Clinical therapeutics
-
Clinical therapeutics · Nov 2015
Multicenter StudyLong-term Safety and Efficacy of Tapentadol Extended Release Following up to 2 Years of Treatment in Patients With Moderate to Severe, Chronic Pain: Results of an Open-label Extension Trial.
Tapentadol extended release (ER) has demonstrated efficacy and safety for the management of moderate to severe, chronic pain in adults. This study evaluated the long-term safety and tolerability of tapentadol ER in patients with chronic osteoarthritis or low back pain. ⋯ Pain relief and improvements in quality of life achieved during the preceding studies were maintained throughout this extension study, during which tapentadol ER was well tolerated for the long-term treatment of chronic osteoarthritis or low back pain over up to 2 years of treatment. (ClinicalTrials.gov identifier: NCT00487435.).
-
Clinical therapeutics · Nov 2015
Management of the 2014 Enterovirus 68 Outbreak at a Pediatric Tertiary Care Center.
Enterovirus 68 (EV-D68) is an uncommonly recognized cause of acute respiratory tract infections. During the late summer of 2014, an international EV-D68 outbreak occurred. We review the steps of outbreak recognition and management in the context of 1 hospital's experience with the EV-D68 outbreak. ⋯ Following the steps of outbreak management is critical to providing optimal patient care and ensuring the health of the public. During the 2014 EV-D68 outbreak, close adherence to outbreak principles led to swift recognition of illness, rapid diagnostic measures, institution of appropriate therapies, and dissemination of information to health care providers and the public. Equally important was the subsequent identification of an increase in acute flaccid myelitis cases against the backdrop of an increase in EV-D68 detections nationally. Future prospective studies are needed to determine the true burden of EV-D68 disease, potential vaccines and therapeutics, and outcomes of children with EV-D68 infection.
-
Clinical therapeutics · Nov 2015
Randomized Controlled Trial Multicenter StudyA Randomized, Multicenter, Double-blind, Placebo-controlled, 3 × 3 Factorial Design, Phase II Study to Evaluate the Efficacy and Safety of the Combination of Fimasartan/Amlodipine in Patients With Essential Hypertension.
The objective of this study was to evaluate the efficacy and safety of a fimasartan/amlodipine combination in patients with hypertension and to determine the optimal composition for a future single-pill combination formulation. ⋯ Fimasartan combined with amlodipine produced superior blood pressure reductions and low levels of AEs compared with either monotherapy. Therefore, a single-pill combination with fimasartan 60 mg/amlodipine 10 mg will be developed. ClinicalTrials.gov: NCT01518998.
-
Clinical therapeutics · Nov 2015
ReviewReview of the Persistence of Herpes Zoster Vaccine Efficacy in Clinical Trials.
The live attenuated herpes zoster vaccine(*) was approved for the prevention of shingles in 2006. Initial Phase III clinical trials proved vaccine efficacy persisted during the study duration; however, assessment of long-term efficacy required additional studies. This article reviews efficacy data for the zoster vaccine that have been published since 2004. It focuses on studies assessing declining vaccine efficacy. ⋯ Initial zoster vaccine efficacy is significant, but declines in post-vaccination years 3 to 11. This raises the question about the need for possible revaccination with the zoster vaccine. Clinicians should consider the declining efficacy when administering the zoster vaccine to patients. Future studies will need to address the impact of the varicella vaccine on the incidence of shingles and whether this impacts the efficacy of the zoster vaccine.
-
Clinical therapeutics · Nov 2015
Randomized Controlled TrialEffects of Therapeutic and Supratherapeutic Doses of Siponimod (BAF312) on Cardiac Repolarization in Healthy Subjects.
The International Conference on Harmonisation E14 guideline mandates an intensive cardiac safety evaluation in a clinical thorough QT study, typically in healthy subjects, for all new non-antiarrhythmic drugs with systemic bioavailability. This thorough QT study investigated the effects of therapeutic (2 mg) and supratherapeutic (10 mg) doses of siponimod (BAF312) on cardiac repolarization in healthy subjects. ⋯ The findings provide evidence that siponimod is not associated with a significant arrhythmogenic potential related to QT prolongation.