A Randomized Controlled Trial of the Hemodynamic Effects of Empagliflozin in Patients with Type 2 Diabetes at High Cardiovascular Risk (the SIMPLE Trial)
Abstract
Treatment with the sodium glucose cotransporter-2 inhibitor (SGLT-2i) empagliflozin significantly reduces cardiovascular events in patients with type 2 diabetes (T2DM), however the mechanisms behind the reduction in cardiovascular (CV) events are unknown. We sought to investigate whether SGLT-2i treatment affected central hemodynamics during rest and exercise in 34 patients with diabetes in this investigator-initiated, randomized, placebo-controlled, double-blinded trial. The primary endpoint was change in pulmonary capillary wedge pressure (PCWP) at a submaximal ergometer workload (25 watt) after 13 weeks of SGLT-2i treatment (25 mg OD) compared to placebo. Secondary endpoints included changes in resting hemodynamics. Baseline and follow-up hemodynamic assessment was performed at rest, submaximal (25 watt), and peak exercise using right heart catheterization. Treatment with empagliflozin for 13 weeks in patients with type 2 diabetes at high cardiovascular risk did not reduce left heart filling pressure more than placebo at submaximal exercise. At rest, we observed that empagliflozin reduced PCWP at a magnitude of clinical significance.
How strong is the evidence?
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. Reported size: 34 participants or records.
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