Increased Bioavailability of Sildenafil in Mexican Men

Flores‐Murrieta, Francisco J.

doi:10.1001/jama.283.14.1825

Cited by 27 publications

(19 citation statements)

References 4 publications

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“…Together with the low rate of discontinuations from treatment due to AEs, we conclude that sildenafil was well tolerated. Although it has been reported that sildenafil concentrations in Mexican men were about two times higher than in white men, 26 the efficacy and safety of sildenafil in the patients included in this study are similar to results reported previously.…”

Section: Discussionsupporting

confidence: 90%

Efficacy and safety of oral sildenafil citrate (Viagra®) in the treatment of male erectile dysfunction in Colombia, Ecuador, and Venezuela: a double-blind, multicenter, placebo-controlled study

Gómez

Dávila

Costa³

et al. 2002

Int J Impot Res

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The objective of this work was to assess the efficacy and safety of sildenafil in patients with erectile dysfunction (ED) from Colombia, Ecuador, and Venezuela. One hundred and fifty-eight outpatients with ED participated in a double-blind, flexible-dose, randomized-controlled trial. Efficacy measures included question 3 (achieving an erection) and question 4 (maintaining an erection) from the International Index of Erectile Function (IIEF), the five functional domains of the IIEF, a global efficacy question, and patient event log. Sildenafil increased patients' ability to achieve=maintain erections (P < 0.01). Seventy-seven per cent of sildenafil-vs 46% of placebotreated patients reported improved erections (P < 0.001). Sixty-five percent and 35% of intercourse attempts were successful among sildenafil and placebo patients, respectively (P < 0.05). Sildenafil patients showed significant improvements in three of the five IIEF functional domains (P < 0.05). Adverse events were reported for 51% and 33% of sildenafil and placebo patients, respectively. It can be concluded that sildenafil is an effective, well-tolerated treatment for ED in patients from Latin America.

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Section: Discussionsupporting

confidence: 90%

Efficacy and safety of oral sildenafil citrate (Viagra®) in the treatment of male erectile dysfunction in Colombia, Ecuador, and Venezuela: a double-blind, multicenter, placebo-controlled study

Gómez

Dávila

Costa³

et al. 2002

Int J Impot Res

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“…Pharmacogenetic differences may exist between ethnic populations. Substantially higher peak sildenafil concentrations of 1044 ng/ml were found after an oral dose of 100mg in Mexican volunteers (12). One paper documenting a fatality from sildenafil overdose reported a concentration of 6270 ng/ml (13).…”

Section: Discussionmentioning

confidence: 99%

Sildenafil citrate ingestion and prolonged priapism and tachycardia in a pediatric patient

Wills

Albinson

Wahl

et al. 2007

Clinical Toxicology

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Introduction.Little is known about the toxicity of sildenafil overdose in the pediatric population. We present a case of prolonged priapism and tachycardia due to unintentional sildenafil overdose in a child. Case report. A 19-month-old male ingested up to six 50 mg Viagra tablets 45 minutes prior to presentation at the emergency department. Initial vital signs included temperature 98.2 o F, blood pressure 90/58 mmHg, heart rate 140, respirations 20, and oxygen saturation of 100% on room air. The child weighed 10.4 kg. Physical exam revealed a happy, smiling, laughing toddler who was cooperative with all aspects of his exam. He had mild facial flushing and an erect penis which was normal in color and had a capillary refill of two seconds. Precordial palpation did not show evidence of increase dynamic force, his heart sounds were regular, and no ectopy was noted. His peripheral pulses were strong and regular in all four extremities. No gastrointestinal decontamination was performed. The patient was started on maintenance IV fluids and admitted to the pediatric floor for observation. The patient had a non-painful tumescent penis and mild tachycardia for about 24 hours post-ingestion. The child never had pain from the constant erection. Sildenafil concentration drawn approximately seven hours after ingestion was 3900 ng/ml (reporting limit 24 ng/ml) and N-desmethylsildenafil level was 1700 ng/ml (reporting limit 24 ng/ml). Conclusion. This case of pediatric sildenafil ingestion (up to 30mg/kg) initially resulted in facial flushing and priapism. The child had asymptomatic tachycardia and prolonged priapism that persisted until hospital discharge approximately 24 hours after ingestion. The erection was non-painful and required no urologic intervention, most likely representing a high flow state. In this ingestion, only supportive care was required.

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“…30,31 A comparison of sildenafil pharmacokinetics in young, healthy, Mexican men with historical pharmacokinetic data from Caucasian men taking the same 100 mg dose of sildenafil showed twofold higher peak levels of sildenafil in the serum of Mexican men, although the drug half-life of about 4 h was similar in both the groups. 32 These data suggest that the bioavailability of sildenafil could be higher in Mexican men than in Caucasians. However, in the current analysis of the Mexican subpopulation in the multinational trial, no serious or severe AEs, discontinuations due to AEs or other causes, or dose reductions were reported in this subgroup, and the occurrence of AEs was similar to that reported in other sildenafil trials.…”

Section: Discussionmentioning

confidence: 91%

Self-esteem, confidence and relationship satisfaction in men with erectile dysfunction: a randomized, parallel-group, double-blind, placebo-controlled study of sildenafil in Mexico

et al. 2008

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Erectile dysfunction (ED) negatively impacts self-esteem and relationship satisfaction. The Self-Esteem and Relationship (SEAR) questionnaire is a validated, ED-specific, patient-reported instrument that specifically addresses self-esteem and relationship issues within the context of ED. Effective ED treatment with sildenafil in a double-blind, placebo-controlled clinical trial conducted in Brazil, Mexico, Australia and Japan showed pooled cross-cultural improvements in self-esteem, confidence and relationship satisfaction. This report focuses on the results from the subgroup of men from nine Mexican centers who participated in the multinational study. A total of 95 men aged X18 years with clinically diagnosed ED and currently in a stable relationship were randomized to placebo (n ¼ 47) or sildenafil (n ¼ 48). The SEAR results for Mexican men showed that sildenafil treatment led to significant improvements in self-esteem, confidence and relationship satisfaction. These data support an earlier study showing that Latin American men taking sildenafil have similar safety and efficacy profiles compared to non-Latin counterparts.

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Increased Bioavailability of Sildenafil in Mexican Men

Cited by 27 publications

References 4 publications

Efficacy and safety of oral sildenafil citrate (Viagra®) in the treatment of male erectile dysfunction in Colombia, Ecuador, and Venezuela: a double-blind, multicenter, placebo-controlled study

Efficacy and safety of oral sildenafil citrate (Viagra®) in the treatment of male erectile dysfunction in Colombia, Ecuador, and Venezuela: a double-blind, multicenter, placebo-controlled study

Sildenafil citrate ingestion and prolonged priapism and tachycardia in a pediatric patient

Self-esteem, confidence and relationship satisfaction in men with erectile dysfunction: a randomized, parallel-group, double-blind, placebo-controlled study of sildenafil in Mexico

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