Efficacy and safety of tadalafil in men with erectile dysfunction with a high prevalence of comorbid conditions: results from MOMENTUS: multiple observations in men with erectile dysfunction in National Tadalafil Study in the US.
Level 4 - case-series / case-control
Open-label, single-arm clinical trial subgroup analysis lacking a control group.
PubMed 17233782 · doi:10.1111/j.1743-6109.2006.00402.x
What was done
An open-label, multicenter study (MOMENTUS) evaluated the efficacy and safety of tadalafil 20 mg taken as needed (up to once daily) for 12 weeks following a 4-week treatment-free period in men with erectile dysfunction (ED). This analysis focused on a multiple comorbid (MCM) subgroup of 155 men out of 1,911 total enrolled participants. The MCM cohort included participants who met overall study criteria but did not fit into other predefined demographic or single-disease cohorts; 84% had two or more comorbidities (72% diabetes, 67% cardiovascular disease including hypertension, 49% hyperlipidemia, 38% depression; mean age 65 ± 9 years; 52% with severe ED). The primary endpoint was change from baseline in the International Index of Erectile Function (IIEF) erectile function (EF) domain score.
What was found
Mean baseline EF domain score was 12.2 ± 6.5. At 12 weeks, the mean EF domain score increased significantly by 7.6 points from baseline (P < 0.001). Among participants with severe ED at baseline, 22% achieved an EF domain score of 26 or greater. The most common adverse events were headache (5.2%), flushing (3.9%), and nasal congestion (3.2%), with 3% of patients discontinuing the drug due to adverse events. Numerical values for secondary endpoints (Sexual Encounter Profile, Global Assessment Questions, and psychological scales) were not reported in the abstract.
Why it matters
This study shows that on-demand tadalafil can improve erectile function in older men with erectile dysfunction complicated by multiple concurrent medical conditions, a group historically considered difficult to treat.
Limits
The study was open-label without a placebo or active control arm, preventing control for placebo effects. The MCM group was a small, residual subset (155 of 1,911) defined by non-inclusion in other study groups rather than standardized comorbidity scoring, introducing potential selection bias. Follow-up was short (12 weeks), and secondary outcome measurements lacked quantitative reporting in the abstract.
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