Long-Term, Multicenter Study of the Safety and Efficacy of Topical Alprostadil Cream in Male Patients with Erectile Dysfunction

Abstract

Introduction Alprostadil is approved for treatment of male erectile dysfunction (ED) by injection or urethral insertion. Topical delivery of alprostadil offers an improved alternative. Aim To evaluate the long-term safety and efficacy of topical alprostadil cream. Methods This was a multicenter, open-label, long-term study in 1,161 patients (998 double-blind rollover; 163 naïve) with ED. For the first 4 weeks, patients could administer eight doses of 200 mcg alprostadil to the penis meatus before intercourse (up to 2 per/week). Patients then self-selected to administer 300 or 100 mcg doses if hypo-responsive or hyper-responsive, respectively, or 200 mcg if no change, for up to 9 months (2 doses/week). Main Outcome Measures Safety evaluated patient/partner adverse events (AEs), changes in vital signs, clinical laboratory tests, physical examinations, and electrocardiograms. Efficacy assessed International Index of Erectile Function, Sexual Encounter Profile, Patient Self Assessment of Erection, and Global Assessment Questionnaire. Results Approximately 12% of patients discontinued due to hypo-/hyper-responsiveness, 16% withdrew consent for a variety of reasons, and less than 5% discontinued because of AEs. The majority of patients (73%) selected 300 mcg alprostadil as the final dose. The most common AEs involved application site burning or erythema (12.2%), meatal or glans pain (4.4%), and prolonged or painful erection (1.3%). Only 5 (0.4%) patients reported a prolonged erection of ≥4 hours (priapism). Vaginal burning or itching (2.1%) was reported most frequently by partners. The majority of patients (74%) demonstrated an overall improvement in erectile function on most end-points, especially after adjusting dose strength to their individual responsiveness. Conclusions Topical alprostadil cream was considered effective and safe by most patients and their partners, with most AEs limited to the application site. Dose adjustment to 300 mcg alprostadil facilitated the greatest improvement in erectile function in the majority of patients. A separate report will integrate patient data from the open-label extension and prior double-blind studies.

Alprostadil cream in the treatment of erectile dysfunction: clinical evidence and experience

“…In contrast, common local AEs with alprostadil cream include penile burning sensation (25%) and penile erythema (11%). Furthermore, AEs leading to discontinuation were rarely reported with alprostadil cream: 4.3% were reported in clinical trials [Rooney et al 2009] compared with 12% with PDE5 inhibitors [Jiann et al 2006] and over 40% with PGE1 intracavernous injections [Hatzimouratidis et al 2015]. (4) Furthermore, the results of a survey of patients (n = 152) asked to express their preferences for an ED treatment according to the route of administration (systemic/ oral, injectable, intraurethral, or cream/ topical) showed that 53% of subjects would select a cream as the first choice [Moncada and Cuzin, 2015].…”

Alprostadil in cream — a new option of treating erectile dysfunctions in diabetic patients

“…SEP2 -Were you able to insert your penis into your female partner's vagina?, SEP3 -Did the erection allowed you to have a satisfactory sexual intercourse?, was observed in the group of men taking the dose of 300 µg. Accordingly 80.3% and 61.1% of men gave positive answers to questions SEP2 and SEP3 at the end of the study, whereas during the first appointment (after taking 200 µg of alprostadil for 30 days), this percentage was 65.8% and 46.9%, respectively [39].…”

“…The efficacy of the preparation was assessed in both short-term and long-term studies. The efficacy of alprostadil in cream administered initially for 4 weeks at the dose of 200 µg and then at the modified dose of up to 100 µg, 200 µg or 300 µg depending on the response of the patient to the treatment which was continued twice a week for up to 9 months was assessed in the open-label, multicentre study [39]. 75% of men chose the dose of 300 µg as the final dose, which was administered every 4-7 days.…”

“…The vast majority (97%) of side effects observed in studies was characterised by low intensity and short duration not exceeding 60 minutes [34][35][36][37][38][39][40]. Almost all the side effects limited to the site of administration of the cream and they mostly included: burning of the penis (23%), redness of the glans (11.3%), and balanitis (4.6%) [38].…”

New treatments for erectile dysfunction

“…12 For the first 28 days, patients could administer eight doses of 200 mg alprostadil cream; for the next nine months, patients then self-selected to continue to administer the 200 mg cream, or to switch to administering 300 mg or 100 mg cream, based on their perceived therapeutic response. About one patient in eight (12%) of patients discontinued due to hypo-/hyper-responsiveness and <5% discontinued because of adverse effects (application site erythema in 12%, meatal or glans pain in 4% and prolonged or painful erection in 1.3%), and only five patients reported priapism; 2.1% of partners reported vaginal burning or pruritus.…”