Ocular safety of sildenafil citrate when administered chronically for pulmonary arterial hypertension: results from phase III, randomised, double masked, placebo controlled trial and open label extension.
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ABSTRACT:
SUBMITTER: Wirostko BM
PROVIDER: S-EPMC3283528 | biostudies-literature | 2012 Feb
REPOSITORIES: biostudies-literature
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Ocular safety of sildenafil citrate when administered chronically for pulmonary arterial hypertension: results from phase III, randomised, double masked, placebo controlled trial and open label extension.
Wirostko Barbara M BM Tressler Charles C Hwang Lie-Ju LJ Burgess Gary G Laties Alan M AM
BMJ (Clinical research ed.) 20120221
<h4>Objective</h4>To assess the ocular effects and safety profile of chronic sildenafil oral dosing in patients with pulmonary arterial hypertension.<h4>Design</h4>12 week, double masked, randomised, placebo controlled, phase III trial with open label extension.<h4>Setting</h4>53 institutions worldwide.<h4>Participants</h4>277 adults with idiopathic pulmonary arterial hypertension or pulmonary arterial hypertension associated with connective tissue disease or after congenital heart disease repai ...[more]
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Project description:BackgroundMen with erectile dysfunction (ED) often have low self-esteem, confidence, and sexual relationship satisfaction.ObjectiveWe evaluated the impact of sildenafil citrate and its generalizability across cultures on self-esteem, confidence, and sexual relationship satisfaction in men with ED using the Self-Esteem And Relationship (SEAR) questionnaire.DesignPooled analysis of 2 double-blind, placebo-controlled, flexible-dose trials of sildenafil with identical protocols: 1 was conducted in the United States and the other in Mexico, Brazil, Australia, and Japan.PatientsMen > or = 18 years old with ED.MeasurementsThe impact of treatment on psychosocial factors associated with ED was determined by patient responses to the SEAR questionnaire. Erectile function was determined using the International Index of Erectile Function (IIEF) and a global efficacy question. Successful sexual intercourse attempts were derived from event logs of sexual activity. Treatment effect sizes were calculated for all study outcomes.ResultsCompared with patients who received placebo (n = 274), patients who received sildenafil (n = 279) reported significantly greater improvements (P < .0001) in self-esteem, confidence, sexual relationship satisfaction, and in all sexual function domains of the IIEF. Treatment effect sizes were large (range, 0.7 to 1.2) for all SEAR components, and improvement in psychosocial measures showed moderate to high correlations (range, 0.50 to 0.83, P < .0001) with improvement in erectile function, percentage of successful intercourse attempts, and global efficacy.ConclusionsIn men with ED from 5 different nations, sildenafil produced substantial improvements in self-esteem, confidence, and sexual relationship satisfaction. Improvements in these psychosocial factors were observed crossculturally and correlated significantly and tangibly with improvements in erectile function.
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