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Erectile dysfunction predicts cardiovascular events in high-risk patients receiving telmisartan, ramipril, or both: The ONgoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial/Telmisartan Randomized AssessmeNt Study in ACE iNtolerant subjects with cardiovascular Disease (ONTARGET/TRANSCEND) Trials.

Abstract

BACKGROUND

Although erectile dysfunction (ED) is associated with cardiovascular risk factors and atherosclerosis, it is not known whether the presence of ED is predictive of future events in individuals with cardiovascular disease. We evaluated whether ED is predictive of mortality and cardiovascular outcomes, and because inhibition of the renin-angiotensin system in high-risk patients reduces cardiovascular events, we also tested the effects on ED of randomized treatments with telmisartan, ramipril, and the combination of the 2 drugs (ONTARGET), as well as with telmisartan or placebo in patients who were intolerant of angiotensin-converting enzyme inhibitors (TRANSCEND).

METHODS AND RESULTS

In a prespecified substudy, 1549 patients underwent double-blind randomization, with 400 participants assigned to receive ramipril, 395 telmisartan, and 381 the combination thereof (ONTARGET), as well as 171 participants assigned to receive telmisartan and 202 placebo (TRANSCEND). ED was evaluated at baseline, at 2-year follow-up, and at the penultimate visit before closeout. ED was predictive of all-cause death (hazard ratio [HR] 1.84, 95% confidence interval [CI] 1.21 to 2.81, P=0.005) and the composite primary outcome (HR 1.42, 95% CI 1.04 to 1.94, P=0.029), which consisted of cardiovascular death (HR 1.93, 95% CI 1.13 to 3.29, P=0.016), myocardial infarction (HR 2.02, 95% CI 1.13 to 3.58, P=0.017), hospitalization for heart failure (HR 1.2, 95% CI 0.64 to 2.26, P=0.563), and stroke (HR 1.1, 95% CI 0.64 to 1.9, P=0.742). The study medications did not influence the course or development of ED.

CONCLUSIONS

ED is a potent predictor of all-cause death and the composite of cardiovascular death, myocardial infarction, stroke, and heart failure in men with cardiovascular disease. Trial treatment did not significantly improve or worsen ED.

CLINICAL TRIAL REGISTRATION

URL: http://www.clinicaltrials.gov. Unique identifier: NCT 00153101.

Links

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  • Authors+Show Affiliations

    ,

    Department of Cardiology, University of the Saarland, Saarbrücken, Germany. boehm@uks.eu

    , , , , , , , , , , , ,

    Source

    Circulation 121:12 2010 Mar 30 pg 1439-46

    MeSH

    Angiotensin II Type 1 Receptor Blockers
    Angiotensin-Converting Enzyme Inhibitors
    Benzimidazoles
    Benzoates
    Cardiovascular Diseases
    Double-Blind Method
    Drug Therapy, Combination
    Erectile Dysfunction
    Humans
    Male
    Mortality
    Predictive Value of Tests
    Ramipril
    Telmisartan
    Treatment Outcome

    Pub Type(s)

    Journal Article
    Randomized Controlled Trial
    Research Support, Non-U.S. Gov't

    Language

    eng

    PubMed ID

    20231536

    Citation

    Böhm, Michael, et al. "Erectile Dysfunction Predicts Cardiovascular Events in High-risk Patients Receiving Telmisartan, Ramipril, or Both: the ONgoing Telmisartan Alone and in Combination With Ramipril Global Endpoint Trial/Telmisartan Randomized AssessmeNt Study in ACE iNtolerant Subjects With Cardiovascular Disease (ONTARGET/TRANSCEND) Trials." Circulation, vol. 121, no. 12, 2010, pp. 1439-46.
    Böhm M, Baumhäkel M, Teo K, et al. Erectile dysfunction predicts cardiovascular events in high-risk patients receiving telmisartan, ramipril, or both: The ONgoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial/Telmisartan Randomized AssessmeNt Study in ACE iNtolerant subjects with cardiovascular Disease (ONTARGET/TRANSCEND) Trials. Circulation. 2010;121(12):1439-46.
    Böhm, M., Baumhäkel, M., Teo, K., Sleight, P., Probstfield, J., Gao, P., ... Yusuf, S. (2010). Erectile dysfunction predicts cardiovascular events in high-risk patients receiving telmisartan, ramipril, or both: The ONgoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial/Telmisartan Randomized AssessmeNt Study in ACE iNtolerant subjects with cardiovascular Disease (ONTARGET/TRANSCEND) Trials. Circulation, 121(12), pp. 1439-46. doi:10.1161/CIRCULATIONAHA.109.864199.
    Böhm M, et al. Erectile Dysfunction Predicts Cardiovascular Events in High-risk Patients Receiving Telmisartan, Ramipril, or Both: the ONgoing Telmisartan Alone and in Combination With Ramipril Global Endpoint Trial/Telmisartan Randomized AssessmeNt Study in ACE iNtolerant Subjects With Cardiovascular Disease (ONTARGET/TRANSCEND) Trials. Circulation. 2010 Mar 30;121(12):1439-46. PubMed PMID: 20231536.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Erectile dysfunction predicts cardiovascular events in high-risk patients receiving telmisartan, ramipril, or both: The ONgoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial/Telmisartan Randomized AssessmeNt Study in ACE iNtolerant subjects with cardiovascular Disease (ONTARGET/TRANSCEND) Trials. AU - Böhm,Michael, AU - Baumhäkel,Magnus, AU - Teo,Koon, AU - Sleight,Peter, AU - Probstfield,Jeffrey, AU - Gao,Peggy, AU - Mann,Johannes F, AU - Diaz,Rafael, AU - Dagenais,Gilles R, AU - Jennings,Garry L R, AU - Liu,Lisheng, AU - Jansky,Petr, AU - Yusuf,Salim, AU - ,, Y1 - 2010/03/15/ PY - 2010/3/17/entrez PY - 2010/3/17/pubmed PY - 2010/5/25/medline SP - 1439 EP - 46 JF - Circulation JO - Circulation VL - 121 IS - 12 N2 - BACKGROUND: Although erectile dysfunction (ED) is associated with cardiovascular risk factors and atherosclerosis, it is not known whether the presence of ED is predictive of future events in individuals with cardiovascular disease. We evaluated whether ED is predictive of mortality and cardiovascular outcomes, and because inhibition of the renin-angiotensin system in high-risk patients reduces cardiovascular events, we also tested the effects on ED of randomized treatments with telmisartan, ramipril, and the combination of the 2 drugs (ONTARGET), as well as with telmisartan or placebo in patients who were intolerant of angiotensin-converting enzyme inhibitors (TRANSCEND). METHODS AND RESULTS: In a prespecified substudy, 1549 patients underwent double-blind randomization, with 400 participants assigned to receive ramipril, 395 telmisartan, and 381 the combination thereof (ONTARGET), as well as 171 participants assigned to receive telmisartan and 202 placebo (TRANSCEND). ED was evaluated at baseline, at 2-year follow-up, and at the penultimate visit before closeout. ED was predictive of all-cause death (hazard ratio [HR] 1.84, 95% confidence interval [CI] 1.21 to 2.81, P=0.005) and the composite primary outcome (HR 1.42, 95% CI 1.04 to 1.94, P=0.029), which consisted of cardiovascular death (HR 1.93, 95% CI 1.13 to 3.29, P=0.016), myocardial infarction (HR 2.02, 95% CI 1.13 to 3.58, P=0.017), hospitalization for heart failure (HR 1.2, 95% CI 0.64 to 2.26, P=0.563), and stroke (HR 1.1, 95% CI 0.64 to 1.9, P=0.742). The study medications did not influence the course or development of ED. CONCLUSIONS: ED is a potent predictor of all-cause death and the composite of cardiovascular death, myocardial infarction, stroke, and heart failure in men with cardiovascular disease. Trial treatment did not significantly improve or worsen ED. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT 00153101. SN - 1524-4539 UR - https://www.unboundmedicine.com/medline/citation/20231536/Erectile_dysfunction_predicts_cardiovascular_events_in_high_risk_patients_receiving_telmisartan_ramipril_or_both:_The_ONgoing_Telmisartan_Alone_and_in_combination_with_Ramipril_Global_Endpoint_Trial/Telmisartan_Randomized_AssessmeNt_Study_in_ACE_iNtolerant_subjects_with_cardiovascular_Disease__ONTARGET/TRANSCEND__Trials_ L2 - http://www.ahajournals.org/doi/full/10.1161/CIRCULATIONAHA.109.864199?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -