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)…
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