Source: DGNews  |  Posted 3 years ago

By Chris Berrie

BRUSSELS, Belgium -- December 10, 2008 -- The novel phosphodiesterase-5 (PDE5) inhibitor lodenafil shows satisfactory efficacy and safety in the treatment of men with erectile dysfunction (ED), according to a phase 3 clinical trial presented at the Joint Congress of the European and International Societies for Sexual Medicine (ESSM-ISSM).

For inclusion in this multicentre, prospective trial, subjects had to be at least 18 years old, with ED of any cause lasting at least 6 months and an International Index of Erectile Function-Erectile Function (IIEF-EF) domain score of 24 or less. A standard range of exclusion criteria were applied, noted lead author Sidney Glina, MD, PhD, Instituto H. Ellis and Hospital Ipiranga, Sao Paolo, Brazil, speaking here on December 9.

The primary efficacy endpoints were improvements to IIEF-EF score, IIEF questions 3 and 4, and Sexual Encounter Profile (SEP) questions 2 and 3. The secondary endpoints included the individual IIEF-EF domains.

Following phase 2 studies of lodenafil, 107 subjects were randomised to once-daily treatments with placebo (mean age 55.5 years); 107 subjects were randomised to lodenafil 40 mg (mean age 56.1 years); and 105 subjects were randomised to lodenafil 80 mg (mean age 53.5 years).

The main baseline clinical characteristics were similar across the 3 treatment groups (placebo, lodenafil 40 mg, and lodenafil 80 mg, respectively): body mass index (27.40, 27.05, 27.22 kg/m²), ED duration (54.0, 48.1, 45.4 months) and basal IIEF (13.9, 13.6, 13.4). The ED severities were also similar, at around 20% mild, 34% moderate/mild, 38% moderate, and 7.5% severe.

With all primary efficacy endpoints showing significant benefits over placebo at lodenafil 80 mg, Dr. Glina highlighted more specifically the significantly improved IIEF-EF increases, from placebo (0.9) to lodenafil 40 mg (5.0; P < .05) and 80 mg (7.2; P < .01). Similarly, improvement in scores on the SEP question 3 were seen in 9.5% of placebo patients, 31.2% of patients on lodenafil 40 mg (P < .05), and 45.2% of those on lodenafil 80 mg (P < .01).

For the secondary efficacy endpoints, the main significant improvements over placebo were again seen for lodenafil 80 mg, on intercourse satisfaction (0.4 vs 2.6; P < .01) and overall satisfaction (0.6 vs 2.0; P < .05). Trends for benefits of active treatment, however, did not reach significance for orgasmic function and sexual desire.

Adverse events, Dr. Glina said, "were almost the same as for the other PDE5 inhibitors … and most [nearly 98%] of the adverse events were mild or moderate, with very few people who discontinued the trial because of adverse events."

The main adverse events in this trial were as follows (placebo vs lodenafil 80 mg): rhinitis (8.3% vs 32.7%), headache (9.3% vs 29.9%), flushing (4.6% vs 25.5%), dizziness (1.9% vs 8.4%), and visual disorder (0.9% vs 6.5%).

Dr. Glina concluded: "Lodenafil carbonate showed a satisfactory efficacy-safety profile for the oral treatment of men with erectile dysfunction."

Funding for this study was provided by Cristalia Prod Quím Farmacêuticos LTDA.

[Presentation title: Efficacy and Tolerability of Lodenafil Carbonate for Oral Therapy in Erectile Dysfunction: A Phase 3 Clinical Trial. Abstract PD-055]