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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

2009 The Authors; Journal compilation 2009 BJU International SILDENAFIL IN PTSD-EMERGENT EDSAFARINEJAD Safety and efficacy of sildenafil citrate in
treating erectile dysfunction in patients with
combat-related post-traumatic stress disorder:
a double-blind, randomized and

BJUI placebo-controlled study
Mohammad Reza Safarinejad, Ali Asgar Kolahi* and Gholamhossein Ghaedi†
Urology and Nephrology Research Centre, *Department of Health and Community Medicine, Shahid Beheshti
University Research Centre (MC) and †Department of Psychiatry, Faculty of Medicine, Shahed University, Tehran, Iran

Accepted for publication 21 November 2008 was reported by 13 (9.8%), and 11 (8.3%) smokers of more than five cigarettes daily of patients on the sildenafil and placebo were excluded. The patients were randomly regimens, respectively (P = 0.09). Patients divided into a group of 133 who received treated with sildenafil had no statistically OBJECTIVE
100 mg of on-demand sildenafil 0.75–2 h significantly greater improvement in the five sexual function domains of the IIEF received placebo. Patients were asked to use sildenafil citrate for treating erectile ≥16 doses or attempts at home. The efficacy placebo (P = 0.08). The incidences of dysfunction (ED) in patients with combat- of the treatments was assessed every four related post-traumatic stress disorder (PTSD).
attempts during treatment, and at the end significantly greater in the sildenafil arm than in the placebo group (P = 0.01).
question International Index of Erectile Function (IIEF), Sexual Encounter Profile CONCLUSIONS
diary questions 2 and 3, Erectile Dysfunction with ED (aged 37–59 years) were recruited. questionnaire, patients’ event logs of sexual Manual of Mental Disorders-IV criteria for activity, and a Global Assessment Question randomized clinical trials are warranted in PTSD according to the Structured Clinical Interview for Patients, Investigator Version. with PTSD to better elucidate the role of The patients were also evaluated with the Clinician-Administered PTSD Scale, both to Sildenafil did not produce significantly and KEYWORDS
with psychogenic ED were included in the study. Patients with comorbid conditions secondary outcome measures (P = 0.08). A erectile dysfunction, post-traumatic stress (diabetes mellitus, hypercholesterolaemia, normal EF domain score (≥26) at endpoint INTRODUCTION
domains and define PTSD: re-experiencing among the veterans of wars typically last for more than two decades [7]. There has been Post-traumatic stress disorder (PTSD) was first arousal symptoms (DSM IV TR) [3]. It has been very limited investigation of the prevalence of recognized after the devastating effects that shown that veterans with chronic PTSD have sexual dysfunction (SD) in patients with PTSD. war experiences had on soldiers serving in emotional, social and professional problems more likely to report ‘low sexual desire’ than developed PTSD during, or at some point after, intrapersonal and interpersonal difficulties, were subjects without PTSD [8]. Letourneau the Vietnam War [1]. PTSD is listed as an including problems with family cohesion, et al. [9] reported that >80% of combat veterans with PTSD experience SD, of whom Statistical Manual of Mental Disorders (DSM)- affection, hostility and aggression [5,6]. The IV [2]. The symptoms of PTSD fall into three symptoms of PTSD and comorbid conditions J O U R N A L C O M P I L A T I O N 2 0 0 9 B J U I N T E R N A T I O N A L | 1 0 4 , 3 7 6 – 3 8 3 | doi:10.1111/j.1464-410X.2009.08560.x S I L D E N A F I L I N P T S D - E M E R G E N T E D negative collateral effect on their spouses measure symptom severity. All patients were [10]. It was also shown that partners of seen with their wives, and interviewed about patients with past but not current PTSD, and a veterans reported significantly increased their sexual activity and patient’s erectile lifetime psychotic disorder, organic brain somatic symptoms, as well as significantly function (EF). To minimize the problem of disorder or substance abuse or dependence, response bias, patients and their wives were were excluded. Patients were also excluded if families, than a control group [11]. Therefore interviewed privately. They had a preliminary they met DSM-IV criteria for a psychotic/ assessment, including a medical and sexual affective disorder other than PTSD or non- problems of couples. Clinical studies show history, physical examination, a resting 12- combat-related PTSD. Other exclusion criteria sildenafil to be effective in treating ED of were: patients with clinically significant penile various causes [12–14]. Thus we conducted an interview diagnostic of mental and physical deformities or penile implants; a primary study addressing the safety and efficacy of International Index of EF (IIEF) [23], and including premature ejaculation or untreated Sexual Encounter Profile (SEP) diary questions endocrine disease; a history of cardiovascular 2 and 3. The baseline severity of ED was determined using the IIEF EF domain score, infarction or myocardial revascularization); PATIENTS AND METHODS
with mild ED characterized by a score of pelvic surgery, stroke or spinal cord injury; 17–25, moderate ED of 11–16, and severe ED systolic blood pressure >170 or <90 mmHg or Men exposed to combat during the Iran-Iraq of 1–10 [24]. The patterns of attempts at diastolic blood pressure >100 or <50 mmHg; war were recruited through referrals and sexual intercourse, by treatment group, were renal or liver impairment; and those unlikely admitted to our clinics for the treatment of to be available for follow-up. Use of organic ED. Patients were eligible if they had a current number of intercourse attempts per week, nitrates, other nitric-oxide (NO) donors, or diagnosis of PTSD. They met DSM-IV criteria potent CYP3A4 inhibitors (e.g. ritonavir, for PTSD [2] according to the Structured Clinical Interview for Patients, Investigator attempts. To be able to exclude organic SD, anticoagulants, and erythromycin were not Version [15]. From April 2005 to July 2006, fasting blood glucose level, urine analysis, 388 married men (aged 37–59 years) with medications included α-blockers (except PTSD, and their wives, were enrolled in the tamsulosin), androgens, antiandrogens, and study for screening. The diagnosis of ED indicated, other tests were used to establish trazodone. Of 388 enrolled patients, 266 met was established according to the National the diagnosis of vasculogenic and neurogenic the inclusion/exclusion criteria and agreed to Institute of Health statement on ED [16]. All ED, including penile colour duplex Doppler patients had been screened for the standard exclusionary criteria for treatment with Eligible patients were randomized to sildenafil sildenafil citrate. Enrolled patients agreed not prostaglandin E1, pudendal nerve conduction 100 mg (133) or indistinguishable placebo to use another form of ED treatment during tests and impaired sensory-evoked potential (133) tablets using a stratified permuted- the entire study, including the screening block randomization procedure. The clinician period. After procedures and possible side- prescriber and the patients were all unaware effects were explained to patients, all gave The enrolled patients had a total score ≥50 on of the treatment conditions. Patients were their informed consent, and the study was the CAPS and a score ≥4 on the Clinical Global asked to use at least 16 doses/attempts at conducted in accordance with the Declaration Impression of Severity scale at baseline. The home, but not to have more than one attempt patients had to be in a stable relationship with approved the study protocol. We recruited a partner for at least the previous 6 months. consume alcoholic drinks within 6 h of sexual patients free of psychiatric medication use for All patients were free of medical illnesses, activity. All patients were given an instruction ≥12 weeks. This study was done without based on a history, physical examination and sheet before starting the treatment, which sponsorship, it was not advertised, and no laboratory tests, and were medication-free for ≥12 weeks. Patients’ reports that they had not administration (0.75–2 h before sexual been treated with psychotropic medications stimulation) as well as the absolute need for We obtained information about all lifetime sexual stimulation. In addition, the instruction traumatic events, including the earliest, most physicians. All patients had to expect having sheet stressed that medication should be used recent and most severe events, and the ages the same female sexual partner throughout 2–3 h after a low fat meal. None of the at which these events occurred, using the the study, to ensure reliability in recording patients had formal psychosexual counselling.
responses to efficacy endpoints. Patients with any degree of ED severity (mild, moderate or Experiences Scale [18], the Hamilton Rating severe) were permitted to enrolment. Only Scale for Depression [19], the Hamilton Rating patients with psychogenic ED were included Scale for Anxiety [20], and the Liebowitz efficacy assessed every four attempts and conditions, including diabetes mellitus, hypercholesterolaemia, hypertension, and designated primary outcome measures were administered PTSD Scale (CAPS) [22], both to Peyronie’s disease, and smokers of more than the changes in IIEF and responses to the five cigarettes daily, were excluded. Due to questions from the IIEF: question 3, ‘When 2 0 0 9 T H E A U T H O R SJ O U R N A L C O M P I L A T I O N 2 0 0 9 B J U I N T E R N A T I O N A L you attempted sexual intercourse, how often TABLE 1 The demographic characteristics of the patients at baseline; none of the differences were were able to penetrate your partner?’ and question 4, ‘During sexual intercourse, how often were able to maintain your erection to Mean (range) or (SEM) or n (%) variable completion of intercourse?’ and SEP diary questions 2 (‘Were you able to insert your penis into your partner’s vagina?’) and 3 (‘Did your erection last long enough for you to have successful intercourse?’). Responses questionnaire were rated on a scale of 1–5, with five response options: 1, almost never/ never; 2, a few times (much less than half the time); 3, sometimes (about half the time); 4, most times (much more than half the time); responses to the remaining 13 IIEF questions. Each patient also responded to a GAQ (‘Were your erections rigid, and did they last long enough to have successful intercourse?’) and recorded the date of the medication taken, hardness of erections on a four-point scale, the number of attempts at sexual intercourse and the number of attempts that were successful. Patient and partner satisfaction was assessed using the patient version of the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaire, a validated (6.8%) in sildenafil and placebo groups, 11-item instrument to assess ED treatment satisfaction, with a final score ranging from 0 participation before the fourth attempt), an (extremely low) to 100 (extremely high) [25]. intent-to-treat analysis using last observation In all, 145 (54.5%) patients had severe ED and Other secondary efficacy variables included carried forward was done. The responses to the mean (SEM) baseline IIEF EF domain score successful attempts at sexual intercourse, was 12.2 (4.5). The study groups appeared mean intercourse frequency and quality of life regression. Comparison of sexual satisfaction rates of patients and their wives were tested demographic characteristics, including age, aetiology, ED and PTSD duration, and IIEF Safety and tolerability were evaluated on the correction or Fisher’s exact test, when domain scores. The distribution of baseline necessary. Tests of treatment effects were severity was also similar, with similar numbers effects, and physical examination during each conducted at a two-sided α of 0.05.
of mild (19, 14.3% vs 18, 13.5%), moderate patient’s visit. Patients were asked to report all (43, 32.3% vs 41, 30.8%), and severe (71, treatment-emergent adverse events (TEAEs), 53.4% vs 74, 55.5%) ED in the sildenafil and which were assessed by the investigator using The baseline characteristics of the patients Activities (version 5.0) for severity and who completed the study protocol are shown All patients were interviewed, with their relationship to study drug. TEAEs were defined in Table 1. Of 266 randomized patients, 24 as any AE that first occurred or worsened failed to complete any scheduled outcome activity and patient’s EF. Sildenafil did not after randomization. Patients voluntarily assessment (first four attempts) because of protocol discontinuation. Ten discontinued greater improvement than placebo in each of because of AEs (nine randomized to sildenafil the primary outcome measures (P = 0.08). The All statistical analyses were based on the and one to placebo), nine because of a lack of intent-to-treat principle. TEAEs were analysed effect (four in the sildenafil and five in the sildenafil treatment (able to attain and placebo group), and five (two in the sildenafil maintain an erection sufficient to allow sexual and three in the placebo group) were lost intercourse; 15, 11.3%), was not significantly multivariate repeated-measures ANOVA. To higher than with placebo (12, 9.0%; P = 0.08). discontinuation rate was 15 (11.3%) and nine The primary endpoint of mean IIEF EF score J O U R N A L C O M P I L A T I O N 2 0 0 9 B J U I N T E R N A T I O N A L S I L D E N A F I L I N P T S D - E M E R G E N T E D 4 than at baseline (P = 0.1). SEP2 is designed TABLE 2 Improvement in EF primary and secondary efficacy measures, and the mean final scores to to measure the patient’s overall ability to question 1, 2, and 5–15 of the IIEF, at the end of trial penetrate the partner’s vagina. The mean per-patient rate changed from 6.5% and 6.4% at baseline, to 18.2% and 17.3% at the end of trial, in the sildenafil and placebo groups, Efficacy measures
respectively (P = 0.1). In response to the SEP3 question, the mean per-patient success rate at baseline was 21.4% and 22.4%, improving to 26.2% and 24.8%, at the end of the trial for patients who received sildenafil and placebo, respectively (P = 0.08; Table 2). The per- patient success rates for these variables (SEP2 and SEP3) did not tend to increase over time.
For secondary efficacy measures, differences sildenafil and placebo in the intent-to-treat analysis (Table 2). Patients treated with sildenafil had no statistically significantly 1. How often were you able to get an erection during function domains of the IIEF questionnaire than those treated with placebo (P = 0.08) 2. When you had erection with sexual stimulation, how (Table 2). The mean (SEM) baseline IIEF domain were your erections hard enough for penetration? scores for patients with ED were 12.2 (4.6) for 5. During sexual intercourse, how difficult was to EF, 5.6 (1.4) for orgasmic function, 5.1 (1.8) maintain your erection to completion of intercourse? for sexual desire, 4.9 (1.6) for intercourse 6. How many times have you attempted sexual 7. When you attempted sexual intercourse, how often increased to 15.8 (4.8), 6.1 (1.5), 5.9 (1.6), 5.4 (1.6) and 4.8 (1.3) with sildenafil, and 8. How much have you enjoyed sexual intercourse? 14.6 (4.4), 6.0 (1.4), 5.7 (1.4), 5.7 (1.6) and 9. When you had sexual intercourse, how often did you 4.9 (1.3) with placebo, respectively (all 10. When you had sexual intercourse, how often did you Patients on sildenafil treatment also had no statistically significant increase in mean 12. How would you rate your level of sexual desire? 13. How satisfied have you been with your overall sex life? placebo (P = 0.1). The benefit of sildenafil 14. How satisfied have you been with your sexual compared with placebo was not statistically 15. How do you rate your confidence that you could get responses to the GAQ, 12.8% (sildenafil) and 11.3% (placebo) of men thought that the treatment improved their erections (P = 0.08; Table 2). The mean total QoL scores were similar between groups at baseline, and improved from 12.1 (4.4) and 12.3 (4.6) at increased from 1.1 to 1.4, and from 1.0 to 1.4, throughout the study changes in QoL were baseline to 15.8 (5.6) and 14.6 (5.4) for respectively. From the ANOVA with multiple not significantly between the groups (P = 0.1). patients in the sildenafil and placebo groups, comparisons, treatment with sildenafil did not respectively (P = 0.08). A normal EF domain cause a greater increase in mean scores for intercourse that were successful also did score (≥26) at endpoint was reported by 13 question 3 and 4 than placebo (P = 0.1; not increase significantly with sildenafil (9.8%) and 11 (8.3%) of the patients on the Table 2). The number of patients achieving a treatment (P = 0.1). Sildenafil also did not sildenafil and placebo regimens, respectively response of 4 or 5 to IIEF questions 3 and 4 increase statistically significant sexual (P = 0.09). At the end of trial, the mean score was 13 (9.8%) and 11 (8.3%), and 12 (9.0%) satisfaction scores both in patients and and 11 (8.3%) in the sildenafil and placebo their wives (P = 0.08; Table 3). Overall, the baseline mean of 1.2 to 1.7, and from 1.2 to groups, respectively. Treatment with sildenafil treatment, defined by Lewis et al. [27] as a significantly higher scores for question 3 and final EDITS score of >50, was 11.3% for the 2 0 0 9 T H E A U T H O R SJ O U R N A L C O M P I L A T I O N 2 0 0 9 B J U I N T E R N A T I O N A L sildenafil and 12.8% for the placebo group TABLE 3 Treatment satisfaction; none of the differences were statistically significant The incidences of TEAEs were significantly greater in the sildenafil than the placebo group (P = 0.01; Table 4). AEs were mild, moderate and severe in ≈30%, 35% and 35% of patients reporting them, respectively. Ten AEs led to early discontinuation (nine randomized to sildenafil and one to placebo). Of the nine patients taking sildenafil who discontinued, three had a severe headache after two doses, two had dyspepsia after two doses, two had abdominal pain (with nausea) headache (19, 14.3%), flushing (12, 9.0%), nausea (nine, 6.8%), vision disturbances (11, 8.3%), rhinitis (nine, 6.8%), dyspepsia (six, 4.5%) and myalgia (four, 3.0%). Sildenafil was not well tolerated, with side-effects noted in 4 Patient’s feelings about continuing treatment 22.6% of patients, but only 5.9% had to discontinue treatment.
The results of the present study show that oral sildenafil is not effective in restoring the ability to achieve and maintain erections in patients with PTSD-emergent ED. Responses to IIEF questions 3 and 4, which addressed these two aspects of EF, did not significantly differ between the groups. Partner responses to similarly worded questions corroborated the patients’ reports. Also, responses to the GAQ showed that 100 mg sildenafil was no better than placebo in improving EF. The present study also evaluated the treatment response to sildenafil by assessing the IIEF domains of male sexual function, i.e. EF, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction with sex within 3 months. For many others, symptoms life. There were no statistically significant persist for >12 months, forming a chronic, differences between sildenafil and placebo. debilitating condition [2,29]. Patients with cardiovascular disease [33], ischaemic heart This shows that all of the sexual aspects of disease [34], spinal cord injuries [35], after male sexual function are inhibited strongly in interpersonal withdrawal [2]. SD is very radical prostatectomy [36], multiple sclerosis patients with PTSD, and peripherally acting [37], and depression [38]. However, despite its vasoactive drugs (such as sildenafil) are effectiveness, 30–50% of subjects receiving prevalence of SD in Vietnam combat veterans therapy [39]. In addition, marketing data premature ejaculation or failure to achieve or worldwide showed that discontinuation rates for sildenafil are up to 50% of patients treated dramatic impact on patients’ well-being and [40]. Therefore, sildenafil is not useful and social functioning, with major public health Since its approval in 1998, oral sildenafil has effective in about half of the 150 million men significance in terms of its high prevalence, become a first-line treatment option for men chronicity and disability [28,29]. In about half with ED. It has been shown that sildenafil projected to more than double by the year of all cases a complete recovery might occur effectively treats ED of various aetiologies, 2025 [41,42]. The anticipated increase in the J O U R N A L C O M P I L A T I O N 2 0 0 9 B J U I N T E R N A T I O N A L S I L D E N A F I L I N P T S D - E M E R G E N T E D population of patients seeking treatment for antagonist, is an effective and well-tolerated REFERENCES
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J O U R N A L C O M P I L A T I O N 2 0 0 9 B J U I N T E R N A T I O N A L S I L D E N A F I L I N P T S D - E M E R G E N T E D Abbreviations: ED, erectile dysfunction;
Disorders; CAPS, Clinician-administered
PTSD, post-traumatic stress disorder; IIEF,
Satisfaction; GAQ, Global Assessment
PTSD Scale; NO, nitric oxide; QoL, quality of
International Index of Erectile Function; SEP,
Question; SD, sexual dysfunction; DSM,
life; TEAE, treatment-emergent adverse
Sexual Encounter Profile; EDITS, Erectile
Diagnostic and Statistical Manual of Mental 2 0 0 9 T H E A U T H O R SJ O U R N A L C O M P I L A T I O N 2 0 0 9 B J U I N T E R N A T I O N A L

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