William B White, Christopher Chapple, Christian Gratzke, Sender Herschorn, Dudley Robinson, Jeffrey Frankel, Arwin Ridder, Matthias Stoelzel, Asha Paireddy, Robert van Maanen, Michael A Weber
There have been concerns that treatment of overactive bladder with β3 -adrenoceptor agonists may potentially have detrimental cardiovascular (CV) side effects. We evaluated the CV safety of mirabegron, a β3 -adrenoceptor agonist, alone and in combination therapy with the antimuscarinic agent solifenacin. The SYNERGY trial was a multinational, multicenter, randomized, double-blind, parallel-group, placebo and active-controlled phase 3 trial. Patients were randomized to receive solifenacin 5 mg + mirabegron 50 mg (combination 5 + 50 mg), solifenacin 5 mg + mirabegron 25 mg (combination 5 + 25 mg), solifenacin 5 mg monotherapy, mirabegron 25 mg monotherapy, mirabegron 50 mg monotherapy, or placebo for a 12-week double-blind treatment period...
April 12, 2018: Journal of Clinical Pharmacology