Current medical research and opinion
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Courtesy of the development of the Internet, bursts of information technology, and globalization, huge multicenter studies along with meta-analyses have been introduced to the medical sciences society. Meta-analyses and multicenter studies revolutionized modern medicine and drug development, and empowered evidence based medicine by providing extremely high levels of evidence. ⋯ Nevertheless, we should keep in mind that in certain circumstances, single center studies are of great importance, and are preferred to multicenter studies and meta-analyses. In order to have a better understanding of why and when multicenter studies along with meta-analyses might not be the best options, we have discussed three different scenarios.
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An increasing body of data indicates that a reduction of ticagrelor maintenance dose (MD) in stabilized patients might improve ticagrelor's safety profile and adherence to the treatment. The aim of this review was to discuss the rationale and summarize the current pharmacodynamic and clinical outcomes-based evidence from reduced MD of ticagrelor in patients with coronary artery disease (CAD). ⋯ Ticagrelor doses below 90 mg BID generally show an acceptable profile of platelet inhibition. The number of studies reporting clinical outcomes in CAD patients receiving reduced MD of ticagrelor are limited, however available results indicate that in a stable setting this strategy offers improved safety with preserved efficacy in the prevention of thrombotic events.
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Regulations for new drug approvals require stringent safety testing and efficacy trial programs. The approval process for generic drugs, however, is significantly streamlined. Bioavailability data can substitute for new rounds of efficacy trials, thereby both decreasing time to approval and reducing the costs required for new studies. ⋯ Long-acting, inert delivery vehicles for the drug have become available for the same indications. Safety and bioavailability profiles of the long-acting products are the same or improved over the parent product. A review of the long-acting drugs provides compelling evidence to recommend that generic drug-controlled release products may be eligible for alternative regulatory programs.