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

J Perinatol

Departamento de Neonatología, Hospital de Pediatría, Unidad Médica de Alta Especialidad, Centro Médico Nacional de Occidente, Instituto Mexicano del Seguro Social, Guadalajara, Jalisco, México.

Published: July 2006

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

Study Design: 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.

Results: 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.

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

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http://dx.doi.org/10.1038/sj.jp.7211518DOI Listing

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