1,764 results match your criteria Clinical drug investigation[Journal]


Admissions and Cost of Hospitalisation of Phenylketonuria: Spanish Claims Database Analysis.

Clin Drug Investig 2019 Feb 18. Epub 2019 Feb 18.

BCN Health Economics and Outcomes Research S.L., Barcelona, Spain.

Background: Phenylketonuria is a well-known rare disease included in the neonatal screening of many countries. Therefore, there are few published data on the admissions and costs of phenylketonuria in Spain.

Objective: The objective of this study was to assess the number of admissions and the economic burden of phenylketonuria in Spain. Read More

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http://dx.doi.org/10.1007/s40261-019-00760-1DOI Listing
February 2019

Targeting Immune Checkpoints in Lung Cancer: Current Landscape and Future Prospects.

Clin Drug Investig 2019 Feb 16. Epub 2019 Feb 16.

Department of Pathology, School of Basic Medical Science, Wuhan University, 185 Donghu Road, Medical Building 8, 10th Floor, Wuchang District, Wuhan, 430071, Hubei, People's Republic of China.

Lung cancer is the most prevalent and deadly cancer worldwide. Immune checkpoint therapy, which targets regulatory pathways in T cells to boost anti-tumor immune response, has revolutionized lung cancer treatment paradigms. Inhibitors of the most established immune checkpoints such as programmed death-1 (PD-1)/PD-ligand 1 (PD-L1) have been approved by the US Food and Drug Administration in the management of lung cancer. Read More

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http://dx.doi.org/10.1007/s40261-018-00746-5DOI Listing
February 2019

Bevacizumab Plus Direct Oral Anticoagulant Therapy in Ovarian Cancer Patients with Distal Deep Vein Thrombosis.

Clin Drug Investig 2019 Feb 8. Epub 2019 Feb 8.

Department of Obstetrics and Gynecology, Toho University Faculty of Medicine, 6-11-1 Omorinishi, Ota-ku, Tokyo, 143-8541, Japan.

Background And Objective: Administration of bevacizumab to ovarian cancer patients with distal deep vein thrombosis (DVT) is problematic because of lack of evidence about the likely outcomes. We conducted a preliminary study in ovarian cancer patients with DVT who received bevacizumab combined with a direct oral anticoagulant (DOAC).

Methods: We retrospectively investigated patients with advanced or recurrent epithelial ovarian cancer and distal DVT diagnosed by ultrasonography who underwent chemotherapy containing bevacizumab (15 mg/kg every 3 weeks) combined with DOAC therapy. Read More

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http://dx.doi.org/10.1007/s40261-019-00757-wDOI Listing
February 2019
1 Read

Efficacy and Safety of Loxoprofen Hydrogel Transdermal Patch Versus Loxoprofen Tablet in Chinese Patients with Myalgia: A Double-Blind, Double-Dummy, Parallel-Group, Randomized, Controlled, Non-Inferiority Trial.

Clin Drug Investig 2019 Feb 6. Epub 2019 Feb 6.

Department of Rheumatology and Immunology, Peking University People's Hospital, No. 11 Xizhimen South Street, Xicheng District, Beijing, People's Republic of China.

Background And Objective: Loxoprofen (LOX) is a nonsteroidal anti-inflammatory drug (NSAID). Although oral administration of LOX has been widely prescribed, clinical guidelines for osteoarthritis generally recommend topical rather than oral NSAIDs in specific patients. However, there is limited information on the effects of loxoprofen sodium oral (LOX-O) versus loxoprofen sodium hydrogel transdermal patch (LOX-T) in myalgia patients. Read More

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http://link.springer.com/10.1007/s40261-019-00756-x
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http://dx.doi.org/10.1007/s40261-019-00756-xDOI Listing
February 2019
7 Reads

Correction to: Neratinib in Early-Stage Breast Cancer: A Profile of Its Use in the EU.

Authors:
Sohita Dhillon

Clin Drug Investig 2019 Feb;39(2):231

Springer, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand.

An Online First version of this article was made available online at. Read More

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http://dx.doi.org/10.1007/s40261-019-00758-9DOI Listing
February 2019

Correction to: Relative and Absolute Risk of Tendon Rupture with Fluoroquinolone and Concomitant Fluoroquinolone/Corticosteroid Therapy: Population-Based Nested Case-Control Study.

Clin Drug Investig 2019 Feb;39(2):215

Pharmacovigilance and Epidemiology Department, European Medicines Agency, London, UK.

The article Relative and Absolute Risk of Tendon Rupture with Fluoroquinolone and Concomitant Fluoroquinolone/Corticosteroid Therapy: Population-Based Nested Case-Control Study, written by Morales DR, Slattery J, Pacurariu A, Pinheiro L, McGettigan P, Kurz X, was originally published Online First without open access. Read More

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http://dx.doi.org/10.1007/s40261-019-00755-yDOI Listing
February 2019

Investigation on Dabigatran Etexilate and Worsening of Renal Function in Patients with Atrial fibrillation: The IDEA Study.

Clin Drug Investig 2019 Jan 29. Epub 2019 Jan 29.

Department of Clinical Sciences and Community Health, Laboratory of Medical Statistics, Epidemiology, and Biometry G. A. Maccacaro, University of Milan, via Vanzetti 5, 20133, Milan, Italy.

Background And Objectives: Warfarin-related nephropathy is an unexplained acute kidney injury, and may occur in patients with supratherapeutic INR, in the absence of overt bleeding. Similar findings have been observed in rats treated with dabigatran etexilate. We conducted a prospective study in dabigatran etexilate-treated patients to assess the incidence of dabigatran-related nephropathy and to investigate the possible correlation between dabigatran plasma concentration (DPC) and worsening renal function. Read More

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http://dx.doi.org/10.1007/s40261-018-0742-1DOI Listing
January 2019
1.704 Impact Factor

Adverse Cutaneous Drug Reactions Associated with Old- and New- Generation Antiepileptic Drugs Using the Japanese Pharmacovigilance Database.

Clin Drug Investig 2019 Jan 28. Epub 2019 Jan 28.

Education and Research Center for Clinical Pharmacy, Osaka University of Pharmaceutical Sciences, 4-20-1 Nasahara, Takatsuki, Osaka, 569-1094, Japan.

Background And Objective: Adverse cutaneous drug reactions associated with antiepileptic drugs (AEDs) are a serious problem in the clinical setting. New-generation AEDs have been reported to be better tolerated than old-generation forms; however, information about the risks of adverse cutaneous drug reactions to new-generation AEDs is limited.

Objective: The purpose of this study was to clarify the association of AEDs with adverse cutaneous drug reactions using a spontaneous reporting database. Read More

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http://dx.doi.org/10.1007/s40261-019-00754-zDOI Listing
January 2019

Cost-effectiveness of Teriflunomide Compared to Interferon Beta-1b for Relapsing Multiple Sclerosis Patients in China.

Clin Drug Investig 2019 Jan 25. Epub 2019 Jan 25.

Pharmerit (Shanghai) Company Limited, Shanghai, China.

Background And Objective: Teriflunomide is a once-daily oral immunomodulatory agent approved in 80 countries for the treatment of patients with relapsing multiple sclerosis (RMS). The study objective was to estimate the cost effectiveness of teriflunomide (14 mg tablet, daily) versus interferon beta-1b (250 mcg subcutaneous injection, every other day) among RMS patients from the Chinese healthcare system perspective.

Methods: A Markov model with annual cycles and a lifetime horizon was utilized to assess cost-effectiveness of teriflunomide in comparison with interferon beta-1b in RMS patients. Read More

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http://dx.doi.org/10.1007/s40261-019-00750-3DOI Listing
January 2019
1.704 Impact Factor

Association of First- vs. Second-Generation Antipsychotics with Lipid Abnormalities in Individuals with Severe Mental Illness: A Systematic Review and Meta-Analysis.

Clin Drug Investig 2019 Jan 24. Epub 2019 Jan 24.

Research Department, East London NHS Foundation Trust, London, UK.

BACKGROUND AND OBJECTIVE: Individuals with severe mental illness experience increased morbidity and mortality as a result of metabolic problems that may partly be related to the adverse effects of antipsychotics. Compared with first-generation antipsychotics, second-generation antipsychotics collectively are considered to have stronger associations with lipid abnormalities, but evidence for this specific claim has not been systematically reviewed. The objective of this review was to evaluate the risk of dyslipidaemia with second-generation versus first-generation antipsychotics amongst individuals with severe mental illness. Read More

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http://dx.doi.org/10.1007/s40261-019-00751-2DOI Listing
January 2019
1 Read

Adverse Event Profiles of Anti-CTLA-4 and Anti-PD-1 Monoclonal Antibodies Alone or in Combination: Analysis of Spontaneous Reports Submitted to FAERS.

Clin Drug Investig 2019 Jan 23. Epub 2019 Jan 23.

Department of Pharmacy, Children's Hospital of Chongqing Medical University, Ministry of Education Key Laboratory of Child Development and Disorders, China International Science and Technology Cooperation Base of Child Development and Critical Disorders, Chongqing Key Laboratory of Pediatric, Chongqing, 400014, China.

Background And Objective: Immune checkpoint inhibitors (ICIs)-cytotoxic T-lymphocyte antigen-4 (CTLA-4) and programmed death receptor-1 (PD-1) monoclonal antibodies (mAbs)-either as single agents or in combination have become the standard of care for an increasing number of indications. Understanding both the ICI-associated adverse events (AEs) and the possible rank-order of these drugs in terms of susceptibility is essential if we are to improve the curative effect and reduce toxicity.

Methods: We detected signals of the AEs of ICIs by data mining using the US Food and Drug Administration (FDA) AEs Reporting System (FAERS) database. Read More

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http://dx.doi.org/10.1007/s40261-018-0735-0DOI Listing
January 2019
2 Reads

Evaluation of the Pharmacokinetics of Abiraterone Acetate and Abiraterone Following Single-Dose Administration of Abiraterone Acetate to Healthy Subjects.

Clin Drug Investig 2019 Jan 22. Epub 2019 Jan 22.

Pharma Medica Research Inc., 6100 Belgrave Road, Mississauga, ON, L5R 0B7, Canada.

Background And Objective: Following oral administration of abiraterone acetate, the parent compound abiraterone acetate is rapidly metabolized to abiraterone. To our knowledge, bioanalytical methods to date have not been able to detect the parent compound in human plasma, and bioassay was only performed on the metabolite. A highly sensitive bioanalytical method was developed and validated to measure plasma concentrations of the parent compound. Read More

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http://link.springer.com/10.1007/s40261-019-00752-1
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http://dx.doi.org/10.1007/s40261-019-00752-1DOI Listing
January 2019
5 Reads

Efficacy of Off-Label Topical Treatments for the Management of Androgenetic Alopecia: A Review.

Clin Drug Investig 2019 Jan 17. Epub 2019 Jan 17.

Dermatology, Department of Experimental, Diagnostic and Specialty Medicine, University of Bologna, Bologna, Italy.

Androgenetic alopecia (AGA) is characterized by non-scarring follicle miniaturization. Despite the success of approved therapies, commonly reported side effects and the need for continual use has led to the investigation of alternative therapies. The aim of this paper is to critically review the success of off-label, topical monotherapies for treatment of AGA in men. Read More

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http://dx.doi.org/10.1007/s40261-018-00743-8DOI Listing
January 2019
1 Read

Correction to: Unexpected Benefit from Alpelisib and Fulvestrant in a Woman with Highly Pre-treated ER-Positive, HER2-Negative PIK3CA Mutant Metastatic Breast Cancer.

Clin Drug Investig 2019 01;39(1):113

Department of Gynaecology and Obstetrics, University Hospitals Leuven, KU Leuven, University of Leuven, Herestraat 49, 3000, Louvain, Belgium.

Dr. Arteaga serves on an Advisory Board for Novartis and was a consultant for AstraZeneca from 2015 to 2016. All other authors declare that they have no competing interests. Read More

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http://dx.doi.org/10.1007/s40261-019-00748-xDOI Listing
January 2019
3 Reads

Opioid Use and Pain Control in the Elderly After Elective or Urgent Orthopaedic Surgery: A Retrospective Cohort Study.

Clin Drug Investig 2019 Jan 10. Epub 2019 Jan 10.

Department of Pharmacy Services, McGill University Health Centre, Montréal, Québec, Canada.

Background: As an increasing number of elderly are undergoing orthopaedic procedures, it is important to understand and evaluate postoperative pain management in this population, especially in regard to opioid use. Data in the literature pertaining to the very elderly remains scarce.

Objectives: This study was conducted to evaluate whether older patients require lower opioid doses than their younger counterparts after undergoing an elective or urgent orthopaedic procedure, and to assess the cumulative incidence of adverse events and length of stay for each age group. Read More

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http://link.springer.com/10.1007/s40261-018-00744-7
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http://dx.doi.org/10.1007/s40261-018-00744-7DOI Listing
January 2019
8 Reads

Clinical Characteristics of Japanese Patients with Palmoplantar Pustulosis.

Clin Drug Investig 2019 Jan 10. Epub 2019 Jan 10.

Department of Dermatology, Fukushima Medical University, Hikarigaoka 1, Fukushima, 960-1295, Japan.

Palmoplantar pustulosis (PPP) is a chronic inflammatory disorder characterized by sterile pustules predominantly involving the palms and soles. The purpose of this review was to describe the characteristics of Japanese PPP patients as PPP is frequently observed within the Japanese population. Most Japanese dermatologists consider PPP a distinct entity, and co-existence of PPP and psoriasis is rare; however, outside Japan, PPP is often considered to be palmoplantar psoriasis, and an extra-palmoplantar lesion associated with PPP is considered to be psoriasis. Read More

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http://link.springer.com/10.1007/s40261-018-00745-6
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http://dx.doi.org/10.1007/s40261-018-00745-6DOI Listing
January 2019
13 Reads

Comment on: Pharmacokinetics, Pharmacodynamics, and Safety of the Novel Calcimimetic Agent Evocalcet in Healthy Japanese Subjects: First-in-Human Phase I Study.

Clin Drug Investig 2019 Jan;39(1):105-107

Zydus Research Centre, a Division of Cadila Healthcare Ltd, Sarkhej-Bavla NH 8A, Moraiya, Ahmedabad, Gujarat, 382 210, India.

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http://link.springer.com/10.1007/s40261-018-0738-x
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http://dx.doi.org/10.1007/s40261-018-0738-xDOI Listing
January 2019
5 Reads

Response to Comments on "Pharmacokinetics, Pharmacodynamics, and Safety of the Novel Calcimimetic Agent Evocalcet in Healthy Japanese Subjects: First-in-Human Phase I Study".

Clin Drug Investig 2019 Jan;39(1):109-111

Division of Nephrology, Endocrinology, and Metabolism, Department of Internal Medicine, Tokai University School of Medicine, 143 Shimokasuya, Isehara-shi, Kanagawa, 259-1193, Japan.

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http://link.springer.com/10.1007/s40261-018-0737-y
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http://dx.doi.org/10.1007/s40261-018-0737-yDOI Listing
January 2019
7 Reads

Switching of Oral P2Y Inhibitor Treatment in Patients with Acute Coronary Syndrome: Prevalence, Predictors, and Prognosis.

Clin Drug Investig 2019 Jan 8. Epub 2019 Jan 8.

Department of Cardiology, Hospital General Universitario de Alicante, Instituto de Investigación Sanitaria y Biomédica de Alicante (ISABIAL), C/ Maestro Alonso s/n, 03010, Alicante, Spain.

Background And Objective: Dual antiplatelet therapy is one of the main treatments in acute coronary syndrome (ACS). Switching antiplatelet agents may be necessary in some patients to improve efficacy or safety. The objective of this study was to determine the prevalence, predictors, and implications of clinical switching in patients during hospital admission and 1-year follow-up at discharge. Read More

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http://link.springer.com/10.1007/s40261-018-0736-z
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http://dx.doi.org/10.1007/s40261-018-0736-zDOI Listing
January 2019
7 Reads

HIV Integrase Inhibitor Pharmacogenetics: An Exploratory Study.

Clin Drug Investig 2019 Jan 8. Epub 2019 Jan 8.

Department of Pharmaceutical Sciences, Gatton College of Pharmacy, East Tennessee State University, Box 70594, Johnson City, TN, 37614-1708, USA.

Background And Objectives: Integrase strand transfer inhibitors (INSTIs), dolutegravir, elvitegravir, and raltegravir, have become integral in the treatment of HIV, with close monitoring of continued efficacy and tolerability. As side effect occurrence varies among subjects receiving these drugs, we sought to perform an exploratory analysis examining the role of several single-nucleotide polymorphisms (SNPs) on drug concentration changes, selected clinical outcomes, and the occurrence of subject-reported adverse events.

Methods: Adults (aged ≥ 18 years) receiving INSTI-based regimens for treatment of HIV were recruited and genotyped with an iPLEX ADME PGx Pro v1. Read More

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http://dx.doi.org/10.1007/s40261-018-0739-9DOI Listing
January 2019
1 Read

Neratinib in Early-Stage Breast Cancer: A Profile of Its Use in the EU.

Authors:
Sohita Dhillon

Clin Drug Investig 2019 Feb;39(2):221-229

Springer, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand.

Neratinib (Nerlynx) is an oral, irreversible pan-human epidermal growth factor receptor (HER) tyrosine kinase inhibitor of HER1, HER2 and HER4. Neratinib therapy for 12 months significantly reduced the risk of invasive disease recurrence or death relative to placebo at both 2 and 5 years post-randomization in the pivotal ExteNET trial in women with early-stage HER2-positive breast cancer who had completed adjuvant trastuzumab. Subgroup analyses showed that patients with hormone receptor (HRc)-positive disease derived greater benefit with neratinib than patients with HRc-negative disease, and patients who initiated neratinib within 1 year of completing trastuzumab had better outcomes than those who started treatment 1-2 years after trastuzumab. Read More

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http://link.springer.com/10.1007/s40261-018-0741-2
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http://dx.doi.org/10.1007/s40261-018-0741-2DOI Listing
February 2019
21 Reads

A Literature Review of Psychotropic Medications and Alcohol as Risk Factors for Falls in Community Dwelling Older Adults.

Clin Drug Investig 2019 Feb;39(2):117-139

School of Public Health and Health Systems, University of Waterloo, Waterloo, Canada.

Psychotropic medications and alcohol are potential risk factors for falls in older adults. However, there has been no appraisal of the literature on whether these medications, both singly and in combination with alcohol, are associated with falls in community dwelling older adults (those aged 60 years and older living independently without care). Four databases (PubMed, EMBASE, CINAHL and SCOPUS) and the grey literature (i. Read More

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http://dx.doi.org/10.1007/s40261-018-0721-6DOI Listing
February 2019
2 Reads

Effect of Levothyroxine Treatment on Incident Dementia in Adults with Atrial Fibrillation and Hypothyroidism.

Clin Drug Investig 2019 Feb;39(2):187-195

Center for Primary Health Care Research, Lund University, Malmö, Sweden.

Background And Objective: The possible adverse or positive effects of levothyroxine treatment among patients with atrial fibrillation have been debated. Atrial fibrillation, levothyroxine treatment, and dementia are common among older adults, yet little is known about the effects of levothyroxine on the development of dementia.

Methods: The study population included all adults (n = 12,057) aged ≥ 45 years with a diagnosis of atrial fibrillation at 75 primary care centers in Sweden during 2001-2007 without an earlier recorded dementia diagnosis. Read More

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http://dx.doi.org/10.1007/s40261-018-0740-3DOI Listing
February 2019
1 Read

Effects on Satisfaction and Service Engagement of Paliperidone Palmitate Compared with Oral Paliperidone in Patients with Schizophrenia: An Open Label Randomized Controlled Trial.

Clin Drug Investig 2019 Feb;39(2):169-178

Department of Neuroscience, "Rita Levi Montalcini", University of Turin, Turin, Italy.

BACKGROUND AND OBJECTIVE: Clinical practice guidelines recommend antipsychotic monotherapy, including oral and long-acting formulations, in the treatment of schizophrenia. This open-label, randomized, controlled trial aimed to evaluate the efficacy and tolerability in patients with schizophrenia of once-monthly long-acting paliperidone palmitate (PP1M) compared with oral paliperidone extended release (ER), with a particular focus on satisfaction, subjective well-being, and service engagement.

Methods: Seventy-two consecutive outpatients with schizophrenia (DSM-5) were randomly assigned for 6 months to: (1) PP1M (50-150 mg equivalent) or (2) paliperidone ER (6-12 mg/day). Read More

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http://dx.doi.org/10.1007/s40261-018-0734-1DOI Listing
February 2019
5 Reads

Effects of Sodium-glucose Cotransporter 2 Inhibitors on Amputation, Bone Fracture, and Cardiovascular Outcomes in Patients with Type 2 Diabetes Mellitus Using an Alternative Measure to the Hazard Ratio.

Clin Drug Investig 2019 Feb;39(2):179-186

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: Empagliflozin and canagliflozin decreased the risk of major adverse cardiovascular events (MACE) compared with placebo in randomized clinical trials which were conducted to evaluate their cardiovascular risks. However, canagliflozin increased the risks of amputation and bone fracture, and the reasons for these observed differences remain unclear. The objective of this study was to evaluate the safety risks, specifically the risks of amputation and bone fracture, associated with sodium-glucose cotransporter 2 (SGLT2) inhibitors by using the difference in restricted mean survival time (RMST), an alternative measure to the hazard ratio. Read More

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http://dx.doi.org/10.1007/s40261-018-0731-4DOI Listing
February 2019
1 Read

Correction to: Neuropsychological Assessment in Elderly Men with Benign Prostatic Hyperplasia Treated with Dutasteride.

Clin Drug Investig 2019 01;39(1):103

Department of Clinical and Experimental Medicine, University Hospital of Messina, Messina, Italy.

Catalano Antonino, Martino Gabriella, Bellone Federica, Papalia Maria, Lasco Carmen, Basile Giorgio, Sardella Alberto, Nicocia Giacomo, Morabito Nunziata, Lasco Antonino. Read More

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http://dx.doi.org/10.1007/s40261-018-0733-2DOI Listing
January 2019
1 Read

Comparison of Skin Cancer Incidence in Caucasian and Non-Caucasian Liver Vs. Lung Transplant Recipients: A Tale of Two Regimens.

Clin Drug Investig 2019 Feb;39(2):197-203

Department of Dermatology, University of Southern California, 1975 Zonal Ave, Los Angeles, CA, 90033, USA.

Background: Organ transplantation is a significant risk factor for the development of skin cancer. The impact of skin type, immunosuppressive regimens, and photosensitizing agents requires further study.

Objective: The objective of this study was to compare skin cancer development between Caucasian and non-Caucasian transplant recipients at the University of Southern California. Read More

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http://dx.doi.org/10.1007/s40261-018-0732-3DOI Listing
February 2019
29 Reads

Relative and Absolute Risk of Tendon Rupture with Fluoroquinolone and Concomitant Fluoroquinolone/Corticosteroid Therapy: Population-Based Nested Case-Control Study.

Clin Drug Investig 2019 Feb;39(2):205-213

Pharmacovigilance and Epidemiology Department, European Medicines Agency, London, UK.

Background And Objective: Tendon rupture can result from fluoroquinolone exposure. The objective of this study was to quantify relative and absolute risk and determine how risk is affected by timing of exposure.

Methods: The UK Health Improvement Network primary care database was used to perform a nested case-control study measuring the association between fluoroquinolone exposure and tendon rupture. Read More

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http://dx.doi.org/10.1007/s40261-018-0729-yDOI Listing
February 2019
32 Reads

A Systematic Review on the Extent and Quality of Pharmacoeconomic Publications in Egypt.

Clin Drug Investig 2019 Feb;39(2):157-168

Department of Accounting, Finance and Economics, Bournemouth University, Fern Barrow, Poole, Dorset, BH12 5BB, UK.

Background: Egypt faces many challenges when matching patient needs with available resources. Consequently, there has been an increasing interest in pharmacoeconomics as an aid tool in health decision-making to better allocate resources.

Objectives: To review and evaluate the volume and the quality of published pharmacoeconomic studies in Egypt. Read More

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http://dx.doi.org/10.1007/s40261-018-0730-5DOI Listing
February 2019
9 Reads

Drugs that Can Kill a Toddler with One Tablet or Teaspoonful: A 2018 Updated List.

Clin Drug Investig 2019 Feb;39(2):217-220

Maccabi-Kahn Institute of Research and Innovation, 4 Koifman St, 8th floor, 6812509, Tel Aviv, Israel.

Background And Objective: Young children may be accidentally exposed to adult dose forms of medications, some of which can be fatal, even with a single dose. As numerous new medications have been introduced, we herein update a 2004 list of potentially toxic drugs that can be lethal for toddlers when taking one adult dose unit.

Methods: We reviewed all medications available in North America and identified their reported fatal doses per kilogram in children, or in adults if no pediatric data were available. Read More

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http://dx.doi.org/10.1007/s40261-018-0726-1DOI Listing
February 2019
2 Reads

Efficacy and Safety of Eltrombopag for Aplastic Anemia: A Systematic Review and Meta-analysis.

Clin Drug Investig 2019 Feb;39(2):141-156

Fujian Provincial Key Laboratory on Hematology, Department of Hematology, Fujian Institute of Hematology, Fujian Medical University Union Hospital, No. 29 Xinquan Street, Gulou District, Fuzhou, 350001, China.

Background And Objectives: Eltrombopag seems to be effective in treating patients with aplastic anemia in several clinical trials. This paper aims to perform the first meta-analysis analyzing the efficacy and safety of eltrombopag for aplastic anemia.

Methods: Literatures were retrieved from PubMed, EMBASE, OVID, Web of Science, Cochrane, Wanfang, http://clinicaltrials. Read More

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http://link.springer.com/10.1007/s40261-018-0725-2
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http://dx.doi.org/10.1007/s40261-018-0725-2DOI Listing
February 2019
22 Reads

Response to "Comment on: Botulinum Toxin Type A Overdoses: Analysis of the FDA Adverse Event Reporting System Database".

Clin Drug Investig 2018 Dec;38(12):1199-1200

Health Services Administration Graduate Program, University of Wyoming School of Pharmacy, Laramie, WY, USA.

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http://dx.doi.org/10.1007/s40261-018-0724-3DOI Listing
December 2018
3 Reads

Comment on: Botulinum Toxin Type A Overdoses: Analysis of the FDA Adverse Event Reporting System Database.

Authors:
Philippe Picaut

Clin Drug Investig 2018 Dec;38(12):1197-1198

Ipsen Bioscience, Inc., 650 East Kendall Street, Cambridge, MA, 02142, USA.

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http://dx.doi.org/10.1007/s40261-018-0723-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6267525PMC
December 2018
2 Reads

Safety and Efficacy Profile of Neratinib: A Systematic Review and Meta-Analysis of 23 Prospective Clinical Trials.

Clin Drug Investig 2019 Jan;39(1):27-43

Department of Oncology and State Key Laboratory of Biotherapy, Cancer Center, West China Hospital, Sichuan University, Number 37, Guoxue Alley, Chengdu, 610041, Sichuan, People's Republic of China.

Background: Neratinib is a novel pan-human epidermal growth factor receptor (HER) tyrosine kinase inhibitor that has shown promising activity against several types of malignancies, especially HER2-overexpressing breast cancer.

Objective: The objective of the current study was to provide a comprehensive insight into the efficacy and safety profiles of neratinib-based therapies.

Methods: Comprehensive literature searches of the PubMed, EMBASE, and Web of Science electronic databases were performed for all relevant clinical trials. Read More

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http://link.springer.com/10.1007/s40261-018-0719-0
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http://dx.doi.org/10.1007/s40261-018-0719-0DOI Listing
January 2019
19 Reads

Pharmacokinetics, Safety and Tolerability of Tylerdipine Hydrochloride, a Novel Dihydropyridine Dual L/T-type Calcium Channel Blocker, after Single and Multiple Oral Doses in Healthy Chinese Subjects.

Clin Drug Investig 2019 Jan;39(1):85-96

Phase I Clinical Trial Unit, The First Affiliated Hospital with Nanjing Medical University, #300 Guangzhou Road, Nanjing, 210029, Jiangsu, China.

Background And Objective: Tylerdipine hydrochloride (KBP-5660) is a novel L/T-type dual calcium channel blocker developed for the treatment of hypertension. We aimed to study the pharmacokinetics, safety and tolerability of tylerdipine in healthy Chinese subjects.

Methods: Two double-blind, randomized, dose-escalation studies were conducted that included a total of 88 healthy subjects: (1) a single-ascending dose (SAD) study; and (2) a multiple-ascending dose (MAD) study. Read More

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http://link.springer.com/10.1007/s40261-018-0722-5
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http://dx.doi.org/10.1007/s40261-018-0722-5DOI Listing
January 2019
10 Reads

Neuropsychological Assessment in Elderly Men with Benign Prostatic Hyperplasia Treated with Dutasteride.

Clin Drug Investig 2019 Jan;39(1):97-102

Department of Clinical and Experimental Medicine, University Hospital of Messina, Messina, Italy.

Background And Objective: Benign prostatic hyperplasia (BPH) is a common disease found in elderly men and 5α-reductase (5α-R) inhibitors are a commonly used treatment option. 5α-reduced steroids are compounds that play a role in several functions across different organs and systems. In the adult brain, 5α-R accounts for neuroactive steroid production. Read More

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http://link.springer.com/10.1007/s40261-018-0720-7
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http://dx.doi.org/10.1007/s40261-018-0720-7DOI Listing
January 2019
9 Reads

Is It Necessary to Perform the Pharmacological Interventions for Intrahepatic Cholestasis of Pregnancy? A Bayesian Network Meta-Analysis.

Clin Drug Investig 2019 Jan;39(1):15-26

Center for Liver Diseases, Nantong Third People's Hospital, Nantong University, 60 Mid-Youth Road, Nantong, 226006, Jiangsu, China.

Background And Objective: Although many meta-analyses have evaluated the pharmacotherapy of intrahepatic cholestasis of pregnancy (ICP) and recommended ursodeoxycholic acid (UDCA) as an effective treatment, the defect of the pair-wise analyses and the mixture of the control group made the outcome uncertain and unclear. We aimed to employ Bayesian network meta-analysis (NMA) to compare the maternal and fetal outcomes after UDCA, S-adenosylmethionine (SAMe) mono-therapy or the combination treatment of these two drugs for ICP patients.

Methods: Multiple electronic database searches were conducted for articles published up to 1 September 2018. Read More

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http://dx.doi.org/10.1007/s40261-018-0717-2DOI Listing
January 2019
6 Reads
1.704 Impact Factor

Cardiovascular Toxicities with Vascular Endothelial Growth Factor Receptor Tyrosine Kinase Inhibitors in Cancer Patients: A Meta-Analysis of 77 Randomized Controlled Trials.

Authors:
Jing Li Jian Gu

Clin Drug Investig 2018 Dec;38(12):1109-1123

College of Pharmacy, Southwest Minzu University, No. 16 South 4th Section, 1st Ring Road, Chengdu, Sichuan, 610041, People's Republic of China.

Background And Objective: Use of the vascular endothelial growth factor receptor tyrosine kinase inhibitors (VEGFR-TKIs) has led to considerable improvements in the clinical outcome of patients with various tumor types. However, VEGFR-TKIs may be associated with increased incidence of cardiovascular toxicities. We conducted this meta-analysis to systematically review the risk of cardiovascular toxicities with VEGFR-TKIs in cancer patients. Read More

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http://dx.doi.org/10.1007/s40261-018-0709-2DOI Listing
December 2018
2 Reads

Physicians' and Pharmacists' Clinical Considerations for Elderly Patients with Type 2 Diabetes Mellitus: The IMPLICA2 Study.

Clin Drug Investig 2019 Jan;39(1):73-84

Medical Affairs at Mylan, C/ General Aranaz nº 86, 28027, Madrid, Spain.

Background: Management of elderly patients with type 2 diabetes mellitus (T2DM) is complex due to their age-related conditions. Several clinical guidelines provide specific recommendations for management of these patients but little is known about their implementation in clinical practice.

Objective: To describe physician and community pharmacist perceptions and routine clinical practice in the management of elderly T2DM patients. Read More

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http://dx.doi.org/10.1007/s40261-018-0713-6DOI Listing
January 2019
6 Reads

The Association between Polypharmacy and Hip Fracture in Osteoporotic Women: A Nested Case-Control Study in South Korea.

Clin Drug Investig 2019 Jan;39(1):63-71

College of Pharmacy and Research Institute of Pharmaceutical Sciences, Kyungpook National University, Daegu, 41566, South Korea.

Background And Objective: Polypharmacy, regarded as an indicator of potentially inappropriate medications (PIMs), may lead to a higher risk of serious health consequences in elderly patients with osteoporosis. Thus, this study aimed to analyze the association between polypharmacy and hip fracture in patients with osteoporosis because only a limited number of studies have reported on this association, with inconsistent results to date.

Methods: In this nested case-control study using a population-based sample cohort, the target cases were female patients with hip fracture diagnosed with osteoporosis and aged ≥ 50 years. Read More

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http://link.springer.com/10.1007/s40261-018-0716-3
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http://dx.doi.org/10.1007/s40261-018-0716-3DOI Listing
January 2019
4 Reads

Safety, Tolerability, and Pharmacokinetics of the Novel Anti-influenza Agent Baloxavir Marboxil in Healthy Adults: Phase I Study Findings.

Clin Drug Investig 2018 Dec;38(12):1189-1196

Project Management Department, Shionogi & Co., Ltd, Osaka, Japan.

Background And Objective: Baloxavir marboxil, a prodrug that is metabolized to baloxavir acid, suppresses viral replication by inhibiting cap-dependent endonuclease. This first-in-human phase I study evaluated the safety, tolerability, and pharmacokinetics of baloxavir marboxil/baloxavir acid in healthy Japanese volunteers (Study 1), while food effects were evaluated in a separate phase I, crossover study in healthy Japanese volunteers (Study 2).

Methods: Study 1 participants were randomized to single-dose oral baloxavir marboxil (6, 20, 40, 60, or 80 mg; n = 6 per dose) or placebo (n = 10), while Study 2 participants (n = 15) received single-dose oral baloxavir marboxil 20 mg in fasted, fed, and before-meal states. Read More

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http://link.springer.com/10.1007/s40261-018-0710-9
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http://dx.doi.org/10.1007/s40261-018-0710-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6267547PMC
December 2018
4 Reads

Safety and Plasma Concentrations of a Cyclin-dependent Kinase 9 (CDK9) Inhibitor, FIT039, Administered by a Single Adhesive Skin Patch Applied on Normal Skin and Cutaneous Warts.

Clin Drug Investig 2019 Jan;39(1):55-61

Department of Dermatology, Kyoto University Hospital, Kyoto, Japan.

Background: Cutaneous warts are caused by human papilloma virus (HPV) infection. FIT039, a specific inhibitor of CDK9, suppresses the proliferation of DNA viruses in vitro.

Purpose: We evaluated the safety, plasma concentrations, and efficacy of FIT039 delivered by single application of an adhesive skin patch on normal back skin and cutaneous warts. Read More

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http://dx.doi.org/10.1007/s40261-018-0712-7DOI Listing
January 2019
11 Reads

Impaired Renal Function May Not Negate the Efficacy of Tolvaptan in the Treatment of Cirrhotic Patients with Refractory Ascites.

Clin Drug Investig 2019 Jan;39(1):45-54

Division of Gastroenterology and Hepatology, Department of Internal Medicine, Tokai University School of Medicine, 143 Shimokasuya, Isehara, Kanagawa, 259-1193, Japan.

Background And Objective: Tolvaptan, an oral vasopressin V2 receptor antagonist, has been widely used for the treatment of patients with cirrhosis and ascites. However, its efficacy in patients with renal dysfunction remains unknown. The objective of this study was to investigate the efficacy and safety of tolvaptan in patients with decompensated cirrhosis and severe chronic kidney disease (s-CKD). Read More

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http://link.springer.com/10.1007/s40261-018-0714-5
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http://dx.doi.org/10.1007/s40261-018-0714-5DOI Listing
January 2019
4 Reads

Signal Detection Between Fluoroquinolone Use and the Risk of Rhegmatogenous Retinal Detachment: Sequence Symmetry Analysis Using Nationwide South Korean Healthcare Database Between 2004 and 2015.

Clin Drug Investig 2018 Dec;38(12):1179-1188

School of Pharmacy, Sungkyunkwan University, Suwon, South Korea.

Background And Objectives: The association between fluoroquinolone and rhegmatogenous retinal detachment (RRD) has been controversial as a result of inconsistent findings. We set out to detect a possible association of fluoroquinolone use and risk of RRD, using sequence symmetry analysis (SSA).

Methods: We conducted an SSA, case-only design, using a Korean nationwide healthcare database between 2004 and 2015. Read More

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http://link.springer.com/10.1007/s40261-018-0708-3
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http://dx.doi.org/10.1007/s40261-018-0708-3DOI Listing
December 2018
5 Reads

Cost-utility of Sunitinib Versus Pazopanib in Metastatic Renal Cell Carcinoma in Canada using Real-world Evidence.

Clin Drug Investig 2018 Dec;38(12):1155-1165

Health Economics and Outcomes Research, Research Institute of the McGill University Health Center, Surgery/Urology, McGill University, 5252 Maisonneuve West, Montreal, QC, H4A 3S5, Canada.

Background And Objective: The development of new targeted therapies in kidney cancer has shaped disease management in the metastatic phase. Our study aims to conduct a cost-utility analysis of sunitinib versus pazopanib in first-line setting in Canada for metastatic renal cell carcinoma (mRCC) patients using real-world data.

Methods: A Markov model with Monte-Carlo microsimulations was developed to estimate the clinical and economic outcomes of patients treated in first-line with sunitinib versus pazopanib. Read More

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http://dx.doi.org/10.1007/s40261-018-0705-6DOI Listing
December 2018
9 Reads

Highly Purified Human Menopausal Gonadotropin (Menopur): A Profile of Its Use in Infertility.

Authors:
Emma D Deeks

Clin Drug Investig 2018 Nov;38(11):1077-1084

Springer, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand.

Menopur is a highly purified, urine-derived, human menopausal gonadotropin containing both follicle stimulating hormone (FSH) and luteinizing hormone (LH) activity. It is an effective option for controlled ovarian stimulation (COS) in assisted reproductive technology protocols and for ovulation induction (OI) in anovulatory infertility, and is associated with a different endocrine profile from that of recombinant (r) FSH in these settings (in terms of serum levels of FSH, androgens and/or estradiol). When used for COS in women undergoing in vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI), Menopur was as good as rFSH in terms of pregnancy rates (despite being associated with a lower oocyte yield) and was found to improve some aspects of embryo quality in the IVF (but not ICSI) setting; using Menopur in combination with highly purified urinary FSH resulted in similar reproductive outcomes as Menopur alone. Read More

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http://dx.doi.org/10.1007/s40261-018-0703-8DOI Listing
November 2018
20 Reads

The Effects of Novel Antidiabetic Drugs on Albuminuria in Type 2 Diabetes Mellitus: A Systematic Review and Meta-analysis of Randomized Controlled Trials.

Clin Drug Investig 2018 Dec;38(12):1089-1108

Department of Cardiology, The First Affiliated Hospital, Chongqing Medical University, Chongqing, 400016, China.

Background And Objective: The effects of novel antidiabetic drugs, including sodium-glucose cotransporter 2 (SGLT-2) inhibitors, glucagon-like peptide 1 (GLP-1) receptor agonists, and dipeptidyl peptidase 4 (DPP-4) inhibitors, on albuminuria in patients with type 2 diabetes mellitus (T2DM) are still controversial. Therefore, we performed a meta-analysis to evaluate the effects of novel antidiabetic drugs on albuminuria in patients with T2DM.

Methods: We conducted a random-effects meta-analysis of randomized controlled trials (RCTs) by searching the MEDLINE, EMBASE and Cochrane Central Register of Controlled Trials databases up to 16 August 2018. Read More

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http://dx.doi.org/10.1007/s40261-018-0707-4DOI Listing
December 2018
6 Reads

Effects of Cilostazol-Based Triple Antiplatelet Therapy Versus Dual Antiplatelet Therapy After Coronary Drug-Eluting Stent Implantation: An Updated Meta-Analysis of the Randomized Controlled Trials.

Clin Drug Investig 2019 Jan;39(1):1-13

Department of Geriatric Cardiology, First Affiliated Hospital, China Medical University, No. 155 Nanjingbei Street, 110001 Heping District, Shenyang, China.

Background And Objective: The results of studies on cilostazol-based triple antiplatelet therapy (TAT) after drug-eluting stent (DES) implantation were inconsistent. To assess the effects of TAT compared with dual antiplatelet therapy (DAT) after DES/second-generation DES implantation, we performed a meta-analysis of randomized controlled trials (RCTs).

Methods: All relevant studies evaluated were identified by searching the PubMed, EMBASE, Cochrane Library, and ISI Web of Science databases without time and language limitation. Read More

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http://dx.doi.org/10.1007/s40261-018-0711-8DOI Listing
January 2019
19 Reads

Riociguat for the Treatment of Raynaud's Phenomenon: A Single-Dose, Double-Blind, Randomized, Placebo-Controlled Cross-Over Pilot Study (DIGIT).

Clin Drug Investig 2018 Nov;38(11):1061-1069

Clinic III for Internal Medicine, Department of Cardiology, Heart Center, University Hospital of Cologne, Kerpener Str. 62, 50937, Cologne, Germany.

Background And Objective: Raynaud's phenomenon (RP) is characterized by transient digital ischemia and is commonly associated with connective tissue disease. Treatment remains unsatisfactory. Here we evaluate the efficacy, safety, and pharmacokinetics of a single dose of the soluble guanylate cyclase stimulator riociguat in RP. Read More

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http://dx.doi.org/10.1007/s40261-018-0698-1DOI Listing
November 2018
10 Reads