Effects of tadalafil and SGLT2 inhibitors on erectile and diastolic functions in men with metabolic syndrome: A randomized controlled study
Abstract
Background Erectile dysfunction (ED) is an early manifestation of systemic endothelial dysfunction and is increasingly linked to subclinical myocardial impairment. Whether sodium – glucose cotransporter-2 inhibitors (SGLT2i), alone or combined with phosphodiesterase-5 inhibition, confer simultaneous cardio-sexual benefit in men with metabolic syndrome remains unknown. This study aimed to compare the effects of tadalafil, SGLT2i and their combination on erectile and left ventricular diastolic functions in patients with metabolic syndrome (MetS).Methods In this prospective, randomized, assessor-blinded, parallel-group trial, 60 men with metabolic syndrome and ED were assigned 1:1:1 to tadalafil 5 mg daily, an SGLT2 inhibitor (dapagliflozin or empagliflozin 10 mg daily), or their combination for 3 months. The primary endpoint was change in Erectile function domain of the International Index of Erectile Function (IIEF-EF, 6 items). Secondary endpoints included changes in echocardiographic diastolic indices (ratio of early mitral inflow velocity (E) to early diastolic mitral annular velocity (e′) ‘E/e′’, isovolumic relaxation time ‘IVRT’, deceleration time, and pulmonary artery systolic pressure ‘PASP’), the correlation between ΔIIEF-EF (Change from baseline) and ΔE/e′, and independent predictors of erectile improvement.Results All three regimens significantly improved IIEF-EF scores (all p < 0.01). Between-group analysis showed a significant difference in ΔIIEF-EF (p = 0.049),…
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: 60 participants or records.
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