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    1575 results match your criteria Clinical drug investigation[Journal]

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    Efficacy and Safety of Tazarotene 0.1% Plus Clindamycin 1% Gel Versus Adapalene 0.1% Plus Clindamycin 1% Gel in Facial Acne Vulgaris: A Randomized, Controlled Clinical Trial.
    Clin Drug Investig 2017 Sep 14. Epub 2017 Sep 14.
    Department of Pharmacology, All India Institute of Medical Sciences (AIIMS), Bhubaneswar, Odisha, India.
    Background: Acne vulgaris is a multifactorial disorder which is ideally treated with combination therapy with topical retinoids and antibiotics.

    Objectives: The present study was conducted to compare the efficacy and safety of tazarotene plus clindamycin against adapalene plus clindamycin in facial acne vulgaris.

    Methods: This study is a randomized, open-label, parallel design clinical trial conducted on 60 patients with facial acne at the outpatient dermatology department in a tertiary healthcare center. Read More

    Genetic Polymorphisms of SLCO1B1, CYP2E1 and UGT1A1 and Susceptibility to Anti-Tuberculosis Drug-Induced Hepatotoxicity: A Chinese Population-Based Prospective Case-Control Study.
    Clin Drug Investig 2017 Sep 12. Epub 2017 Sep 12.
    Clinic and Research Center of Tuberculosis, Shanghai Key Laboratory of Tuberculosis, Shanghai Pulmonary Hospital, Tongji University School of Medicine, No. 507 Zhengmin Road, Yangpu District, Shanghai, 200433, China.
    Background: Drug transporters and drug-metabolizing enzymes have been linked to drug-induced hepatotoxicity. Solute carrier organic anion transporter family member 1B1 (SLCO1B1), cytochrome P450 2E1 (CYP2E1), and UDP glucuronosyltransferase 1A1 (UGT1A1) were selected as candidate genes to explore their association with susceptibility to anti-tuberculosis drug-induced hepatotoxicity (ATDH).

    Methods: Thirty-four tag single nucleotide polymorphisms (tagSNPs) in SLCO1B1, CYP2E1, and UGT1A1 with 10-kb expansion up- and down-stream were genotyped in 461 patients with ATDH and 466 patients without ATDH in a prospective 1:1 matched case-control study. Read More

    Bilateral Salpingo-Oophorectomy Versus GnRH Analogue in the Adjuvant Treatment of Premenopausal Breast Cancer Patients: Cost-Effectiveness Evaluation of Breast Cancer Outcome, Ovarian Cancer Prevention and Treatment.
    Clin Drug Investig 2017 Sep 11. Epub 2017 Sep 11.
    Gynecologic Oncology Unit, Fondazione "Policlinico Universitario A.Gemelli", Catholic University, L.go A. Gemelli 8, 00168, Rome, Italy.
    BACKGROUND AND OBJECTIVE: There is no available evidence to recommend gonadotropin-releasing hormone (GnRH) analogue-based ovarian suppression versus bilateral salpingo-oophorectomy (BSO) in the adjuvant treatment of early breast cancer, since the two approaches are considered equivalent in terms of oncologic outcome. The role of surgical ovarian ablation has been revitalized based on the advances of minimally invasive surgery, and a better understanding of clinical and molecular basis of hereditary breast/ovarian cancer syndromes. The aim of this study is to analyze the cost-effectiveness of laparoscopic BSO and GnRH analogue administration in patients aged 40-49 years with hormone-sensitive breast cancer. Read More

    Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir with or without Ribavirin for Treatment of Hepatitis C Virus Genotype 1: A Systematic Review and Meta-analysis.
    Clin Drug Investig 2017 Sep 4. Epub 2017 Sep 4.
    Pharmacology Department, Faculty of Veterinary Medicine, Suez Canal University, Ismailia, 41522, Egypt.
    Background And Objective: Interferon-free regimens are rapidly evolving for patients with chronic hepatitis C virus (HCV) infection. We performed this meta-analysis to investigate the safety and efficacy of a combination regimen (ombitasvir [OBV]/paritaprevir [PTV]/ritonavir [r] ± dasabuvir [DSV]) for the treatment of patients with HCV genotype 1 infection.

    Methods: A computerized literature search for relevant clinical trials was conducted during May 2017. Read More

    Pharmacokinetic Profiles of Ticagrelor Orodispersible Tablets in Healthy Western and Japanese Subjects.
    Clin Drug Investig 2017 Aug 30. Epub 2017 Aug 30.
    AstraZeneca Pharmaceutical Technology and Development, Gothenburg, Sweden.
    Background And Objectives: Ticagrelor is an antiplatelet agent for patients with acute coronary syndrome or a history of myocardial infarction. Two studies compared pharmacokinetic profiles of orodispersible (OD) ticagrelor tablets versus immediate-release (IR) tablets in Western and Japanese subjects.

    Methods: Both studies were open-label, randomized, crossover, single-center trials. Read More

    Safety of Antiplatelet Agents: Analysis of 'Real-World' Data from the Italian National Pharmacovigilance Network.
    Clin Drug Investig 2017 Aug 30. Epub 2017 Aug 30.
    Department of Biomedical and Biotechnological Sciences, Section of Pharmacology, University of Catania, Via S. Sofia 97, Catania, Italy.
    Introduction: According to the Italian National Report on drug use, thienopyridines (ticlopidine, clopidogrel and prasugrel) and ticagrelor represent the most prescribed antiplatelet agents, beside aspirin. The aim of this study was to analyse the safety profile of these drugs using data from spontaneous reporting of suspected adverse reactions (ADRs).

    Methods: Suspected ADRs for ticlopidine, clopidogrel, prasugrel and ticagrelor, reported on the Italian National Pharmacovigilance Network between January 2009 and December 2016, were included in the analysis. Read More

    Pharmacokinetics of Cromolyn and Ibuprofen in Healthy Elderly Volunteers.
    Clin Drug Investig 2017 Aug 30. Epub 2017 Aug 30.
    AZTherapies, Inc, 222 Berkeley Street, 12th Floor, Boston, MA, 02116, USA.
    BACKGROUND AND OBJECTIVES: The combination of cromolyn and ibuprofen is being investigated as a treatment for early Alzheimer's disease (AD). This study investigated the pharmacokinetics, safety, and tolerability of cromolyn and ibuprofen co-administration in healthy elderly adult volunteers.

    Methods: In this open-labeled study, 26 subjects, aged 55-75 years, received co-administration of inhaled cromolyn (single dose 17. Read More

    Lactate Levels with Chronic Metformin Use: A Narrative Review.
    Clin Drug Investig 2017 Aug 23. Epub 2017 Aug 23.
    Faculty of Health, University of Tasmania, Hobart, Australia.
    Metformin has been associated with lactic acidosis. Lactate levels are not commonly tested in clinical practice, and it is unclear to what extent metformin would typically increase lactate levels with chronic use. The aim of this review was to determine whether regular monitoring of the plasma lactate level would be beneficial in avoiding lactate accumulation and, ultimately, minimising the incidence of lactic acidosis in metformin-treated patients. Read More

    Age-Related Differences in Non-Persistence with Statin Treatment in Patients after a Transient Ischaemic Attack.
    Clin Drug Investig 2017 Aug 8. Epub 2017 Aug 8.
    Independent Pharmaceutical Consultant, 8 Birchdale, Gerrards Cross, Buckinghamshire, SL9 7JA, UK.
    Background And Objective: Non-persistence with secondary preventive measures, including medications such as statins, adversely affects the prospects of successful outcomes. This study was aimed at evaluating non-persistence with statin therapy in cohorts of young and elderly patients after a transient ischaemic attack (TIA) and identifying patient-associated characteristics that influence the risk for non-persistence.

    Methods: The study cohorts included 797 adult patients who were initiated on statin therapy following a TIA diagnosis between 1 January 2010 and 31 December 2010. Read More

    A Randomized Trial to Assess the Effect of Doravirine on the QTc Interval Using a Single Supratherapeutic Dose in Healthy Adult Volunteers.
    Clin Drug Investig 2017 Aug 7. Epub 2017 Aug 7.
    Merck & Co., Inc., RY34-A500, 126 E Lincoln Avenue, Rahway, NJ, 07065, USA.
    Introduction: Doravirine is a novel HIV-1 non-nucleoside reverse transcriptase inhibitor exhibiting a robust safety and efficacy profile in combination with other antiretrovirals. While existing data do not suggest that doravirine delays cardiac repolarization, the aim of this trial was to evaluate the effects of a supratherapeutic dose of doravirine on the heart-rate corrected QT (QTc) interval in healthy adults.

    Methods: A randomized, three-period, crossover, placebo-controlled trial was conducted in healthy adults, 18-55 years of age. Read More

    Effectiveness of Switch to Erythropoiesis-Stimulating Agent (ESA) Biosimilars versus Maintenance of ESA Originators in the Real-Life Setting: Matched-Control Study in Hemodialysis Patients.
    Clin Drug Investig 2017 Aug 4. Epub 2017 Aug 4.
    University "Federico II", Naples, Italy.
    Background: In hemodialysis (HD), switching from erythropoiesis-stimulating agent (ESA) originators to biosimilars is associated with the need for doses approximately 10% higher, according to industry-driven studies.

    Objective: The aim of this study was to evaluate the efficacy on anemia control of switching from ESA originators to biosimilars in daily clinical practice.

    Methods: We retrospectively selected consecutive HD patients receiving stable intravenous ESA doses, and who had not been transfused in the previous 6 months, from 12 non-profit Italian centers. Read More

    Acetaminophen (Paracetamol) Induces Hypothermia During Acute Cold Stress.
    Clin Drug Investig 2017 Aug 1. Epub 2017 Aug 1.
    ASPETAR, Qatar Orthopaedic and Sports Medicine Hospital, Athlete Health and Performance Research Centre, Aspire Zone, Doha, Qatar.
    Background: Acetaminophen is an over-the-counter drug used to treat pain and fever, but it has also been shown to reduce core temperature (T c) in the absence of fever. However, this side effect is not well examined in humans, and it is unknown if the hypothermic response to acetaminophen is exacerbated with cold exposure.

    Objective: To address this question, we mapped the thermoregulatory responses to acetaminophen and placebo administration during exposure to acute cold (10 °C) and thermal neutrality (25 °C). Read More

    Effects of Central Nervous System Drugs on Recovery After Stroke: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.
    Clin Drug Investig 2017 Jul 29. Epub 2017 Jul 29.
    Department of Pharmacy, Faculty of Science, National University of Singapore, 18 Science Drive 4, Singapore, 117543, Singapore.
    Background And Objective: Pilot trials have suggested that pharmacotherapy may aid stroke recovery. The aim of this study was to systematically review the effects of antidepressants, anti-Alzheimer drugs, anti-Parkinson drugs, central nervous system (CNS) stimulants and piracetam on gross motor function, cognition, disability, dependency and quality of life (QOL) after stroke.

    Methods: PubMed, EMBASE and the Cochrane Central Register of Controlled Trials databases were searched, and 44 randomized controlled trials that compared outcomes of interest between drug treatment and placebo or no treatment were included. Read More

    Nusinersen: The First Option Beyond Supportive Care for Spinal Muscular Atrophy.
    Clin Drug Investig 2017 Jul 28. Epub 2017 Jul 28.
    Department of Pharmacology, All India Institute of Medical Sciences, New Delhi, 110029, India.
    Spinal muscular atrophy (SMA) is an autosomal recessive neuromuscular disorder characterized by degeneration of spinal motor neurons and poses significant adverse outcome in affected population. Survival motor neuron 1 (SMN1) protein encoded by SMN1 gene located on 5q(13) is critical for survival and functioning of motor neurons. Almost identical gene SMN2, present on the same chromosome, produces a small truncated protein (SMN2) because of skipping of exon 7 from translation due to translation silent C6U substitution in exon 7 of SMN2 pre-mRNA transcript. Read More

    Novel Biologic Agents Targeting Interleukin-23 and Interleukin-17 for Moderate-to-Severe Psoriasis.
    Clin Drug Investig 2017 Jul 28. Epub 2017 Jul 28.
    Department of Dermatology, Shanghai Tenth People's Hospital, Tongji University School of Medicine, No. 301, Middle Yanchang Road, Jing'an District, Shanghai, 200072, China.
    Psoriasis is a common, chronic inflammatory skin disease and cannot be cured. The treatment of moderate-to-severe plaque psoriasis has been revolutionized with the development of biologic agents for nearly 20 years. Current studies show that interleukin-23 and interleukin-17 play remarkable roles in the pathogenesis of psoriasis. Read More

    Pharmacokinetics of DFN-15, a Novel Oral Solution of Celecoxib, Versus Celecoxib 400-mg Capsules: A Randomized Crossover Study in Fasting Healthy Volunteers.
    Clin Drug Investig 2017 Jul 26. Epub 2017 Jul 26.
    Center for Translational Medicine, University of Maryland, Baltimore, MD, USA.
    Background: COX-2 inhibitors can be effective for acute migraine, but none is supplied in a rapidly absorbed, ready-to-use oral liquid formulation. DFN-15, a novel oral liquid formulation of celecoxib, is being developed for the acute treatment of migraine with or without aura. Clinical studies with this formulation are ongoing. Read More

    Prescription Drug Price Paradox: Cost Analysis of Canadian Online Pharmacies versus US Medicare Beneficiaries for the Top 100 Drugs.
    Clin Drug Investig 2017 Jul 22. Epub 2017 Jul 22.
    School of Pharmacy, University of Texas at El Paso, 500 W. University Ave, El Paso, TX, 79968, USA.
    Background And Objectives: Despite the introduction of Medicare Part D (MPD) and 2012 Affordable Care Act (ACA), patients have a cost burden due to increases in drug prices. To overcome cost barriers, some patients purchase their medications from Canadian online pharmacies as Canadian prescription drug prices are believed to be lower than US prescription drug prices. The objective of this study was to determine which top 100 Medicare drugs can be imported to the USA legally, and to determine which type of prescription drug would be more beneficial to be purchased from Canadian online pharmacies. Read More

    Effectiveness, Adverse Effects and Drug Compliance of Long-Acting Injectable Risperidone in Children and Adolescents.
    Clin Drug Investig 2017 Jul 19. Epub 2017 Jul 19.
    Child and Adolescent Psychiatry Department, Ankara Pediatric and Pediatric Hematology Oncology Training and Research Hospital, Ankara, Turkey.
    Background And Objectives: Although the use of oral risperidone in children and adolescents has been well studied, there is little information on the intramuscular use of long-acting injectable risperidone (LAIR). The aims of this study were to investigate the effectiveness and adverse effects of LAIR in children and adolescents with conduct disorder, bipolar disorder, and schizophrenia.

    Methods: In total, 42 patients (age range 12-17 years) who were non-adherent to oral antipsychotic drugs, received 25 mg of LAIR intramuscularly every 2 weeks. Read More

    Interventions for Refractory Trigeminal Neuralgia: A Bayesian Mixed Treatment Comparison Network Meta-Analysis of Randomized Controlled Clinical Trials.
    Clin Drug Investig 2017 Jul 17. Epub 2017 Jul 17.
    Department of Oral Health, College of Medicine, Nursing and Health Sciences, Fiji National University, Suva, Fiji.
    Introduction: Patients with trigeminal neuralgia (TN) are often refractory to recommended first-line agents. Due to the absence of a systematic review, we undertook a network meta-analysis to assess various interventions that can be used to manage refractory TN.

    Methods: Electronic databases were searched using appropriate strategies to identify randomized controlled clinical trials in patients with refractory TN, evaluating the proportion of patients with a minimum of 50% reduction in pain or a minimum of 2 cm reduction in score in an appropriate pain scale or complete pain relief by subjective pain scales. Read More

    Single- and Multiple-Dose Pharmacokinetics, Safety and Tolerability of Lurasidone in Healthy Chinese Subjects.
    Clin Drug Investig 2017 Jul 10. Epub 2017 Jul 10.
    Phase I Clinical Research Unit, Shanghai Xuhui Central Hospital, No. 966, Huaihai Rd.(M), Shanghai, 200031, China.
    Background And Objective: The pharmacokinetics of lurasidone have been studied in healthy Japanese and Caucasian subjects, but not in Chinese subjects. The objective of this study was to evaluate the pharmacokinetics, safety, and tolerability of oral lurasidone in healthy Chinese subjects.

    Methods: This single-center, randomized, parallel-group, placebo-controlled, and double-blind study evaluated the pharmacokinetics, safety, and tolerability of oral lurasidone administered as a single dose (20, 40, and 80 mg) and multiple doses for 5 days (40 mg administered once daily) in healthy Chinese subjects. Read More

    Effect of Degarelix, a Gonadotropin-Releasing Hormone Receptor Antagonist for the Treatment of Prostate Cancer, on Cardiac Repolarisation in a Randomised, Placebo and Active Comparator Controlled Thorough QT/QTc Trial in Healthy Men.
    Clin Drug Investig 2017 Jun 28. Epub 2017 Jun 28.
    Ferring Pharmaceuticals A/S, Kay Fiskers Plads 11, 2100, Copenhagen, Denmark.
    Background And Objectives: Degarelix is a gonadotropin-releasing hormone antagonist registered for the treatment of advanced hormone-dependent prostate cancer. Treatment causing androgen deprivation is associated with QT prolongation and this study investigated whether degarelix at supratherapeutic concentrations has an intrinsic effect per se on cardiac repolarisation and the QT interval.

    Methods: This was a single-centre, randomised, crossover study comparing the effect of degarelix, placebo, and the positive control moxifloxacin on the QT interval. Read More

    Economic Evaluation of Tobramycin Inhalation Powder for the Treatment of Chronic Pulmonary Pseudomonas aeruginosa Infection in Patients with Cystic Fibrosis.
    Clin Drug Investig 2017 Aug;37(8):795-805
    Novartis Pharmaceuticals Corporation, One Health Plaza, East Hanover, NJ, 07936, USA.
    Background: Chronic lung infection with Pseudomonas aeruginosa occurs in approximately 50% of patients with cystic fibrosis (CF). This infection further compromises lung function, and significantly contributes to the increased healthcare costs.

    Objectives: Inhaled tobramycin, used to manage P. Read More

    Basal and Bolus Insulin Dose Changes after Switching Basal Insulin to Insulin Degludec in Patients with Type 1 Diabetes Mellitus: A Pilot Study.
    Clin Drug Investig 2017 Jun 17. Epub 2017 Jun 17.
    Center for Diabetes and Endocrinology, The Tazuke Kofukai Foundation, Medical Research Institute, Kitano Hospital, Osaka, Japan.
    Background And Objectives: Ultra-long-acting insulin degludec (DEG) has a longer duration of action and less daily variability relative to other basal insulin (BI), and thus may benefit patients with type 1 diabetes mellitus (T1DM). We examined the impact of switching BI to DEG on glycemic control and insulin dose in T1DM.

    Methods: T1DM patients (n = 22; six male; mean age: 64. Read More

    Assessment of the Impact of L-Thyroxine Therapy on Bleeding Risk in Patients Receiving Vitamin K Antagonists.
    Clin Drug Investig 2017 Jun 13. Epub 2017 Jun 13.
    Emergency Department, Clermont-Ferrand University Hospital, 58 Rue Montalembert, 63003, Clermont-Ferrand, France.
    Background: Several studies have suggested a link exists between L-thyroxine and the coagulation system, and, according to some drug interaction studies, L-thyroxine can potentiate the effect of warfarin. This study sought to assess whether thyroid hormone therapy could impact the risk of bleeding in patients receiving vitamin K antagonists (VKAs).

    Methods: We conducted a monocentric, retrospective study on prospectively collected data from consecutive patients enrolled in the Registry of patient with AntiThrombotic agents admitted to an Emergency Department (RATED) database, and compared the hemorrhage rates (both major and nonmajor) of patients receiving treatment with and without L-thyroxine. Read More

    Cost-Effectiveness Analysis of Rivaroxaban for Treatment of Deep Vein Thrombosis and Pulmonary Embolism in Greece.
    Clin Drug Investig 2017 Jun 12. Epub 2017 Jun 12.
    Department of Health Services Organization and Management, National School of Public Health, 196 Alexandras Avenue, 11521, Athens, Greece.
    Background And Objective: Venous thromboembolism (VTE), comprising deep-vein thrombosis (DVT) and pulmonary embolism (PE), is a major healthcare concern that results in substantial morbidity and mortality with great economic burden for healthcare systems. Hence, the need for effective and efficient treatment of patients with VTE is important for both clinical and economic reasons. The objective of this study was to evaluate the cost effectiveness of rivaroxaban compared to standard of care (SoC) with enoxaparin followed by dose-adjusted vitamin-K antagonists for the treatment of DVT and PE in Greece. Read More

    Potential Role of Allopurinol in Preventing Contrast-Induced Nephropathy in Patients Undergoing Percutaneous Coronary Intervention: A Randomized Placebo-Controlled Trial.
    Clin Drug Investig 2017 Jun 12. Epub 2017 Jun 12.
    Tehran Heart Center, Tehran University of Medical Sciences, Tehran, Iran.
    Background: Contrast-induced nephropathy (CIN) is a major drawback in percutaneous coronary intervention (PCI). Significant uricosuria has been reported following contrast exposure. Allopurinol-a xanthine oxidase inhibitor-has been suggested to prevent the formation of oxygen-free radicals, which may contribute to CIN. Read More

    Effectiveness of Lipid-Lowering Statin Therapy in Patients With and Without Psoriasis.
    Clin Drug Investig 2017 Aug;37(8):775-785
    Pfizer Inc, 445 Eastern Point Road, Groton, CT, 06340, USA.
    Background: Psoriasis is associated with dyslipidemia and metabolic syndrome, and has been linked to an increased cardiovascular risk. The aim of this study was to compare baseline characteristics and effects of statin therapy on lipid levels and cardiovascular outcomes in patients with and without psoriasis.

    Methods: This post-hoc analysis assessed patients from one primary cardiovascular prevention statin trial (Collaborative AtoRvastatin Diabetes Study [CARDS]) and two secondary cardiovascular prevention statin trials (Treating to New Targets [TNT] and Incremental Decrease in End Points Through Aggressive Lipid Lowering [IDEAL]). Read More

    Decrease in Switches to 'Unsafe' Proton Pump Inhibitors After Communications About Interactions with Clopidogrel.
    Clin Drug Investig 2017 Aug;37(8):787-794
    Department of Clinical Pharmacy, Medisch Spectrum Twente, Enschede, The Netherlands.
    Background: In 2009 and 2010 medicines regulatory agencies published official safety statements regarding the concomitant use of proton pump inhibitors and clopidogrel. We wanted to investigate a change in prescription behaviour in prevalent gastroprotective drug users (2008-2011).

    Methods: Data on drug use were retrieved from the Out-patient Pharmacy Database of the PHARMO Database Network. Read More

    Surfactants in Acute Respiratory Distress Syndrome in Infants and Children: Past, Present and Future.
    Clin Drug Investig 2017 Aug;37(8):729-736
    Chiesi Farmaceutici Spa, Parma, Italy.
    There is a lack of definitive data on the effective management of acute respiratory distress syndrome (ARDS) in infants and children. The development and validation of the Berlin definition (BD) for ARDS and the Pediatric Acute Lung Injury Consensus Conference (PALICC) recommendations in children represented a major advance in optimizing research and treatment, mainly due to the introduction of a severe ARDS category. Proposed reasons for the lack of consistent results with surfactants in children and infants compared with neonates include different causes, type of lung damage (direct or indirect), timing and mode of administration as well as the type of surfactant used. Read More

    Treatment of Bipolar Disorder in a Lifetime Perspective: Is Lithium Still the Best Choice?
    Clin Drug Investig 2017 Aug;37(8):713-727
    Mood Disorder Lucio Bini Center, Cagliari, Rome, Italy.
    Lithium preparations have been successfully used to treat bipolar disorder (BD), and remain the best established long-term treatment for the disorder. In fact, lithium is a cornerstone of treatment to minimize the risk of recurrences and improve inter-episodic symptomatology. We reviewed the available evidence for the use of lithium in the treatment of BD, including its efficacy, limitations, and potential benefits also in consideration of the different formulations available. Read More

    Prevalence of Gabapentin Abuse: Comparison with Agents with Known Abuse Potential in a Commercially Insured US Population.
    Clin Drug Investig 2017 Aug;37(8):763-773
    Department of Pharmacy Practice, College of Pharmacy-Glendale, Midwestern University, 19555 N. 59th Avenue, Glendale, AZ, 85308, USA.
    Background: Despite international calls to make gabapentin a controlled substance, studies of gabapentin use/abuse patterns are limited to small/high-risk samples and adverse event reports.

    Objective: The aim of this study was to conduct a systematic assessment of the abuse potential/prevalence of gabapentin in a large sample.

    Data Source: Truven Health MarketScan(®) Commercial Claims and Encounters database, years 2013-2015. Read More

    Prescription Appropriateness of Cyproterone Acetate/Ethinylestradiol in Primary Care: A Population-Based Study in Italy.
    Clin Drug Investig 2017 Aug;37(8):755-762
    Dermatology and Venereology Private Practice, Bari, Italy.
    Background And Objective: We evaluated the prescription appropriateness of cyproterone acetate in combination with ethinylestradiol (CPA/EE) in a primary care setting before and after the 2013 European Medicines Agency's (EMA) recommendation relating to the risk profile of CPA/EE.

    Methods: Data were obtained from the Health Search IMS Health Longitudinal Patient Database (HSD). We compared the results from 2011 to 2012 with the results of 2014, namely before and after the 2013 EMA recommendation, and investigated the burden of concurrent use of CPA/EE and other hormonal contraceptives (HCs) and the reported indication at the time of CPA/EE prescription. Read More

    Can Long-Term Pharmacotherapy Prevent Relapses in Generalized Anxiety Disorder? A Systematic Review.
    Clin Drug Investig 2017 Aug;37(8):737-743
    Federal University of Rio de Janeiro, R. Timóteo da Costa 444/604, Rio de Janeiro, RJ, 22440-034, Brazil.
    Background And Objectives: Generalized anxiety disorder (GAD) is a persistent anxiety disorder with a high rate of relapse. While several trials have demonstrated the efficacy of pharmacotherapy for GAD treatment, fewer studies have investigated its efficacy in preventing symptom relapse in long-term treatment. The aim of this study is to evaluate if long-term pharmacotherapy may prevent relapses in GAD patients. Read More

    Pharmacokinetics, Safety, and Tolerability of Single and Multiple Doses of Guanfacine Extended-Release Formulation in Healthy Japanese and Caucasian Male Adults.
    Clin Drug Investig 2017 Aug;37(8):745-753
    Clinical Pharmacology and Pharmacokinetics, Project Management Department, Shionogi & Co., Ltd., 12F Hankyu Terminal Bldg., 1-4, Shibata 1-chome, Kita-ku, Osaka, 530-0012, Japan.
    Background And Objective: Guanfacine extended-release (guanfacine XR) could be a useful treatment option for children and adolescent patients with attention-deficit/hyperactivity disorder (ADHD). As an initial step in the development in Japan, the pharmacokinetics, safety and tolerability were assessed in healthy Japanese and non-Hispanic Caucasian adults.

    Methods: A Phase 1, double-blind, randomized, placebo-controlled, single- and multiple-oral dose escalation study of guanfacine XR was conducted. Read More

    Relationship Between the Expression of O(6)-Methylguanine-DNA Methyltransferase (MGMT) and p53, and the Clinical Response in Metastatic Pancreatic Adenocarcinoma Treated with FOLFIRINOX.
    Clin Drug Investig 2017 Jul;37(7):669-677
    Department of Gastroenterology, University Hospital Centre, Angers, France.
    Background: To date, no predictive biomarker for the efficacy of FOLFIRINOX in metastatic pancreatic adenocarcinoma has been demonstrated. Deficiency in O(6)-methylguanine-DNA methyltransferase (MGMT) has been associated with a therapeutic response in endocrine tumors of the pancreas and the lack of expression of protein 53 (p53) could interfere with the action of MGMT.

    Objective: The aim of our study was to assess the prevalence of MGMT and p53 in patients with metastatic pancreatic adenocarcinoma treated with FOLFIRINOX as a first-line treatment and to investigate their association with therapeutic response and survival. Read More

    Evaluation of the Pharmacokinetics and Pharmacodynamics of Prasugrel in Japanese Elderly Subjects.
    Clin Drug Investig 2017 Jul;37(7):679-685
    Safety and Risk Management Department, Daiichi Sankyo Co., Ltd., Tokyo, Japan.
    Background And Objective: An increased incidence in bleeding events has been reported in Western elderly patients receiving prasugrel. Therefore, doses in Japanese elderly subjects need to be carefully determined. We assessed the pharmacokinetic and pharmacodynamic effects of prasugrel at the clinical dose used in Japan in healthy Japanese elderly subjects compared with non-elderly subjects. Read More

    Efficacy of Interferon-Free Therapies for Chronic Hepatitis C: A Systematic Review of All Randomized Clinical Trials.
    Clin Drug Investig 2017 Jul;37(7):635-646
    Department of Pharmacy, Pharmaceutical Sciences Postgraduate Program, Universidade Federal do Paraná, Av. Pref. Lothario Meissner, 632, Jardim Botânico, Curitiba, PR, 80210170, Brazil.
    Background And Objectives: Second-generation direct-acting antivirals (DAAs) have recently arisen as more effective and safer treatments for chronic hepatitis C. These drugs can be combined into treatments without interferon (IFN), and are therefore called IFN-free therapies.

    Objective: The objective of this study systematic review was to evaluate the efficacy of IFN-free therapies for the treatment of chronic hepatitis C, and thus increase the clinical evidence for these therapies. Read More

    Oral Teicoplanin as an Alternative First-Line Regimen in Clostridium difficile Infection in Elderly Patients: A Case Series.
    Clin Drug Investig 2017 Jul;37(7):699-703
    Pharmacie Hospitalière, Hôpital Universitaire Raymond-Poincaré, AP-HP, 92380, Garches, France.
    Background: Elderly patients are more susceptible to Clostridium difficile infections (CDIs). Despite existing guidelines, there is no specific treatment for CDI in geriatrics. Vancomycin is commonly used in the treatment of CDI. Read More

    Disease Burden, Early Discontinuation, and Healthcare Costs in Hepatitis C Patients with and without Chronic Kidney Disease Treated with Interferon-Free Direct-Acting Antiviral Regimens.
    Clin Drug Investig 2017 Jul;37(7):687-697
    Health Economics and Outcomes Research, Optum, 11000 Optum Circle, Eden Prairie, MN, 55344, USA.
    Background: Hepatitis C virus (HCV) is a risk factor for chronic kidney disease (CKD) and end-stage renal disease (ESRD). Direct-acting antiviral agents (DAAs) have improved HCV management in CKD patients, however real-world clinical practice data are limited.

    Objective: This study examined the prevalence of CKD among HCV patients receiving oral DAAs in a real-world setting. Read More

    Current Clinical Trials on the Use of Ceftaroline in the Pediatric Population.
    Clin Drug Investig 2017 Jul;37(7):625-634
    Department of Pharmacy, Moses H. Cone Memorial Hospital, 1200 N. Elm St, Greensboro, NC, 27401, USA.
    The rate of antibiotic resistance in children continues to rise requiring the use of new antibiotics. Ceftaroline fosamil, a newer-generation cephalosporin, was recently approved for the treatment of acute bacterial skin and skin structure infections and community-acquired bacterial pneumonia in children aged >2 months. Ceftaroline provides coverage against staphylococcal and streptococcal infections, including methicillin-resistant Staphylococcus aureus and penicillin-resistant Streptococcus pneumoniae. Read More

    Exposure-Safety Response Relationship for Ombitasvir, Paritaprevir/Ritonavir, Dasabuvir, and Ribavirin in Patients with Chronic Hepatitis C Virus Genotype 1 Infection: Analysis of Data from Five Phase II and Six Phase III Studies.
    Clin Drug Investig 2017 Jul;37(7):647-657
    Research and Development, Clinical Pharmacology and Pharmacometrics, AbbVie, Inc., Department R4PK, Building AP31-3, 1 North Waukegan Road, North Chicago, IL, 60064, USA.
    Background And Objectives: All-oral direct-acting antiviral regimens that include combinations of ombitasvir, paritaprevir, ritonavir, and dasabuvir with or without ribavirin were evaluated in hepatitis C virus-infected patients in phase II/III clinical studies. The objective of these analyses was to quantify the relationship between exposures of the components of the regimen and laboratory values and to determine covariates that could influence the relationship.

    Methods: Exposure-safety response relationships between individual components of the direct-acting antiviral regimens and clinically important laboratory values were explored using data from 2998 patients from 11 phase II/III clinical studies. Read More

    Acid-Suppressive Therapy and Risk of Infections: Pros and Cons.
    Clin Drug Investig 2017 Jul;37(7):587-624
    The Canberra Hospital, ACT Health, Canberra, Australia.
    This narrative review summarises the benefits, risks and appropriate use of acid-suppressing drugs (ASDs), proton pump inhibitors and histamine-2 receptor antagonists, advocating a rationale balanced and individualised approach aimed to minimise any serious adverse consequences. It focuses on current controversies on the potential of ASDs to contribute to infections-bacterial, parasitic, fungal, protozoan and viral, particularly in the elderly, comprehensively and critically discusses the growing body of observational literature linking ASD use to a variety of enteric, respiratory, skin and systemic infectious diseases and complications (Clostridium difficile diarrhoea, pneumonia, spontaneous bacterial peritonitis, septicaemia and other). The proposed pathogenic mechanisms of ASD-associated infections (related and unrelated to the inhibition of gastric acid secretion, alterations of the gut microbiome and immunity), and drug-drug interactions are also described. Read More

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