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Sildenafil citrate for erectile dysfunction in men receiving multiple antihypertensive agents: a randomized controlled trial.
Am J Hypertens. 2004 Dec; 17(12 Pt 1):1135-42.AJ

Abstract

BACKGROUND

Erectile dysfunction (ED) is common among men taking antihypertensive drugs to control blood pressure. We evaluated the safety and efficacy of sildenafil citrate for treating ED in men taking multiple antihypertensive medications in a randomized, double-blind, placebo-controlled trial.

METHODS

A total of 568 men (> or =18 years) with ED and hypertension who were taking two or more antihypertensives were randomized to sildenafil (n = 281) or matching placebo (n = 287) for a 6-week double-blind trial followed by a 6-week open-label phase during which all patients received sildenafil. Primary efficacy variables were questions (Q) 3 and 4 (frequency of erections and penetration) of the International Index of Erectile Function (IIEF), and secondary efficacy variables were two global efficacy assessment (GEA) questions regarding improvement in erections and intercourse.

RESULTS

A total of 562 men (mean age, 59 years) took > or =1 dose of study drug. At week 6, mean scores on both Q3 and Q4 improved significantly among sildenafil-treated compared with placebo-treated patients. In regard to Q3 and Q4 there were no differences between patients taking two and those taking three or more antihypertensive agents. In all, 71% and 69% of sildenafil-treated patients reported improved erections (GEA1) and intercourse (GEA2) compared with 18% and 20% of placebo-treated patients, respectively. By week 12, >80% of all patients (regardless of initial treatment group) had improved erections and intercourse. During double-blind treatment, 40% of sildenafil-treated and 25% of placebo-treated patients experienced adverse events; fewer than 2% in each group discontinued because of adverse events.

CONCLUSIONS

Sildenafil was an effective and well tolerated treatment for ED in men receiving multiple antihypertensives. The results suggest that there were no additional safety risks associated with the use of sildenafil in these patients.

Authors+Show Affiliations

Columbia University Medical College, New York, New York 10032, USA. tp2114@columbia.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

15607620

Citation

Pickering, Thomas G., et al. "Sildenafil Citrate for Erectile Dysfunction in Men Receiving Multiple Antihypertensive Agents: a Randomized Controlled Trial." American Journal of Hypertension, vol. 17, no. 12 Pt 1, 2004, pp. 1135-42.
Pickering TG, Shepherd AM, Puddey I, et al. Sildenafil citrate for erectile dysfunction in men receiving multiple antihypertensive agents: a randomized controlled trial. Am J Hypertens. 2004;17(12 Pt 1):1135-42.
Pickering, T. G., Shepherd, A. M., Puddey, I., Glasser, D. B., Orazem, J., Sherman, N., & Mancia, G. (2004). Sildenafil citrate for erectile dysfunction in men receiving multiple antihypertensive agents: a randomized controlled trial. American Journal of Hypertension, 17(12 Pt 1), 1135-42.
Pickering TG, et al. Sildenafil Citrate for Erectile Dysfunction in Men Receiving Multiple Antihypertensive Agents: a Randomized Controlled Trial. Am J Hypertens. 2004;17(12 Pt 1):1135-42. PubMed PMID: 15607620.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Sildenafil citrate for erectile dysfunction in men receiving multiple antihypertensive agents: a randomized controlled trial. AU - Pickering,Thomas G, AU - Shepherd,Alexander M M, AU - Puddey,Ian, AU - Glasser,Dale B, AU - Orazem,John, AU - Sherman,Nancy, AU - Mancia,Giuseppe, PY - 2003/04/17/received PY - 2003/07/09/revised PY - 2004/07/09/accepted PY - 2004/12/21/pubmed PY - 2006/9/1/medline PY - 2004/12/21/entrez SP - 1135 EP - 42 JF - American journal of hypertension JO - Am. J. Hypertens. VL - 17 IS - 12 Pt 1 N2 - BACKGROUND: Erectile dysfunction (ED) is common among men taking antihypertensive drugs to control blood pressure. We evaluated the safety and efficacy of sildenafil citrate for treating ED in men taking multiple antihypertensive medications in a randomized, double-blind, placebo-controlled trial. METHODS: A total of 568 men (> or =18 years) with ED and hypertension who were taking two or more antihypertensives were randomized to sildenafil (n = 281) or matching placebo (n = 287) for a 6-week double-blind trial followed by a 6-week open-label phase during which all patients received sildenafil. Primary efficacy variables were questions (Q) 3 and 4 (frequency of erections and penetration) of the International Index of Erectile Function (IIEF), and secondary efficacy variables were two global efficacy assessment (GEA) questions regarding improvement in erections and intercourse. RESULTS: A total of 562 men (mean age, 59 years) took > or =1 dose of study drug. At week 6, mean scores on both Q3 and Q4 improved significantly among sildenafil-treated compared with placebo-treated patients. In regard to Q3 and Q4 there were no differences between patients taking two and those taking three or more antihypertensive agents. In all, 71% and 69% of sildenafil-treated patients reported improved erections (GEA1) and intercourse (GEA2) compared with 18% and 20% of placebo-treated patients, respectively. By week 12, >80% of all patients (regardless of initial treatment group) had improved erections and intercourse. During double-blind treatment, 40% of sildenafil-treated and 25% of placebo-treated patients experienced adverse events; fewer than 2% in each group discontinued because of adverse events. CONCLUSIONS: Sildenafil was an effective and well tolerated treatment for ED in men receiving multiple antihypertensives. The results suggest that there were no additional safety risks associated with the use of sildenafil in these patients. SN - 0895-7061 UR - https://www.unboundmedicine.com/medline/citation/15607620/Sildenafil_citrate_for_erectile_dysfunction_in_men_receiving_multiple_antihypertensive_agents:_a_randomized_controlled_trial_ L2 - https://academic.oup.com/ajh/article-lookup/doi/10.1016/j.amjhyper.2004.07.004 DB - PRIME DP - Unbound Medicine ER -