Oral sildenafil citrate lacks genotoxicity and cytotoxicity in a primate model: Callithrix jacchus

To determine sildenafil citrate (SC) genotoxicity and cytotoxicity in the Callithrix jacchus.

Fifteen organisms were assigned to one of three groups as follows: experimental (25 mg/kg of SC); negative control (glucose solution 5%); and positive control (3 mg/kg of cytocine arabinoside). Systemic hemodynamic changes were monitored in each animal before and after each treatment. A drop of blood was obtained before and after the treatment at 24-120 h. Smears were made and the frequency of micronucleated erythrocytes (MNE), micronucleated polychromatic erythrocytes (MNPCE) and polychromatic erythrocytes (PCE) was counted.

No significant differences in MNE, MNPCE and PCE were found in the group that received sildenafil and negative control. A significant increase in genotoxicity and cytotoxicity was observed in the positive control group. No changes were observed in systemic hemodynamic changes.

The macro-dose of SC lacks genotoxic, cytotoxic or systemic hemodynamic changes effects in this species.