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    1676 results match your criteria Clinical drug investigation[Journal]

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    Correction to: Meta-analysis of Placebo Response in Randomized Clinical Trials of Antipsychotic Drugs Using PANSS Focusing on Different Approaches to the Handling of Missing Data.
    Clin Drug Investig 2018 Jun 19. Epub 2018 Jun 19.
    Department of Clinical Medicine (Pharmaceutical Medicine), Graduate School of Pharmaceutical Sciences, Kitasato University, 5-9-1 Shirokane, Minato-ku, Tokyo, 108-8641, Japan.
    In the original publication, the Estimate column with values under Multivariate meta-regression (LOCF) in Table 1 was missed. The corrected table is shown below. Read More

    Pharmacokinetics of Fentanyl Sublingual Spray in Opioid-Naïve Participants: Results of a Phase 1, Multiple Ascending Dose Study.
    Clin Drug Investig 2018 Jun 16. Epub 2018 Jun 16.
    Insys Development Company, Inc, Chandler, AZ, USA.
    Background And Objectives: Fentanyl sublingual spray may be a viable alternative to intravenous (IV) opioids for the treatment of acute pain. As patients with acute pain may include those who have limited prior exposure to opioids, this phase 1, open-label, randomized, multiple ascending-dose study was conducted to assess the pharmacokinetics, pharmacodynamics, safety, and tolerability of multiple doses of fentanyl sublingual spray in opioid-naïve participants. This article primarily reports the pharmacokinetics results. Read More

    Pharmacokinetics of a Novel Sildenafil Orodispersible Film Administered by the Supralingual and the Sublingual Route to Healthy Men.
    Clin Drug Investig 2018 Jun 16. Epub 2018 Jun 16.
    CROSS Research S.A., Via F.A. Giorgioli 14, 6864, Arzo, Switzerland.
    Background: Sildenafil was the first selective drug available on the market as oral therapy for erectile dysfunction (ED). A novel sildenafil orodispersible film (ODF) for ED treatment, containing sildenafil citrate, has recently been marketed.

    Objectives: Study objective was to investigate sildenafil bioavailability of the novel ODF formulation after sublingual and supralingual administration. Read More

    Paliperidone Palmitate 3-Monthly Versus 1-Monthly Injectable in Patients With Schizophrenia With or Without Prior Exposure to Oral Risperidone or Paliperidone: A Post Hoc, Subgroup Analysis.
    Clin Drug Investig 2018 Jun 7. Epub 2018 Jun 7.
    Janssen Research & Development, LLC, 1125 Trenton-Harbourton Road, Titusville, NJ, 08560, USA.
    Background And Objective: Paliperidone palmitate 3-monthly (PP3M) injectable formulation offers an advantage of improved medication adherence and lower relapse risk in patients with schizophrenia. This post hoc analysis compared outcomes following PP3M versus paliperidone palmitate 1-monthly (PP1M) treatment in patients with schizophrenia treated/untreated with oral risperidone/paliperidone (RIS/PALI).

    Methods: Patients were treated with PP1M (50, 75, 100, or 150 mg equivalent [eq. Read More

    Meta-analysis of Placebo Response in Randomized Clinical Trials of Antipsychotic Drugs Using PANSS Focusing on Different Approaches to the Handling of Missing Data.
    Clin Drug Investig 2018 Jun 1. Epub 2018 Jun 1.
    Department of Clinical Medicine (Pharmaceutical Medicine), Graduate School of Pharmaceutical Sciences, Kitasato University, 5-9-1 Shirokane, Minato-ku, Tokyo, 108-8641, Japan.
    Background And Objective: Schizophrenia treatment has been shifting to resocialization by efficacious antipsychotic drugs. However, even some of the pivotal studies of approved new antipsychotic drugs with proven efficacy had failed due to high placebo response. The aim of this study was to identify the potential factors affecting placebo response by meta-analysis for randomized clinical trials for antipsychotic drugs using Positive and Negative Syndrome Scale (PANSS) focusing on the current methodological change in the handling of missing data [from last observation carried forward (LOCF) to mixed-effect models for repeated measures (MMRM)] for successful future clinical trials. Read More

    Peri-operative Medication Dosing in Adult Obese Elective Surgical Patients: A Systematic Review of Clinical Studies.
    Clin Drug Investig 2018 Jun 1. Epub 2018 Jun 1.
    Division of Pharmacy, School of Medicine, Faculty of Health, University of Tasmania, Pharmacy Building, Dobson Road, Private Bag 26, Hobart, TAS, 7001, Australia.
    Background: Despite the increasing numbers of obese patients undergoing elective surgery, there is a lack of evidence-based dosing guidelines for peri-operative medications in obesity.

    Objective: The objective was to systematically review the dosing and outcomes of peri-operative medications used in obese elective surgical patients.

    Methods: Medical subject headings and general keywords were used to systematically search multiple databases (PubMed, EMBASE, Cochrane Library and CINAHL). Read More

    Multiple Rising Doses of Oral BI 425809, a GlyT1 Inhibitor, in Young and Elderly Healthy Volunteers: A Randomised, Double-Blind, Phase I Study Investigating Safety and Pharmacokinetics.
    Clin Drug Investig 2018 May 30. Epub 2018 May 30.
    Boehringer Ingelheim International GmbH, Birkendorfer Str. 65, 88397, Biberach an der Riss, Germany.
    Background And Objective: Schizophrenia and Alzheimer's disease are characterised by abnormalities in glutamatergic pathways related to N-methyl-D-aspartate receptor hypofunction. Glycine is an N-methyl-D-aspartate receptor co-agonist; inhibition of glycine transporter 1 may improve N-methyl-D-aspartate receptor function. This phase I, randomised, two-part study evaluated the safety, tolerability and pharmacokinetic profile of BI 425809, a novel glycine transporter 1 inhibitor, in healthy male and female volunteers. Read More

    The Utility of 5 Hypothetical Health States in Heart Failure Using Time Trade-Off (TTO) and EQ-5D-5L in Korea.
    Clin Drug Investig 2018 May 26. Epub 2018 May 26.
    School of Pharmacy, Sungkyunkwan University, 2066, Seobu-ro, Jangan-gu, Suwon-si, Gyeonggi-do, 16419, South Korea.
    Background And Objective: Utility provides a preference for specific health state in economic evaluation, and they obtained from general population could be useful in respect of societal resource allocation. We aimed to investigate the utilities of health states for heart failure (HF), a major and growing public health problem, related to hospitalization and adverse drug effects by interrogating the general Korean population.

    Methods: Five health states for patients with HF were developed based on literature reviews: stable chronic heart failure (SCHF), hospitalization, SCHF + cough, SCHF + hypotension, and SCHF + hyperkalemia. Read More

    Efficacy and Safety of Neoadjuvant Treatment with Bevacizumab, Liposomal Doxorubicin, Cyclophosphamide and Paclitaxel Combination in Locally/Regionally Advanced, HER2-Negative, Grade III at Premenopausal Status Breast Cancer: A Phase II Study.
    Clin Drug Investig 2018 May 9. Epub 2018 May 9.
    Department of Pharmacology, Medical School, National and Kapodistrian University of Athens, 75 Mikras Asias, Goudi, 11527, Athens, Greece.
    Background: In the era of personalized therapy, targeted treatment in specific patient populations is mandated.

    Objective: We evaluated the efficacy and safety of neoadjuvant treatment on locally advanced breast cancer (LABC) with a monoclonal agent against vascular endothelial growth factor (VEGF), bevacizumab plus chemotherapy combination of liposomal doxorubicin, cyclophosphamide and paclitaxel (PLAC-B).

    Methods: Patients enrolled were at premenopausal status and characterized by human epidermal growth factor receptor 2 (HER2)-negative, hormone-receptor positive (estrogen receptor/progesterone receptor-positive [ER/PR+]) or triple-negative (TNBC), LABC (T > 3 cm), with high-grade ductal carcinoma. Read More

    Current and Future Use of Chloroquine and Hydroxychloroquine in Infectious, Immune, Neoplastic, and Neurological Diseases: A Mini-Review.
    Clin Drug Investig 2018 May 8. Epub 2018 May 8.
    Department of Clinical Experimental Oncology, Regina Elena National Cancer Institute, IFO, Via Elio Chianesi 53, 00144, Rome, Italy.
    The process of finding new therapeutic indications for currently used drugs, defined as 'repurposing', is receiving growing attention. Chloroquine and hydroxychloroquine, with an original indication to prevent or cure malaria, have been successfully used to treat several infectious (HIV, Q fever, Whipple's disease, fungal infections), rheumatological (systemic lupus erythematosus, antiphospholipid antibody syndrome, rheumatoid arthritis, Sjögren's syndrome), and other immunological diseases. Indeed, they have anti-inflammatory, immunomodulating, anti-infective, antithrombotic, and metabolic effects. Read More

    Health Economic Analysis of Antiplatelet Therapy for Acute Coronary Syndromes in the Context of Five Eastern Asian Countries.
    Clin Drug Investig 2018 Apr 30. Epub 2018 Apr 30.
    Department of Cardiology, Ren Ji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China.
    Background And Objective: The economic outcomes of dual antiplatelet therapy in East Asian patients are still unclear. We aimed to evaluate the economic outcomes of ticagrelor versus clopidogrel for patients with acute coronary syndrome (ACS) in China, Japan, Korea, Taiwan and Hong Kong.

    Methods: A two-phase model consisting of a 1-year decision tree and a lifetime Markov model was used to estimate the economic outcomes. Read More

    Retraction Note to: Efficacy of Menatetrenone (Vitamin K2) against Non-Vertebral and Hip Fractures in Patients with Neurological Diseases : Meta-Analysis of Three Randomized, Controlled Trials.
    Clin Drug Investig 2018 May;38(5):479
    Institute for Integrated Sports Medicine, Keio University School of Medicine, Tokyo, Japan.
    The Editor-in-Chief has retracted this article because two of the three studies [1, 2] included in the meta-analysis (cited as references 11 and 12) have been retracted due to fabrication of the data, which has rendered the results of this meta-analysis invalid. Read More

    Retraction Note to: Combination Antiemetic Regimens for Prevention of Postoperative Nausea and Vomiting : Focus on High-Risk Patients.
    Clin Drug Investig 2018 May;38(5):477
    Department of Anaesthesiology, University of Tsukuba Institute of Clinical Medicine, Tsukuba City, Ibaraki, Japan.
    The Editor-in-Chief has retracted the original article [1] because a number of studies [2-15] included in this review (cited as references 25-29, 31, 32, 47, 48, 50-54) have been retracted, specifically those included in table III, table IV, section 3 and section 4.2. This has rendered the content of the review scientifically unreliable. Read More

    Safety, Tolerability, and Pharmacokinetics of Suvorexant: A Randomized Rising-Dose Trial in Healthy Men.
    Clin Drug Investig 2018 Apr 28. Epub 2018 Apr 28.
    Merck & Co., Inc., Kenilworth, NJ, USA.
    Background And Objectives: Suvorexant (MK-4305) is an orexin receptor antagonist approved for the treatment of insomnia in the USA and other regions. This randomized, double-blind, placebo-controlled, sequential-panel, Phase 1 trial assessed the safety, tolerability, and pharmacokinetic data following single and multiple dosing of suvorexant in healthy men (aged 18-45 years).

    Methods: Within allocated panels, subjects (n = 8) were randomized to receive nightly doses of suvorexant (10, 20, 40, 80, and 100 mg) administered orally for 14 days, or placebo. Read More

    Cost-Effectiveness of Fixed-Dose Combinations Therapies for Chronic Obstructive Pulmonary Disease Treatment.
    Clin Drug Investig 2018 Apr 13. Epub 2018 Apr 13.
    Pharmacoeconomics and Outcomes Research Iberia (PORIB), Madrid, Spain.
    Background And Objective: Chronic obstructive pulmonary disease (COPD), a progressive lung disorder associated with decline of respiratory function, affects 10.2% of Spanish adults (40-80 years of age). This study aimed to assess the cost-effectiveness of two fixed-dose combinations of long-acting muscarinic antagonist and long-acting β2-agonist therapies for COPD, with Spanish National Health System perspective. Read More

    Abuse-Deterrent Opioid Formulations: A Key Ingredient in the Recipe to Prevent Opioid Disasters?
    Clin Drug Investig 2018 Apr 12. Epub 2018 Apr 12.
    Department of Pharmaceutical Sciences, Gatton College of Pharmacy, East Tennessee State University, Box 70594, Johnson City, TN, 37614-1708, USA.
    The US Food and Drug Administration (FDA) is encouraging the innovation of long-acting opioid formulations that are manipulation-resistant. The purpose of this commentary is to assess the benefits and limitations of abuse-deterrent opioid formulations (ADFs) and discuss their role in mitigating the current opioid epidemic. ADFs have been created with chemical properties that make it difficult for people who non-medically use prescription drugs to crush and dissolve opioid tablets, as well as by combining opioids with antagonists such as naloxone or naltrexone, which are released only when the dosage form has been manipulated or the drug is taken by a non-intended route. Read More

    Impact of Anthracyclines on Diabetes Mellitus Development in B-Cell Lymphoma Patients: A Nationwide Population-based Study.
    Clin Drug Investig 2018 Apr 9. Epub 2018 Apr 9.
    Division of Endocrinology and Metabolism, Department of Medicine, Taichung Veterans General Hospital, 1650 Taiwan Boulevard Sect. 4, Taichung, 40705, Taiwan.
    Background And Objectives: Although anthracyclines are effective chemotherapeutic agents for treating B-cell lymphoma, adverse effects, such as bone marrow suppression and cardiotoxicity, limit their clinical application. We assessed whether anthracycline treatment also increases the risk for diabetes mellitus in patients with B-cell lymphoma.

    Methods: Using data obtained from the Taiwanese National Health Insurance Research Database from 2004 to 2011, we compared overall survival and clinical features for B-cell lymphoma patients administered anthracyclines (n = 3147) and those not administered anthracyclines (n = 837). Read More

    Translating Benzodiazepine Utilization Data into Meaningful Population Exposure: Integration of Two Metrics for Improved Reporting.
    Clin Drug Investig 2018 Apr 4. Epub 2018 Apr 4.
    College of Pharmacy, Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, MB, Canada.
    Drug utilization research on benzodiazepines remains important for measuring trends in consumption within and across borders over time for the sake of monitoring prescribing patterns and identifying potential population safety concerns. The defined daily dose (DDD) system by the World Health Organization (WHO) remains the internationally accepted standard for measuring drug consumption; however, beyond consumption, DDD-based results are difficult to interpret when individual agents are compared with one another or are pooled into a total class-based estimate. The diazepam milligram equivalent (DME) system provides approximate conversions between benzodiazepines and Z-drugs (i. Read More

    Adherence to Antidepressants and Mortality in Elderly Patients with Cardiovascular Disease.
    Clin Drug Investig 2018 Mar 27. Epub 2018 Mar 27.
    Laboratory of Healthcare Research and Pharmacoepidemiology, Unit of Biostatistics, Epidemiology and Public Health, Department of Statistics and Quantitative Methods, University of Milano-Bicocca, Milan, Italy.
    BACKGROUND AND OBJECTIVE: Conflicting findings from studies evaluating the association between use of antidepressant drugs and mortality have been reported. We tested the hypothesis that better adherence to antidepressant therapy may reduce mortality.

    Methods: The cohort included 29,845 individuals aged ≥ 65 years from several Italian health units who were newly treated with antidepressant drugs after hospital discharge with a diagnosis for cardiovascular disease during 2008-2010. Read More

    Fluticasone Propionate/Salmeterol MDPI (AirDuo RespiClick): A Review in Asthma.
    Clin Drug Investig 2018 May;38(5):463-473
    Duke Clinical Research Institute and Durham Veterans Administration Medical Center, Durham, NC, USA.
    The novel, easy-to-use, breath-actuated fluticasone propionate/salmeterol multidose dry powder inhaler (MDPI) (AirDuo RespiClick) was recently approved in the USA for twice-daily treatment of asthma in patients aged ≥ 12 years. This inhaled corticosteroid (ICS) and long-acting β-adrenoreceptor agonist (LABA) combination treatment is available in low-, mid- and high-dosage formulations (55/14, 113/14 and 232/14 μg, respectively). In 12-week, phase III trials in patients aged ≥ 12 years with persistent asthma, all three dosages of fluticasone propionate/salmeterol MDPI treatment produced significant improvements in lung function and other asthma symptoms compared with fluticasone propionate MDPI monotherapy or placebo MDPI. Read More

    Safety and Pharmacokinetics of DS-8500a, a Novel GPR119 Agonist, After Multiple Oral Doses in Healthy Japanese Males.
    Clin Drug Investig 2018 Jun;38(6):519-525
    Clinical Development Department, Daiichi Sankyo Co., Ltd, 1-2-58 Hiromachi, Shinagawa-ku, Tokyo, 140-8710, Japan.
    Background And Objectives: G protein-coupled receptor 119 (GPR119) agonists reduce plasma glucose by promoting insulin secretion in a glucose-dependent manner. We evaluated the safety and pharmacokinetics of multiple oral doses of DS-8500a, a GPR119 agonist, under fed conditions in healthy adult Japanese male subjects.

    Methods: In this Phase 1, randomized, placebo-controlled, double-blind, multiple oral dose study, participants were aged ≥ 20 and ≤ 45 years with a body mass index ≥ 18. Read More

    Interventions and Strategies to Improve Oral Anticoagulant Use in Patients with Atrial Fibrillation: A Systematic Review of Systematic Reviews.
    Clin Drug Investig 2018 Mar 22. Epub 2018 Mar 22.
    School of Pharmacy, Monash University Malaysia, Bandar Sunway, Selangor, Malaysia.
    Introduction: Anticoagulation therapy is the fundamental approach for stroke prevention in atrial fibrillation (AF) patients. Numerous systematic reviews comparing anticoagulation strategies have been published. We aim to summarize the efficacy and safety evidence of these strategies in AF patients from previously published systematic reviews. Read More

    Cardiovascular Mortality of Oral Antidiabetic Drugs Approved Before and After the 2008 US FDA Guidance for Industry: A Systemic Review and Meta-Analysis.
    Clin Drug Investig 2018 Jun;38(6):491-501
    Department of Pharmaceutical Systems and Policy, School of Pharmacy, West Virginia University, Morgantown, WV, 26506, USA.
    Background: Both diabetes and antidiabetic drugs (ADDs) increase the risk for cardiovascular (CV) diseases. Due to the increasing concern about CV safety associated with ADDs, the US FDA revised regulatory guidelines in 2008 to include CV safety as an endpoint.

    Objective: The objective of the current study was to conduct a systematic review with meta-analysis to compare CV mortality of oral ADDs approved before and after the FDA's 2008 guidance. Read More

    Long-Term Response and Remission with Pixantrone in Patients with Relapsed or Refractory Aggressive Non-Hodgkin Lymphoma: Post-Hoc Analysis of the Multicenter, Open-Label, Randomized PIX301 Trial.
    Clin Drug Investig 2018 Jun;38(6):527-533
    MHAT "Hristo Botev", Vratsa, Bulgaria.
    Background: Pixantrone is recommended in relapsed and refractory non-Hodgkin lymphoma (NHL) or heavily pretreated NHL patients. Its conditional approval in Europe was based on results from the open-label, randomized, phase 3 PIX301 study, comparing pixantrone monotherapy with physician's choice of treatment in 140 patients with relapsed or refractory aggressive NHL.

    Methods: This post-hoc analysis of the PIX301 study investigated possible correlations between patient characteristics and clinical response in 17 patients (24%) treated with pixantrone who achieved a complete response (CR) or an unconfirmed complete response (CRu) at study end. Read More

    The Impact of Laparoscopic Sleeve Gastrectomy with Duodenojejunal Bypass on Intestinal Microbiota Differs from that of Laparoscopic Sleeve Gastrectomy in Japanese Patients with Obesity.
    Clin Drug Investig 2018 Jun;38(6):545-552
    Division of Endocrinology, Metabolism, and Nephrology, Department of Internal Medicine, School of Medicine, Keio University, 35 Shinanomachi, Shinjuku, Tokyo, 160-8582, Japan.
    Background And Objectives: Bariatric surgery improves metabolic diseases and alters the intestinal microbiota in animals and humans, but different procedures reportedly have different impacts on the intestinal microbiota. We developed laparoscopic sleeve gastrectomy with duodenojejunal bypass (LSG-DJB) as an alternative to laparoscopic Roux-en-Y gastric bypass (LRYGB) in addition to laparoscopic sleeve gastrectomy (LSG) for Japanese patients with obesity. We investigated the precise change in the intestinal microbiota induced by these procedures in the present study. Read More

    Effect of Sedation Regimen on Weaning from Mechanical Ventilation in the Intensive Care Unit.
    Clin Drug Investig 2018 Jun;38(6):535-543
    Department of Anaesthesiology and Intensive Care, Danderyd Hospital, 18288, Stockholm, Sweden.
    Background: Intensive care unit patients undergoing mechanical ventilation have traditionally been sedated to make them comfortable and to avoid pain and anxiety. However, this may lead to prolonged mechanical ventilation and a longer length of stay.

    Objective: The aim of this retrospective study was to explore whether different sedation regimens influence the course and duration of the weaning process. Read More

    Epoetin Biosimilars in the Treatment of Renal Anemia: What Have We Learned from a Decade of European Experience?
    Clin Drug Investig 2018 Jun;38(6):481-490
    Service de Néphrologie Transplantation Dialyse Aphérèse, Centre Hospitalier Universitaire de Bordeaux, Bordeaux, France.
    Biosimilars are biological medicines that are approved via stringently defined regulatory pathways on the basis that comparable safety, efficacy, and quality have been demonstrated to their reference medicine. The advantage of biosimilar drugs is that they may be less expensive than the reference medicine, allowing for greater patient access and cost savings in already stretched healthcare budgets. Biosimilar epoetins have been available in Europe for a decade. Read More

    A Phase I Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of the Novel Dopamine D1 Receptor Partial Agonist, PF-06669571, in Subjects with Idiopathic Parkinson's Disease.
    Clin Drug Investig 2018 Jun;38(6):509-517
    Pfizer Inc, Cambridge, MA, USA.
    Background And Objectives: There is an unmet medical need for additional treatment options for Parkinson's disease. This was a Phase I, double-blind clinical trial assessing safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple doses of the novel dopamine D1 receptor partial agonist, PF-06669571, in subjects with idiopathic Parkinson's disease on a stable dose of L-DOPA.

    Methods: Subjects received PF-06669571 (or matching placebo) titrated from 1 mg to 3 mg over 7 days. Read More

    Safety of Intravenous Diltiazem in Reduced Ejection Fraction Heart Failure with Rapid Atrial Fibrillation.
    Clin Drug Investig 2018 Jun;38(6):503-508
    William Beaumont School of Medicine, Oakland University, Troy, MI, USA.
    Background And Objective: Diltiazem is a nondihydropyridine calcium channel blocker that is used to control rapid ventricular response in patients who have atrial fibrillation or flutter. Diltiazem has a negative inotropic effect and may cause hemodynamic decompensation in patients with reduced ejection fraction. This study evaluated outcomes in patients who had low ejection fraction and were treated with diltiazem. Read More

    First-Line Cetuximab Monotherapy in KRAS/NRAS/BRAF Mutation-Negative Colorectal Cancer Patients.
    Clin Drug Investig 2018 Jun;38(6):553-562
    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

    Antipsychotic Prescribing and Safety Monitoring Practices in Children and Youth: A Population-Based Study in Alberta, Canada.
    Clin Drug Investig 2018 May;38(5):449-455
    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 May;38(5):457-462
    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 May;38(5):389-400
    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 May;38(5):427-437
    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 May;38(5):439-448
    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 May;38(5):401-415
    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 Apr;38(4):341-351
    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 May;38(5):417-426
    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 Apr;38(4):287-312
    "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 Apr;38(4):367-372
    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


    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 2018 Mar;38(3):219-229
    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 2018 Apr;38(4):353-363
    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

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