The efficacy of Tadalafil and Tadalafil + Dapoxetine in managing sexual dysfunction in individuals with type-2 diabetes mellitus: A clinical study

Abstract

Objective: The present study was aimed to evaluate effect of metabolic parameters on erectile dysfunction (ED) in individuals with type-2 diabetes mellitus (T2DM) and to assess the efficacy of Tadalafil and Tadalafil + Dapoxetine combination. Materials and Methods: A prospective, observational, cross-sectional, bicentric study included 216 males with T2DM who are not treated with phosphodiesterase 5 inhibitors and without chronic kidney disease. The data were obtained from demographic questionnaire, clinical laboratory reports of glycometabolic parameters namely body mass index (BMI), hemoglobin A1c (HbA1c), testosterone, vitamin B12 (VitB12), and lipid profile and analyses of the International Index of Erectile Function (IIEF) questionnaire. The effect of physical and metabolic parameters on IIEF sub-domains namely erectile function; orgasmic function; sexual desire (SD); intercourse satisfaction; and overall satisfaction was evaluated. A statistical significance was evaluated using χ2 test or t-test. Result: SD is most significantly lower in subjects with imbalanced physiological and metabolic characteristics including BMI, HbA1c, testosterone, VitB12, triglyceride, high-density lipoprotein, and low-density lipoprotein. Both Tadalafil and Tadalafil + Dapoxetine significantly improved almost all IIEF parameters without any pronounced effect of either. Similarly, both the treatments improved all the IIEF parameters for subjects with high BMI except for SD. In subjects with cardiac comorbidities, the use of either treatment significantly enhanced all the IIEF scores. Conclusion: The findings of this study outline the need of careful examination of sexual dysfunction in healthcare clinics for diabetic individuals. An imbalanced physiological and metabolic profile leads to ED in individuals with T2DM. Additionally, the presence of co-morbidities further elevates the odds of ED prevalence. The treatment with Tadalafil and Tadalafil + Dapoxetine drug combination shows promising results in improving the ED but a study with larger pool of subjects is needed to determine the additional benefits of Dapoxetine.