Lilly’s Cialis plus Merck’s Proscar yields BPH symptom improvement
This article was originally published in Scrip
In an ongoing bid to boost the prospects of its Cialis (tadalafil) franchise, Eli Lilly has Phase III data showing that co-administering the drug with finasteride (Merck's Proscar) could improve lower urinary tract symptoms (LUTS) in men with of benign prostatic hyperplasia (BPH) and enlarged prostates. Lilly has not indicated how or if it plans to respond to the findings.
Finasteride is a type II 5alpha-reductase inhibitor (5-ARI) approved for the treatment of BPH in men with an enlarged prostate. Tadalafil, a phosphodiesterase type 5 inhibitor, is also indicated for the signs and symptoms of BPH (as well as for the treatment of men with erectile dysfunction and men with both erectile dysfunction and the signs and symptoms of BPH). Thus, both drugs are competing for share in the crowded BPH market.
Explaining the rationale for the latest trial, Lilly said, "Symptomatic improvement with 5-ARI therapy (finasteride) is observed after six to twelve months of treatment; therefore, the study aimed to understand if men with prostatic enlargement experience earlier improvement of BPH symptoms when tadalafil is co-administered with a 5-ARI therapy."
Presenting at the annual European Association of Urology Congress in Milan, Italy, Lilly announced that Cialis (5 mg once daily) co-administered with finasteride significantly improved scores on the International Prostate Symptom Score (IPSS), compared with placebo/finasteride, in men with LUTS of BPH and enlarged prostates.
IPSS is a questionnaire evaluating LUTS occurring during the preceding month where lower scores indicate less severe LUTS. This was the primary measure used in the trial.
Cialis/finasteride met the primary endpoint by significantly improving IPSS total scores through 12 weeks versus placebo/finasteride (-5.2 versus -3.8, p = 0.001). Cialis/finasteride also significantly improved IPSS total scores versus placebo/finasteride at 4 weeks (-3.9 versus -2.3, p < 0.001)="" and="" 26="" weeks="" (-5.5="" versus="" -4.5,="" p="">
The company added that on a pre-specified secondary measure, Cialis/finasteride also improved erectile function scores versus placebo/finasteride in those men who had both LUTS/BPH and erectile dysfunction at baseline.
In a similar vein, Lilly last year announced a Phase III study showing that tadalafil, in parallel with tamsulosin (Boehringer Ingelheim's Flomax) as an active control, significantly improved prostate symptom scores in men with signs and symptoms suggestive of BPH (scripintelligence.com, 7 February 2012).