Original Article

Journal of Perinatology (2006) 26, 423–427. doi:10.1038/sj.jp.7211518; published online 4 May 2006

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

M L Lemus-Varela1, A Sola2, B C Gómez-Meda3, A L Zamora-Perez3, M L Ramos-Ibarra3, C M Batista-González3 and G M Zúñiga-González3

  1. 1Departamento de Neonatología, Hospital de Pediatría, Unidad Médica de Alta Especialidad, Centro Médico Nacional de Occidente, Instituto Mexicano del Seguro Social, Guadalajara, Jalisco, México
  2. 2Neonatal–Perinatal Fellowship Program, Emory University School of Medicine, Atlanta, GA, USA
  3. 3Laboratorio de Mutagénesis, Centro de Investigación Biomédica de Occidente, Instituto Mexicano del Seguro Social, Guadalajara, Jalisco, México

Correspondence: Dr ML Lemus-Varela, Departamento de Neonatología, Hospital de Pediatría, Unidad Médica de Alta Especialidad, Centro Médico Nacional de Occidente, Instituto Mexicano del Seguro Social, Belisario Domínguez 735, Sector Reforma, CP 44340, Guadalajara Jalisco, México. E-mail: lulalemus@hotmail.com; mutagenesis95@hotmail.com

Received 3 January 2006; Revised 30 March 2006; Accepted 4 April 2006; Published online 4 May 2006.

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Abstract

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.

Keywords:

micronucleated erythrocytes, systemic hemodynamic changes, common marmoset

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