Efficacy and Safety of Tadalafil Across Ethnic Groups and Various Risk Factors in Men with Erectile Dysfunction: Use of a Novel Noninferiority Study Design

Abstract

Aim This U.S. multicenter open-label study used a noninferiority trial design to assess the efficacy of tadalafil 20 mg to treat erectile dysfunction (ED) in the black American and Hispanic groups compared with a reference group of Caucasians. A secondary objective was to demonstrate the efficacy and safety of tadalafil 20 mg in various populations of men with ED. Methods A total of 1,911 patients with ED were enrolled into eight predefined groups: (1–3) Caucasian (Reference group), Black American, or Hispanic patients, ≤65 years of age with no diabetes mellitus or depression; (4) patients with depression, ≤65 years of age, no diabetes; (5) patients with diabetes, ≤65 years of age, no depression; (6) patients >65 years of age, no diabetes or depression; (7) patients who met enrollment criteria but were not included in any other group; and (8) patients with ED due to traumatic spinal cord injury. The study had a 4-week run-in period, followed by a 12-week treatment period with tadalafil taken as needed, up to one dose/day, prior to sexual activity. Change from baseline to endpoint in the Erectile Function (EF) domain of the International Index of Erectile Function (IIEF) was used to determine noninferiority of groups 2 and 3 from group 1. Secondary efficacy measures included other IIEF domains and Sexual Encounter Profile (SEP). Results Noninferiority analyses based on the EF domain score showed that tadalafil was as efficacious in the Hispanic and Black American groups as in the Reference group. Patients in each of the eight groups had a significant change from baseline (P < 0.001) in the IIEF EF domain score and positive responses to SEP Questions 1–5. The most common treatment-emergent adverse events reported by patients in all eight groups were headache, nasal congestion, dyspepsia, flushing, and back pain. Conclusion Tadalafil 20 mg was as efficacious in the Hispanic and black American groups as in the Caucasian/Reference group. Tadalafil was efficacious and well tolerated in each of the groups studied in this trial.

Daily patterns of sexual intercourse attempts by men with erectile dysfunction treated with tadalafil: influence of age and marital status

“…10 The study was reviewed and approved by the Ethics Review Boards at each participating site, and all patients provided a written informed consent before undergoing any protocol procedure or receiving any protocol treatment. The purpose of the trial was to evaluate the efficacy and safety of tadalafil (20 mg) over a 12-week treatment period in various populations of men with ED; those from different ethnic backgrounds (Caucasian, Hispanic and Black) and those who had various ED risk factors, such as diabetes, clinical diagnosis of depression and/or spinal cord injury.…”

“…Patient exclusion criteria were discussed in a previous report. 10 Patients were excluded if they had a recent history of stroke, unstable cardiovascular status, use of nitrates, cancer chemotherapy, anti-androgens, failure to achieve any erection due to radical prostatectomy or pelvic surgery, or clinically significant penile deformities or penile implants and who did not respond, in the opinion of the investigator, to previous use of other phosphodiesterase type 5 inhibitors.…”

“…10 Patient disposition and reasons for discontinuation from the study are discussed elsewhere. 10 The most common reasons for discontinuation in the study were the inability to contact patients (4.2%) and adverse events (2.8%). Patient demographic and baseline clinical characteristics of the entire sample are presented in previous reports.…”

“…Patient demographic and baseline clinical characteristics of the entire sample are presented in previous reports. 10,12 Of the enrolled patients, 18% (n ¼ 341) were p44 years of age, 67% (n ¼ 1285) were 45-65 years and 15% (n ¼ 285) were X66 years. In addition, 73% (n ¼ 1386) of the patients were married and 27% (n ¼ 523) were unmarried.…”

Response to treatment with tadalafil in men with erectile dysfunction who reported no successful intercourse attempts at baseline

“…16 The study was reviewed and approved by the ethics review boards at each participating site, and all patients provided written informed consent consistent before undergoing any protocol procedure or receiving any protocol treatment. The purpose of the trial was to evaluate the efficacy and safety of tadalafil at a dose of 20 mg as needed, up to once daily, over a 12-week period in populations of men with ED, including those from different ethnic backgrounds (Caucasian, Hispanic and Black) and those with various ED risk factors, such as diabetes, clinical diagnosis of depression or spinal cord injury.…”