Annals of internal medicine
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Randomized Controlled Trial Multicenter Study
Effect of Sotagliflozin on Total Hospitalizations in Patients With Type 2 Diabetes and Worsening Heart Failure : A Randomized Trial.
In the SOLOIST-WHF (Effect of Sotagliflozin on Cardiovascular Events in Patients With Type 2 Diabetes Post Worsening Heart Failure) trial, sotagliflozin, a sodium-glucose cotransporter-1 and sodium-glucose cotransporter-2 inhibitor, reduced total occurrences of cardiovascular deaths, hospitalizations for heart failure, and urgent visits for heart failure relative to placebo by 33%. ⋯ Sanofi at initiation and Lexicon Pharmaceuticals at completion.
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Multiple candidate vaccines to prevent COVID-19 have entered large-scale phase 3 placebo-controlled randomized clinical trials, and several have demonstrated substantial short-term efficacy. At some point after demonstration of substantial efficacy, placebo recipients should be offered the efficacious vaccine from their trial, which will occur before longer-term efficacy and safety are known. The absence of a placebo group could compromise assessment of longer-term vaccine effects. ⋯ Deferred vaccination, if done open-label, may lead to riskier behavior in the unblinded original vaccine group, confounding estimates of long-term vaccine efficacy. Hence, deferred vaccination via blinded crossover, where the vaccine group receives placebo and vice versa, would be the preferred way to assess vaccine durability and potential delayed harm. Deferred vaccination allows placebo recipients timely access to the vaccine when it would no longer be proper to maintain them on placebo, yet still allows important insights about immunologic and clinical effectiveness over time.
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Randomized Controlled Trial
Effects of Tai Chi or Conventional Exercise on Central Obesity in Middle-Aged and Older Adults : A Three-Group Randomized Controlled Trial.
Central obesity is a major manifestation of metabolic syndrome, which is a common health problem in middle-aged and older adults. ⋯ Health and Medical Research Fund.
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Low back pain is a common problem that is the leading cause of disability and is associated with high costs. Evaluation focuses on identification of risk factors indicating a serious underlying condition and increased risk for persistent disabling symptoms in order to guide selective use of diagnostic testing (including imaging) and treatments. Nonpharmacologic therapies, including exercise and psychosocial management, are preferred for most patients with low back pain and may be supplemented with adjunctive drug therapies. Surgery and interventional procedures are options in a minority of patients who do not respond to standard treatments.