The American journal of managed care
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Cardiovascular outcomes trials (CVOTs) for evaluating the safety of novel antidiabetic agents are required by the FDA. CVOTs vary in their design and inclusion criteria, making it difficult to evaluate their applicability to the general population. This study examined the proportion of adults eligible for 7 ongoing or completed glucagon-like peptide-1 receptor agonist (GLP-1 RA) CVOTs. ⋯ Most adults with T2D in the United States would have qualified for enrollment into at least 1 of the GLP-1 RA CVOTs evaluated. EXSCEL had the most generalizable eligibility criteria of these trials and ELIXA the least.
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Guidance to industry from the FDA requires studies to evaluate the cardiovascular safety of novel type 2 diabetes (T2D) medications. Although the objectives of such cardiovascular outcomes trials (CVOTs) are similar, differences in features such as enrollment criteria present a challenge when trying to assess the applicability of these studies to real-world T2D populations. This study evaluated the proportions of US adults with T2D who met the eligibility criteria for each of the 4 sodium-glucose cotransporter-2 (SGLT2) inhibitor CVOTs. ⋯ There were considerable differences in the proportions of US adults with T2D who met the eligibility criteria for these studies.The DECLARE-TIMI 58 trial criteria were the most generalizable to the US T2D population.
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The efficacy of dapagliflozin as add-on therapy to metformin has been assessed in randomized trials. However, its effectiveness has not been assessed in a US real-world setting. ⋯ In current US clinical practice, patients receiving D + M ± OAD had greater reductions in important clinical outcomes of T2D-A1C level, weight loss, and blood pressure-versus patients receiving M + OAD. This study supports the use of dapagliflozin as add-on therapy to metformin with or without other OADs for patients with T2D.
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A long-held assumption and expectation has been that genomics-based precision medicine will provide clinicians with the tools and therapies they need to consistently deliver the right treatment to the right patient while simultaneously reducing waste and yielding cost savings for health systems. The pace of discovery within the field of precision medicine has been remarkable, yet optimal uptake of new genetic tests and genetically targeted therapies will occur only if payers recognize their value and opt to cover them. Coverage decisions require clear evidence of clinical effectiveness and utility and an understanding of how adoption will impact healthcare costs and utilization within a payer's network. ⋯ Collaboration among payers, scientists, and clinicians is essential for accelerating uptake and value creation. By pairing clinical outcomes with claims and cost data and collaboratively conducting well-designed pragmatic clinical or observational studies, all stakeholders can learn from more meaningful and relevant outcomes. In turn, there will be a collective understanding of how precision medicine innovations impact the health of populations and care delivery within healthcare systems.
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To describe the prevalence and incidence of opioid and nonsteroidal anti-inflammatory drug (NSAID) use before and since the start of the Veterans Health Administration (VHA) Opioid Safety Initiative (OSI) and to assess rates of adverse events (AEs). ⋯ Opioid use declined following implementation of the OSI, whereas NSAID use remained constant. Rates of AEs were higher among opioid users, which provides additional rationale for efforts to use NSAIDs for pain management when appropriate.