Explore the established safety profile of Vitaros
Vitaros demonstrated a discontinuation rate of less than 5% due to adverse events [1-2]
Most adverse events were mild to moderate in severity, resulting in discontinuation rate of less than 5%; 2.7% in the original phase III studies (12 weeks’ treatment)1 and 4.3% in the long-term, open-label safety study, running up to 9 months’ treatment.
Most adverse events recorded were transient and localised [1-2]
Commonly reported adverse events were transient, lasting mostly less than 24 hours and reactions were reversible. Localised urogenital effects comprised of penile burning or erythema, meatal or glans pain and prolonged or painful erection in men, and vaginal burning and vaginitis in female partners.
Vitaros has a low rate of discontinuations due to partner adverse events [1]
Most commonly reported partner adverse events were transient, local vaginal reactions occurring in 3% in the placebo group versus 6.5% in the Vitaros group. As such, it is recommended users wear a condom to prevent this.
Local application means Vitaros is not likely to have drug-drug interactions [3]
Drug-drug interactions are considered unlikely given the pharmacokinetic profile of the product wherein the medication is metabolised locally, as opposed to systemically. However, pharmacokinetic or pharmacodynamic interaction studies have not been conducted.
Vitaros is also not known to be affected by food, alcohol or other medications such as nitrates.
Vitaros may help patients avoid some of the side effects recorded from taking PDE5 inhibitors [3-8]
Vitaros had no recorded incidences of headache, flushing, upper respiratory disorders, dyspepsia, or abnormal vision, in contrast to the leading formulations of PDE5 inhibitors.
For more information, please see the Vitaros Summary of Product Characteristics.
Information on contraindications can be found here.
References
1. Padma-Nathan H, Yeager JL. An integrated analysis of alprostadil topical cream for the treatment of erectile dysfunction in 1732 patients. Urology 2006;68(2):386–91
2.Rooney M, Pfister W, Mahoney M, et al. Long-term, multicenter study of the safety and efficacy of topical alprostadil cream in male patients with erectile dysfunction. J Sex Med 2009;6(2):520–34
3. Cuzin, Béatrice. “Alprostadil cream in the treatment of erectile dysfunction: clinical evidence and experience.” Therapeutic advances in urology vol. 8,4 (2016): 249-256.
4. Hatzimouratidis K, Eardley, I, Giuliano F, et al. EAU Guidelines on Male Sexual Dysfunction: Erectile Dysfunction and Premature Ejaculation - EAU, Arnhem, The Netherlands.
5. Viagra Summary of Product Characteristics. Last accessed: May 2022.
6. Cialis Summary of Product Characteristics. Last accessed: May 2022.
7. Levitra Summary of Product Characteristics. Last accessed: May 2022.
8. Spedra Summary of Product Characteristics. Last accessed: May 2022.
9. Vitaros Summary of Product Characteristics. Last accessed: May 2022.