Analysis of integrated clinical safety data of tadalafil in patients receiving concomitant antihypertensive medications
| Title: | Analysis of integrated clinical safety data of tadalafil in patients receiving concomitant antihypertensive medications |
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| Authors: | Robert A. Kloner, John B. Kostis, Thomas P. McGraw, Chunfu Qiu, Alankar Gupta |
| Source: | The Journal of Clinical Hypertension, Vol 24, Iss 2, Pp 167-178 (2022) |
| Publisher Information: | Wiley, 2022. |
| Publication Year: | 2022 |
| Collection: | LCC:Diseases of the circulatory (Cardiovascular) system |
| Subject Terms: | anti‐hypertensive medication, benign prostatic hyperplasia, concomitant therapy, erectile dysfunction, hypotension, safety, Diseases of the circulatory (Cardiovascular) system, RC666-701 |
| More Details: | Abstract This pooled safety analysis assessed the incidence of hypotension‐related treatment‐emergent adverse events (TEAEs) and major adverse cardiovascular events (MACEs) in patients with concomitant use of tadalafil and antihypertensive medications. Data were pooled from seventy‐two Phase II–IV studies conducted on patients with a diagnosis of erectile dysfunction (ED) and/or benign prostate hyperplasia (BPH). Studies were categorized as either All placebo‐controlled studies or All studies. The incidences of hypotension‐related TEAEs and MACEs were analyzed by indication; by use of concomitant antihypertensive medications; and by the number of concomitant antihypertensive medications. 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 MACEs was ranging between 0.6–1.5% and 0.0–1.0%, respectively, across all indications. Tadalafil was associated with an increase in hypotension‐related TEAEs only in the ED as‐needed group not receiving any concomitant antihypertensive medications (p‐value = .0070); no significant difference was reported between placebo and tadalafil in the groups of patients receiving ≥1 antihypertensive medication (p‐values ≥ .7386). Similarly, no significant differences (p‐values≥ .2238) were observed in the incidence of MACEs between tadalafil and placebo treatment groups, with or without concomitant use of antihypertensive medications, and across all indication categories. In the All studies group, results were similar. The pooled analysis showed no evidence that taking tadalafil alongside antihypertensive medications increases the risk of hypotension‐related TEAEs or MACEs compared with antihypertensive medications alone. |
| Document Type: | article |
| File Description: | electronic resource |
| Language: | English |
| ISSN: | 1751-7176 1524-6175 |
| Relation: | https://doaj.org/toc/1524-6175; https://doaj.org/toc/1751-7176 |
| DOI: | 10.1111/jch.14435 |
| Access URL: | https://doaj.org/article/b6c08b7eacd54509896e0eb4e12177b0 |
| Accession Number: | edsdoj.b6c08b7eacd54509896e0eb4e12177b0 |
| Database: | Directory of Open Access Journals |
| ISSN: | 17517176 15246175 |
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| DOI: | 10.1111/jch.14435 |
| Published in: | The Journal of Clinical Hypertension |
| Language: | English |