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Safety and efficacy of sildenafil citrate in treating erectile dysfunction in patients with combat-related post-traumatic stress disorder: a double-blind, randomized and placebo-controlled study.
BJU Int. 2009 Aug; 104(3):376-83.BI

Abstract

OBJECTIVE

To evaluate the safety and efficacy of sildenafil citrate for treating erectile dysfunction (ED) in patients with combat-related post-traumatic stress disorder (PTSD).

PATIENTS AND METHODS

In all, 266 combat-exposed war veterans with ED (aged 37-59 years) were recruited. They met the Diagnostic and Statistical Manual of Mental Disorders-IV criteria for PTSD according to the Structured Clinical Interview for Patients, Investigator Version. The patients were also evaluated with the Clinician-Administered PTSD Scale, both to establish the diagnosis of PTSD and to measure symptom severity. Only patients with psychogenic ED were included in the study. Patients with comorbid conditions (diabetes mellitus, hypercholesterolaemia, hypertension, Peyronie's disease) and smokers of more than five cigarettes daily were excluded. The patients were randomly divided into a group of 133 who received 100 mg of on-demand sildenafil 0.75-2 h before sexual stimulation, and 133 who received placebo. Patients were asked to use > or =16 doses or attempts at home. The efficacy of the treatments was assessed every four attempts during treatment, and at the end of the study, using responses to the 15-question International Index of Erectile Function (IIEF), Sexual Encounter Profile diary questions 2 and 3, Erectile Dysfunction Inventory of Treatment Satisfaction questionnaire, patients' event logs of sexual activity, and a Global Assessment Question about erections.

RESULTS

Sildenafil did not produce significantly and substantially greater improvement than placebo in each of the primary and secondary outcome measures (P = 0.08). A normal EF domain score (> or =26) at endpoint was reported by 13 (9.8%), and 11 (8.3%) of patients on the sildenafil and placebo regimens, respectively (P = 0.09). Patients treated with sildenafil had no statistically significantly greater improvement in the five sexual function domains of the IIEF questionnaire than those treated with placebo (P = 0.08). The incidences of treatment-emergent adverse events were significantly greater in the sildenafil arm than in the placebo group (P = 0.01).

CONCLUSIONS

Sildenafil is no better than placebo in treating PTSD-emergent ED. Further randomized clinical trials are warranted in combat veterans and other populations with PTSD to better elucidate the role of phosphodiesterase type 5 inhibitors in treating PTSD-emergent ED.

Authors+Show Affiliations

Urology and Nephrology Research Centre, Shahid Beheshti University Research Centre, Tehran, Iran. safarinejad@unrc.irNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

19389004

Citation

Safarinejad, Mohammad Reza, et al. "Safety and Efficacy of Sildenafil Citrate in Treating Erectile Dysfunction in Patients With Combat-related Post-traumatic Stress Disorder: a Double-blind, Randomized and Placebo-controlled Study." BJU International, vol. 104, no. 3, 2009, pp. 376-83.
Safarinejad MR, Kolahi AA, Ghaedi G. Safety and efficacy of sildenafil citrate in treating erectile dysfunction in patients with combat-related post-traumatic stress disorder: a double-blind, randomized and placebo-controlled study. BJU Int. 2009;104(3):376-83.
Safarinejad, M. R., Kolahi, A. A., & Ghaedi, G. (2009). Safety and efficacy of sildenafil citrate in treating erectile dysfunction in patients with combat-related post-traumatic stress disorder: a double-blind, randomized and placebo-controlled study. BJU International, 104(3), 376-83. https://doi.org/10.1111/j.1464-410X.2009.08560.x
Safarinejad MR, Kolahi AA, Ghaedi G. Safety and Efficacy of Sildenafil Citrate in Treating Erectile Dysfunction in Patients With Combat-related Post-traumatic Stress Disorder: a Double-blind, Randomized and Placebo-controlled Study. BJU Int. 2009;104(3):376-83. PubMed PMID: 19389004.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Safety and efficacy of sildenafil citrate in treating erectile dysfunction in patients with combat-related post-traumatic stress disorder: a double-blind, randomized and placebo-controlled study. AU - Safarinejad,Mohammad Reza, AU - Kolahi,Ali Asgar, AU - Ghaedi,Gholamhossein, Y1 - 2009/04/15/ PY - 2009/4/25/entrez PY - 2009/4/25/pubmed PY - 2009/9/2/medline SP - 376 EP - 83 JF - BJU international JO - BJU Int. VL - 104 IS - 3 N2 - OBJECTIVE: To evaluate the safety and efficacy of sildenafil citrate for treating erectile dysfunction (ED) in patients with combat-related post-traumatic stress disorder (PTSD). PATIENTS AND METHODS: In all, 266 combat-exposed war veterans with ED (aged 37-59 years) were recruited. They met the Diagnostic and Statistical Manual of Mental Disorders-IV criteria for PTSD according to the Structured Clinical Interview for Patients, Investigator Version. The patients were also evaluated with the Clinician-Administered PTSD Scale, both to establish the diagnosis of PTSD and to measure symptom severity. Only patients with psychogenic ED were included in the study. Patients with comorbid conditions (diabetes mellitus, hypercholesterolaemia, hypertension, Peyronie's disease) and smokers of more than five cigarettes daily were excluded. The patients were randomly divided into a group of 133 who received 100 mg of on-demand sildenafil 0.75-2 h before sexual stimulation, and 133 who received placebo. Patients were asked to use > or =16 doses or attempts at home. The efficacy of the treatments was assessed every four attempts during treatment, and at the end of the study, using responses to the 15-question International Index of Erectile Function (IIEF), Sexual Encounter Profile diary questions 2 and 3, Erectile Dysfunction Inventory of Treatment Satisfaction questionnaire, patients' event logs of sexual activity, and a Global Assessment Question about erections. RESULTS: Sildenafil did not produce significantly and substantially greater improvement than placebo in each of the primary and secondary outcome measures (P = 0.08). A normal EF domain score (> or =26) at endpoint was reported by 13 (9.8%), and 11 (8.3%) of patients on the sildenafil and placebo regimens, respectively (P = 0.09). Patients treated with sildenafil had no statistically significantly greater improvement in the five sexual function domains of the IIEF questionnaire than those treated with placebo (P = 0.08). The incidences of treatment-emergent adverse events were significantly greater in the sildenafil arm than in the placebo group (P = 0.01). CONCLUSIONS: Sildenafil is no better than placebo in treating PTSD-emergent ED. Further randomized clinical trials are warranted in combat veterans and other populations with PTSD to better elucidate the role of phosphodiesterase type 5 inhibitors in treating PTSD-emergent ED. SN - 1464-410X UR - https://www.unboundmedicine.com/medline/citation/19389004/Safety_and_efficacy_of_sildenafil_citrate_in_treating_erectile_dysfunction_in_patients_with_combat_related_post_traumatic_stress_disorder:_a_double_blind_randomized_and_placebo_controlled_study_ L2 - https://doi.org/10.1111/j.1464-410X.2009.08560.x DB - PRIME DP - Unbound Medicine ER -