Tags

Type your tag names separated by a space and hit enter

Telmisartan, ramipril, or both in patients at high risk for vascular events.

Abstract

BACKGROUND

In patients who have vascular disease or high-risk diabetes without heart failure, angiotensin-converting-enzyme (ACE) inhibitors reduce mortality and morbidity from cardiovascular causes, but the role of angiotensin-receptor blockers (ARBs) in such patients is unknown. We compared the ACE inhibitor ramipril, the ARB telmisartan, and the combination of the two drugs in patients with vascular disease or high-risk diabetes.

METHODS

After a 3-week, single-blind run-in period, patients underwent double-blind randomization, with 8576 assigned to receive 10 mg of ramipril per day, 8542 assigned to receive 80 mg of telmisartan per day, and 8502 assigned to receive both drugs (combination therapy). The primary composite outcome was death from cardiovascular causes, myocardial infarction, stroke, or hospitalization for heart failure.

RESULTS

Mean blood pressure was lower in both the telmisartan group (a 0.9/0.6 mm Hg greater reduction) and the combination-therapy group (a 2.4/1.4 mm Hg greater reduction) than in the ramipril group. At a median follow-up of 56 months, the primary outcome had occurred in 1412 patients in the ramipril group (16.5%), as compared with 1423 patients in the telmisartan group (16.7%; relative risk, 1.01; 95% confidence interval [CI], 0.94 to 1.09). As compared with the ramipril group, the telmisartan group had lower rates of cough (1.1% vs. 4.2%, P<0.001) and angioedema (0.1% vs. 0.3%, P=0.01) and a higher rate of hypotensive symptoms (2.6% vs. 1.7%, P<0.001); the rate of syncope was the same in the two groups (0.2%). In the combination-therapy group, the primary outcome occurred in 1386 patients (16.3%; relative risk, 0.99; 95% CI, 0.92 to 1.07); as compared with the ramipril group, there was an increased risk of hypotensive symptoms (4.8% vs. 1.7%, P<0.001), syncope (0.3% vs. 0.2%, P=0.03), and renal dysfunction (13.5% vs. 10.2%, P<0.001).

CONCLUSIONS

Telmisartan was equivalent to ramipril in patients with vascular disease or high-risk diabetes and was associated with less angioedema. The combination of the two drugs was associated with more adverse events without an increase in benefit. (ClinicalTrials.gov number, NCT00153101 [ClinicalTrials.gov].).

Links

  • FREE Publisher Full Text
  • Authors+Show Affiliations

    ,

    Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON, Canada. yusufs@mcmaster.ca

    , , , , , , , ,

    Source

    The New England journal of medicine 358:15 2008 Apr 10 pg 1547-59

    MeSH

    Aged
    Angioedema
    Angiotensin II Type 1 Receptor Blockers
    Angiotensin-Converting Enzyme Inhibitors
    Benzimidazoles
    Benzoates
    Blood Pressure
    Cardiovascular Diseases
    Creatinine
    Diabetes Mellitus
    Double-Blind Method
    Drug Therapy, Combination
    Female
    Follow-Up Studies
    Hospitalization
    Humans
    Kaplan-Meier Estimate
    Male
    Middle Aged
    Ramipril
    Risk
    Telmisartan

    Pub Type(s)

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

    Language

    eng

    PubMed ID

    18378520

    Citation

    ONTARGET Investigators, et al. "Telmisartan, Ramipril, or Both in Patients at High Risk for Vascular Events." The New England Journal of Medicine, vol. 358, no. 15, 2008, pp. 1547-59.
    ONTARGET Investigators, Yusuf S, Teo KK, et al. Telmisartan, ramipril, or both in patients at high risk for vascular events. N Engl J Med. 2008;358(15):1547-59.
    Yusuf, S., Teo, K. K., Pogue, J., Dyal, L., Copland, I., Schumacher, H., ... Anderson, C. (2008). Telmisartan, ramipril, or both in patients at high risk for vascular events. The New England Journal of Medicine, 358(15), pp. 1547-59. doi:10.1056/NEJMoa0801317.
    ONTARGET Investigators, et al. Telmisartan, Ramipril, or Both in Patients at High Risk for Vascular Events. N Engl J Med. 2008 Apr 10;358(15):1547-59. PubMed PMID: 18378520.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Telmisartan, ramipril, or both in patients at high risk for vascular events. AU - ,, AU - Yusuf,Salim, AU - Teo,Koon K, AU - Pogue,Janice, AU - Dyal,Leanne, AU - Copland,Ingrid, AU - Schumacher,Helmut, AU - Dagenais,Gilles, AU - Sleight,Peter, AU - Anderson,Craig, Y1 - 2008/03/31/ PY - 2008/4/2/pubmed PY - 2008/4/19/medline PY - 2008/4/2/entrez SP - 1547 EP - 59 JF - The New England journal of medicine JO - N. Engl. J. Med. VL - 358 IS - 15 N2 - BACKGROUND: In patients who have vascular disease or high-risk diabetes without heart failure, angiotensin-converting-enzyme (ACE) inhibitors reduce mortality and morbidity from cardiovascular causes, but the role of angiotensin-receptor blockers (ARBs) in such patients is unknown. We compared the ACE inhibitor ramipril, the ARB telmisartan, and the combination of the two drugs in patients with vascular disease or high-risk diabetes. METHODS: After a 3-week, single-blind run-in period, patients underwent double-blind randomization, with 8576 assigned to receive 10 mg of ramipril per day, 8542 assigned to receive 80 mg of telmisartan per day, and 8502 assigned to receive both drugs (combination therapy). The primary composite outcome was death from cardiovascular causes, myocardial infarction, stroke, or hospitalization for heart failure. RESULTS: Mean blood pressure was lower in both the telmisartan group (a 0.9/0.6 mm Hg greater reduction) and the combination-therapy group (a 2.4/1.4 mm Hg greater reduction) than in the ramipril group. At a median follow-up of 56 months, the primary outcome had occurred in 1412 patients in the ramipril group (16.5%), as compared with 1423 patients in the telmisartan group (16.7%; relative risk, 1.01; 95% confidence interval [CI], 0.94 to 1.09). As compared with the ramipril group, the telmisartan group had lower rates of cough (1.1% vs. 4.2%, P<0.001) and angioedema (0.1% vs. 0.3%, P=0.01) and a higher rate of hypotensive symptoms (2.6% vs. 1.7%, P<0.001); the rate of syncope was the same in the two groups (0.2%). In the combination-therapy group, the primary outcome occurred in 1386 patients (16.3%; relative risk, 0.99; 95% CI, 0.92 to 1.07); as compared with the ramipril group, there was an increased risk of hypotensive symptoms (4.8% vs. 1.7%, P<0.001), syncope (0.3% vs. 0.2%, P=0.03), and renal dysfunction (13.5% vs. 10.2%, P<0.001). CONCLUSIONS: Telmisartan was equivalent to ramipril in patients with vascular disease or high-risk diabetes and was associated with less angioedema. The combination of the two drugs was associated with more adverse events without an increase in benefit. (ClinicalTrials.gov number, NCT00153101 [ClinicalTrials.gov].). SN - 1533-4406 UR - https://www.unboundmedicine.com/medline/citation/18378520/Telmisartan_ramipril_or_both_in_patients_at_high_risk_for_vascular_events_ L2 - https://www.nejm.org/doi/10.1056/NEJMoa0801317?url_ver=Z39.88-2003&amp;rfr_id=ori:rid:crossref.org&amp;rfr_dat=cr_pub=www.ncbi.nlm.nih.gov DB - PRIME DP - Unbound Medicine ER -