1. ¹Case Western Reserve University, University Hospitals of Cleveland, Cleveland, Ohio, USA
2. ²University Hospitals of Cleveland, Case Western Reserve University School of Medicine, Cleveland, Ohio, USA
3. ³Division of Nuclear Medicine, Department of Radiology, Indiana University School of Medicine, Indianapolis, Indiana, USA
4. ⁴ICOS Corporation, Bothell, Washington, USA
5. ⁵Lilly Research Laboratories, Indianapolis, Indiana, USA
6. ⁶University of Washington School of Medicine, Seattle, Washington, USA

Correspondence: AD Seftel, Department of Urology, Case Western Reserve University, University Hospitals of Cleveland, Cleveland VA Medical Center, 11100 Euclid Ave., Cleveland, OH 44106-5046, USA. E-mail: ads6@po.cwru.edu

Received 7 April 2005; Accepted 20 May 2005; Published online 21 July 2005.

Abstract

The potential mechanisms underlying back pain and/or myalgia experienced by men taking tadalafil were investigated. An integrated analysis of 10 placebo-controlled tadalafil clinical trials (N=1846) showed that the incidence of back pain and/or myalgia was 9.4% in patients receiving tadalafil 10 mg (N=394), 8.3% in patients receiving tadalafil 20 mg (N=883) and 3.7% in placebo-treated patients (N=569). One (0.3%) patient receiving tadalafil 10 mg, six (0.7%) patients receiving tadalafil 20 mg, and no patients receiving placebo discontinued treatment due to back pain and/or myalgia. In a prospective study in healthy volunteers, no substantial changes were observed in laboratory markers indicative of inflammation or muscle damage, and tadalafil did not affect renal plasma flow nor produce lumbar or gluteal myositis by positron emission tomography scan or magnetic resonance imaging. Although the mechanism of back pain and/or myalgia remains unknown, these events appear to be self-limiting and a general effect of phosphodiesterase 5 inhibition.