Current medical research and opinion
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Randomized Controlled Trial
A randomized, double-blind, placebo-controlled study of the efficacy and safety of MNK-795, a dual-layer, biphasic, immediate-release and extended-release combination analgesic for acute pain.
To investigate the efficacy and safety of a bilayer combination oxycodone (OC) and acetaminophen (APAP) analgesic with both immediate-release and extended-release (ER) components (OC/APAP ER) in patients with moderate to severe pain using an established acute pain model. ⋯ OC/APAP ER was efficacious and generally well tolerated in an established model of moderate to severe acute pain, providing an onset of analgesia in approximately 30 minutes and sustained pain relief over the 12 hour dosing period.
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Insulin and incretin agents (dipeptidyl peptidase-4 inhibitors [DPP4is] and glucagon-like peptide-1 receptor agonists [GLP1 RAs]) are second-line treatment options in patients with type 2 diabetes (T2D) not achieving glycemic targets with metformin. Combinations of insulin with incretin agents have been explored in randomized controlled trials (RCTs) and retrospective studies. However, the optimal approach is still elusive; numerous combination regimens can be envisioned, differing in composition and in order of addition. ⋯ Insulin/incretin combination therapy comprises a variety of efficacious, weight-sparing regimens and may be considered for many patients who do not achieve glycemic targets when treated with insulin or an incretin agent.
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Randomized Controlled Trial
Can a high reloading dose of atorvastatin prior to percutaneous coronary intervention reduce periprocedural myocardial infarction?
Periprocedural myocardial infarction (MI) is a common complication following percutaneous coronary intervention (PCI) and statins have been shown to reduce MI in statin-naïve patients. We aimed to identify whether a high reloading dose of atorvastatin can prevent MI following PCI in patients who were already being treated with statins. ⋯ Administration of a high reloading dose of atorvastatin within 24 hours before PCI could significantly reduce the frequency of periprocedural MI. CLINICAL TRIAL REGISTRATION CODE: IRCT201205209768N1.
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Randomized Controlled Trial
Once daily glycopyrronium for the treatment of COPD: pooled analysis of the GLOW1 and GLOW2 studies.
Glycopyrronium is a once daily (o.d.) long-acting muscarinic antagonist that is approved for maintenance treatment of COPD. This post-hoc pooled analysis of two phase III studies, GLycopyrronium bromide in COPD airWays 1 and 2 (GLOW1 and GLOW2), evaluated the effects of glycopyrronium compared with placebo and tiotropium over 26-52 weeks in patients with moderate-to-severe COPD. ⋯ Glycopyrronium 50 μg o.d. provided early bronchodilation after the first dose that was sustained for 24 hours, and reduced the risk of exacerbations compared with placebo, with efficacy at least equivalent to tiotropium.
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Previous studies have raised concerns around the transparency and disclosure rates of clinical trial results on clinical trial registries and in the scientific literature. The objective of this study was to assess the timely disclosure in the public domain of results of company-sponsored clinical trials related to all new medicines approved by the European Medicines Agency (EMA) over a recent 3 year period. ⋯ Results of over three-quarters of all company-sponsored clinical trials related to new medicines recently approved by the EMA were disclosed within a year of completion or regulatory approval, and almost 90% were disclosed by 31 January 2013, suggesting transparency is now better than has sometimes been reported previously.