Do SGLT2 inhibitors increase the risk of amputation? Make haste slowly
Abstract
This editorial refers to ‘The association of amputations and peripheral artery disease in type 2 diabetes patients receiving sodium–glucose co-transporter 2 inhibitors: real-world study’†, by S. Paul et al., on page 1728. Σπεῦδε βραδέως or, in his Latin version, ‘festina lente’, is a saying by Chilon of Sparta (fl. 6th century BC) who was one of the Seven Sages of Greece, and has been adopted as a motto by numerous historical figures, such as the emperor Augustus and the Medicis. ‘Make haste slowly’ is an oxymoron that encompasses the wisdom of balancing urgency and diligence. A devoted researcher wants to produce results that will benefit patients as soon as possible but should not draw conclusions in haste. The ultimate decision on clinical application relies on the proper weighing of original research output with confirmation or refutation with real-world data from a variety of background patient profiles and circumstances. But is there a limit to accruing data? All steps in research testing should be taken. Before clinical endpoints can be evaluated, biomarkers provide confidence.1 , 2 Subsequently, randomized controlled trials (RCTs) offer the most robust evidence, in fixed conditions. However, the full picture is not drawn until real-world data become available. The new direct oral anticoagulants that showed benefit over warfarin offer a good example of the usual agreement between randomized studies3 and registries.4 On the other hand, rofecoxib and rosiglitazone are…
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Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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