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    1632 results match your criteria Clinical drug investigation[Journal]

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    First-Line Cetuximab Monotherapy in KRAS/NRAS/BRAF Mutation-Negative Colorectal Cancer Patients.
    Clin Drug Investig 2018 Feb 22. Epub 2018 Feb 22.
    City Cancer Center, Saint Petersburg, 197758, Russia.
    Background: Colorectal carcinomas (CRCs) are sensitive to treatment by anti-epidermal growth factor receptor (EGFR) antibodies only if they do not carry activating mutations in down-stream EGFR targets (KRAS/NRAS/BRAF). Most clinical trials for chemo-naive CRC patients involved combination of targeted agents and chemotherapy, while single-agent cetuximab or panitumumab studies included either heavily pretreated patients or subjects who were not selected on the basis of molecular tests. We hypothesized that anti-EGFR therapy would have significant efficacy in chemo-naive patients with KRAS/NRAS/BRAF mutation-negative CRC. Read More

    Correction to: Budget Impact Analysis of Brivaracetam Adjunctive Therapy for Partial-Onset Epileptic Seizures in Valencia Community, Spain.
    Clin Drug Investig 2018 Feb 20. Epub 2018 Feb 20.
    Department of Neurology, Hospital Clínico Universitario de Valencia, Valencia, Spain.
    In the original publication, the abstract, conclusion was incorrectly published. Read More

    Antipsychotic Prescribing and Safety Monitoring Practices in Children and Youth: A Population-Based Study in Alberta, Canada.
    Clin Drug Investig 2018 Feb 16. Epub 2018 Feb 16.
    Department of Pediatrics, University of Calgary, Calgary, AB, Canada.
    Background And Objective: Antipsychotic medication use has steadily increased in Canada, with an expansion in the profile of users and the diagnoses for which they are used. The use of antipsychotics is associated with a number of adverse effects for which routine monitoring is recommended. The objectives of this study were to determine the most common diagnoses associated with antipsychotic use in children in Alberta, Canada and the proportion who receive recommended laboratory tests for adverse effects. Read More

    Differences in Metabolic Factors Between Antipsychotic-Induced Weight Gain and Non-pharmacological Obesity in Youths.
    Clin Drug Investig 2018 Feb 12. Epub 2018 Feb 12.
    Department of Translational Medicine, Federico II University of Naples, Naples, Italy.
    Background: Youth exposed to antipsychotics may experience several metabolic consequences that often limit the effectiveness of this class of drugs.

    Objectives: The aim of this study was to compare several metabolic markers between subjects who experienced antipsychotic-induced weight gain and untreated obese patients.

    Methods: Nineteen non-diabetic youth (mean age 159 months, mean body mass index z-score 1. Read More

    Sustained Virological Response in Special Populations with Chronic Hepatitis C Using Interferon-Free Treatments: A Systematic Review and Meta-analysis of Observational Cohort Studies.
    Clin Drug Investig 2018 Feb 12. Epub 2018 Feb 12.
    Pharmaceutical Sciences Post-Graduate Program, Department of Pharmacy, Universidade Federal do Paraná, Av. Pref. Lothario Meissner, 632, Jardim Botânico, Curitiba, PR, 80210170, Brazil.
    Background And Objectives: Hepatitis C treatment has changed considerably in recent years, and many interferon (IFN)-free therapies are now available. Considering the high rates of sustained virological response (SVR) presented by clinical trials for these treatments, high rates of effectiveness are also expected in real-world clinical practice. Hence, this study aimed to conduct a systematic review and meta-analysis of observational cohort studies to evaluate the clinical effectiveness and safety of IFN-free therapies for hepatitis C. Read More

    Cost Effectiveness of Daclatasvir Plus Asunaprevir Therapy for Chinese Patients with Chronic Hepatitis C Virus Genotype 1b.
    Clin Drug Investig 2018 Feb 7. Epub 2018 Feb 7.
    Medical Decision and Economic Group, Department of Pharmacy, Ren Ji Hospital, South Campus, School of Medicine, Shanghai Jiaotong University, Shanghai, China.
    Background And Objectives: Daclatasvir plus asunaprevir has shown superior efficacy and safety for treating hepatitis C virus genotype 1b infection in comparison with pegylated interferon and ribavirin. The objective of this analysis is to investigate the cost effectiveness of daclatasvir plus asunaprevir compared with interferon-α-based therapies from the perspective of the Chinese healthcare system.

    Methods: A Markov model was established to measure economic and health outcomes of daclatasvir plus asunaprevir compared with general interferon-α plus ribavirin and pegylated interferon plus ribavirin for hepatitis C virus genotype 1b infection. Read More

    Drug Interchangeability of Generic and Brand Products of Fixed Dose Combination Tablets of Sofosbuvir and Ledipasvir (400/90 mg): Employment of Reference Scaled Average Bioequivalence Study on Healthy Egyptian Volunteers.
    Clin Drug Investig 2018 Feb 7. Epub 2018 Feb 7.
    Department of Pharmaceutics, Faculty of Pharmacy, Deraya University, Minya, Egypt.
    Background And Objectives: The purpose of this study was to apply the reference-scaled average bioequivalence (RSABE) approach to evaluate the bioequivalence and to investigate the pharmacokinetic properties of two formulations of fixed dose combination (FDC) tablet of sofosbuvir (SOF) and ledipasvir (LED) (400/90 mg) in 36 healthy Egyptian volunteers.

    Methods: The study was performed in single-dose, randomized-sequence, open-label, reference-replicated, 3-period crossover design (RTR, TRR, RRT), with a washout period of 2 weeks. A rapid and simple LC-MS/MS method was developed and validated for the simultaneous estimation of SOF and LED using eplerenone as an internal standard (IS). Read More

    Safety, Tolerability and Pharmacokinetics of the Serotonin 5-HT6 Receptor Antagonist, SUVN-502, in Healthy Young Adults and Elderly Subjects.
    Clin Drug Investig 2018 Jan 29. Epub 2018 Jan 29.
    Discovery Research, Suven Life Sciences Ltd, Serene Chambers, Road-5, Avenue-7, Banjara Hills, Hyderabad, 500034, India.
    Background And Objective: SUVN-502, a selective 5-HT6 receptor antagonist, was found to be active in preclinical models of cognitive deterioration suggesting a potential role in the treatment of dementia related to Alzheimer's disease. The objective of this study was to characterize the safety, tolerability and pharmacokinetics of SUVN-502 in healthy young adults and elderly subjects following single and multiple oral doses.

    Methods: Single doses (5, 15, 50, 100 and 200 mg SUVN-502) and multiple doses (50, 100 and 130 mg SUVN-502 once daily for 7 days) were evaluated in healthy young adults and multiple doses (50 and 100 mg SUVN-502 once daily for 14 days) were evaluated in elderly subjects using randomized, double-blind, placebo-controlled, dose-escalating study designs. Read More

    Pharmacodynamics, Safety, and Tolerability of the NHE3 Inhibitor Tenapanor: Two Trials in Healthy Volunteers.
    Clin Drug Investig 2018 Jan 23. Epub 2018 Jan 23.
    Ardelyx Inc., 34175 Ardenwood Blvd, Suite 200, Fremont, CA, 94555, USA.
    Background: Tenapanor, a small molecule with minimal systemic availability, is a first-in-class sodium/hydrogen exchanger 3 (NHE3) inhibitor that acts in the gut. Here, we evaluate the pharmacodynamics and safety of tenapanor in healthy adults.

    Methods: Two phase I, single-center, randomized, double-blind, placebo-controlled studies were performed. Read More

    Cost-Effectiveness of Empagliflozin for the Treatment of Patients with Type 2 Diabetes Mellitus at Increased Cardiovascular Risk in Greece.
    Clin Drug Investig 2018 Jan 18. Epub 2018 Jan 18.
    Department of Health Services Organization and Management, National School of Public Health, Athens, Greece.
    Background And Objective: Type 2 diabetes mellitus (T2DM) is frequently associated with co-morbidities that exacerbate cardiovascular (CV) risk. CV disease is the leading cause of death in people with diabetes across the world and accounts for approximately half the deaths in the T2DM population. Hence, the objective of present study was to evaluate the cost-effectiveness of empagliflozin, in addition to standard of care (SoC), for the treatment of adult patients with T2DM and high CV risk in Greece. Read More

    Pharmacological Insights into the Use of Apomorphine in Parkinson's Disease: Clinical Relevance.
    Clin Drug Investig 2018 Jan 11. Epub 2018 Jan 11.
    "Behavior and Basal Ganglia" Research Unit (EA 4712), University of Rennes 1, Rennes, France.
    The present paper consists of a comprehensive review of the literature on apomorphine pharmacological properties and its usefulness in Parkinson's disease (PD). The chemistry, structure-activity relationship, pharmacokinetics and pharmacodynamics of apomorphine are described with regard to its effects on PD symptoms, drug interactions, interindividual variability and adverse events. Apomorphine chemical structure accounts for most of its beneficial and deleterious properties, both dopaminergic and non-dopaminergic. Read More

    Combination of Omega-3 Fatty Acids and Valproic Acid in Treatment of Borderline Personality Disorder: A Follow-Up Study.
    Clin Drug Investig 2018 Jan 5. Epub 2018 Jan 5.
    Department of Neuroscience, Centre for Personality Disorders, University of Turin, Via Cherasco 11, 10126, Turin, Italy.
    Background And Objectives: Some evidence of efficacy has been found for omega-3 fatty acids in patients with borderline personality disorder (BPD). In a previous 12-week randomized trial we assessed the efficacy of the combination of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) with valproic acid, in comparison with valproic acid monotherapy, in 43 BPD outpatients. Combined therapy was superior to valproic acid monotherapy (the control group) in the treatment of some BPD symptoms: impulsive-behavioral dyscontrol, outbursts of anger, and self-harm. Read More

    Author Correction to: Prevalence of Use and Cost of Biological Drugs for Cancer Treatment: A 5-Year Picture from Southern Italy.
    Clin Drug Investig 2017 Dec 30. Epub 2017 Dec 30.
    Clinical Pharmacology Unit, A.O.U. Policlinico "G. Martino", Messina, Italy.
    Unfortunately, many errors were identified in the published article. The original article was corrected. Read More

    Surveillance on The Safety and Efficacy of Ambrisentan (Volibris Tablet 2.5 mg) in Patients with Pulmonary Arterial Hypertension in Real Clinical Practice: Post-marketing Surveillance (Interim Analysis Report).
    Clin Drug Investig 2017 Dec 27. Epub 2017 Dec 27.
    PMS Department, GlaxoSmithKline K.K, 1-8-1 Akasaka, Minato-ku, Tokyo, 107-0052, Japan.
    Background And Objective: Pulmonary arterial hypertension (PAH) is an intractable and rare disease and the accumulation of clinical evidence under real-world setting is needed. A post-marketing surveillance for the endothelin receptor antagonist ambrisentan (Volibris tablet) has been conducted by all-case investigation since September 2010. This paper is an interim report on the safety and efficacy of ambrisentan in 702 patients with PAH. Read More

    Budget Impact Analysis of Brivaracetam Adjunctive Therapy for Partial-Onset Epileptic Seizures in Valencia Community, Spain.
    Clin Drug Investig 2017 Dec 21. Epub 2017 Dec 21.
    Department of Neurology, Hospital Clínico Universitario de Valencia, Valencia, Spain.
    Background And Objective: More than 30% of patients with epilepsy have inadequate control of seizures with drug therapy. The goal of this study is to determine the budget impact (BI) of the introduction of brivaracetam to the portfolio of approved drugs in Spain as adjunctive therapy for the treatment of partial-onset epilepsy in patients over 16 years old with a 5-year time horizon in the Valencia Community, a Spanish region with a population of 5 million.

    Methods: The BI model compares the pharmaceutical expenditure on antiepileptics in two scenarios: with and without brivaracetam. Read More

    Intentional Drug Overdose Involving Pregabalin and Gabapentin: Findings from the National Self-Harm Registry Ireland, 2007-2015.
    Clin Drug Investig 2017 Dec 20. Epub 2017 Dec 20.
    National Suicide Research Foundation, University College Cork, Room 4.28, Fourth Floor, Western Gateway Building, Western Road, Cork, Ireland.
    Introduction: Intentional drug overdose (IDO) is a significant public health problem. Concerns about the misuse of gabapentinoids, i.e. Read More

    A Pilot Study of the Normative Range of Overnight Urinary Free Cortisol Corrected for Creatinine in Children.
    Clin Drug Investig 2017 Dec 18. Epub 2017 Dec 18.
    Medical Science, Mundipharma Research Limited, Cambridge, UK.
    Background: For more than a decade, urinary free cortisol corrected for creatinine (OUFCC) has been used to assess the systemic bioactivity of inhaled corticosteroids in children with asthma. Paediatric normative ranges, however, have not been established. The aim of the present study was to define a preliminary range for OUFCC in Tanner stage 1 children. Read More

    A Review of Switching Biologic Agents in the Treatment of Moderate-to-Severe Plaque Psoriasis.
    Clin Drug Investig 2017 Dec 16. Epub 2017 Dec 16.
    Department of Dermatology, Shanghai Tenth People's Hospital, Tongji University School of Medicine, Shanghai, 200072, China.
    Psoriasis is an immune-mediated polygenic inherited skin disease. Many biologic agents have been approved for the treatment of moderate-to-severe plaque psoriasis. The most commonly utilized biologics include TNF-α antagonists (etanercept, infliximab, and adalimumab), IL-12/23P40 antagonist (ustekinumab), IL-23P19 antagonist (guselkumab), IL-17A antagonist (secukinumab and ixekizumab), and IL-17RA antagonist (brodalumab). Read More

    Adjusted Indirect Comparison Using Propensity Score Matching of Osimertinib to Platinum-Based Doublet Chemotherapy in Patients with EGFRm T790M NSCLC Who Have Progressed after EGFR-TKI.
    Clin Drug Investig 2017 Dec 15. Epub 2017 Dec 15.
    AstraZeneca, Cambridge, UK.
    Background And Objective: An adjusted indirect comparison was conducted to assess efficacy outcomes, particularly overall survival (OS), of osimertinib versus platinum-based doublet chemotherapy in patients with epidermal growth factor receptor-mutated (EGFRm) T790M mutation-positive non-small-cell lung cancer (NSCLC) who had progressed following an EGFR tyrosine kinase inhibitor (TKI). Analysis of treatment effect from two separate trials had the potential to more accurately estimate the magnitude of OS benefit due to absence of confounding due to treatment switching from the control arm to the osimertinib arm of the ongoing randomized control trial, AURA3.

    Methods: Two non-randomized individual datasets were compared: pooled patients from the AURA extension and AURA2 trials (osimertinib 80 mg, n = 405, with a confirmed T790M mutation using tissue samples), and patients from the control arm of the IMPRESS study (platinum-based doublet chemotherapy, n = 61, with a confirmed T790M mutation using plasma circulating tumour DNA [ctDNA]). Read More

    Adverse Events under Tacrolimus and Cyclosporine in the First 3 Years Post-Renal Transplantation in Children.
    Clin Drug Investig 2018 Feb;38(2):157-171
    Department of Paediatric Pharmacology and Pharmacogenetics, Hospital Robert Debré, APHP, 48 Boulevard Sérurier, 75019, Paris, France.
    Background: Progress in immunosuppression has reduced acute rejection, graft loss and mortality after renal transplantation. Adverse drug reactions are well described in adults but few data are available in children. Our objectives were to analyse the adverse events reported in the first 3 years post-transplantation in children receiving tacrolimus or cyclosporine-based immunosuppression and compare them with the information of the Summary of Product Characteristics. Read More

    Comparison of Once-Daily Bemiparin with Twice-Daily Enoxaparin for Acute Deep Vein Thrombosis: A Multicenter, Open-Label, Randomized Controlled Trial.
    Clin Drug Investig 2018 Feb;38(2):181-189
    Berlin-Chemie AG, Menarini Group, Berlin, Germany.
    Background: Individuals with deep vein thrombosis (DVT) have an increased risk of pulmonary embolism (PE), death, and long-term thrombotic complications.

    Objectives: To evaluate the efficacy and safety of bemiparin once daily versus enoxaparin twice daily in the treatment of acute DVT, and to establish therapeutic non-inferiority of bemiparin.

    Patients And Methods: This multicenter, randomized, open-label, active-controlled phase III clinical trial enrolled patients with acute proximal DVT confirmed by complete compression ultrasound (CCUS). Read More

    Pharmacokinetics of Oral and Intravenous Paracetamol (Acetaminophen) When Co-Administered with Intravenous Morphine in Healthy Adult Subjects.
    Clin Drug Investig 2017 Dec 6. Epub 2017 Dec 6.
    Mallinckrodt Pharmaceuticals, Perryville III Corporate Park, 53 Frontage Road Third Floor, P.O. Box 9001, Hampton, NJ, 08827-9001, USA.
    Background And Objective: Several features favor paracetamol (acetaminophen) administration by the intravenous rather than the oral route in the postoperative setting. This study compared the pharmacokinetics and bioavailability of oral and intravenous paracetamol when given with or without an opioid, morphine.

    Methods: In this randomized, single-blind, parallel, repeat-dose study in healthy adults, subjects received four repeat doses of oral or intravenous 1000 mg paracetamol at 6-h intervals, and morphine infusions (0. Read More

    Adherence to Inhaled Medications and its Effect on Healthcare Utilization and Costs Among High-Grade Chronic Obstructive Pulmonary Disease Patients.
    Clin Drug Investig 2017 Dec 5. Epub 2017 Dec 5.
    Division of Pulmonary, Allergy and Critical Care Medicine, Department of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, 222 Banpodaero, Seochogu, Seoul, 06591, South Korea.
    Background: Adherence to inhaled medication regimens affects chronic obstructive pulmonary disease (COPD) prognosis and quality of life, and reduces the use of healthcare services, resulting in cost savings.

    Objectives: To examine the effects of adherence to inhaled medication regimens on healthcare utilization and costs in high-grade COPD patients.

    Methods: We performed an observational retrospective cohort study using a longitudinal data set from the Korean Health Insurance Review and Assessment Service (2008-2013) containing healthcare services' information for 50 million beneficiaries. Read More

    Pharmacokinetics and Safety of Ingenol Disoxate Gel Administered Under Maximum-Use Conditions to Patients With Actinic Keratosis.
    Clin Drug Investig 2017 Dec 4. Epub 2017 Dec 4.
    LEO Pharma A/S, Ballerup, Denmark.
    Background And Objectives: Ingenol disoxate (LEO 43204) is a field therapy in development for the treatment of actinic keratosis (AK) on areas between 25 and 250 cm. We evaluated the systemic exposure and safety of ingenol disoxate under maximum-use conditions.

    Methods: This was a phase I, open-label, non-randomized, multicenter trial. Read More

    Lithium Toxicity in Older Adults: a Systematic Review of Case Reports.
    Clin Drug Investig 2017 Nov 30. Epub 2017 Nov 30.
    Division of Geriatric Psychiatry, Department of Psychiatry, Sunnybrook Health Sciences Centre, Toronto, Canada.
    Background And Objectives: Despite concerns regarding the vulnerability of older adults to lithium toxicity, this has not been well studied. This literature review aims to characterize the nature of lithium toxicity in older adults, the doses and serum lithium levels associated with toxicity, as well as its clinical and laboratory manifestations, precipitating factors, management and outcome.

    Methods: A systematic 10-year search of English articles was conducted using Ovid Medline, Embase Classic + Embase, Cochrane Central Register of Controlled Trials and PsycINFO. Read More

    Agreement Among Different Scales for Causality Assessment in Drug-Induced Liver Injury.
    Clin Drug Investig 2017 Nov 28. Epub 2017 Nov 28.
    Department of Clinical Pharmacology, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, 605 006, India.
    Background And Objective: The causality assessment of drug-induced liver injury (DILI) remains a challenge and eagerly awaits the development of reliable hepatotoxicity biomarkers. None of the different available algorithms used for the causality assessment of DILI has been universally accepted as the gold standard. This study was conducted to examine the agreement among different causality assessment scales in reporting DILI. Read More

    Discontinuation of Efavirenz in Paediatric Patients: Why do Children Switch?
    Clin Drug Investig 2017 Nov 27. Epub 2017 Nov 27.
    The Family Clinic, Imperial College Healthcare NHS Trust, St Mary's Hospital, Praed Street, London, UK.
    Background: Efavirenz, a non-nucleoside reverse transcriptase inhibitor (NNRTI) is used globally as first-line antiretroviral therapy (ART) in combination with a dual nucleoside backbone in adults and children from 3 years of age. Up to 40% of adults taking efavirenz report central nervous system (CNS) adverse effects, and the rates of discontinuation of efavirenz-based treatment are higher than other first-line regimens. Data on efavirenz discontinuation are more limited for children and adolescents. Read More

    Ledipasvir-Sofosbuvir for 8 Weeks in Non-Cirrhotic Patients with Previously Untreated Genotype 1 HCV Infection ± HIV-1 Co-Infection.
    Clin Drug Investig 2017 Nov 24. Epub 2017 Nov 24.
    Department of Infectious Diseases, Military Medical Academy, St Petersburg, Russian Federation.
    BACKGROUND AND OBJECTIVES: The efficacy of < 12 weeks of hepatitis C virus (HCV) treatment in patients co-infected with HCV and human immunodeficiency virus type 1 (HIV-1) has not been established. We assessed the efficacy and safety of ledipasvir-sofosbuvir for 8 weeks in HCV mono-infected and HCV/HIV-1 co-infected patients.

    Methods: We enrolled patients mono-infected with genotype 1 HCV or co-infected with HCV and HIV-1 who were HCV treatment-naive and did not have cirrhosis. Read More

    Pharmacokinetics, Pharmacodynamics, and Safety of Rasagiline Transdermal Patch: A Preliminary Study in Healthy Chinese Subjects.
    Clin Drug Investig 2018 Feb;38(2):125-133
    Clinical Pharmacology Laboratory, The Second Affiliated Hospital of Soochow University, No. 1055 Sanxiang Road, Suzhou, 215004, China.
    Background And Objectives: Rasagiline tablet is an oral MAO-B inhibitor applied in early or advanced Parkinson's disease (PD). However, when patients with PD cannot take their usual oral medications, a rasagiline transdermal patch can be used as a way to offer continuous rasagiline while avoiding plasma concentration peaks and troughs. The objectives of this study were to investigate the pharmacokinetics, pharmacodynamics, and safety of the rasagiline transdermal patch in healthy Chinese subjects. Read More

    Oxycodone/Naloxone Prolonged Release: A Review in Severe Chronic Pain.
    Clin Drug Investig 2017 Dec;37(12):1191-1201
    Springer, Private Bag 65901, Mairangi Bay, 0754, Auckland, New Zealand.
    Oral oxycodone/naloxone prolonged release (PR) [Targin, Targinact, Targiniq] is a 12-hourly opioid receptor agonist and opioid receptor antagonist fixed-dose combination product that is approved in countries in the EU for the management of severe pain (adequately manageable only with opioid analgesics) in adults. Oral naloxone prevents oxycodone from binding to μ-receptors in the gastrointestinal (GI) tract, thereby counteracting opioid-induced constipation (OIC). In short-term (5- to 12-week) clinical trials of adults with moderate to severe, chronic pain and OIC (OXN3001, OXN3006, OXN3506), oxycodone/naloxone PR significantly improved OIC while providing noninferior analgesia relative to oxycodone PR; results were consistent between cancer and non-cancer patients in OXN3506. Read More

    Clinical Factors Associated with Initial Decrease in Body-Fat Percentage Induced by Add-on Sodium-Glucose Co-transporter 2 Inhibitors in Patient with Type 2 Diabetes Mellitus.
    Clin Drug Investig 2018 Jan;38(1):19-27
    Diabetes Care Center, Jinnouchi Hospital, 6-2-3 Kuhonji, Chuo-ku, Kumamoto, 862-0976, Japan.
    Background And Objective: Obesity is globally recognized as an important clinical problem and sodium-glucose co-transporter 2 (SGLT2) inhibitors are considered a suitable therapy for obese patients with type 2 diabetes mellitus (T2DM). We examined the clinical factors associated with initial decrease in body-fat percentage (Fat %) induced by SGLT2 inhibitors in patients with T2DM.

    Methods: We retrospectively enrolled patients newly treated with SGLT2 inhibitors in addition to ongoing medications at Jinnouchi Hospital between April 2014 and December 2015. Read More

    Tofacitinib: A New Oral Therapy for Psoriasis.
    Clin Drug Investig 2018 Feb;38(2):101-112
    Department of Dermatology, Centro Hospitalar do Porto, Rua D. Manuel II, S/N, ex-CICAP, 4099-001, Porto, Portugal.
    Psoriasis is a common, chronic, immune-mediated disease associated with several comorbidities. Biologic therapy revolutionized the treatment of moderate-to-severe psoriasis, improving physical and emotional burden of the disease. Still, there are unmet needs in the treatment of psoriasis regarding long-term efficacy, tolerability, safety, route of administration, and cost. Read More

    West Syndrome: A Review and Guide for Paediatricians.
    Clin Drug Investig 2018 Feb;38(2):113-124
    Pediatric Clinic, Department of Surgical and Biomedical Sciences, Università degli Studi di Perugia, Piazza Menghini 1, 06129, Perugia, Italy.
    West syndrome (WS), also known as infantile spasms, occurs in infancy with a peak between 4 and 7 months. Spasms, neurodevelopmental regression and hypsarrhythmia on electroencephalogram (EEG) basically define WS. The International League Against Epilepsy commission classifies the aetiologies of WS into genetic, structural, metabolic and unknown. Read More

    Impact of Herpes Zoster and Post-Herpetic Neuralgia on Health-Related Quality of Life in Japanese Adults Aged 60 Years or Older: Results from a Prospective, Observational Cohort Study.
    Clin Drug Investig 2018 Jan;38(1):29-37
    Health Economics Department, GSK, Wavre, Belgium.
    Background And Objectives: Herpes zoster (HZ) and its most frequent complication, post-herpetic neuralgia (PHN), have been shown to considerably impact quality of life (QoL). This has not yet been demonstrated in Japan.

    Methods: QoL in HZ and PHN patients was evaluated using the Zoster Brief Pain Inventory (ZBPI), EuroQoL-5 Dimension (EQ-5D), Short-Form 12 version 2. Read More

    Do Statins Increase the Risk of Esophageal Conditions? Findings from Four Propensity Score-Matched Analyses.
    Clin Drug Investig 2018 Feb;38(2):135-146
    Division of General Internal Medicine, University of Texas Southwestern Medical Center, Dallas, TX, USA.
    Background And Objective: Statins are commonly used medications. Whereas some observational studies suggested an association of statin use with Barrett's esophagus and some upper gastrointestinal symptoms, there is a dearth of data on the association of statins and common esophageal conditions such as gastroesophageal reflux disease and esophagitis. The aim of this study is to examine the association of statins with esophageal conditions. Read More

    Burden of Disease of Human Papillomavirus (HPV): Hospitalizations in the Marche and Veneto Regions. An observational study.
    Clin Drug Investig 2018 Feb;38(2):173-180
    Hygiene and Public Health Unit, Department of Cardiac, Thoracic and Vascular Sciences, Institute of Hygiene, University of Padua, Via Loredan, 18, 35121, Padova, Italy.
    Background And Objectives: HPV (human papillomavirus) is the virus most often responsible for sexually transmitted infections. The burden of HPV-related diseases on hospital resources represents a major public health problem. The aim of this study was to assess the economic burden of HPV-related diseases (anal cancer, genital cancer, genital warts, oropharyngeal cancer) on hospital resources in two Italian regions. Read More

    Cost Effectiveness of Exenatide Once Weekly Versus Insulin Glargine and Liraglutide for the Treatment of Type 2 Diabetes Mellitus in Greece.
    Clin Drug Investig 2018 Jan;38(1):67-77
    Department of Health Services Organization and Management, National School of Public Health, 196 Alexandras Avenue, 11521, Athens, Greece.
    Objective: The objective of this study was to evaluate the long-term cost effectiveness of exenatide once weekly (ExQW) versus insulin glargine (IG) or liraglutide 1.2 mg (Lira1.2mg) for the treatment of adult patients with type 2 diabetes mellitus (T2DM) not adequately controlled on oral antidiabetic drug (OAD) therapy in Greece. Read More

    Association between Serum Amiodarone and N-Desethylamiodarone Concentrations and Development of Thyroid Dysfunction.
    Clin Drug Investig 2018 Jan;38(1):39-48
    Division of Clinical Drug Informatics, Kindai University School of Pharmacy, 3-4-1, Kowakae, Higashi-osaka, Osaka, 577-8502, Japan.
    Objective: This retrospective cohort study was performed to examine the association between serum amiodarone (AMD) and N-desethylamiodarone (DEA) concentrations and the development of thyroid dysfunction.

    Methods: Patients treated with AMD from January 2012 to April 2016 were identified from the computerized hospital information system database at the National Cerebral and Cardiovascular Center. Only patients whose serum AMD and DEA concentrations had been determined at least once were included in the study. Read More

    Who Receives Nalmefene and How Does It Work in the Real World? A Single-Arm, Phase IV Study of Nalmefene in Alcohol Dependent Outpatients: Baseline and 1-Month Results.
    Clin Drug Investig 2018 Feb;38(2):147-155
    Addictive Behaviors Unit, Clinic Hospital, University of Barcelona, Barcelona, Spain.
    Background: Alcohol dependence remains a major health problem from both a public health and clinical perspective. Harm reduction strategies have been increasingly recognized as suitable treatment goals. Nalmefene has been recently approved for this precise therapeutic indication after completion of phase III trials. Read More

    Prevalence of Use and Cost of Biological Drugs for Cancer Treatment: A 5-Year Picture from Southern Italy.
    Clin Drug Investig 2017 Oct 26. Epub 2017 Oct 26.
    Clinical Pharmacology Unit, A.O.U. Policlinico "G. Martino", Messina, Italy.
    Background And Objectives: Considering the clinical and economic burden of biological and non-biological targeted therapies in cancer treatment, it is necessary to explore how these drugs are used in routine care in Italy and how they affect the sustainability of the National Health Services. This study aimed to investigate the prevalence of use and costs of biological and non-biological targeted therapies for cancer treatment in a general population of Southern Italy in the years 2010-2014.

    Methods: This was a retrospective, observational study using data from the healthcare administrative databases of Messina Province for the years 2010-2014. Read More

    The Challenge of Pharmacotherapy in Children and Adolescents with Epilepsy-ADHD Comorbidity.
    Clin Drug Investig 2018 Jan;38(1):1-8
    Child Neurology and Psychiatry Unit, Tor Vergata University of Rome, Via Montpellier 1, 00133, Rome, Italy.
    Epilepsy is common in children and adolescents where its prevalence is 3.2-5.5/1000. Read More

    A Review of Asenapine in the Treatment of Bipolar Disorder.
    Clin Drug Investig 2018 Feb;38(2):87-99
    Psychiatry Section of the Ramón y Cajal University Hospital, IRYCIS, CIBERSAM, University of Alcalá, Ctra. Colmenar Viejo, km. 9,100, 28034, Madrid, Spain.
    Bipolar disorder places a significant burden on the affected individuals, their family, healthcare systems and the overall economy. More treatment options are needed, especially those with better efficacy and tolerability. Asenapine is a second-generation antipsychotic approved in Europe (brand name Sycrest) for the treatment of moderate-to-severe manic episodes associated with bipolar I disorder in adults, and in the US (brand name Saphris) for the treatment of manic or mixed episodes of bipolar I disorder in adults and children aged 10-17 years. Read More

    Improvements in Quality-Adjusted Life Years and Cost-Utility After Pharmacotherapy for Premenstrual Dysphoric Disorder: A Retrospective Study.
    Clin Drug Investig 2018 Jan;38(1):49-55
    Department of Psychiatry, Tohoku Medical and Pharmaceutical University Hospital, 1-12-1 Fukumuro, Miyagino-ku, Sendai, 983-8512, Japan.
    Background And Objective: To investigate the cost-effectiveness of pharmacotherapy for premenstrual dysphoric disorder (PMDD), a relatively new classification of depressive disorder that is characterized by recurrent depression during the premenstrual phase of the menstrual cycle.

    Methods: We performed a retrospective analysis of data from 49 previously untreated PMDD patients who visited our psychiatric department between October 2013 and February 2016 and received pharmacotherapy for 3 or 6 subsequent menstrual cycles. Quality-adjusted life years (QALYs) were estimated across individual menstrual cycles using mean EuroQoL-5D values. Read More

    Cost Effectiveness of Imatinib, Dasatinib, and Nilotinib as First-Line Treatment for Chronic-Phase Chronic Myeloid Leukemia in China.
    Clin Drug Investig 2018 Jan;38(1):79-86
    Department of Pharmacy, Fujian Medical University Union Hospital, No. 29 Xinquan Road, Fuzhou, 350001, Fujian, China.
    Background And Objective: Tyrosine kinase inhibitors (TKIs) have obvious effects on chronic myeloid leukemia (CML), but they are expensive in China. Moreover, the overall cost of treatment of CML is high and the medical economic burden of patients with CML on the government is heavy. This study tested the cost effectiveness of imatinib, nilotinib, and dasatinib as first-line treatment in Chinese patients who were first diagnosed with chronic myeloid leukemia in the chronic phase (CML-CP). Read More

    Risk Factors for and Incidence of Seizures in Metastatic Castration-Resistant Prostate Cancer: A Real-World Retrospective Cohort Study.
    Clin Drug Investig 2017 Dec;37(12):1183-1190
    Astellas Pharma, Inc., 1 Astellas Way, Northbrook, IL, 60062, USA.
    Background And Objective: This real-world study assessed the prevalence, risk factors for, and incidence of seizures in patients with metastatic castration-resistant prostate cancer (mCRPC).

    Methods: Patients with mCRPC were selected from MarketScan Commercial and Medicare Supplemental Databases between 1 January 2009 and 31 July 2012. Prevalence of seizure risk factors were described separately and in combination with other risk factors. Read More

    Effect of Food on the Pharmacokinetics of Saroglitazar Magnesium, a Novel Dual PPARαγ Agonist, in Healthy Adult Subjects.
    Clin Drug Investig 2018 Jan;38(1):57-65
    Zydus Research Center, Survey No. 396/403, Sarkhej-Bavla, N.H. No. 8A, Moraiya, Ahmedabad, Gujarat, 382213, India.
    Background And Objective: Peroxisome proliferator-activated receptors (PPARs) have recently become a focus of interest for their important roles in glucose and lipid metabolism. In humans, PPARactivation causes a decrease in plasma triglyceride (TG) levels, enhancement of high-density lipoprotein cholesterol (HDL-C) and simultaneous enhancement of very-low-density lipoprotein (VLDL) lipolysis, whereas PPARγ agonists act as insulin sensitizers and improve insulin resistance, which is very useful in patients with type 2 diabetes mellitus (T2DM). Saroglitazar magnesium is a dual PPAR agonist with potent predominant PPARand moderate PPARactivity and the first glitazar to be granted marketing authorization in India. Read More

    Calcium Channel Blockers in Secondary Cardiovascular Prevention and Risk of Acute Events: Real-World Evidence from Nested Case-Control Studies on Italian Hypertensive Elderly.
    Clin Drug Investig 2017 Dec;37(12):1165-1174
    Local Health Unit n.2 Marca Trevigiana, Veneto Region, Treviso, Italy.
    Background And Objectives: Antihypertensive treatment with calcium channel blockers (CCBs) is consolidated in clinical practice; however, different studies observed increased risks of acute events for short-acting CCBs. This study aimed to provide real-world evidence on risks of acute cardiovascular (CV) events, hospitalizations and mortality among users of different CCB classes in secondary CV prevention.

    Methods: Three case-control studies were nested in a cohort of Italian elderly hypertensive CV-compromised CCBs users. Read More

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