MiscellaneousCardiovascular Safety Update of Tadalafil: Retrospective Analysis of Data from Placebo-Controlled and Open-Label Clinical Trials of Tadalafil With As Needed, Three Times-per-Week or Once-a-Day Dosing
Section snippets
Methods
Studies were approved by institutional review boards, and each patient gave informed consent. Studies were conducted in accordance with the Helsinki Declaration and the Guidelines for Good Clinical Practice.
Baseline demographics
There were 12,487 tadalafil-treated and 2,047 placebo-treated men with erectile dysfunction across the 36 clinical trials. The mean age of patients receiving tadalafil was 55 years (19% were >65 years old), and the mean age of patients receiving placebo was 56 years (21% were >65 years old). The body mass index was ≥30 kg/m2 in 2,998 tadalafil-treated patients (24%) and 464 placebo-treated patients (23%). The ethnicities of patients receiving tadalafil (n = 12,487) were Caucasian (81%), Asian
Discussion
This was a retrospective analysis of pooled data from 36 clinical trials of tadalafil using placebo-controlled and open-label study designs. The analysis included 12,487 tadalafil-treated and 2,047 placebo-treated men with erectile dysfunction. Across the trials, dosing regimens of tadalafil included as needed, 3 times/week, and once a day. The incidence rate of serious CVTEAEs was low in all groups evaluated, with comparable incidence rates in tadalafil- and placebo-treated patients. In
Acknowledgment
The authors thank Yi Xia, MS, Lingling Xie, MS, and Shuhuan Zhang, MS, Lilly Research Laboratories, Eli Lilly and Company, for their assistance with statistical analyses.
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This study was supported by Lilly ICOS LLC, Indianapolis, Indiana, and Bothell, Washington.
Conflict of interest statement: Dr. Kloner was a speaker and consultant to Bayer GSJ, Lilly ICOS, and Pfizer, a Consultant to Schering Plough and Platin-King, and received research support from Lilly LCOS. Dr. Jackson was a consultant to Lilly LCOS and Pfizer and received educational grants from Bayer, Lilly LCOS, and Pfizer. Dr Hutter was a consultant to Lilly LCOS. Dr. Mittleman was a consultant to Bayer, Lilly LCOS, and Pfizer. Ms. Chan and Drs. Costigan, Vail, and Warner are stockholders of Eli Lilly and Company.