The U.S. Agency for Healthcare Research and Quality has published a review of the available evidence on the newer medicines for the treatment of lower urinary tract symptoms (LUTS) attributed to benign prostatic hyperplasia (BPH).
The review reveals that, although better efficacy was shown in short-term studies over a placebo, comparative studies show these new drugs, either alone or in combination with older therapies, have no added improvement of clinical outcome over more established treatments and higher adverse effects.
Pharmacological management of LUTS related to BPH has greatly evolved in the last few decades. The more established treatments, whose efficacy has been thoroughly proved, include alpha blockers (ABs) and 5-alpha reductase inhibitors (5-ARIs). Drugs in these and other classes have been recently developed and show promise. Given this wide variety of available medicines, the tailoring of treatment, either as monotherapy or combination treatments, may significantly improve its effectiveness and reduce side effects.
Researchers in this study assess medications used in the last 10 years. A search was performed in Ovid MEDLINE, the Cochrane Central Register of Controlled Trials, and Ovid Embase bibliographic databases. The eligible studies, including clinical trials and observational studies for adverse event assessment, were those evaluating an alpha blocker Rapaflo (silodosin), several antimuscarinics such as Detrol (tolterodine), Vesicare (solifenacin), and Toviaz (fesoterodine); one beta-3 adrenoceptor agonist (mirabegron), and several phosphodiesterase type 5 (PDE-5) inhibitors like Cialias (tadalafil) and Viagra (sildenafil) or combination therapy with one of these medications.
According to the studies assessed, monotherapy with the new AB Rapaflo was more effective than a placebo in the treatment of LUTS and similar to Flomax (tamsulosin), a traditional AB treatment, although it presented more adverse effects, such as abnormal ejaculation. Cialis improved LUTS more than a placebo but had more adverse effects, and it was similar to Flomax.
Vesicare/AB combination therapy was better than a placebo, but Detrol/AB, Vesicare/AB, and Toviaz/AB combination therapy were similar to AB monotherapy.
Overall, researchers found that the new monotherapies or combination treatments were superior to a placebo, but added no improvements over the already established AB treatments. Researchers found insufficient evidence to draw any conclusions regarding long-term efficacy and prevention of symptom progression.
Given these results, the authors recommend that these new medicines “should therefore best be viewed as offering alternative treatment options rather than superior management options, although oftentimes associated with greater uncertainty with regards to associated harms.”
Evidence from long-term studies could potentially provide more understanding regarding the newer drugs.