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Real-world studies no substitute for RCTs in establishing efficacy

Published on Jan 1, 2019in The Lancet59.102
· DOI :10.1016/S0140-6736(18)32840-X
Hertzel C. Gerstein93
Estimated H-index: 93
(Population Health Research Institute),
John J.V. McMurray151
Estimated H-index: 151
(Glas.: University of Glasgow),
Rury R. Holman99
Estimated H-index: 99
(University of Oxford)
Abstract
  • References (10)
  • Citations (14)
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References10
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Aims: Treatment ‘effects’ are often inferred from non-randomized and observational studies. These studies have inherent biases and limitations, which may make therapeutic inferences based on their results unreliable. We compared the conflicting findings of these studies to those of prospective randomized controlled trials (RCTs) in relation to pharmacological treatments for heart failure (HF). Methods and results: We searched Medline and Embase to identify studies of the association between non-...
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Abstract Background Prior studies found patients treated with sodium-glucose co-transporter-2 inhibitors (SGLT-2i) had lower rates of death and heart failure (HF). Whether the benefits of SGLT-2i vary based upon the presence of cardiovascular disease (CVD) is unknown. Objectives This study sought to determine the association between initiation of SGLT-2i therapy and HF or death in patients with and without CVD. Methods The CVD-REAL (Comparative Effectiveness of Cardiovascular Outcomes in New Use...
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In December 2008, the U.S. Food and Drug Administration issued guidance to the pharmaceutical industry setting new expectations for the development of antidiabetes drugs for type 2 diabetes. This guidance expanded the scope and cost of research necessary for approval of such drugs by mandating long-term cardiovascular outcomes trials (CVOTs) for safety. Since 2008, 9 CVOTs have been reported, 13 are under way, and 4 have been terminated. Reassuringly, each of the completed trials demonstrated th...
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