Analysis of integrated clinical safety data of tadalafil in patients receiving concomitant antihypertensive medications
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 s...
| Main Authors: | , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Wiley
2022-02-01
|
| Series: | The Journal of Clinical Hypertension |
| Subjects: | |
| Online Access: | https://doi.org/10.1111/jch.14435 |
| _version_ | 1827778905312854016 |
|---|---|
| author | Robert A. Kloner John B. Kostis Thomas P. McGraw Chunfu Qiu Alankar Gupta |
| author_facet | Robert A. Kloner John B. Kostis Thomas P. McGraw Chunfu Qiu Alankar Gupta |
| author_sort | Robert A. Kloner |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-11T14:43:41Z |
| format | Article |
| id | doaj.art-b6c08b7eacd54509896e0eb4e12177b0 |
| institution | Directory Open Access Journal |
| issn | 1524-6175 1751-7176 |
| language | English |
| last_indexed | 2024-03-11T14:43:41Z |
| publishDate | 2022-02-01 |
| publisher | Wiley |
| record_format | Article |
| series | The Journal of Clinical Hypertension |
| spelling | doaj.art-b6c08b7eacd54509896e0eb4e12177b02023-10-30T13:26:35ZengWileyThe Journal of Clinical Hypertension1524-61751751-71762022-02-0124216717810.1111/jch.14435Analysis of integrated clinical safety data of tadalafil in patients receiving concomitant antihypertensive medicationsRobert A. Kloner0John B. Kostis1Thomas P. McGraw2Chunfu Qiu3Alankar Gupta4Huntington Medical Research Institutes Pasadena California USACardiovascular Institute Rutgers Robert Wood Johnson Medical School New Brunswick New Jersey USAMedical Affairs Department Sanofi Consumer Healthcare Bridgewater New Jersey USADepartment of Biostatistics Sanofi Bridgewater New Jersey USAMedical Affairs Department Sanofi Consumer Healthcare Bridgewater New Jersey USAAbstract 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.https://doi.org/10.1111/jch.14435anti‐hypertensive medicationbenign prostatic hyperplasiaconcomitant therapyerectile dysfunctionhypotensionsafety |
| spellingShingle | Robert A. Kloner John B. Kostis Thomas P. McGraw Chunfu Qiu Alankar Gupta Analysis of integrated clinical safety data of tadalafil in patients receiving concomitant antihypertensive medications The Journal of Clinical Hypertension anti‐hypertensive medication benign prostatic hyperplasia concomitant therapy erectile dysfunction hypotension safety |
| title | Analysis of integrated clinical safety data of tadalafil in patients receiving concomitant antihypertensive medications |
| title_full | Analysis of integrated clinical safety data of tadalafil in patients receiving concomitant antihypertensive medications |
| title_fullStr | Analysis of integrated clinical safety data of tadalafil in patients receiving concomitant antihypertensive medications |
| title_full_unstemmed | Analysis of integrated clinical safety data of tadalafil in patients receiving concomitant antihypertensive medications |
| title_short | Analysis of integrated clinical safety data of tadalafil in patients receiving concomitant antihypertensive medications |
| title_sort | analysis of integrated clinical safety data of tadalafil in patients receiving concomitant antihypertensive medications |
| topic | anti‐hypertensive medication benign prostatic hyperplasia concomitant therapy erectile dysfunction hypotension safety |
| url | https://doi.org/10.1111/jch.14435 |
| work_keys_str_mv | AT robertakloner analysisofintegratedclinicalsafetydataoftadalafilinpatientsreceivingconcomitantantihypertensivemedications AT johnbkostis analysisofintegratedclinicalsafetydataoftadalafilinpatientsreceivingconcomitantantihypertensivemedications AT thomaspmcgraw analysisofintegratedclinicalsafetydataoftadalafilinpatientsreceivingconcomitantantihypertensivemedications AT chunfuqiu analysisofintegratedclinicalsafetydataoftadalafilinpatientsreceivingconcomitantantihypertensivemedications AT alankargupta analysisofintegratedclinicalsafetydataoftadalafilinpatientsreceivingconcomitantantihypertensivemedications |