UCBM participates in the first Italian study that reveals the different response between men and women to the drug tadalafil, effective in the treatment of diabetic cardiomyopathy
June 23, 2022 - It often happens that scientific research uncovers a different therapeutic application for a drug than the one for which it is currently used. The tadalafil belongs to the class of named medicines phosphodiesterase type 5 inhibitors (PDE5i) and finds application in the andrological field for the treatment of erectile dysfunction. A recent Italian study entitled 'Sex-specific effects of daily tadalafil on diabetic heart kinetics in recogito, a randomized, double-blind, placebo-controlled trial', demonstrated the beneficial effects deriving from the daily use of tadalafil against the renal and cardiovascular complications of diabetes, revealing how the response to treatment is different in male and female subjects.
It is a clear example of drug repurposing or drug repositioning, which in Italian translates into drug repositioning: a research approach aimed at identifying a new role for an active ingredient already in use for a specific pathology. The research, published in the journal Science Translational Medicine, was born from the collaboration between various departments of the University of Rome "La Sapienza" and Irccs Neuromed, theUniversità Campus Bio-Medico di Roma, the Fatebenefratelli Hospital and the University of Cagliari and was coordinated by Andrea Isidori, Professor of Endocrinology at the Department of Experimental Medicine of the University of Rome "La Sapienza".
The study design involved the enrollment of 122 subjects, men and women, with type 2 diabetes mellitus and diabetic cardiomyopathy aged between 45 and 80 years and was expressly designed to investigate the differences between men and women in response to tadalafil. It is known that there are some gender differences in drug response, but over the years clinical studies have often neglected this aspect involving mainly male patients. The obtained results show that the effects of tadalafil are gender-specific: in men and women it favors renal function, while in male subjects it also improves the cardiac situation. The researchers are sure that the different response is linked to the lack of estrogen, all the women involved were in fact in menopause. This opens up interesting scenarios on the role of female hormones as mediators of cardiac drugs and underlines how important the representativeness of both sexes is in clinical trials.
The effectiveness, moreover, was achieved in the face of negligible adverse reactions. Further investigations will be needed to monitor the safety and possible drug interactions of this drug which can represent a valid therapeutic alternative.
"We participated in this original study involving patients belonging to the Endocrinology and Diabetology Area of our Polyclinic, who were able to derive a significant benefit from participating in the trial" explained the prof. Paolo Pozzilli, Head of the Endocrinology and Diabetology Research Unit UCBM.
