Cialis (tadalafil) treatment in older men with lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH) is less efficient but well-tolerated, a pool of Phase 2 and 3 clinical trials show.

The analysis, “Efficacy and safety of tadalafil 5 mg once daily in the treatment of lower urinary tract symptoms associated with benign prostatic hyperplasia in men aged ≥75 years: integrated analyses of pooled data from multinational, randomized, placebo-controlled clinical studies,” appeared in the British Journal of Urology (BJU International).

In aging men, LUTS/BPH can be common. Erectile dysfunction often coexists with LUTS/BPH and its incidence increases with LUTS severity. Despite an existing body of literature, effectiveness and safety data of various LUTS treatments for men 75 and older is non-existent. But as people age, altered pharmacology profiles associated with changes in organ blood flow and reduced organ function may affect drug efficacy.

Among these agents, Cialis is a widely approved phosphodiesterase type 5 inhibitor used to treat LUTS/BPH, indicated in a 5 mg once a day dosing.

The research team, led by Lars Viktrup, an MD and PhD with Eli Lilly, the drug’s manufacturer, analyzed Cialis’ effectiveness and safety in men with LUTS/BPH as reported in previous clinical trials. Additional safety analysis was performed in men with erectile dysfunction. The analysis compared patients over age 75 with others up to age 75 in terms of  short-term (12–26 weeks) efficacy and short- and long-term (42–52 weeks) safety.

The pool included 12 Phase 2 and 3 randomized and double-blind studies involving 3,309 patients. All patients received 5 mg of Cialis or placebo once each day. Efficacy was assessed with a written screening tool evaluating urinary symptoms and quality of life. Safety analysis focused on treatment-emergent adverse events (TEAEs), adverse events (AEs) leading to discontinuation, serious AEs (SAEs), and cardiovascular AEs. All study participants had moderate-to-severe LUTS/BPH symptoms for at least six months. In the case of erectile dysfunction, only patients with three or more months of disease history were included.

Researchers observed that efficacy outcomes were significantly different in men age 75 and older compared to those younger than 75 across Cialis and placebo groups, although maintenance of Cialis’ efficacy was similar in both groups. Although Cialis was not significantly better than placebo in men 75 and older, the magnitude of effects varied between studies.

Short-term data also showed that the older age group has higher incidence of TEAEs (2.6% vs 1.8%); AEs leading to discontinuation (1.9% vs 3.0%); cardiovascular AEs (2.6% vs 1.8%); and SAEs (2.6% vs 0.9%).

But long-term safety analysis did not show clinically relevant differences between age groups. Of note, however, the patient pool of men 75 and older was limited in the studies, which precludes analysis of the possible interference of confounding factors.

Overall, the review study found that Cialis, at the dose given, showed greater effectiveness in the younger group of patients than those 75 and older. However, the variability in older men suggests that some men 75 and older “may still experience a clinically significant improvement” with Cialis, the researchers said. Furthermore, “the older age group had more concomitant diseases and used more drugs, which may have reduced efficacy.”

Importantly, the study showed that treatment with Cialis was safe and found no evidence of increased cardiovascular AEs in older men. The authors state that “while clinicians may continue to prescribe tadalafil in men aged [75 and older], efficacy and safety in this population should be closely monitored.”