Abstract 10964: Clinical Safety of Tadalafil in Patients Receiving Concomitant Antihypertensive Medication

Abstract

Introduction: It is important that physicians and patients are aware of the cardiovascular safety of options available to treat erectile dysfunction (ED)/benign prostatic hyperplasia (BPH) while on concomitant antihypertensive medications (AHM). Objective: This integrated safety analysis assessed the incidence of hypotension-related treatment-emergent adverse events (TEAEs) and major adverse cardiovascular events (MACE) in patients with concomitant use of tadalafil and AHM. Methods: Data were integrated from seventy-two Phase II-IV studies conducted on patients with a diagnosis of ED and/or BPH. Studies were categorized as either All placebo-controlled studies or All studies. The incidences of hypotensive-related TEAEs and MACE were analyzed by indication; by use of concomitant AHM; and by the number of concomitant AHM. Results: A total of 15,030 and 22,825 patients were included in the analyses for All placebo-controlled studies and All studies, respectively. In the All placebo-controlled studies, the incidence of hypotension-related TEAEs and MACE was ranging between 0.6-1.5% and 0.0-1.0%, respectively, across all indications and use of AHM. Tadalafil was associated with an increase in hypotension-related TEAEs only in the ED as-needed category not receiving any concomitant AHM (p-value=0.0070); no difference was reported between placebo and tadalafil in all indication categories of patients receiving ≥1 AHM (p-value≥ 0.7386). Similarly, no differences (p-value≥ 0.2238) were observed in the incidence of MACE between tadalafil and placebo treatment groups, with or without concomitant use of AHM, and across all indication categories. In the All studies results were similar. Conclusion: The concomitant use of tadalafil alongside AHM did not increase the risk of hypotension-related TEAEs or MACE compared with AHM alone. Figure Odds ratio of incidences of hypotension-related TEAEs between placebo and tadalafil groups by number of concomitant AHM