A three-part study to investigate the incidence and potential etiologies of tadalafil-associated back pain or myalgia

A. D. Seftel, J. Farber, James Fletcher, M. C. Deeley, A. Elion-Mboussa, A. Hoover, A. Yu, P. Fredlund

Research output: Contribution to journalArticle

8 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)455-461
Number of pages7
JournalInternational Journal of Impotence Research
Volume17
Issue number5
DOIs
StatePublished - Sep 2005

Fingerprint

Myalgia
Back Pain
Incidence
Placebos
Type 5 Cyclic Nucleotide Phosphodiesterases
Renal Plasma Flow
Myositis
Controlled Clinical Trials
Tadalafil
Positron-Emission Tomography
Healthy Volunteers
Biomarkers
Magnetic Resonance Imaging
Prospective Studies
Inflammation
Muscles

Keywords

  • Back pain
  • Impotence
  • Myositis
  • Phosphodiesterase inhibitors

ASJC Scopus subject areas

  • Urology

Cite this

A three-part study to investigate the incidence and potential etiologies of tadalafil-associated back pain or myalgia. / Seftel, A. D.; Farber, J.; Fletcher, James; Deeley, M. C.; Elion-Mboussa, A.; Hoover, A.; Yu, A.; Fredlund, P.

In: International Journal of Impotence Research, Vol. 17, No. 5, 09.2005, p. 455-461.

Research output: Contribution to journalArticle

Seftel, A. D. ; Farber, J. ; Fletcher, James ; Deeley, M. C. ; Elion-Mboussa, A. ; Hoover, A. ; Yu, A. ; Fredlund, P. / A three-part study to investigate the incidence and potential etiologies of tadalafil-associated back pain or myalgia. In: International Journal of Impotence Research. 2005 ; Vol. 17, No. 5. pp. 455-461.
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