVID-19 related outcomes, we analysed data from over 7 million recipients of at least one COVID-19 vaccine dose in Italy. Taking 0-14 days post-first dose as reference, the SARS-CoV-2 infection risk subsequently decreased, reaching a reduction by 78% (incidence rate ratios (IRR): 0.22; 95% CI: 0.21-0.24) 43-49 days post-first dose. Similarly, hospitalisation and death risks decreased, with 89% (IRR: 0.11; 95% CI: 0.09-0.15) and 93% (IRR: 0.07; 95% CI: 0.04-0.11) reductions 36-42 days post-first dose. Our results support ongoing vaccination campaigns.
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http://dx.doi.org/10.2807/1560-7917.ES.2021.26.25.2100507DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8229378PMC
June 2021

Impact of Prior Antibiotic Use in Primary Care on Resistance to Third Generation Cephalosporins: A Case-Control Study.

Antibiotics (Basel) 2021 Apr 16;10(4). Epub 2021 Apr 16.

Department of Medical Sciences and Public Health, Faculty of Medicine and Surgery, University of Cagliari, 09124 Cagliari, Italy.

Research is lacking on the reversibility of antimicrobial resistance (AMR). Thus, we aimed to determine the influence of previous antibiotic use on the development and decay over time of third generation cephalosporin (3GC)-resistance of . Using the database of hospital laboratories of the Autonomous Province of Bolzano/Bozen (Italy), anonymously linked to the database of outpatient pharmaceutical prescriptions and the hospital discharge record database, this matched case-control study was conducted including as cases all those who have had a positive culture from any site for 3GC resistant (3GCREC) during a 2016 hospital stay. Data were analyzed by conditional logistic regression. 244 cases were matched to 1553 controls by the date of the first isolate. Male sex (OR 1.49, 95% CI 1.10-2.01), older age (OR 1.11, 95% CI 1.02-1.21), the number of different antibiotics taken in the previous five years (OR 1.20, 95% CI 1.08-1.33), at least one antibiotic prescription in the previous year (OR 1.92, 95% CI 1.36-2.71), and the diagnosis of diabetes (OR 1.57, 95% CI 1.08-2.30) were independent risk factors for 3GCREC colonization/infection. Patients who last received an antibiotic prescription two years or three to five years before hospitalization showed non-significant differences with controls (OR 0.97, 95% CI 0.68-1.38 and OR 0.85, 95% CI 0.59-1.24), compared to an OR of 1.92 (95% CI 1.36-2.71) in those receiving antibiotics in the year preceding hospitalization. The effect of previous antibiotic use on 3GC-resistance of is highest after greater cumulative exposure to any antibiotic as well as to 3GCs and in the first 12 months after antibiotics are taken and then decreases progressively.
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http://dx.doi.org/10.3390/antibiotics10040451DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8073604PMC
April 2021

[Therapeutic drug plans: how many and which ones? Overview of a prescriptive and care appropriateness tool.]

Recenti Prog Med 2021 04;112(4):243-249

Fondazione ReS (Ricerca e Salute), Bologna.

Therapeutic plans (TPs) were introduced in Italy in 2004 in order to ensure the continuity in the prescription of new drugs between specialist physicians and general practitioners (GPs). Over the years this prescription tool was updated several times: starting from a paper form without any template ("paper TP") to a template defined by AIFA to collect specific clinical information, up to a web-based form to collect all information into a database. Over time-critical issues concerning its usefulness have been raised, especially when AIFA established several extensions for TP validity to ensure the social distancing required by the covid-19 pandemic. Therefore, after several years from their establishment, pending adoption of necessary implementing of Ministerial Decree of 25th March 2020, a check of the actual impact of TPs is required, in order to plan their review. This study provide a detailed overview of all TPs active in Italy at the 11th May 2020. From Farmadati database, all drugs reimbursed by the National Health Service (class A drugs) and requiring TP were selected. The consumption of these drugs has been derived from OsMed Reports that make available data of medicines consumption and expenditure in the general population in Italy. The analysis showed that TP is required for the prescription of 935 medicinal products (9.6% of class-A drugs) and 147 different active substances (belonging to 34 different Therapeutic Groups and 66 subgroups). Out of these, 67 (46%) required a paper TP without any template, 72 (49%) a paper TP on AIFA template, and 8 (5%) a web-based TP. The Therapeutic Group with the largest number of active ingredients with TP were antidiabetics (19.7%), followed by immunomodulating and immunosuppressants (9.5%) and medications for asthma and COPD (6.8%). Consumption analysis of drugs with TP showed that this prescription tool covers 943,899,598 DDD per year, equal to 2,586,026 DDD/day. This means that TPs have a very high impact in terms of the prevalence of patients treated on the entire care process. Of all annual DDDs prescribed on TP, 46.8% concerned drugs with TP on template AIFA, 34.5% drugs with web-based TP, while the remaining 18.7% drugs with paper TP without a template. This analysis may provide the basis for an analytical case-by-case review of TP maintenance needs, trying to maximize the benefits of this tool and to reduce its possible adverse effects. This review could be helpful to ensure the appropriateness in the drug uses, to enhance the role of general medicine, and to simplify the pathways of millions of patients ensuring the continuity of their care.
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http://dx.doi.org/10.1701/3584.35683DOI Listing
April 2021

[The use of antibiotics in Italy. The national OsMed report 2019.]

Recenti Prog Med 2021 03;112(3):186-190

Agenzia Italiana del Farmaco, Roma.

The OsMed report "The use of antibiotics in Italy - 2019", produced by the Italian Medicines Agency, shows how the prescriptions of these drugs are still too high in our country, albeit with high variability between different regions. A significant degree of inappropriate use of antibiotics also emerges, especially in respiratory infections. In general, the results highlight the need to implement prevention and control actions in order to counter antibiotic resistance.
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http://dx.doi.org/10.1701/3565.35456DOI Listing
March 2021

Trends in hip and distal femoral fracture rates in Italy from 2007 to 2017.

Bone 2021 01 12;142:115752. Epub 2020 Nov 12.

Department of Cardiovascular, Endocrine-metabolic Diseases and Aging, Istituto Superiore di Sanità, Rome, Italy.

Osteoporosis-related fractures are a growing public health concern worldwide due to high societal and economic burden. The study aims to assess trends in incidence rates of hip and distal femoral fractures and in the use of anti-osteoporosis drugs in Italy between 2007 and 2017. Patients with hip and distal femoral fractures (ICD-9-CM codes 820.x and 821.x) were identified in the Italian National Hospital Discharge Database while anti-osteoporosis medication data were retrieved from the National Observatory on the Use of Medicines Database. A joinpoint regression analysis was performed to identify the years where the trends in incidence rates of hip and distal femoral fractures changed significantly; the average annual percentage change for the period of observation was estimated. Hospitalizations for femoral fractures were 991,059, of which 91.4% were hip fractures and 76.5% occurred in women. Age-standardized hip fractures rate per 100,000 person-years decreased both in women (-8.7%; from 789.9 in 2007 to 721.5 in 2017) and in men (-4.3%; from 423.9 to 405.6), while the rate of distal femoral fractures increased by 23.9% in women (from 67.78 to 83.95) and 22.7% in men (from 27.76 to 34.06). These changes were associated with an increment in the use of anti-osteoporosis drugs from 2007 to 2011 (from 9.1 to 12.4 DDD/1000 inhabitants/day), followed by a plateau in the period 2012-2017. The use of bisphosphonates increased progressively from 2007 to 2010 (from 8.2 to 10.5 DDD/1000 inhabitants/day), followed by a plateau and then decreased from 2015 onwards. The decreasing trend of hip fractures could be related to a major intake of anti-osteoporosis medications while the increment of distal femoral fractures might be due to population aging and to the use of bisphosphonates and denosumab. Further research is needed to identify and implement interventions to prevent hip and distal femoral fractures.
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http://dx.doi.org/10.1016/j.bone.2020.115752DOI Listing
January 2021

Renin-Angiotensin-Aldosterone System Inhibitors and Risk of Death in Patients Hospitalised with COVID-19: A Retrospective Italian Cohort Study of 43,000 Patients.

Drug Saf 2020 12;43(12):1297-1308

Pharmacoepidemiology Unit, National Centre for Drug Research and Evaluation, Istituto Superiore di Sanità, Viale Regina Elena 299, 00161, Rome, Italy.

Introduction: The epidemic due to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection has been spreading globally, raising increasing concerns. There are several controversial hypotheses on the potentially harmful or beneficial effects of antihypertensive drugs acting on the renin-angiotensin-aldosterone system (RAAS) in coronavirus disease 2019 (COVID-19). Furthermore, there is accumulating evidence, based on several observational studies, that angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) do not increase the risk of contracting SARS-CoV-2 infection. On the other hand, conflicting findings regarding the role of ACEIs/ARBs as prognosis modifiers in COVID-19 hospitalised patients have been reported.

Objective: The aim of this large-scale, retrospective cohort study was to investigate whether prior exposure to ACEIs and/or ARBs was associated with all-cause mortality among over 40,000 hospitalised COVID-19 patients compared with calcium channel blockers (CCBs), a potential therapeutic alternative.

Methods: This study was conducted using COVID-19 registries linked to claims databases from Lombardy, Veneto and Reggio Emilia (overall, 25% of Italian population). Overall, 42,926 patients hospitalised between 21 February and 21 April 2020 with a diagnosis of COVID-19 confirmed by real-time polymerase chain reaction tests were included in this study. All-cause mortality occurring in or out of hospital, as reported in the COVID-19 registry, was estimated. Using Cox models, adjusted hazard ratios (HRs) of all-cause mortality (along with 95% confidence intervals [CIs]) were estimated separately for ACEIs/ARBs and other antihypertensives versus CCBs and non-use.

Results: Overall, 11,205 in- and out-of-hospital deaths occurred over a median of 24 days of follow-up after hospital admission due to COVID-19. Compared with CCBs, adjusted analyses showed no difference in the risk of death among ACEI (HR 0.97, 95% CI 0.89-1.06) or ARB (HR 0.98, 95% CI 0.89-1.06) users. When non-use of antihypertensives was considered as a comparator, a modest statistically significant increase in mortality risk was observed for any antihypertensive use. However, when restricting to drugs with antihypertensive indications only, these marginal increases disappeared. Sensitivity and subgroup analyses confirmed our main findings.

Conclusions: ACEI/ARB use is not associated with either an increased or decreased risk of all-cause mortality, compared with CCB use, in the largest cohort of hospitalised COVID-19 patients exposed to these drugs studied to date. The use of these drugs therefore does not affect the prognosis of COVID-19. This finding strengthens recommendations of international regulatory agencies about not withdrawing/switching ACEI/ARB treatments to modify COVID-19 prognosis.
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http://dx.doi.org/10.1007/s40264-020-00994-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7450482PMC
December 2020

Monitoring the community use of antibiotics in Italy within the National Action Plan on antimicrobial resistance.

Br J Clin Pharmacol 2021 03 7;87(3):1033-1042. Epub 2020 Sep 7.

Agenzia Sanitaria e Sociale Regionale Emilia-Romagna, Bologna, Italy.

Background: In Italy both the consumption of antibiotics and the prevalence of bacterial resistance are higher than in other European countries. In 2017, the first National Action Plan on Antimicrobial Resistance (PNCAR) was adopted in Italy. In response to the PNCAR two national reports on antibiotic use in the human setting have been published. This article's aim is to describe the pattern of antibiotic consumption in the community setting in Italy from 2013 to 2018.

Methods: To analyse the consumption for reimbursed antibiotics dispensed by community pharmacies different data sources were used. Consumption was measured in terms of defined daily dose (DDD), prescriptions or prevalence of use.

Results: In 2018, the consumption of antibiotics in Italy amounted to 16.1 DDD per 1000 inhabitants per day. The rates of consumption by geographical area were: 12.7 DDD in the north, 16.9 in the centre and 20.4 in the south. The use was greater in the extreme age groups than in the population aged from 20 to 64 years. The consumption was higher in winter season, with high peaks in the incidence of flu syndromes. In the paediatric population, a utilization rate of 1010 prescriptions per 1000 children, with a prevalence of use of 40.8%, was found.

Conclusion: The study provides useful information on the geographical variability of antibiotic use in Italy to guide decision makers in the introduction of tailored interventions, as suggested by PNCAR, aimed at promoting a more rational use of antibiotics for humans and reducing antimicrobial resistance.
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http://dx.doi.org/10.1111/bcp.14461DOI Listing
March 2021

Broad Spectrum project: factors determining the quality of antibiotic use in primary care: an observational study protocol from Italy.

BMJ Open 2020 07 6;10(7):e038843. Epub 2020 Jul 6.

National Centre for Pre-Clinical and Clinical Drug Research and Surveillance (CNRVF), Istituto Superiore di Sanita, Rome, Italy.

Introduction: The overuse of antibiotics is causing worldwide spread of antimicrobial resistance (AMR). Compared with other countries, Italy has both high antibiotic consumption rates and high rates of AMR. Due to the fact that around 90% of antibiotics are prescribed by general practitioners (GPs), this study aims to measure the impact of knowledge, attitudes and sociodemographic and workplace-related factors on the quality of antibiotic prescriptions filled by GPs in the Italian Region of Sardinia.

Methods And Analysis: Knowledge, attitude, sociodemographic and workplace-related factors deemed to influence physicians prescribing behaviour will be evaluated in a cross-sectional study conducted among all GPs of the Italian Region of Sardinia (n=1200). A knowledge and attitudes questionnaire (Knowledge and Attitudes on Antibiotics and Resistance - Italian version: ITA-KAAR) accompanied by a sociodemographic form will be linked to drug prescription data reimbursed by the National Health System. European Surveillance of Antibiotic Consumption quality indicators for outpatient antibiotic use will be calculated from drug prescription records. Every GP will be deemed to have demonstrated an adequate quality of prescriptions of antibiotics if half of the indicator score plus one is better than the median of the region. A multivariate Poisson regression model with robust variance estimation will be used to evaluate the impact of the determinants of antibiotic prescriptions on the actual prescribing quality of each physician.

Ethics And Dissemination: The project has been approved by the ethics committee of the Regional Health Trust of Sardinia (176/2019/CE, 24 September 2019). The results will be useful to inform evidence-based interventions to tackle irrational antibiotic use in the community.
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http://dx.doi.org/10.1136/bmjopen-2020-038843DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7342852PMC
July 2020

[Vitamin D and coronavirus: a new field of use?]

Recenti Prog Med 2020 Apr;111(4):253-256

Agenzia Italiana del Farmaco (AIFA), Roma.

Given the succession of communications in scientific and popular circuits, tending to take for granted a role for vitamin D in the control of the coronavirus pandemic, the authors conducted an analysis of the literature currently available in order to recognize what is supported by opinions personal and what evidence of effectiveness. At the end of the bibliographic survey there is the current absence of evidence of efficacy in favor of vitamin D in the treatment of coronavirus infection in its various expressions. The diffusion of personal opinions as if they were evidence can be a disturbing factor for adequate assistance and for correct research.
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http://dx.doi.org/10.1701/3347.33188DOI Listing
April 2020

[Prescribing appropriateness, use and consumption of antibiotics in Italy. An extract from the National Report 2018.]

Recenti Prog Med 2020 Jan;111(1):13-29

Ufficio Monitoraggio della Spesa Farmaceutica e Rapporti con le Regioni, Agenzia Italiana del Farmaco.

Introduction: Antimicrobial resistance is a major global public health concern. In Italy, in 2017, the National Plan to Fight Antimicrobial Resistance (PNCAR 2017-2020) was approved, in line with the Global One Health Action Plan. Despite the decreasing trend, the consumption of antibiotics in Italy continues to be higher than the European average, with a great variability between regions. In the European investigation on the distribution of resistant bacteria in Europe, Italy holds together with Greece the record for the spread of resistant germs.

Objective: The present study, dedicated to antibiotics for human use, allows to monitor the trend of consumption and expenditure in Italy and at the same time to identify areas of potential inappropriateness of use.

Methods: The analyses presented concern the use of antibiotics in the community setting, with a focus on consumption in the paediatric population and on the prescription of fluoroquinolones in specific population subgroups. In addition, the analysis on the use of antibiotics in hospital settings, the analysis on the private purchase of reimbursed antibiotics and the evaluation of indicators of appropriateness of antibiotic prescribing were also included. The analyses are based on the reading and integration of the data collected through different administrative healthcare databases: OsMed, Purchase by public health facilities, Direct distribution, Hospital consumption, Monitoring of pharmaceutical prescriptions, Private purchase by citizens, Hospital Discharge Records (Schede di Dimissione Ospedaliera, SDO), InfluNet surveillance.

Results: The consumption of antibiotics in Italy in 2018 stood at 21.4 DDD/1000 ab. die and, despite the downward trend, is still above the European average. In terms of consumption within the territory (community setting), there is a considerable regional variety - ranging from 8.9 of the provincial government of Bolzano to 23.4 DDD/1000 ab. die of Campania (national average 16.1 DDD) - with higher values in the South and the Islands and lower in the North. The differences in drug use concern not only the number of prescriptions but also the type of antibiotics prescribed (type of molecules; broad spectrum vs. narrow spectrum). The association amoxicillin/clavulanic acid is the most widely used antibiotic both in the community and in hospitals. In the paediatric population (0-13 years) there is a peak prevalence of use of 50% in the first year of life of the child, with no differences between males and females. The consumption of antibiotics in hospitals is increasing in the three-year period 2016-2018 and presents a wide variability between different geographical areas.
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http://dx.doi.org/10.1701/3294.32650DOI Listing
January 2020

Anticancer drug prices and clinical outcomes: a cross-sectional study in Italy.

BMJ Open 2019 12 10;9(12):e033728. Epub 2019 Dec 10.

Department of Epidemiology of the Regional Health Service Lazio, Rome, Italy

Objective: To investigate whether the prices of new anticancer drugs correlated with their relative benefit despite negotiation.

Design: Retrospective cross-sectional study correlating new anticancer drugs prices with clinical outcomes.

Setting: We did a retrospective cross-sectional study including all new anticancer drugs approved by the European Medicines Agency (EMA) (2010-2016) and reimbursed in Italy.

Main Outcomes And Measures: Information on clinical outcomes-in terms of median overall survival (OS), median progression-free survival (PFS) and objective response rate (ORR)-was extracted from pivotal trials as reported in the European Public Assessment Reports available on the EMA website. Cost of a full course treatment was estimated on negotiated official and discounted prices. Regression coefficients β, their levels of significance p and the coefficients of determination R were estimated adjusting by tumour type.

Results: Overall, 30 new anticancer drugs (with 35 indications) were available for analysis. Where data on OS were available, we observed no correlation between the improvement in median OS (in weeks) and negotiated price (R=0.067, n=16 drugs for 17 indications). When the clinical outcomes were expressed as improvements in the median PFS or ORR, 25 drugs (29 indications) were available for the analysis, and again, there was no correlation with prices (R=0.004 and 0.006, respectively).

Conclusions And Relevance: Our results suggest that the prices of anticancer drugs in Italy do not reflect their therapeutic benefit. Drug price negotiations, which is mandatory by law in Italy, do not seem to ensure that prices correlate with clinical benefits provided by the cancer drugs. These results call for further efforts to establish the standard determinants of drug prices available at the time of negotiation. These findings need to be confirmed in other countries where price negotiations are in place. Moreover, further investigations may verify whether outcome data obtained after drug marketing would improve the correlation between prices and therapeutic benefit.
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http://dx.doi.org/10.1136/bmjopen-2019-033728DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6924817PMC
December 2019

Adverse events following cannabis for medical use in Tuscany: An analysis of the Italian Phytovigilance database.

Br J Clin Pharmacol 2020 01 3;86(1):106-120. Epub 2020 Jan 3.

Department of Neurosciences, Psychology, Drug Research and Child Health, Section of Pharmacology and Toxicology, University of Florence, Florence, Italy.

Aims: Despite a significant increase in using cannabis for medical purposes, current evidence on its safety in real-world clinical practice is still poorly characterised. By a case-by-case analysis of spontaneous reports of suspected adverse events (AEs) collected in Tuscany within the Italian Phytovigilance database, the aim of the present study was to describe AEs occurred in patients exposed to medical cannabis.

Methods: We evaluated all reports of cannabis-related suspected AEs collected within the Phytovigilance database up to December 2018. Information regarding cannabis therapy, patient's demographic and clinical characteristics, concomitant medications, AE description according to the Medical Dictionary for Regulatory Activities (MedDRA) classification, AE seriousness and AE outcome, were collected. The causality assessment was performed following World Health Organisation-Uppsala Monitoring Centre criteria.

Results: Fifty-three cannabis-related AE reports were analysed. The majority of patients were females (77.3%), with a mean age of 61.9 years. Thirty-nine (73.6%) cases were defined as nonserious and the majority of them (86.9%) showed a complete resolution or improvement. Forty-six (86.8%) cases were judged as probably related to cannabis consumption. The most frequently reported system organ class was psychiatric and nervous system disorders, and a potential drug-drug interaction was present in 16 cases.

Conclusion: Cannabis was generally well tolerated and the majority of AEs were mild and transient. Our analysis highlighted important safety issues for clinical practice, in particular the need for an accurate prescription monitoring during the titration phase, particularly in the presence of concomitant medications.
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http://dx.doi.org/10.1111/bcp.14140DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6983517PMC
January 2020

Suspected adverse reactions associated with herbal products used for weight loss: spontaneous reports from the Italian Phytovigilance System.

Eur J Clin Pharmacol 2019 Nov 19;75(11):1599-1615. Epub 2019 Aug 19.

Centre for Drug Research and Evaluation, National Institute of Health, Viale Regina Elena 299, 00161, Rome, Italy.

Purpose: Overweight and obesity represent worldwide a rising health problem. In this context, dietary supplements and herbal preparations are often used as self-medication for weight loss. The aim of this study was to describe the safety profile of dietary supplements for weight control by analyzing spontaneous reports of suspected adverse reactions (ARs) received by the Italian Phytovigilance System, from July 2010 to October 2017.

Methods: The suspected ARs were collected using an ad hoc reporting form, registered in a database at the National Institute of Health and evaluated by a multidisciplinary group of experts. The causality assessment was performed using the WHO-UMC system or the CIOMS/RUCAM score. In case of serious adverse reactions, a feedback is provided to the reporter by e-mail.

Results: Sixty-six spontaneous reports were collected. ARs involved cardiovascular system (26%), liver (14%), central nervous system (12%), skin (9%), gastrointestinal system (17%), thyroid (8%), kidney (4%), and other organs/systems (10%). In 64% of cases, the reaction was serious. Dechallenge was positive in 46 cases; three cases of positive rechallenge were reported. After the causality assessment, the association between the product intake and the adverse reaction was judged as possible in the majority of the cases (n = 43; 65%).

Conclusions: The data collected confirmed the existence of safety concerns on herbal dietary supplements used for body weight control, mainly related to quality of products and their use as self-medication. In this scenario, spontaneous reports represent the only tools available to monitor safety of these products.
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http://dx.doi.org/10.1007/s00228-019-02746-6DOI Listing
November 2019

Comparative Effectiveness of Two Tiotropium Formulations: A Retrospective Cohort Study.

COPD 2018 10;15(5):418-423

a Pharmacoepidemiology Unit, National Center for Drug Research and Evaluation , National Institute of Health (ISS) , Rome , Italy.

The effectiveness of the tiotropium Respimat formulation in routine clinical practice is still an open issue due to concern about the generalizability of the Tiotropium Safety and Performance in Respimat (TIOSPIR) trial findings. Our aim was to compare the incidence of acute respiratory events between new users of tiotropium Respimat and HandiHaler. The study population comprised patients aged ≥45 years resident in two Italian regions who received a first tiotropium prescription (HandiHaler or Respimat) between 1 July 2011 and 30 November 2013. The cohort was identified within the database of drug prescriptions reimbursed by the Italian National Health Service. Clinical outcomes were obtained from hospital records. The primary outcome was the first hospitalization for respiratory events, including chronic obstructive pulmonary disease (COPD) exacerbation, respiratory failure, hypoxemia/hyperventilation and pneumonia, during the exposure period. The hazard ratios were estimated for the propensity score matched groups with Cox regression. After matching, 31,334 patients with incident tiotropium prescriptions were included. Similar incidence rates of the primary outcome between the Respimat and HandiHaler users were identified (adjusted hazard ratio 0.95, 95% CI 0.84-1.07). No differences emerged in the subgroup analyses conducted according to the baseline characteristics of the tiotropium users. This study confirms the findings observed in the TIOSPIR trial in a more heterogeneous population that included patient subgroups with severe respiratory disease and unstable COPD.
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http://dx.doi.org/10.1080/15412555.2018.1554032DOI Listing
October 2018

Patterns and trends of utilization of incretin-based medicines between 2008 and 2014 in three Italian geographic areas.

BMC Endocr Disord 2019 Feb 7;19(1):18. Epub 2019 Feb 7.

Epidemiology Unit, Agenzia regionale di sanità della Toscana, Florence, Italy.

Background: The incretin-based medicines GLP1 analogues (GLP1a) and dipeptidyl peptidase-4 inhibitors (DPP4i) are hypoglycaemic agents licensed for the treatment of type 2 diabetes mellitus (T2DM). Although these drugs possess comparable efficacy and low risk of hypoglycaemia, differences in terms of route of administration (subcutaneous versus oral), effect on body weight and gastrointestinal tolerabily can impact their actual use in clinical practice. This study aimed to describe the real-world utilization of incretin-based medicines in the Italian clinical practice.

Methods: A multi-database, population-based, descriptive, cohort study was performed using administrative data collected between 2008 and 2014 from three Italian geographic areas. Subjects aged ≥18 were selected. New users were defined as those with ≥1 dispensing of GLP1a or DPP4i during the year of interest and none in the past. Trends of cumulative annual incidence of use in the general adult population were observed. New users of GLP1a or DPP4i were respectively described in terms of demographic characteristics and use of antidiabetic drugs during 1 year before and after the first incretin dispensing.

Results: The overall study population included 4,943,952 subjects. A total of 7357 new users of GLP1a and 41,907 of DPP4i were identified during the study period. Incidence of use increased between 2008 (0.2‰ for both GLP1a and DPP4i) and 2011 (GLP1a = 0.6‰; DPP4i = 2.5‰) and slightly decreased thereafter. In 2014, 61% of new GLP1a users received once-daily liraglutide while 52% of new DPP4i users received metformin/DPP4i in fixed-dose. The percentage of new DPP4i users older than 65 years of age increased from 30.9 to 62.6% during the study period. Around 12% of new users had not received any antidiabetic before starting an incretin.

Conclusions: During the study period, DPP4i rapidly became the most prescribed incretin-based medicine, particularly among older new user. The choice of the specific incretin-based medicine at first prescription appeared to be directed towards those with higher convenience of use (e.g. oral DPP4i rather than subcutaneous GLP1a, once-daily liraglutide rather than twice-daily exenatide). The non-negligibile use of incretin-based medicines as first-line pharmacotherapy for T2DM warrants further effectiveness and safety evaluations to better define their place in therapy.
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http://dx.doi.org/10.1186/s12902-019-0334-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6367760PMC
February 2019

Cardiovascular safety of tiotropium Respimat vs HandiHaler in the routine clinical practice: A population-based cohort study.

PLoS One 2017 21;12(4):e0176276. Epub 2017 Apr 21.

Pharmacoepidemiology Unit, National Centre for Epidemiology, National Institute of Health, Rome, Italy.

The cardiovascular safety of tiotropium Respimat formulation in the routine clinical practice is still an open issue. Our aim was to compare the risk of acute myocardial infarction and heart rhythm disorders in incident users of either tiotropium Respimat or HandiHaler. The study population comprises patients aged ≥45 years, resident in two Italian regions with a first prescription of tiotropium (HandiHaler or Respimat) between 01/07/2011-30/11/2013. The cohort was identified through the database of prescriptions reimbursed by the Italian National Health Service. Comorbidities and clinical outcomes were obtained from hospital records. The primary outcome was the first hospitalization for acute myocardial infarction and/or for heart rhythm disorders during the exposure period. Hazard ratios were estimated in the propensity score-matched groups through Cox regression. After matching, 31,334 patients with incident prescription of tiotropium were included. The two groups were balanced with regard to baseline characteristics. Similar incidence rates of the primary outcome between Respimat and HandiHaler users were identified (adjusted hazard ratio 1.02, 95% CI 0.82-1.28). No risk difference between Respimat and HandiHaler emerged when considering clinical events separately. This large cohort study showed a comparable acute cardiovascular safety profile of the two tiotropium formulations.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0176276PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5400270PMC
September 2017

Adverse reactions to dietary supplements containing red yeast rice: assessment of cases from the Italian surveillance system.

Br J Clin Pharmacol 2017 04 19;83(4):894-908. Epub 2017 Jan 19.

Centre for Epidemiology, National Institute of Health, Viale Regina Elena 299, 00161, Rome, Italy.

Aims: Red yeast rice (RYR) is contained in dietary supplements for patients with dyslipidemia. RYR supplements contain monacolin K, which is chemically identical to lovastatin, a licensed drug with a well-known risk profile. We aim to describe the safety profile of RYR by analysing spontaneous reports of suspected adverse reactions (ARs).

Methods: Within the Italian Surveillance System of Natural Health Products, suspected ARs were collected and evaluated by a multidisciplinary group of experts to assess causality using the WHO-UMC system or the CIOMS/RUCAM score, for hepatic reactions. The public version of the WHO-Vigibase was also queried.

Results: From April 2002 to September 2015, out of 1261 total reports, 52 reports concerning 55 ARs to RYR dietary supplements were collected. ARs consisted in myalgia and/or increase in creatine phosphokinase (19), rhabdomyolysis (1), liver injury (10), gastrointestinal reactions (12), cutaneous reactions (9) and other reactions (4). Women were involved in 70% of cases. In 13 cases, the reaction required hospitalization, and 28 patients were taking other medications. Dechallenge was positive in 40 reactions (73%), rechallenge was positive in 7. Causality resulted as certain (1), probable (31, 56%), possible (18, 34%), unlikely (3) or unassessable (2). Similar distribution emerged from the WHO-Vigibase.

Conclusions: The potential safety signals of myopathies and liver injury raise the hypothesis that the safety profile of RYR is similar to that of statins. Continuous monitoring of dietary supplements should be promoted to finally characterize their risk profile, thus supporting regulatory bodies for appropriate actions.
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http://dx.doi.org/10.1111/bcp.13171DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5346868PMC
April 2017

The way forward in Italy for iodine.

Minerva Med 2017 Apr 12;108(2):159-168. Epub 2017 Jan 12.

Endocrinology Unit, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.

Italy is dealing with iodine deficiency since ancient times. In 1848 an ad hoc committee appointed by the king of Sardinia, identified extensive areas afflicted by endemic goiter and endemic cretinism in Piedmont, Liguria and Sardinia. Since then many epidemiological studies have been conducted in our country. These showed that iodine deficiency was present not only in mountain areas but also in coastal areas. In 1972 the iodization of salt at 15 mg/kg was allowed by law and iodized salt was distributed on request to selected endemic areas. Five years later the distribution was extended to the whole country. However the sale of iodized salt was not mandatory at that time and only a small fraction of the Italian population started using iodized salt. In 1991 the content of iodine in the salt was raised to 30 mg/kg and in 2005 a nationwide salt iodization program was finally implemented. Some years later a nationwide monitoring program of iodine prophylaxis was also implemented. Since 2005 the sale of iodized salt in Italian supermarkets has increased (34% in 2006, 55% in 2012), although it has been observed that the use of iodized salt is still low in the communal eating areas and in the food industry. These data are coherent with recent epidemiological studies showing that some regions in our country are still characterized by mild iodine deficiency and a high frequency of goiter and other iodine deficiency disorders. This implies that further efforts should be made to successfully correct iodine deficiency in Italy.
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http://dx.doi.org/10.23736/S0026-4806.17.04877-7DOI Listing
April 2017

Intussusception hospitalizations incidence in the pediatric population in Italy: a nationwide cross-sectional study.

Ital J Pediatr 2016 Sep 27;42(1):89. Epub 2016 Sep 27.

National Centre for Epidemiology, Surveillance and Health Promotion, Italian National Institute of Health, Viale Regina Elena 299, Rome, 00161, Italy.

Background: Study to investigate the intussusception incidence background in the pediatric population and its temporal trend in Italy.

Methods: A cross-sectional study was conducted on the pediatric population aged 0 to 15 years, in the period 1 January 2002 to 31 December 2012. Intussusception cases were identified using the national hospital discharge database. The annual intussusception incidence, the incidence rate ratios (IRRs) and the related 95 % confidence Intervals (CI) were calculated.

Results: The overall intussusception incidence rate was 21 per 100,000 children aged ≤15 years, and was higher among boys than girls. The highest intussusception incidence rate occurred in infants <1 year of age (39 per 100,000 infants). Among infants, incidence varied with the geographical area, with higher rates in the central Italy (50 per 100,000 infants). The annual incidence rates in infants were stable since 2004 and up to 2012, ranging from 40.1 and 33.0 per 100,000 infants. Similar stable patterns were observed when conducting the analysis on children over 1 year of age.

Conclusions: This study provided the intussusception incidence background in Italy in different pediatric ages, including infants, over an 11-year period. This information is essential in post-marketing safety surveillance, to continuously monitor the benefit/risk profile of rotavirus vaccinations.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5039877PMC
http://dx.doi.org/10.1186/s13052-016-0298-8DOI Listing
September 2016

Henoch-Schönlein purpura and drug and vaccine use in childhood: a case-control study.

Ital J Pediatr 2016 Jun 18;42(1):60. Epub 2016 Jun 18.

National Center for Epidemiology, Surveillance and Health Promotion, National Institute of Health, Viale Regina Elena, 299 - 00161, Rome, Italy.

Background: Henoch-Schönlein purpura (HSP) is the most common vasculitis in childhood; nevertheless, its etiology and pathogenesis remain unknown despite the fact that a variety of factors, mainly infectious agents, drugs and vaccines have been suggested as triggers for the disease. The aim of this study was to estimate the association of HSP with drug and vaccine administration in a pediatric population.

Methods: An active surveillance on drug and vaccine safety in children is ongoing in 11 clinical centers in Italy. All children hospitalized through the local Paediatric Emergency Department for selected acute clinical conditions of interest were enrolled in the study. Data on drug and vaccine use in children before the onset of symptoms leading to hospitalization were collected by parents interview. A case-control design was applied for risk estimates: exposure in children with HSP, included as cases, was compared with similar exposure in children with gastroduodenal lesions, enrolled as controls. HSP cases were validated according to EULAR/PRINTO/PRES criteria. Validation was conducted retrieving data from individual patient clinical record.

Results: During the study period (November 1999-April 2013), 288 cases and 617 controls were included. No increased risk of HSP was estimated for any drug. Among vaccines, measles-mumps-rubella (MMR) vaccine showed an increased risk of HSP (OR 3.4; 95 % CI 1.2-10.0).

Conclusions: This study provides further evidence on the possible role of MMR vaccine in HSP occurrence.
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http://dx.doi.org/10.1186/s13052-016-0267-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4912703PMC
June 2016

How did the Introduction of Biosimilar Filgrastim Influence the Prescribing Pattern of Granulocyte Colony-Stimulating Factors? Results from a Multicentre, Population-Based Study, from Five Italian Centres in the Years 2009-2014.

BioDrugs 2016 Aug;30(4):295-306

Department of Biomedical and Dental Sciences and Morphofunctional Imaging, University of Messina, Via Consolare Valeria, 98125, Messina, Italy.

Background: Granulocyte colony-stimulating factors (G-CSFs) are biological products for which the main indication of use is chemotherapy-induced neutropenia. Biosimilars of G-CSFs have been available in Europe since 2007.

Objective: The objective of this study was to investigate the prescribing pattern of G-CSFs in five Italian centres using different healthcare policy interventions to promote the use of biosimilars in routine care.

Methods: This retrospective, population-based drug utilization study was conducted during the years 2009-2014 using the administrative databases of the Caserta, Treviso and Palermo Local Health Units (LHUs) and the Tuscany and Umbria regions. G-CSF users were characterized and the prevalence of use, proportion of biosimilar users and switching pattern of different G-CSFs were evaluated over time and across centres.

Results: Overall, 30,247 patients were treated with G-CSFs in the years 2009-2014, of which 29,083 (96.2 %) were naïve users. The overall prevalence of G-CSF use increased from 0.8 per 1000 inhabitants in 2009 to 1.1 per 1000 in 2014. An increase in the proportion of the use of the biosimilar filgrastim by the total G-CSF users was observed in all centres: from 0.2 % (2009) to 66.2 % (2014). However, heterogeneity across different centres was reported, with the largest increase in Treviso LHU (from 0 to 89.1 % from 2009 to 2014). During the first year of treatment, switching between different G-CSFs was frequent (20.3 %).

Conclusions: Heterogeneity in the use of G-CSF and, in particular, biosimilar filgrastim across different Italian centres was observed, probably due to different regional healthcare policy interventions. During the first year of treatment, switching between different G-CSFs was frequent. Considering the impact of biological drugs on pharmaceutical expenses, it is necessary to harmonize healthcare policies promoting the use of biological drugs with the lowest cost.
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http://dx.doi.org/10.1007/s40259-016-0175-4DOI Listing
August 2016

Switching Between Epoetins: A Practice in Support of Biosimilar Use.

BioDrugs 2016 Feb;30(1):27-32

Pharmacoepidemiology Unit, National Centre for Epidemiology, National Institute of Health, Viale Regina Elena 299, 00161, Rome, Italy.

Background: The acceptability of switching between reference drugs and their biosimilars is often disputed. It is unclear whether this concern is specific to the use of biosimilars or is relevant to the practice of switching between any biological drugs.

Objective: The objective of this study was to quantify the occurrence of switching between different erythropoiesis-stimulating agents.

Methods: A retrospective drug utilization study was conducted in the Umbria region (Italy). The study population included all residents who received their first epoetin prescription between 1 July 2011 and 31 December 2014. The Umbria drug prescription database and the regional archive of residents were used to gather information. Switching was defined as any transition between different epoetins (different substances and/or different products of the same substance) in a series of two prescriptions. The probability of switching was described in relationship to the duration of treatment in a survival analysis.

Results: Overall, 3258 subjects received prescriptions of epoetins. Among the 2896 patients with at least two prescriptions, 354 (12.2%) experienced one or more switches. The probability of switching depended on the duration of treatment: approximately 15% of users switched within 12 months of observation and 25% switched within 2 years. Switching was not limited to reference and biosimilar epoetins and it affected patent and off-patent epoetins equally.

Conclusions: Switching between different epoetins was related to the duration of use and most episodes of switching involved epoetins that have never been contrasted in a comparability exercise. The present level of switching may provide reassurance to physicians when taken together with other sources of comparative evidence.
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http://dx.doi.org/10.1007/s40259-015-0155-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4746226PMC
February 2016

Antihypertensive drug use during pregnancy: a population based study.

Ann Ist Super Sanita 2015 ;51(3):236-43

Reparto di Farmacoepidemiologia, Centro Nazionale di Epidemiologia, Sorveglianza e Promozione della Salute, Istituto Superiore di Sanità, Rome, Italy.

Purpose: The study aimed at assessing if the European guideline on the use of antihypertensive drugs (AD) in pregnancy are followed in clinical practice. We also evaluated the association between the use of non-recommended drugs and individual characteristics.

Methods: This study analyzed a cohort of 86 171 singleton deliveries occurring between 2009-2010 in the Lombardy region, Italy. Women with first prescription of AD during pregnancy were considered as incident users. Methyldopa, labetalol and nifedipine were considered as "recommended drugs"; all other AD were considered as "non-recommended". Odds Ratio and 95% confidence intervals were estimated.

Results: Among the 1009 patients (1.2%) exposed to AD during pregnancy, 675 (66.9%) were incident users. Among the incident users, 31% received non-recommended drugs; this proportion decreased to 18% among women who started treatment in the third trimester. Women with at least four concomitant diseases had an elevated risk of receiving non-recommended drugs in pregnancy (OR 2.68; 95% CI 1.10-6.73).

Conclusions: Exposure to recommended antihypertensives increased during pregnancy. Nevertheless, a fraction of users that continued or began treatment with non-recommended medications was still present.
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http://dx.doi.org/10.4415/ANN_15_03_12DOI Listing
January 2017

Risk factors influencing the prescription of tiotropium Respimat formulation: a population-based cohort study.

BMJ Open 2015 May 25;5(5):e006619. Epub 2015 May 25.

Pharmacoepidemiology Unit, National Centre for Epidemiology, Italian National Institute of Health, Rome, Italy.

Objectives: The study aims at investigating the influence of several factors on the probability of receiving one of the two tiotropium formulations (Respimat or Handihaler).

Design: Drug utilisation study.

Setting: All residents in the Region Umbria, Italy, aged ≥45 years, who received prescriptions of tiotropium during 2011-2012.

Participants: Two groups of patients were studied: (1) incident users of the two tiotropium formulations (ie, without tiotropium prescriptions in the previous 6 months); (2) switchers from Handihaler to Respimat. Users of the two formulations were compared with regard to baseline characteristics and medical history. The adjusted OR of receiving Respimat was estimated for several factors.

Results: Incident users of the two formulations (4390 participants) had similar characteristics. They were older and with more comorbidities than patients included in randomised control trials (RCTs). Among prevalent users of Handihaler, the probability of switching to Respimat was greater in patients with severe respiratory disease (users of ≥4 respiratory drugs: adjusted OR=4.62; 95% CI 2.46 to 8.69) and among β-blocker users (adjusted OR=1.76; 95% CI 1.13 to 2.75). Age above 75 years and lipid-lowering drug use reduced the probability of switching. A positive association was also found between neurological conditions and the use of Respimat.

Conclusions: When starting tiotropium treatment, the choice between the two formulations is weakly affected by comorbidities and chronic obstructive pulmonary disease severity. Instead, these characteristics influence the likelihood of switching from Handihaler to Respimat. Since tiotropium users in clinical practice are more severe than those included in RCTs, further aetiological studies are needed to compare the safety profile of the two formulations in routine care.
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http://dx.doi.org/10.1136/bmjopen-2014-006619DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4452750PMC
May 2015

Generic substitution of antidiabetic drugs in the elderly does not affect adherence.

Ann Ist Super Sanita 2014 ;50(4):333-40

Agenzia Italiana del Farmaco, Rome, Italy. E-mail:

Introduction: The possibility that variation in packaging and pill appearance may reduce adherence is a reason for concern, especially for chronic diseases. The objectives of the study were to quantify the extent of switches between generic antidiabetics and to verify whether switching between different products of the same substance affects adherence.

Materials And Methods: All elderly residents of the Umbria Region who received at least 2 prescriptions of antidiabetics in 2010 and 2011 were included in the study. Switching was defined as the dispensing of two different products of the same substance in a series of two prescriptions. Single and multiple switchers were identified according to the number of switches during 2011. Switching relevant to the three off-patent substances with generic use ≥ 5% (metformin, gliclazide and repaglinide) was quantified. The effect of switching on adherence, defined as the proportion of days in 2011 covered by prescriptions (Medication Possession Ratio, MPR), was estimated.

Results: Among the 15 964 patients receiving antidiabetics (14.4% of the elderly population) 9211 were prescribed at least one of the generic substances. Of these patients, 23.3% experienced a single switch and 15.7% were multiple switchers (61.0% never switched). The proportion of multiple switchers increased with the number of prescriptions, reaching 26% among patients with ≥ 11 prescriptions. MPR was 62%, 62% and 72%, respectively among non-switchers, single and multiple switchers.

Conclusions: In elderly patients treated with antidiabetics, the substitution between branded and unbranded products (as well as between generics) of the same substance, did not negatively affect adherence.
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http://dx.doi.org/10.4415/ANN_14_04_07DOI Listing
October 2016

Triptan use in Italy: Insights from administrative databases.

Cephalalgia 2015 Jun 22;35(7):619-26. Epub 2014 Sep 22.

Department of Pharmaceutical Sciences, ''A. Avogadro'' University, Italy

Introduction: In this drug utilization study, we aimed at assessing the pattern of triptan use in Italy by means of the drug prescription databases of two local health authorities, accounting for approximately 1 million citizens.

Methods: The study population included all residents aged 18 to 84 years in the Vercelli province (about 175,000 inhabitants) and in the Umbria region (about 885,000 inhabitants), who had at least one dispensation for triptans in 2012. A frequent user, who might be at risk of medication-overuse headache (MOH), was defined as a patient being dispensed at least 10 defined daily doses (DDD) of triptans every month for at least three consecutive months.

Results: Triptans were used by 0.7%-1% of the population. While most patients were dispensed fewer than 60 DDDs per year, about 10% of all triptan users were classified as frequent users. In both areas, patients below the age of 29 were less likely to be frequent users while the 40- to 49-year-old population was the most affected, with no sex difference. About two-thirds of frequent users persisted in this behavior for an additional three-month period in the following six months.

Conclusions: Our data indicate that approximately 10% of all triptan users in the Italian population are potentially at risk for MOH. An approach based on drug prescription databases could be useful to identify patients at risk for MOH.
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http://dx.doi.org/10.1177/0333102414550419DOI Listing
June 2015

Vaccine effectiveness against severe laboratory-confirmed influenza in children: results of two consecutive seasons in Italy.

Vaccine 2014 Jul 21;32(35):4466-4470. Epub 2014 Jun 21.

Anna Meyer Children's University Hospital, Firenze, Italy.

Objective: To evaluate the effectiveness of seasonal influenza vaccine in preventing Emergency Department (ED) visits and hospitalisations for influenza like illness (ILI) in children.

Methods: We conducted a test negative case-control study during the 2011-2012 and 2012-2013 influenza seasons. Eleven paediatric hospital/wards in seven Italian regions participated in the study. Consecutive children visiting the ED with an ILI, as diagnosed by the doctor according to the European Centre for Disease Control case definition, were eligible for the study. Data were collected from trained pharmacists/physicians by interviewing parents during the ED visit (or hospital admission) of their children. An influenza microbiological test (RT-PCR) was carried out in all children.

Results: Seven-hundred and four children, from 6 months to 16 years of age, were enrolled: 262 children tested positive for one of the influenza viruses (cases) and 442 tested negative (controls). Cases were older than controls (median age 46 vs. 29 months), though with a similar prevalence of chronic conditions. Only 25 children (4%) were vaccinated in the study period. The overall age-adjusted vaccine effectiveness (VE) was 38% (95% confidence interval -52% to 75%). A higher VE was estimated for hospitalised children (53%; 95% confidence interval -45% to 85%).

Discussion: This study supports the effectiveness of the seasonal influenza vaccine in preventing visits to the EDs and hospitalisations for ILI in children, although the estimates were not statistically significant and with wide confidence intervals. Future systematic reviews of available data will provide more robust evidence for recommending influenza vaccination in children.
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http://dx.doi.org/10.1016/j.vaccine.2014.06.048DOI Listing
July 2014

Evaluation of safety of A/H1N1 pandemic vaccination during pregnancy: cohort study.

BMJ 2014 May 29;348:g3361. Epub 2014 May 29.

Pharmacoepidemiology Unit, National Centre for Epidemiology, National Institute of Health, Viale Regina Elena 299, 00161 Rome, Italy

Objective: To assess the risk of maternal, fetal, and neonatal outcomes associated with the administration of an MF59 adjuvanted A/H1N1 vaccine during pregnancy.

Design: Historical cohort study.

Setting: Singleton pregnancies of the resident population of the Lombardy region of Italy.

Participants: All deliveries between 1 October 2009 and 30 September 2010. Data on exposure to A/H1N1 pandemic vaccine, pregnancy, and birth outcomes were retrieved from regional databases. Vaccinated and non-vaccinated women were compared in a propensity score matched analysis to estimate risks of adverse outcomes.

Main Outcome Measures: Main maternal outcomes included type of delivery, admission to intensive care unit, eclampsia, and gestational diabetes; fetal and neonatal outcomes included perinatal deaths, small for gestational age births, and congenital malformations.

Results: Among the 86,171 eligible pregnancies, 6246 women were vaccinated (3615 (57.9%) in the third trimester and 2557 (40.9%) in the second trimester). No difference was observed in terms of spontaneous deliveries (adjusted odds ratio 1.02, 95% confidence interval 0.96 to 1.08) or admissions to intensive care units (0.95, 0.47 to 1.88), whereas a limited increase in the prevalence of gestational diabetes (1.26, 1.04 to 1.53) and eclampsia (1.19, 1.04 to 1.39) was seen in vaccinated women. Rates of fetal and neonatal outcomes were similar in vaccinated and non-vaccinated women. A slight increase in congenital malformations, although not statistically significant, was present in the exposed cohort (1.14, 0.99 to 1.31).

Conclusions: Our findings add relevant information about the safety of the MF59 adjuvanted A/H1N1 vaccine in pregnancy. Residual confounding may partly explain the increased risk of some maternal outcomes. Meta-analysis of published studies should be conducted to further clarify the risk of infrequent outcomes, such as specific congenital malformations.
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http://dx.doi.org/10.1136/bmj.g3361DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4038133PMC
May 2014

The impact of regional co-payment and national reimbursement criteria on statins use in Italy: an interrupted time-series analysis.

BMC Health Serv Res 2014 Jan 6;14. Epub 2014 Jan 6.

Department of Public Health, Catholic University of the Sacred Heart, Rome, Italy.

Background: Statins are among the most commonly prescribed drugs worldwide in the prevention of cardiovascular diseases and their effectiveness is largely acknowledged. The consumption of statins increased four-fold during the 2000-2010 decade in Italy and national and regional control policies were developed. Restrictions to reimbursement were fixed at the national level, whereas co-payment was introduced in some, but not all, regions. The aim of the present study is to assess the impact of such policies on the consumption of statins in Italy between 2001-2007 among outpatients.

Methods: The statin use was measured in terms of defined daily doses per 1,000 inhabitants per day (DDD/1000 inh. day) from May 2001 to December 2007. The study was conducted in 17 out of 21 regions, nine of which had implemented a co-payment policy. Time trends in consumption before and after the introduction of co-payment policies and reimbursement criteria were examined using segmented regression analysis of interrupted time-series, adjusting for seasonal components.

Results: The consumption of statins increased by 22.9 DDD/1000 inh. day in May 2001 to 54.7 DDD/1000 inh. day in December 2007. On average, there was a 1.7% increase in statin use each month before the national guideline changed while the increase was about 0.5% afterwards. The revision of the reimbursement criteria was associated with a significant decrease in level (coefficient = -2.80, 95% CI -3.70 to -1.90 p-value <0.001) and trend (coefficient = -0.33, 95% CI -0.37 to -0.29 p-value <0.001). The introduction of co-payment was associated with a significant change in trend of consumption so that the overall use of the drug increased by 0.04 (95% CI 0.02 to 0.07, p-value < 0.001) DDD/1000 inh. day per month in the post-intervention period, but there was no evidence of a change in level of consumption (p-value = 0.163).

Conclusions: Consumption of statins in Italy increased almost three-fold during the study period. The restriction to reimbursement Interventions was associated with an immediate drop and a decrease in trend of statin use, while the regional copayment was associated with a small increase in trend of statin use.
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http://dx.doi.org/10.1186/1472-6963-14-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3893493PMC
January 2014
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