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Sildenafil citrate for erectile dysfunction in men with diabetes and cardiovascular risk factors: a retrospective analysis of pooled data from placebo-controlled trials.
Curr Med Res Opin. 2006 Nov; 22(11):2111-20.CM

Abstract

OBJECTIVE

Cardiovascular (CV) risk factors are associated with an increased risk of erectile dysfunction (ED). In men with diabetes mellitus (DM), pooled from clinical trials of sildenafil treatment for ED, this retrospective analysis determined efficacy and safety, overall and in subgroups with additional CV risk (i.e., hypertension, dyslipidemia, and smoking).

RESEARCH DESIGN AND METHODS

From the manufacturer's database of worldwide research, 12-week data from men with DM were pooled from randomized, double-blind, placebo-controlled trials of flexible-dose sildenafil (25, 50, or 100 mg, PRN) for ED.

MAIN OUTCOME MEASURES

Question 3 (achieving an erection), question 4 (maintaining an erection), and the Erectile Function domain of the International Index of Erectile Function; percentage of successful intercourse attempts according to patient event logs; and response to a global efficacy question (GEQ). Differences between groups were determined using logistic regression (percentage of responders according to GEQ) and analysis of covariance (all other outcomes).

RESULTS

Inclusion criteria were met by 11 trials and by 974 men with DM and ED who were randomized to placebo (n = 482) and sildenafil (n = 492) within the selected trials. For all outcomes, overall and regardless of additional CV risk, the benefit was greater for sildenafil versus placebo (p < or = 0.0001), including 3-fold more men responding that sildenafil treatment improved their erections (62% vs. 18%) and a more than doubling of the mean +/- standard error percentage of successful sexual intercourse attempts (52.6 +/- 5.0 vs. 22.4 +/- 5.1). Adverse events were mild to moderate and included (sildenafil vs. placebo) headache (5% vs. 2%), flushing (7% vs. 2%), and dyspepsia (4% vs. 0%), which is consistent with the profile in the general population of men treated with sildenafil for ED.

CONCLUSION

This retrospective analysis of pooled data showed that sildenafil was well tolerated and improved erectile function and intercourse success in men with ED and DM, regardless of additional CV risk factors.

Authors+Show Affiliations

Ochsner Clinic Foundation, New Orleans, LA 70121, USA. lblonde@ochsner.org

Pub Type(s)

Journal Article
Meta-Analysis
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

17076971

Citation

Blonde, Lawrence. "Sildenafil Citrate for Erectile Dysfunction in Men With Diabetes and Cardiovascular Risk Factors: a Retrospective Analysis of Pooled Data From Placebo-controlled Trials." Current Medical Research and Opinion, vol. 22, no. 11, 2006, pp. 2111-20.
Blonde L. Sildenafil citrate for erectile dysfunction in men with diabetes and cardiovascular risk factors: a retrospective analysis of pooled data from placebo-controlled trials. Curr Med Res Opin. 2006;22(11):2111-20.
Blonde, L. (2006). Sildenafil citrate for erectile dysfunction in men with diabetes and cardiovascular risk factors: a retrospective analysis of pooled data from placebo-controlled trials. Current Medical Research and Opinion, 22(11), 2111-20.
Blonde L. Sildenafil Citrate for Erectile Dysfunction in Men With Diabetes and Cardiovascular Risk Factors: a Retrospective Analysis of Pooled Data From Placebo-controlled Trials. Curr Med Res Opin. 2006;22(11):2111-20. PubMed PMID: 17076971.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Sildenafil citrate for erectile dysfunction in men with diabetes and cardiovascular risk factors: a retrospective analysis of pooled data from placebo-controlled trials. A1 - Blonde,Lawrence, PY - 2006/11/2/pubmed PY - 2006/12/9/medline PY - 2006/11/2/entrez SP - 2111 EP - 20 JF - Current medical research and opinion JO - Curr Med Res Opin VL - 22 IS - 11 N2 - OBJECTIVE: Cardiovascular (CV) risk factors are associated with an increased risk of erectile dysfunction (ED). In men with diabetes mellitus (DM), pooled from clinical trials of sildenafil treatment for ED, this retrospective analysis determined efficacy and safety, overall and in subgroups with additional CV risk (i.e., hypertension, dyslipidemia, and smoking). RESEARCH DESIGN AND METHODS: From the manufacturer's database of worldwide research, 12-week data from men with DM were pooled from randomized, double-blind, placebo-controlled trials of flexible-dose sildenafil (25, 50, or 100 mg, PRN) for ED. MAIN OUTCOME MEASURES: Question 3 (achieving an erection), question 4 (maintaining an erection), and the Erectile Function domain of the International Index of Erectile Function; percentage of successful intercourse attempts according to patient event logs; and response to a global efficacy question (GEQ). Differences between groups were determined using logistic regression (percentage of responders according to GEQ) and analysis of covariance (all other outcomes). RESULTS: Inclusion criteria were met by 11 trials and by 974 men with DM and ED who were randomized to placebo (n = 482) and sildenafil (n = 492) within the selected trials. For all outcomes, overall and regardless of additional CV risk, the benefit was greater for sildenafil versus placebo (p < or = 0.0001), including 3-fold more men responding that sildenafil treatment improved their erections (62% vs. 18%) and a more than doubling of the mean +/- standard error percentage of successful sexual intercourse attempts (52.6 +/- 5.0 vs. 22.4 +/- 5.1). Adverse events were mild to moderate and included (sildenafil vs. placebo) headache (5% vs. 2%), flushing (7% vs. 2%), and dyspepsia (4% vs. 0%), which is consistent with the profile in the general population of men treated with sildenafil for ED. CONCLUSION: This retrospective analysis of pooled data showed that sildenafil was well tolerated and improved erectile function and intercourse success in men with ED and DM, regardless of additional CV risk factors. SN - 1473-4877 UR - https://www.unboundmedicine.com/medline/citation/17076971/Sildenafil_citrate_for_erectile_dysfunction_in_men_with_diabetes_and_cardiovascular_risk_factors:_a_retrospective_analysis_of_pooled_data_from_placebo_controlled_trials_ L2 - http://www.tandfonline.com/doi/full/10.1185/030079906X148256 DB - PRIME DP - Unbound Medicine ER -