Publications by authors named "Salvatore De Cosmo"

140 Publications

Preventing microalbuminuria with benazepril, valsartan, and benazepril-valsartan combination therapy in diabetic patients with high-normal albuminuria: A prospective, randomized, open-label, blinded endpoint (PROBE) study.

PLoS Med 2021 Jul 14;18(7):e1003691. Epub 2021 Jul 14.

Department of Renal Medicine, Clinical Research Center for Rare Diseases, "Aldo e Cele Daccò": Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Ranica, Bergamo, Italy.

Background: Angiotensin converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs) prevent microalbuminuria in normoalbuminuric type 2 diabetic patients. We assessed whether combined therapy with the 2 medications may prevent microalbuminuria better than ACE inhibitor or ARB monotherapy.

Methods And Findings: VARIETY was a prospective, randomized, open-label, blinded endpoint (PROBE) trial evaluating whether, at similar blood pressure (BP) control, combined therapy with benazepril (10 mg/day) and valsartan (160 mg/day) would prevent microalbuminuria more effectively than benazepril (20 mg/day) or valsartan (320 mg/day) monotherapy in 612 type 2 diabetic patients with high-normal albuminuria included between July 2007 and April 2013 by the Istituto di Ricerche Farmacologiche Mario Negri IRCCS and 8 diabetology or nephrology units in Italy. Time to progression to microalbuminuria was the primary outcome. Analyses were intention to treat. Baseline characteristics were similar among groups. During a median [interquartile range, IQR] follow-up of 66 [42 to 83] months, 53 patients (27.0%) on combination therapy, 57 (28.1%) on benazepril, and 64 (31.8%) on valsartan reached microalbuminuria. Using an accelerated failure time model, the estimated acceleration factors were 1.410 (95% CI: 0.806 to 2.467, P = 0.229) for benazepril compared to combination therapy, 0.799 (95% CI: 0.422 to 1.514, P = 0.492) for benazepril compared to valsartan, and 1.665 (95% CI: 1.007 to 2.746, P = 0.047) for valsartan compared to combination therapy. Between-group differences in estimated acceleration factors were nonsignificant after adjustment for predefined confounders. BP control was similar across groups. All treatments were safe and tolerated well, with a slight excess of hyperkalemia and hypotension in the combination therapy group. The main study limitation was the lower than expected albuminuria at inclusion.

Conclusions: Risk/benefit profile of study treatments was similar. Dual renin-angiotensin system (RAS) blockade is not recommended as compared to benazepril or valsartan monotherapy for prevention of microalbuminuria in normoalbuminuric type 2 diabetic patients.

Trial Registration: EudraCT 2006-005954-62; ClinicalTrials.gov NCT00503152.
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http://dx.doi.org/10.1371/journal.pmed.1003691DOI Listing
July 2021

Transthoracic ultrasound shear wave elastography for the study of subpleural lung lesions.

Ultrasonography 2021 Apr 15. Epub 2021 Apr 15.

Unit of Interventional and Diagnostic Ultrasound, Department of Internal Medicine, IRCCS Fondazione Casa Sollievo della Sofferenza, San Giovanni Rotondo, Foggia, Italy.

Purpose: The aim of this study was to assess whether new-generation shear wave elastography (SWE) is suitable for the characterization of lung subpleural lesions.

Methods: In total, 190 consecutive patients with subpleural lung lesions received ultrasonography and SWE. Patients with suspected malignancy underwent ultrasound-guided transthoracic needle biopsy. Final diagnoses were made on the basis of patients' clinical course, microbiological studies, and histological results. SWE was also performed in 25 healthy volunteers.

Results: We found no statistically significant differences in stiffness between lung carcinomas, lung metastases, and pneumonia (P=0.296) or between different histological types of lung cancer (P=0.393). Necrosis was associated with reduced stiffness in pneumonia. Excluding necrotic lesions, pneumonia showed higher stiffness than lung carcinomas (2.95±0.68 m/s vs. 2.60±0.54 m/s, P=0.006). Chronic pneumonia showed increased stiffness (3.03±0.63 m/s), probably due to the presence of fibrotic tissue on histology. Pleural effusion was associated with a statistically significant reduction in stiffness, both in lung carcinomas (P=0.004) and lung metastases (P=0.002). The presence of air in healthy lung tissue may lead to incorrect speed estimates due to shear wave reflection (very high values, 14.64±2.19 m/s).

Conclusion: Transthoracic SWE could not distinguish lung malignancy from pneumonia, or between different histological types of lung carcinomas. In particular, SWE seems unable to resolve the clinical dilemma of chronic subpleural consolidations.
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http://dx.doi.org/10.14366/usg.21021DOI Listing
April 2021

High Rates of Hidden HCV Infections among Hospitalized Patients Aged 55-85.

Pathogens 2021 Jun 3;10(6). Epub 2021 Jun 3.

Liver Unit, IRCCS "Casa Sollievo della Sofferenza", 71013 San Giovanni Rotondo, Italy.

Background And Aims: The WHO has solicited all countries to eliminate HCV by 2030. The Italian government started routine screening for HCV infection in January 2021, initially targeting subjects born between 1969 and 1989. With the aim of achieving micro-elimination, we designed a hospital-wide project focusing on inpatients born from 1935 to 1985 and conducted it in our institution.

Method: All inpatients aged 35 to 85, admitted from 10 February 2020 to 9 February 2021 for many different diseases and conditions underwent HCV antibody (HCVAb) testing by third-generation ELISA. When positive, reflex HCV RNA testing and genotyping were performed. Clinical history, fibrosis diagnosis, laboratory data and concomitant medications were available for all.

Results: The HCV screening rate of inpatients was 100%. In total, 11,748 participants were enrolled, of whom 53.50% were male. The HCVAb positivity rate was 3.03%. The HCVAb rate increased with age and was higher for patients born between 1935 and 1944 (4.81%). The rate of HCV RNA positivity was 0.97%. The vast majority (80.70%) of HCV RNA-positive participants were 55 or older; in about 40% of cases, HCV RNA-positive patients were unaware of their infection. Although 16 patients died after HCV chronic infection diagnosis (two due COVID-19) or HCV treatment prescription (one due to COVID-19), 74.56% of patient HCV diagnoses were linked to HCV treatment, despite their co-morbidities. All patients older than 65 who died had an active HCV infection.

Conclusion: The present study revealed a rate of active HCV infections among inpatients lower than what has been reported in the past in the general population; this appears to be a result of the widespread use of pangenotypic direct-acting antiviral agents (DAAs). The overall rate of active infection was lower than the rate observed in the 1935-1954 cohort. The high rate of inpatients unaware of HCV infections and the high number of deaths among subjects with an active HCV infection born from 1935 to 1954, suggest that, at least in southern Italy, targeted screening of this birth cohort may be required to reduce the number of undiagnosed cases and hidden infections.
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http://dx.doi.org/10.3390/pathogens10060695DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8227146PMC
June 2021

A serum resistin and multi-cytokine inflammatory pathway is linked with and helps predict all-cause death in diabetes.

J Clin Endocrinol Metab 2021 Jun 30. Epub 2021 Jun 30.

Research Unit of Diabetes and Endocrine Diseases, Fondazione IRCCS "Casa Sollievo della Sofferenza", San Giovanni Rotondo, Italy.

Context: Type 2 diabetes shows high mortality rate, partly mediated by atherosclerotic plaque instability. Discovering novel biomarkers may help identify high-risk patients to expose to more aggressive and specific managements. We recently described a serum REsistin and multiMulti-cytokine inflammAatory Pathway (REMAP), including resistin, IL-1β, IL-6, IL-8 and TNF-α) which associates with cardiovascular disease.

Objective: We investigated whether REMAP associates with and improves the prediction of mortality in type 2 diabetes.

Design: A REMAP score was investigated in three cohorts comprising 1,528 patients with T2D (409 incident deaths) and in 59 patients who underwent carotid endoarterectomy (CEA; 24 deaths). Plaques were classified as unstable/stable according to the modified American Heart Association atherosclerosis classification.

Results: REMAP was associated to all-cause mortality in each cohort and in all 1,528 individuals (fully-adjusted HR for one SD increase =1.34, p<0.001). In CEA patients, REMAP was associated with mortality (HR =1.64, p = 0.04) and a modest change was observed when plaque stability was taken into account [HR =1.58; P = 0.07]. REMAP improved discrimination and reclassification measures of both ENFORCE and RECODe, well-established prediction models of mortality in type 2 diabetes (P<0.05-<0.001).

Conclusions: REMAP is independently associated with and improves predict all-cause mortality in type 2 diabetes; it can therefore be used to identify high-risk individuals to be targeted with more aggressive managements. Whether REMAP can also identify those patients who are more responsive to IL-6 and IL-1β monoclonal antibodies which reduce cardiovascular burden and total mortality is an intriguing possibility to be tested.
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http://dx.doi.org/10.1210/clinem/dgab472DOI Listing
June 2021

Which are the limiting factors in lung tissue sampling and diagnostic accuracy for a new Interventional Pulmonology Unit? From expert consensus-based evidence to results of a new-born Unit.

J Thorac Dis 2021 May;13(5):2942-2951

Pathology Unit, Fondazione IRCCS "Casa Sollievo della Sofferenza", San Giovanni Rotondo, (FG), Italy.

Background: There is a gap of knowledge about the factors that may determine the quality and the accuracy of diagnostic bronchoscopic procedures when setting up a new Interventional Pulmonology Unit. As little evidence-based medicine is available on this matter, an online consensus opinion of experts was gathered and compared with real-life data coming from a new Interventional Pulmonology (IP) Unit.

Methods: A survey was emailed to the heads of all Italian IP Units to investigate the factors influencing the success of the diagnostic yield of a new IP Unit. The survey consisted of 24 items grouped by topic; the level of agreement ranged from 1 (no influence) to 7 (strong influence). After responses were collected, we submitted the data on the accuracy of the endoscopic procedures performed during the first two years of our new IP Unit to the attention of the participants for a second round of survey; the level of consistency between the first and second round of responses was assessed.

Results: After having been shown the results of the first two years of activity of our Unit, in the second round of the survey the responders indicated the personal skills of the Interventional Pulmonologist, the availability of echoendoscopic technology and the expertise in evaluating cytological samples as the factors able to positively influence the performance of a newly established IP Unit. Neither the role of dedicated nursing assistance, the availability of a rapid on-site evaluation, nor the presence of anesthesiology assistance were considered to be limiting factors for the final accuracy results.

Conclusions: A consensus of opinion of a group of expert interventional pulmonologists highlighted the factors that may be responsible for the diagnostic success of a newly established Italian IP Unit. These factors are mainly three: personal skills of the interventional pulmonologist, the availability of echoendoscopic technology, and the expertise in reading cytological samples.
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http://dx.doi.org/10.21037/jtd-20-2990DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8182518PMC
May 2021

A "Galactic" Chest X-ray.

Diagnostics (Basel) 2021 May 18;11(5). Epub 2021 May 18.

Unit of Pathology, Department of Services, IRCCS Casa Sollievo della Sofferenza, 71013 San Giovanni Rotondo, Italy.

Clinical manifestations accompanying respiratory failure with insidious and rapidly progressive onset are often non-specific. Symptoms such as a cough, dyspnea, and fever are common to a large number of inflammatory, infectious, or neoplastic diseases. During the COVID-19 pandemic it is essential to limit the use of hospital services and inappropriate diagnostic techniques. A particular radiological pattern can orient the clinical and laboratory scenario and guide the diagnostic workup. A 58-year-old woman was admitted to our COVID-19 unit for suspected coronavirus infection. She was complaining of worsening dyspnea, tachycardia, and low grade fever. A chest X-ray showed diffuse, alveolar, and interstitial lung involvement with micronodules tending to coalescence. This radiographic pattern known as "galaxy sign", consistent with diffuse, coalescing nodular miliary pulmonary involvement, simulating a non-specific alveolar opacification of the lungs is typical of a few pneumological differential diagnoses, represented by sarcoidosis, tuberculosis, pneumoconiosis, and metastatic lesions, and virtually excludes an interstitial viral pneumonitis. The use of endoscopic techniques can, in such cases, confirm the clinical suspicion for initiating appropriate targeted therapies.
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http://dx.doi.org/10.3390/diagnostics11050899DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8158502PMC
May 2021

All-cause mortality prediction models in type 2 diabetes: applicability in the early stage of disease.

Acta Diabetol 2021 May 29. Epub 2021 May 29.

Department of Surgical, Medical, Molecular and Critical Area Pathology, University of Pisa, Pisa, Italy.

Aims: The rate of all-cause mortality is twofold higher in type 2 diabetes than in the general population. Being able to identify patients with the highest risk from the very beginning of the disease would help tackle this burden.

Methods: We tested whether ENFORCE, an established prediction model of all-cause mortality in type 2 diabetes, performs well also in two independent samples of patients with early-stage disease prospectively followed up.

Results: ENFORCE's survival C-statistic was 0.81 (95%CI: 0.72-0.89) and 0.78 (95%CI: 0.68-0.87) in both samples. Calibration was also good. Very similar results were obtained with RECODe, an alternative prediction model of all-cause mortality in type 2 diabetes.

Conclusions: In conclusion, our data show that two well-established prediction models of all-cause mortality in type 2 diabetes can also be successfully applied in the early stage of the disease, thus becoming powerful tools for educated and timely prevention strategies for high-risk patients.
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http://dx.doi.org/10.1007/s00592-021-01746-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8164049PMC
May 2021

Delta-Procalcitonin and Vitamin D Can Predict Mortality of Internal Medicine Patients with Microbiological Identified Sepsis.

Medicina (Kaunas) 2021 Apr 1;57(4). Epub 2021 Apr 1.

Department of Medical Sciences, IRCCS Casa Sollievo della Sofferenza, 71013 San Giovanni Rotondo, Italy.

: The management of septic patients hospitalized in Internal Medicine wards represents a challenge due to their complexity and heterogeneity, and a high mortality rate. Among the available prognostic tools, procalcitonin (PCT) is considered a marker of bacterial infection. Furthermore, an association between vitamin D deficiency and poor sepsis-related outcomes has been described. To evaluate the prognostic accuracy of two consecutive PCT determinations (Delta-PCT) and of vitamin D levels in predicting mortality in a population of patients with microbiological identified sepsis admitted to Internal Medicine wards. : This is a sub-analysis of a previous prospective study. A total of 80 patients had at least two available consecutive PCT determinations, while 63 had also vitamin D. Delta-PCT was defined as a reduction of PCT > 50% after 48 h, >75% after 72 h, and >85% after 96 h. Mortality rate at 28- and 90-days were considered as main outcome. Mortality rate was 18.7% at 28-days and 30.0% at 90-days. Baseline PCT levels did not differ between survived and deceased patients (28-days: 0.525; 90-days: 0.088). A significantly higher proportion of survived patients showed Delta-PCT (28-days: 0.002; 90-days: < 0.001). Delta-PCT was associated with a lower 28-days ( 0.007; OR = 0.12, 95%CI 0.02-0.46) and 90-days mortality ( 0.001; OR = 0.17, 95%CI 0.06-0.48). A significantly higher proportion of deceased patients showed severe vitamin D deficiency (28-days: 0.047; 90-days: 0.049). Severe vitamin D deficiency was associated with a higher 28-days ( 0.058; OR = 3.95, 95%CI 1.04-19.43) and 90-days mortality ( 0.054; OR = 2.94, 95%CI 1.00-9.23). : Delta-PCT and vitamin D represent two useful tests for predicting prognosis of septic patients admitted to Internal Medicine wards.
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http://dx.doi.org/10.3390/medicina57040331DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8066199PMC
April 2021

Low Sensitivity of Admission Lung US Compared to Chest CT for Diagnosis of Lung Involvement in a Cohort of 82 Patients with COVID-19 Pneumonia.

Medicina (Kaunas) 2021 Mar 4;57(3). Epub 2021 Mar 4.

Unit of Interventional and Diagnostic Ultrasound of Internal Medicine, Department of Medical Sciences, IRCCS Fondazione Casa Sollievo della Sofferenza, 71013 San Giovanni Rotondo, Italy.

: The potential role of lung ultrasound (LUS) in characterizing lung involvement in Coronavirus disease 2019 (COVID-19) is still debated. The aim of the study was to estimate sensitivity of admission LUS for the detection of SARS-CoV-2 lung involvement using Chest-CT (Computed Tomography) as reference standard in order to assess LUS usefulness in ruling out COVID-19 pneumonia in the Emergency Department (ED). : Eighty-two patients with confirmed COVID-19 and signs of lung involvement on Chest-CT were consecutively admitted to our hospital and recruited in the study. Chest-CT and LUS examination were concurrently performed within the first 6-12h from admission. Sensitivity of LUS was calculated using CT findings as a reference standard. : Global LUS sensitivity in detecting COVID-19 pulmonary lesions was 52%. LUS sensitivity ranged from 8% in case of focal and sporadic ground-glass opacities (mild disease), to 52% for a crazy-paving pattern (moderate disease) and up to 100% in case of extensive subpleural consolidations (severe disease), although LUS was not always able to detect all the consolidations assessed at Chest-CT. LUS sensitivity was higher in detecting a typical Chest-CT pattern (60%) and abnormalities showing a middle-lower zone predominance (79%). : As admission LUS may result falsely negative in most cases, it should not be considered as a reliable imaging tool in ruling out COVID-19 pneumonia in patients presenting in ED. It may at least represent an expanded clinical evaluation that needs integration with other diagnostic tests (e.g., nasopharyngeal swab, Chest-CT).
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http://dx.doi.org/10.3390/medicina57030236DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8001137PMC
March 2021

Diagnosis of COVID-19 in Patients with Negative Nasopharyngeal Swabs: Reliability of Radiological and Clinical Diagnosis and Accuracy Versus Serology.

Diagnostics (Basel) 2021 Feb 25;11(3). Epub 2021 Feb 25.

Unit of Internal Medicine, Department of Medical Sciences, IRCCS Casa Sollievo della Sofferenza, 71013 San Giovanni Rotondo, Italy.

Background: The diagnosis of Coronavirus disease 2019 (COVID-19) relies on the positivity of nasopharyngeal swab. However, a significant percentage of symptomatic patients may test negative. We evaluated the reliability of COVID-19 diagnosis made by radiologists and clinicians and its accuracy versus serology in a sample of patients hospitalized for suspected COVID-19 with multiple negative swabs.

Methods: Admission chest CT-scans and clinical records of swab-negative patients, treated according to the COVID-19 protocol or deceased during hospitalization, were retrospectively evaluated by two radiologists and two clinicians, respectively.

Results: Of 254 patients, 169 swab-confirmed cases and one patient without chest CT-scan were excluded. A total of 84 patients were eligible for the reliability study. Of these, 21 patients died during hospitalization; the remaining 63 underwent serological testing and were eligible for the accuracy evaluation. Of the 63, 26 patients showed anti-Sars-Cov-2 antibodies, while 37 did not. The inter-rater agreement was "substantial" (kappa 0.683) between radiologists, "moderate" (kappa 0.454) between clinicians, and only "fair" (kappa 0.341) between radiologists and clinicians. Both radiologic and clinical evaluations showed good accuracy compared to serology.

Conclusions: The radiologic and clinical diagnosis of COVID-19 for swab-negative patients proved to be sufficiently reliable and accurate to allow a diagnosis of COVID-19, which needs to be confirmed by serology and follow-up.
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http://dx.doi.org/10.3390/diagnostics11030386DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7996330PMC
February 2021

Ocular involvement in Behçet's disease: relevance of new diagnostic tools.

Rheumatol Adv Pract 2020 10;4(2):rkaa038. Epub 2020 Aug 10.

Unit of Internal Medicine, 'Casa Sollievo della Sofferenza' Hospital, IRCCS, San Giovanni Rotondo.

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http://dx.doi.org/10.1093/rap/rkaa038DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7585404PMC
August 2020

Prescription of Sulphonylureas among Patients with Type 2 Diabetes Mellitus in Italy: Results from the Retrospective, Observational Multicentre Cross-Sectional SUSCIPE (Sulphonyl_UreaS_Correct_Internal_Prescription_Evaluation) Study.

Diabetes Ther 2020 Sep 30;11(9):2105-2119. Epub 2020 Jul 30.

Metabolic Disease and Diabetes Unit, San Luigi Gonzaga Hospital, Orbassano, TO, Italy.

Introduction: Recent guidelines for the treatment of type 2 diabetes mellitus (T2DM) provide evidence supporting limited use of sulphonylureas (SUs), especially in specific risk patient categories, yet data from national registries still suggest their widespread use. The aim of this study was to investigate characteristics of patients with diabetes treated with SUs and quantify the proportion of patients that met the recommendations for use of SUs by recent guidelines and of those presenting characteristics representing an inappropriate prescription risk (IPR).

Methods: A multicenter, retrospective, cross-sectional, observational study in patients with T2DM receiving treatment with SUs (as monotherapy or in combination with another diabetes therapy) was conducted between 2017 and 2018 in 22 outpatient diabetes clinics across Italy. Exclusion criteria were type 1 diabetes, diabetes mellitus secondary to other conditions, and presence of severe/life-threatening diseases.

Results: A total of 510 patients with T2DM (306 men, 204 women; mean age ± standard deviation 69.8 ± 9.3 years) who were receiving treatment with a SU (as monotherapy or in combination therapy) were assessed in the study. Overall, 70.6% [n = 360; 95% confidence interval (CI) 66.4%, 74.5%] were assessed to have an IPR. Of these, approximately half presented one factor for risk of inappropriate prescription, and 27 and 10.6% presented two and three factors, respectively. In terms of factors contributing to the total burden of risk of inappropriate treatment with SUs, 37.5% (95% CI 33.2%, 41.8%) of all patients were obese; 33.3% (95% CI 29.3%, 37.6%)] were aged ≥ 75 years; 18.6% (95% CI 15.3%, 22.3%) had a history of cardiovascular disease; 14.1% (95% CI 11.2%, 17.4%) had chronic renal insufficiency; 1.8% (95% CI 0.8%, 3.3%) had a history of severe hypoglycemia; 1.8% (95% CI 0.8%; 3.3%) had cognitive impairment; and 2.4% (95% CI 1.2%, 4.1%) had a risky occupation.

Conclusions: The results of this study provide evidence of a high rate of inappropriate SU prescription risk among patients with T2DM, especially among those with overweight/obesity, older age, history of cardiovascular disease, and hypoglycemia.
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http://dx.doi.org/10.1007/s13300-020-00871-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7434823PMC
September 2020

Blood pressure reduction and RAAS inhibition in diabetic kidney disease: therapeutic potentials and limitations.

J Nephrol 2020 Oct 17;33(5):949-963. Epub 2020 Jul 17.

University of Genoa and IRCCS Ospedale Policlinico San Martino, Viale Benedetto 15, 6, 16132, Genoa, Italy.

Diabetic kidney disease (DKD) affects approximately one-third of patients with diabetes and taking into consideration the high cardiovascular risk burden associated to this condition a multifactorial therapeutic approach is traditionally recommended, in which glucose and blood pressure control play a central role. The inhibition of renin-angiotensin-aldosterone RAAS system represent traditionally the cornerstone of DKD. Clinical outcome trials have demonstrated clinical significant benefit in slowing nephropathy progression mainly in the presence of albuminuria. Thus, international guidelines mandate their use in such patients. Given the central role of RAAS activity in the pathogenesis and progression of renal and cardiovascular damage, a more profound inhibition of the system by the use of multiple agents has been proposed in the past, especially in the presence of proteinuria, however clinical trials have failed to confirm the usefulness of this therapeutic approach. Furthermore, whether strict blood pressure control and pharmacologic RAAS inhibition entails a favorable renal outcome in non-albuminuric patients is at present unclear. This aspect is becoming an important issue in the management of DKD since nonalbuminuric DKD is currently the prevailing presenting phenotype. For these reasons it would be advisable that blood pressure management should be tailored in each subject on the basis of the renal phenotype as well as related comorbidities. This article reviews the current literature and discusses potentials and limitation of targeting the RAAS in order to provide the greatest renal protection in DKD.
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http://dx.doi.org/10.1007/s40620-020-00803-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7557495PMC
October 2020

Long-term blood pressure variability, incidence of hypertension and changes in renal function in type 2 diabetes.

J Hypertens 2020 11;38(11):2279-2286

University of Genoa and IRCCS Ospedale Policlinico San Martino, Genova.

Objectives: Long-term visit-to-visit SBP variability (VVV) predicts cerebro-cardiovascular and renal events in patients with hypertension. Whether VVV predicts hypertension and/or chronic kidney disease is currently unknown. We assessed the role of VVV on the development of hypertension and changes in renal function in patients with type 2 diabetes and normal blood pressure (NBP) in a real-life clinical setting.

Methods: Clinical records from 8998 patients with type 2 diabetes, NBP, and normal estimated glomerular filtration rate (eGFR) were analyzed. VVV was measured by SD of the mean SBP recorded in at least four visits during 2 consecutive years before follow-up. Hypertension was defined as SBP at least 140 mmHg and DBP at least 90 mmHg or the presence of antihypertensive treatment. Renal function was defined as worsening of albuminuria status and/or a reduction in eGFR at least 30% from baseline.

Results: After a mean follow-up time of 3.5 ± 2.8 years, 3795 patients developed hypertension (12.1 per 100 person-years). An increase of 5 mmHg VVV was associated with a 19% (P < 0.0001) and a 5% (P = 0.008) independent increased risk of developing hypertension and worsening of albuminuria, respectively. We found no association between VVV and eGFR decrease from baseline. Patients with VVV in the upper quartile (>12.8 mmHg) showed a 50% increased risk of developing hypertension (P < 0.0001) and an almost 20% increased risk of worsening albuminuria (P = 0.004) as compared with those in the lower one (<6.9 mmHg).

Conclusion: Increased VVV independently predicts incident hypertension and albuminuria worsening in type 2 diabetes and NBP.
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http://dx.doi.org/10.1097/HJH.0000000000002543DOI Listing
November 2020

Comment on Matricardi PM et al.

Pediatr Allergy Immunol 2020 11 12;31(8):997. Epub 2020 Jun 12.

Department of Medical Sciences, IRCCS Casa Sollievo della Sofferenza Hospital, San Giovanni Rotondo, Italy.

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http://dx.doi.org/10.1111/pai.13277DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7276801PMC
November 2020

Commentary: Ultrasound-Guided Biopsy of Pleural-Based Pulmonary Lesions by Injection of Contrast-Enhancing Drugs.

Front Pharmacol 2020 14;11:365. Epub 2020 Apr 14.

Department of Internal Medicine, Unit of Interventional and Diagnostic Ultrasound, IRCCS Fondazione "Casa Sollievo Della Sofferenza", Foggia, Italy.

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http://dx.doi.org/10.3389/fphar.2020.00365DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7171447PMC
April 2020

Atherogenic dyslipidemia and diabetic nephropathy.

J Nephrol 2020 Oct 23;33(5):1001-1008. Epub 2020 Apr 23.

Unit of Internal Medicine, Department of Medical Sciences, IRCCS Casa Sollievo Della Sofferenza, Viale Cappuccini 1, 71013, San Giovanni Rotondo, FG, Italy.

Chronic kidney disease is associated with altered lipid metabolism and lipid accumulation. Although it is though that hyperlipemia is a consequence of kidney dysfunction, several lines of evidence support that hyperlipidemia may contribute to the onset and progression of kidney disease, also in diabetes. This review describes the results of recent observational studies supporting the concept that glucose is only partly responsible for kidney damage onset, while a cluster of factors, including hypertriglyceridemia and low HDL-cholesterol, could play a relevant role in inducing onset and progression of DKD. We also report the results of randomized clinical trials investigating in type 2 diabetic patients the role of drug improvement of hypertriglyceridemia on renal outcomes. Finally, we discuss putative mechanisms linking hyperlipidemia (i.e. hypertriglyceridemia or low HDL cholesterol) with kidney disease.
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http://dx.doi.org/10.1007/s40620-020-00739-8DOI Listing
October 2020

The Synergic Association of hs-CRP and Serum Amyloid P Component in Predicting All-Cause Mortality in Patients With Type 2 Diabetes.

Diabetes Care 2020 05 6;43(5):1025-1032. Epub 2020 Mar 6.

Research Unit of Diabetes and Endocrine Diseases, Fondazione IRCCS "Casa Sollievo della Sofferenza," San Giovanni Rotondo, Italy

Objective: Type 2 diabetes is characterized by increased death rate. In order to tackle this dramatic event, it becomes essential to discover novel biomarkers capable of identifying high-risk patients to be exposed to more aggressive preventive and treatment strategies. hs-CRP and serum amyloid P component (SAP) are two acute-phase inflammation proteins, which interact physically and share structural and functional features. We investigated their combined role in associating with and improving prediction of mortality in type 2 diabetes.

Research Design And Methods: Four cohorts comprising 2,499 patients with diabetes (643 all-cause deaths) were analyzed. The improvement of mortality prediction was addressed using two well-established prediction models, namely, EstimatioN oF mORtality risk in type 2 diabetiC patiEnts (ENFORCE) and Risk Equations for Complications of Type 2 Diabetes (RECODe).

Results: Both hs-CRP and SAP were independently associated with all-cause mortality (hazard ratios [HRs] [95% CIs]: 1.46 [1.34-1.58] [ < 0.001] and 0.82 [0.76-0.89] [ < 0.001], respectively). Patients with SAP ≤33 mg/L were at increased risk of death versus those with SAP >33 mg/L only if hs-CRP was relatively high (>2 mg/L) (HR 1.96 [95% CI 1.52-2.54] [ < 0.001] and 1.20 [0.91-1.57] [ = 0.20] in hs-CRP >2 and ≤2 mg/L subgroups, respectively; hs-CRP-by-SAP strata interaction < 0.001). The addition of hs-CRP and SAP significantly (all < 0.05) improved several discrimination and reclassification measures of both ENFORCE and RECODe all-cause mortality prediction models.

Conclusions: In type 2 diabetes, hs-CRP and SAP show opposite and synergic associations with all-cause mortality. The use of both markers, possibly in combination with others yet to be unraveled, might improve the ability to predict the risk of death in the real-life setting.
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http://dx.doi.org/10.2337/dc19-2489DOI Listing
May 2020

Electrocardiographic alterations and raised procalcitonin levels during anaphylactic shock.

BMJ Case Rep 2020 Jan 21;13(1). Epub 2020 Jan 21.

Department of Medical Sciences, IRCCS Ospedale Casa Sollievo della Sofferenza, San Giovanni Rotondo, Italy.

Anaphylaxis represents a systemic disease occurring after the exposure to an allergen. Drugs for the treatment of anaphylactic reactions (ie, corticosteroids and adrenalin) could induce autonomic alterations, such as tachycardia, hyperthermia, tachypnoea and leucocytosis. We describe the case of a 52-year-old woman presenting with a severe allergic reaction after the ingestion of amoxicillin-clavulanate. The occurrence of ECG alterations, laboratory abnormalities and procalcitonin (PCT) elevation will be discussed with particular emphasis on the possible misleading role of PCT during anaphylactic shock.
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http://dx.doi.org/10.1136/bcr-2019-233521DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7035842PMC
January 2020

Transthoracic ultrasound sign in severe asthmatic patients: a lack of "gliding sign" mimic pneumothorax.

BJR Case Rep 2019 Dec 15;5(4):20190030. Epub 2019 Nov 15.

Unit of Interventional and Diagnostic Ultrasound of Internal Medicine IRCCS Fondazione Casa Sollievo della Sofferenza, San Giovanni Rotondo, Italy.

Transthoracic ultrasound (TUS) is a validate complementary technique widely used in everyday medical practice. TUS is the gold-standard for studying pleural effusion and for echo-guided thoracentesis, moreover, it is employed in detection of pleural and pulmonary lesions adherent to pleural surface and their ccho-guided percutaneous needle biopsy (PTNB). We used TUS technique to study severe asthma patients. We found that several patterns are constant in these patients. One of these patterns, . lack of gliding sign, mimic pneumothorax (PNX). In this study, we attempted an echographic approach to asthma, trying to lay the first stone for the individuation of common ultrasound patterns in this disease.
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http://dx.doi.org/10.1259/bjrcr.20190030DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6945254PMC
December 2019

The use of procalcitonin for the management of sepsis in Internal Medicine wards: current evidence.

Panminerva Med 2020 Mar 11;62(1):54-62. Epub 2019 Nov 11.

Internal Medicine Unit, Department of Medical Sciences, IRCCS Casa Sollievo della Sofferenza, San Giovanni Rotondo, Foggia, Italy -

Procalcitonin (PCT) is a circulating polypeptide produced in response to bacterial infections. Studies conducted in the Intensive Care Unit (ICU) setting have demonstrated its utility as a biomarker of bacterial infection and sepsis. Thus, PCT is widely used to distinguish between sepsis and SIRS, and to guide antibiotic therapy. At present sepsis represents a frequent diagnosis among patients admitted to internal medicine (IM) departments. Basing on the knowledge derived from ICU studies, the use of PCT has become routine in non-intensive wards, contributing to improve the management of sepsis. However, some differences between the two populations of patients - the IM being older, affected by multiple chronic comorbidities and lacking of invasive monitoring - could limit the generalizability of ICU results. Most of the studies on PCT conducted in the IM setting have focused on chronic obstructive pulmonary disease, pneumonia and sepsis. Although PCT represents one of the best biomarker available in routine clinical practice, there are uncertainties on the optimal cut-offs to be used for starting or discontinuing antibiotic treatment in patients with suspected bacterial infection or sepsis, for predicting outcome and on the role of PCT variations during antibiotic treatment. Moreover, several diseases can produce an elevation of PCT levels, thus producing false positive results. This represents a narrative review summarizing current evidences on PCT for the management of sepsis in an Internal Medicine wards, highlighting differences with ICU, with a special focus on the role of PCT variations as predictor of outcomes in non-ICU wards.
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http://dx.doi.org/10.23736/S0031-0808.19.03809-6DOI Listing
March 2020

Lung Ultrasonography in Pediatric Cardiac Surgery: A Complementary Diagnostic Tool.

Ann Thorac Surg 2020 06 6;109(6):1946. Epub 2019 Nov 6.

Unit of Internal Medicine, IRCCS "Casa Sollievo della Sofferenza", San Giovanni Rotondo, Italy.

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http://dx.doi.org/10.1016/j.athoracsur.2019.09.046DOI Listing
June 2020

Impact of CVOTs in primary and secondary prevention of kidney disease.

Diabetes Res Clin Pract 2019 Nov 30;157:107907. Epub 2019 Oct 30.

Università degli Studi and IRCCS Ospedale Policlinico San Martino, Genoa, Italy. Electronic address:

Type 2 diabetes mellitus is the leading cause of end stage renal disease worldwide. Diabetic kidney disease, whose main clinical manifestations are albuminuria and decline of glomerular filtration rate, affects up to 40% of patients. Sodium Glucose cotransporter-2 inhibitors (SGLT2-is) and Glucagon-like peptide-1 receptor agonists (GLP-1ras) are new classes of anti-hyperglycemic drugs which have demonstrated to improve renal outcome. Renal benefits of both SGLT2-is and GLP-1ras are acknowledged from data of large randomized phase III clinical trials conducted to assess their cardiovascular safety. In this review, we will focus on renal results of major cardiovascular outcome trials, and we will describe direct and indirect mechanisms through which they confer renal protection.
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http://dx.doi.org/10.1016/j.diabres.2019.107907DOI Listing
November 2019

'Bony' heart.

BMJ Case Rep 2019 Aug 30;12(8). Epub 2019 Aug 30.

Department of Medical Sciences, IRCCS Ospedale Casa Sollievo della Sofferenza, San Giovanni Rotondo, Italy.

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http://dx.doi.org/10.1136/bcr-2019-231793DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6721137PMC
August 2019

Takotsubo Syndrome and Inflammatory Bowel Diseases: Does a Link Exist?

Dig Dis 2020 13;38(3):204-210. Epub 2019 Aug 13.

Internal Medicine Unit, Department of Medical Sciences, IRCCS Casa Sollievo della Sofferenza, San Giovanni Rotondo, Italy.

Background: Takotsubo syndrome (TTS) is an acute cardiac dysfunction in the absence of viral causes or obstructive coronary disease completely reversible within 4-8 weeks. Inflammatory bowel diseases (IBD) are a group of diseases caused by the interaction between immune system, genetic, and environmental factors against intestinal mucosa. Both these syndromes are characterized by complex mechanisms involving endothelial dysfunction and affective disorders.

Aim: To assess the possibility of an association between IBD and TTS.

Methods: First, we present a case of TTS in a patient affected by active stenosing Crohn's disease. Articles in English language were collected from PubMed and Google Scholar databases with the search terms "takotsubo," "IBD," "crohn disease," "ulcerative colitis".

Results: Both TTS and IBD show multiple common features: preference for female patients, recurrent course of disease, association with endothelial dysfunction, and affective disorders. Patients affected by IBD could show specific triggers for TTS, such as malabsorption, electrolytes disturbances, and affective disorders.

Conclusions: Despite pathophysiological similarities between TTS and IBD in active phase, future studies are needed to confirm this apparently possible association and to assess the presence of a pathophysiological link between these diseases.
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http://dx.doi.org/10.1159/000502088DOI Listing
July 2020

Lung ultrasonography in pulmonary tuberculosis: Integrating chest radiology?

Eur J Intern Med 2019 11 30;69:e17-e18. Epub 2019 Jul 30.

Unit of Internal Medicine, Department of Medical Sciences, IRCCS Casa Sollievo della Sofferenza, San Giovanni Rotondo, Italy; Unit of Interventional and Diagnostic Ultrasound in Internal Medicine, Department of Medical Sciences, IRCCS Casa Sollievo della Sofferenza, San Giovanni Rotondo, Italy.

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http://dx.doi.org/10.1016/j.ejim.2019.07.023DOI Listing
November 2019

Predictors of mortality of bloodstream infections among internal medicine patients: Mind the complexity of the septic population!

Eur J Intern Med 2019 10 17;68:e22-e23. Epub 2019 Jul 17.

Department of Medical Sciences, IRCCS Casa Sollievo della Sofferenza Hospital, San Giovanni Rotondo, Italy. Electronic address:

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http://dx.doi.org/10.1016/j.ejim.2019.07.008DOI Listing
October 2019

Cardio-ankle vascular index is associated with diabetic retinopathy in younger than 70 years patients with type 2 diabetes mellitus.

Diabetes Res Clin Pract 2019 Sep 17;155:107793. Epub 2019 Jul 17.

Department of Medical Sciences, Scientific Institute "Casa Sollievo della Sofferenza", viale Cappuccini 1, San Giovanni Rotondo (FG), Italy.

Aims: This study aimed to investigate the relationship between cardio-ankle vascular index (CAVI) and diabetic retinopathy (DR) in Caucasian patients with type 2 Diabetes Mellitus (T2DM).

Methods: This was a cross-sectional study of 299 T2DM patients admitted to Endocrine Unit of Foggia. DR was diagnosed using the International Clinical Disease Severity Scale of American Academy of Ophthalmology. The VaSera VS-1500N was used to measure CAVI. Because age is the most powerful determinant of arterial stiffness and affects the progression of DR, we divided the whole sample into two subgroups: above (older) and below (younger) 70 years.

Results: The mean age of patients was 60.4 ± 12.6 years and the mean CAVI value was 8.6 ± 1.7. In the whole population DR was diagnosed in 74 (24.7%) patients. CAVI value was clearly higher in patients with DR (9.5 ± 1.6) than in those without (8.7 ± 1.7) (P = 0.001) although this difference was not any more significant when adjusted by age and gender (P = 0.067). In the multivariate model taking into account several possible confounders, the correlation between DR and CAVI remained significant only in younger subjects. In the same subgroup we found a significant association between the stages of DR and CAVI (p = 0.019 adjusted by age and gender).

Conclusions: This study shows that CAVI is significantly higher in younger patients with DR than in those without, with a relationship between the stages of DR and CAVI in the same subgroup. Physicians should pay attention to sub-clinical macroangiopathy in younger T2DM patients who have DR.
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http://dx.doi.org/10.1016/j.diabres.2019.107793DOI Listing
September 2019