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    1601 results match your criteria Clinical drug investigation[Journal]

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    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 2017 Nov 2. Epub 2017 Nov 2.
    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 2017 Nov 1. Epub 2017 Nov 1.
    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 2017 Oct 31. Epub 2017 Oct 31.
    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 2017 Oct 30. Epub 2017 Oct 30.
    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 2017 Oct 28. Epub 2017 Oct 28.
    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 2017 Oct 28. Epub 2017 Oct 28.
    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 2017 Oct 27. Epub 2017 Oct 27.
    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 2017 Oct 27. Epub 2017 Oct 27.
    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 2017 Oct 27. Epub 2017 Oct 27.
    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 drugs 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 drugs 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 2017 Oct 25. Epub 2017 Oct 25.
    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 2017 Oct 24. Epub 2017 Oct 24.
    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 2017 Oct 14. Epub 2017 Oct 14.
    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 2017 Oct 13. Epub 2017 Oct 13.
    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 2017 Oct 11. Epub 2017 Oct 11.
    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, PPARα activation 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 PPARα and moderate PPARγ activity 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

    A Comparison of Adverse Drug Reaction Profiles in Patients on Antiretroviral and Antitubercular Treatment in Zimbabwe.
    Clin Drug Investig 2017 Sep 30. Epub 2017 Sep 30.
    Department of Clinical Pharmacology, College of Health Sciences, University of Zimbabwe, P O Box A178, Avondale, Harare, Zimbabwe.
    Introduction: Few studies describe the adverse drug event profiles in patients simultaneously receiving antiretroviral and anti-tubercular medicines in resource-limited countries.

    Objectives: To describe and compare the adverse drug reaction profiles in patients on highly active antiretroviral therapy only (HAART), HAART and isoniazid preventive therapy (HHART), and HAART and antitubercular treatment (ATTHAART).

    Methods: We analysed individual case safety reports (ICSRs) for patients on antiretroviral therapy and antitubercular treatment submitted to the national pharmacovigilance centre during the targeted spontaneous reporting (TSR) programme from 1 September 2012 through 31 August 2016. Read More

    Acetazolamide as Add-on Diuretic Therapy in Exacerbations of Chronic Heart Failure: a Pilot Study.
    Clin Drug Investig 2017 Dec;37(12):1175-1181
    Cardiology Department, Postgraduate Medical School, Grenadierow 51/59, 04-073, Warsaw, Poland.
    Background: Congestion is the main cause of morbidity in patients with heart failure. Treatment of fluid overload is often challenging in everyday clinical practice.

    Objective: The aim of this study was to determine the diuretic effect of acetazolamide in patients with exacerbations of chronic heart failure, in addition to their stable diuretic therapy. Read More

    Effect of Food on the Pharmacokinetics of Single- and Multiple-Dose Hydrocodone Extended Release in Healthy Subjects.
    Clin Drug Investig 2017 Dec;37(12):1153-1163
    Teva Pharmaceuticals, 5 Basel St, 42504, Netanya, Israel.
    Background And Objectives: Food intake can alter the pharmacokinetics of certain medications, including changes in their oral bioavailability, which is of particular concern for extended-release (ER) opioids because of the high drug loads. Two randomized, open-label studies assessed the effect of food on the pharmacokinetics of single and multiple doses of hydrocodone ER formulated with CIMA(®) Abuse-Deterrence Technology.

    Methods: Healthy subjects in fed and fasted states received single 90-mg doses of hydrocodone ER (Studies 1 and 2) or multiple doses of hydrocodone ER (45 mg twice daily on days 2-3, 60 mg twice daily on days 4-5, 90 mg twice daily on days 6-10, and 90 mg once in the morning on day 11) (Study 2). Read More

    In Vitro Drug Release After Crushing: Evaluation of Xtampza(®) ER and Other ER Opioid Formulations.
    Clin Drug Investig 2017 Dec;37(12):1117-1124
    Collegium Pharmaceutical, Inc., 780 Dedham St, Ste 800, Canton, MA, 02021, USA.
    Background And Objective: Extended-release (ER) opioids are associated with high rates of abuse. Recreational opioid users often manipulate ER formulations to achieve a high plasma concentration in a short amount of time, resulting in a more rapid and intense high. Patients may also manipulate ER tablets to facilitate swallowing, without recognizing that manipulation could increase release rate. Read More

    Methodological Considerations for Comparison of Brand Versus Generic Versus Authorized Generic Adverse Event Reports in the US Food and Drug Administration Adverse Event Reporting System (FAERS).
    Clin Drug Investig 2017 Dec;37(12):1143-1152
    Department of Health Outcomes Research and Policy, Harrison School of Pharmacy, Auburn University, 2316 Walker Building, Auburn, AL, 36849, USA.
    Background: The US Food and Drug Administration Adverse Event Reporting System (FAERS), a post-marketing safety database, can be used to differentiate brand versus generic safety signals.

    Objective: To explore the methods for identifying and analyzing brand versus generic adverse event (AE) reports.

    Methods: Public release FAERS data from January 2004 to March 2015 were analyzed using alendronate and carbamazepine as examples. Read More

    Role of Ramelteon in Reduction of As-Needed Antipsychotics in Elderly Patients with Delirium in a General Hospital Setting.
    Clin Drug Investig 2017 Dec;37(12):1137-1141
    Department of Clinical Health Professions, St. John's University, Queens, NY, USA.
    Background And Objective: Abnormalities in melatonin levels have been linked to delirium. This dysregulation may be offset with the use of ramelteon, a melatonin receptor agonist. The purpose of this study was to evaluate the role of ramelteon in decreasing the need for as-needed (PRN) use of antipsychotics in elderly patients with delirium. Read More

    Pharmacokinetics and Preliminary Pharmacodynamics of Single- and Multiple-dose Lyophilized Recombinant Glucagon-like Peptide-1 Receptor Agonist (rE-4) in Chinese Patients with Type 2 Diabetes Mellitus.
    Clin Drug Investig 2017 Dec;37(12):1107-1115
    Department of Pharmacy, Peking University People's Hospital, No. 11 Xizhimen South Street, Xicheng District, Beijing, 100044, China.
    Background And Objectives: Recombinant glucagon-like peptide-1 receptor agonist (rE-4) is a glucagon-like peptide-1 receptor agonist, which has the same amino acid sequence to exenatide, except for the C-terminal deamidated. This study assessed the pharmacokinetics and preliminary pharmacodynamics of rE-4, following single and multiple subcutaneous injections in Chinese patients with type 2 diabetes mellitus (T2DM).

    Design And Methods: In the randomized, open-label study, Chinese patients with T2DM (n = 36) were randomly assigned to three groups of rE-4 (n = 12), rE-4 with metformin (n = 12) and exenatide (n = 12, as the control group) for 12 weeks. Read More

    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 Nov;37(11):1083-1091
    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 Dec;37(12):1125-1136
    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 Nov;37(11):1093-1102
    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 Nov;37(11):1009-1023
    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 Nov;37(11):1035-1045
    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 Nov;37(11):1067-1081
    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 Nov;37(11):1025-1034
    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 Nov;37(11):991-1007
    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 Nov;37(11):1047-1054
    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 Oct;37(10):975-984
    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 Oct;37(10):965-973
    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 Nov;37(11):1055-1065
    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 Oct;37(10):901-928
    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 Oct;37(10):891-899
    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 Oct;37(10):937-946
    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 Oct;37(10):957-963
    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 Oct;37(10):947-956
    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

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