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Efficacy and safety of sildenafil in men with serotonergic antidepressant-associated erectile dysfunction: results from a randomized, double-blind, placebo-controlled trial.
J Clin Psychiatry. 2006 Feb; 67(2):240-6.JC

Abstract

OBJECTIVE

To evaluate the efficacy of short-term treatment with sildenafil citrate in men with serotonin reuptake inhibitor (SRI)-associated erectile dysfunction (ED).

METHOD

Men (aged>or=18 years) with major depressive disorder (MDD; DSM-IV criteria) in remission and taking SRIs who experienced SRI-associated ED were enrolled in this multicenter, 6-week, randomized, flexible-dose, double-blind, placebo-controlled trial. The primary study measures were questions 3 (Q3: frequency of penetration) and 4 (Q4: frequency of maintained erections after penetration) of the International Index of Erectile Function (IIEF) questionnaire. Secondary study measures were all other questions and domains of the IIEF, the Erectile Dysfunction Index of Treatment Satisfaction (EDITS), a global efficacy questionnaire (GEQ), and a patient-maintained event log of sexual activity.

RESULTS

Patients receiving sildenafil (N=71) versus placebo (N=71) reported significantly higher mean+/-SE scores on Q3 (3.9+/-0.2 vs. 3.1+/-0.2, p=.003) and Q4 (3.7+/-0.2 vs. 2.8+/-0.2, p<.001) of the IIEF and significantly higher scores on all domains of the IIEF. Patients receiving sildenafil also reported significantly improved scores on all questions of the EDITS questionnaire (p<.02) and the GEQ (p<.0001) and an increased number of successful sexual intercourse attempts per week (p<.0001) compared with patients receiving placebo. All patients remained in MDD remission (score<or=10 on the Hamilton Rating Scale for Depression). Adverse events in patients taking sildenafil (vs. placebo) were headache (9% vs. 9%), dyspepsia (9% vs. 1%), anxiety (6% vs. 4%), and abnormal vision (3% vs. 0%).

CONCLUSIONS

Short-term (6-week) administration of sildenafil was well tolerated and significantly improved erectile function and overall sexual satisfaction in men with ED associated with SRI therapy for MDD. Sildenafil may be successfully used to treat SRI-associated ED without interruption of antidepressant therapy.

Authors+Show Affiliations

Depression Clinical and Research Program, the Department of Psychiatry, Massachusetts General Hospital, Boston 02114, and the Department of Psychiatry, University of New Mexico, Albuquerque, USA. mfava@partners.orgNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

16566619

Citation

Fava, Maurizio, et al. "Efficacy and Safety of Sildenafil in Men With Serotonergic Antidepressant-associated Erectile Dysfunction: Results From a Randomized, Double-blind, Placebo-controlled Trial." The Journal of Clinical Psychiatry, vol. 67, no. 2, 2006, pp. 240-6.
Fava M, Nurnberg HG, Seidman SN, et al. Efficacy and safety of sildenafil in men with serotonergic antidepressant-associated erectile dysfunction: results from a randomized, double-blind, placebo-controlled trial. J Clin Psychiatry. 2006;67(2):240-6.
Fava, M., Nurnberg, H. G., Seidman, S. N., Holloway, W., Nicholas, S., Tseng, L. J., & Stecher, V. J. (2006). Efficacy and safety of sildenafil in men with serotonergic antidepressant-associated erectile dysfunction: results from a randomized, double-blind, placebo-controlled trial. The Journal of Clinical Psychiatry, 67(2), 240-6.
Fava M, et al. Efficacy and Safety of Sildenafil in Men With Serotonergic Antidepressant-associated Erectile Dysfunction: Results From a Randomized, Double-blind, Placebo-controlled Trial. J Clin Psychiatry. 2006;67(2):240-6. PubMed PMID: 16566619.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of sildenafil in men with serotonergic antidepressant-associated erectile dysfunction: results from a randomized, double-blind, placebo-controlled trial. AU - Fava,Maurizio, AU - Nurnberg,H George, AU - Seidman,Stuart N, AU - Holloway,Willis, AU - Nicholas,Susan, AU - Tseng,Li-Jung, AU - Stecher,Vera J, PY - 2006/3/29/pubmed PY - 2006/4/15/medline PY - 2006/3/29/entrez SP - 240 EP - 6 JF - The Journal of clinical psychiatry JO - J Clin Psychiatry VL - 67 IS - 2 N2 - OBJECTIVE: To evaluate the efficacy of short-term treatment with sildenafil citrate in men with serotonin reuptake inhibitor (SRI)-associated erectile dysfunction (ED). METHOD: Men (aged>or=18 years) with major depressive disorder (MDD; DSM-IV criteria) in remission and taking SRIs who experienced SRI-associated ED were enrolled in this multicenter, 6-week, randomized, flexible-dose, double-blind, placebo-controlled trial. The primary study measures were questions 3 (Q3: frequency of penetration) and 4 (Q4: frequency of maintained erections after penetration) of the International Index of Erectile Function (IIEF) questionnaire. Secondary study measures were all other questions and domains of the IIEF, the Erectile Dysfunction Index of Treatment Satisfaction (EDITS), a global efficacy questionnaire (GEQ), and a patient-maintained event log of sexual activity. RESULTS: Patients receiving sildenafil (N=71) versus placebo (N=71) reported significantly higher mean+/-SE scores on Q3 (3.9+/-0.2 vs. 3.1+/-0.2, p=.003) and Q4 (3.7+/-0.2 vs. 2.8+/-0.2, p<.001) of the IIEF and significantly higher scores on all domains of the IIEF. Patients receiving sildenafil also reported significantly improved scores on all questions of the EDITS questionnaire (p<.02) and the GEQ (p<.0001) and an increased number of successful sexual intercourse attempts per week (p<.0001) compared with patients receiving placebo. All patients remained in MDD remission (score<or=10 on the Hamilton Rating Scale for Depression). Adverse events in patients taking sildenafil (vs. placebo) were headache (9% vs. 9%), dyspepsia (9% vs. 1%), anxiety (6% vs. 4%), and abnormal vision (3% vs. 0%). CONCLUSIONS: Short-term (6-week) administration of sildenafil was well tolerated and significantly improved erectile function and overall sexual satisfaction in men with ED associated with SRI therapy for MDD. Sildenafil may be successfully used to treat SRI-associated ED without interruption of antidepressant therapy. SN - 0160-6689 UR - https://www.unboundmedicine.com/medline/citation/16566619/Efficacy_and_safety_of_sildenafil_in_men_with_serotonergic_antidepressant_associated_erectile_dysfunction:_results_from_a_randomized_double_blind_placebo_controlled_trial_ L2 - http://www.psychiatrist.com/jcp/article/pages/2006/v67n02/v67n0210.aspx DB - PRIME DP - Unbound Medicine ER -