Daily Application of Alprostadil Topical Cream (Vitaros) Does Not Impact Vaginal pH, Flora, or Histology in Female Cynomolgus Monkeys

Meier-Davis, Susan; Debar, Salma; Siddoway, Jacob; Rabe, Mark

doi:10.1177/1091581814561870

Cited by 5 publications

(2 citation statements)

References 15 publications

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“…Nevertheless, the cream has not been compared directly with other treatments and there is limited information on long-term safety. However, in animals a recent publication has shown that repeated vaginal exposure to Vitaros did not alter the pH, microflora, or histology after 14 daily doses, supporting the safety of Vitaros transference to the female partner [Meier-Davis et al 2015].…”

Section: Resultsmentioning

confidence: 99%

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

Cuzin

2016

Therapeutic Advances in Urology

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Erectile dysfunction (ED) is a very common disorder with a deep impact on quality of life on both patients and partners. Several options are available for treating ED: oral pharmacotherapy with phosphodiesterase 5 (PDE5) inhibitors currently represents the firstline option for many patients with ED. Alprostadil, a prostaglandin, has been marketed for many years as a urethral stick and an intracavernous injection for the treatment of ED. It is now available in the form of a cream (Vitaros/Virirec), a noninvasive treatment which combines an active drug (alprostadil, a synthetic prostaglandin E1) with a skin enhancer improving its local absorption directly at the site of action. Alprostadil has a favourable pharmacodynamic profile and is poorly absorbed in systemic circulation, which makes it suitable in a lot of circumstances and results in a reduced risk of adverse effects (AEs). Systemic AEs are reported in only 3% of the treated population. Clinical efficacy has been demonstrated in both phase II and III trials, showing a global efficacy up to 83% with the 300 μg dose in patients with severe ED, significantly better than placebo. Its fast onset of action and lack of interactions with other drugs makes alprostadil cream a possible first-line therapeutic option for some patients with ED: individuals who are reluctant to take systemic treatments or have AEs, patients who do not respond, cannot tolerate, or do not accept PDE5 inhibitor therapy, and patients treated with nitrates. Therefore, this new treatment for ED can be offered to patients and could help address the needs unmet by other treatments.

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Section: Resultsmentioning

confidence: 99%

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

Cuzin

2016

Therapeutic Advances in Urology

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“…303 Among the other limitations, the usefulness of this treatment would be precluded by penile abnormalities such as hypospadias or curvatures and should be excluded in men with balanitis or hyper-viscous vascular states and those prone to thrombosis. Evidence-based data thus far have indicated that the alprostadil cream is of modest efficacy in men with ED and indirect comparisons have shown it is somewhat less efficacious than PDE5 inhibitors or IC alprostadil.…”

Section: Topical Alprostadilmentioning

confidence: 99%

Pharmacotherapy for Erectile Dysfunction: Recommendations From the Fourth International Consultation for Sexual Medicine (ICSM 2015)

Hatzimouratidis

Salonia

Adaikan

et al. 2016

The Journal of Sexual Medicine

184

199

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Introduction Treatment of erectile dysfunction is based on pharmacotherapy for most patients. Aim To review the current data on pharmacotherapy for erectile dysfunction based on efficacy, psychosocial outcomes, and safety outcomes. Methods A review of the literature was undertaken by the committee members. All related articles were critically analyzed and discussed. Main Outcome Measures Levels of evidence (LEs) and grades of recommendations (GRs) are provided based on a thorough analysis of the literature and committee consensus. Results Ten recommendations are provided. (i) Phosphodiesterase type 5 (PDE5) inhibitors are effective, safe, and well-tolerated therapies for the treatment of men with erectile dysfunction (LE = 1, GR = A). (ii) There are no significant differences in efficacy, safety, and tolerability among PDE5 inhibitors (LE = 1, GR = A). (iii) PDE5 inhibitors are first-line therapy for most men with erectile dysfunction who do not have a specific contraindication to their use (LE = 3, GR = C). (iv) Intracavernosal injection therapy with alprostadil is an effective and well-tolerated treatment for men with erectile dysfunction (LE = 1, GR = A). (v) Intracavernosal injection therapy with alprostadil should be offered to patients as second-line therapy for erectile dysfunction (LE = 3, GR = C). (vi) Intraurethral and topical alprostadil are effective and well-tolerated treatments for men with erectile dysfunction (LE = 1, GR = A). (vii) Intraurethral and topical alprostadil should be considered second-line therapy for erectile dysfunction if available (LE = 3, GR = C). (viii) Dose titration of PDE5 inhibitors to the maximum tolerated dose is strongly recommended because it increases efficacy and satisfaction from treatment (LE = 2, GR = A). (ix) Treatment selection and follow-up should address the psychosocial profile and the needs and expectations of a patient for his sexual life. Shared decision making with the patient (and his partner) is strongly recommended (LE = 2, GR = A). (x) Counterfeit medicines are potentially dangerous. It is strongly recommended that physicians educate their patients to avoid taking any medication from unauthorized sources (LE = 2, GR = A). The first seven recommendations are the same as those from the Third International Consultation for Sexual Medicine and the last three are new recommendations. Conclusion PDE5 inhibitors remain a first-line treatment option because of their excellent efficacy and safety profile. This class of drugs is continually developed with new molecules and new formulations. Intracavernosal injections continue to be an established treatment modality, and intraurethral and topical alprostadil provide an alternative, less invasive treatment option.

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Optimum Use of Second Line Treatment Options for Erectile Dysfunction

Arcaniolo¹,

Autorino²,

Balsamo

et al. 2016

Practical Tips in Urology

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Daily Application of Alprostadil Topical Cream (Vitaros) Does Not Impact Vaginal pH, Flora, or Histology in Female Cynomolgus Monkeys

Cited by 5 publications

References 15 publications

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

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

Pharmacotherapy for Erectile Dysfunction: Recommendations From the Fourth International Consultation for Sexual Medicine (ICSM 2015)

Optimum Use of Second Line Treatment Options for Erectile Dysfunction

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