Telmisartan to prevent recurrent stroke and cardiovascular events

Salim Yusuf; Hans-Christoph Diener; Ralph L Sacco; Daniel Cotton; Stephanie Ounpuu; William A Lawton; Yuko Palesch; Reneé H Martin; Gregory W Albers; Philip Bath; Natan Bornstein; Bernard P L Chan; Sien-Tsong Chen; Luis Cunha; Björn Dahlöf; Jacques De Keyser; Geoffrey A Donnan; Conrado Estol; Philip Gorelick; Vivian Gu; Karin Hermansson; Lutz Hilbrich; Markku Kaste; Chuanzhen Lu; Thomas Machnig; Prem Pais; Robin Roberts; Veronika Skvortsova; Philip Teal; Danilo Toni; Cam VanderMaelen; Thor Voigt; Michael Weber; Byung-Woo Yoon; PRoFESS Study Group; Helle Klingenberg Iversen

doi:10.1056/NEJMoa0804593

Telmisartan to prevent recurrent stroke and cardiovascular events

Salim Yusuf, Hans-Christoph Diener, Ralph L Sacco, Daniel Cotton, Stephanie Ounpuu, William A Lawton, Yuko Palesch, Reneé H Martin, Gregory W Albers, Philip Bath, Natan Bornstein, Bernard P L Chan, Sien-Tsong Chen, Luis Cunha, Björn Dahlöf, Jacques De Keyser, Geoffrey A Donnan, Conrado Estol, Philip Gorelick, Vivian GuKarin Hermansson, Lutz Hilbrich, Markku Kaste, Chuanzhen Lu, Thomas Machnig, Prem Pais, Robin Roberts, Veronika Skvortsova, Philip Teal, Danilo Toni, Cam VanderMaelen, Thor Voigt, Michael Weber, Byung-Woo Yoon, PRoFESS Study Group, Helle Klingenberg Iversen

Institut for Klinisk Medicin

598 Citationer (Scopus)

Abstract

BACKGROUND: Prolonged lowering of blood pressure after a stroke reduces the risk of recurrent stroke. In addition, inhibition of the renin-angiotensin system in high-risk patients reduces the rate of subsequent cardiovascular events, including stroke. However, the effect of lowering of blood pressure with a renin-angiotensin system inhibitor soon after a stroke has not been clearly established. We evaluated the effects of therapy with an angiotensin-receptor blocker, telmisartan, initiated early after a stroke.

METHODS: In a multicenter trial involving 20,332 patients who recently had an ischemic stroke, we randomly assigned 10,146 to receive telmisartan (80 mg daily) and 10,186 to receive placebo. The primary outcome was recurrent stroke. Secondary outcomes were major cardiovascular events (death from cardiovascular causes, recurrent stroke, myocardial infarction, or new or worsening heart failure) and new-onset diabetes.

RESULTS: The median interval from stroke to randomization was 15 days. During a mean follow-up of 2.5 years, the mean blood pressure was 3.8/2.0 mm Hg lower in the telmisartan group than in the placebo group. A total of 880 patients (8.7%) in the telmisartan group and 934 patients (9.2%) in the placebo group had a subsequent stroke (hazard ratio in the telmisartan group, 0.95; 95% confidence interval [CI], 0.86 to 1.04; P=0.23). Major cardiovascular events occurred in 1367 patients (13.5%) in the telmisartan group and 1463 patients (14.4%) in the placebo group (hazard ratio, 0.94; 95% CI, 0.87 to 1.01; P=0.11). New-onset diabetes occurred in 1.7% of the telmisartan group and 2.1% of the placebo group (hazard ratio, 0.82; 95% CI, 0.65 to 1.04; P=0.10).

CONCLUSIONS: Therapy with telmisartan initiated soon after an ischemic stroke and continued for 2.5 years did not significantly lower the rate of recurrent stroke, major cardiovascular events, or diabetes. (ClinicalTrials.gov number, NCT00153062.)

Originalsprog	Engelsk
Tidsskrift	New England Journal of Medicine
Vol/bind	359
Udgave nummer	12
Sider (fra-til)	1225-37
Antal sider	13
ISSN	0028-4793
DOI	https://doi.org/10.1056/NEJMoa0804593
Status	Udgivet - 18 sep. 2008

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Yusuf, S., Diener, H-C., Sacco, R. L., Cotton, D., Ounpuu, S., Lawton, W. A., Palesch, Y., Martin, R. H., Albers, G. W., Bath, P., Bornstein, N., Chan, B. P. L., Chen, S-T., Cunha, L., Dahlöf, B., De Keyser, J., Donnan, G. A., Estol, C., Gorelick, P., ... Iversen, H. K. (2008). Telmisartan to prevent recurrent stroke and cardiovascular events. New England Journal of Medicine, 359(12), 1225-37. https://doi.org/10.1056/NEJMoa0804593

Yusuf, S, Diener, H-C, Sacco, RL, Cotton, D, Ounpuu, S, Lawton, WA, Palesch, Y, Martin, RH, Albers, GW, Bath, P, Bornstein, N, Chan, BPL, Chen, S-T, Cunha, L, Dahlöf, B, De Keyser, J, Donnan, GA, Estol, C, Gorelick, P, Gu, V, Hermansson, K, Hilbrich, L, Kaste, M, Lu, C, Machnig, T, Pais, P, Roberts, R, Skvortsova, V, Teal, P, Toni, D, VanderMaelen, C, Voigt, T, Weber, M, Yoon, B-W, PRoFESS Study Group & Iversen, HK 2008, 'Telmisartan to prevent recurrent stroke and cardiovascular events', New England Journal of Medicine, bind 359, nr. 12, s. 1225-37. https://doi.org/10.1056/NEJMoa0804593

@article{4501187fe0eb4728ae2be408190785b2,

title = "Telmisartan to prevent recurrent stroke and cardiovascular events",

abstract = "BACKGROUND: Prolonged lowering of blood pressure after a stroke reduces the risk of recurrent stroke. In addition, inhibition of the renin-angiotensin system in high-risk patients reduces the rate of subsequent cardiovascular events, including stroke. However, the effect of lowering of blood pressure with a renin-angiotensin system inhibitor soon after a stroke has not been clearly established. We evaluated the effects of therapy with an angiotensin-receptor blocker, telmisartan, initiated early after a stroke.METHODS: In a multicenter trial involving 20,332 patients who recently had an ischemic stroke, we randomly assigned 10,146 to receive telmisartan (80 mg daily) and 10,186 to receive placebo. The primary outcome was recurrent stroke. Secondary outcomes were major cardiovascular events (death from cardiovascular causes, recurrent stroke, myocardial infarction, or new or worsening heart failure) and new-onset diabetes.RESULTS: The median interval from stroke to randomization was 15 days. During a mean follow-up of 2.5 years, the mean blood pressure was 3.8/2.0 mm Hg lower in the telmisartan group than in the placebo group. A total of 880 patients (8.7%) in the telmisartan group and 934 patients (9.2%) in the placebo group had a subsequent stroke (hazard ratio in the telmisartan group, 0.95; 95% confidence interval [CI], 0.86 to 1.04; P=0.23). Major cardiovascular events occurred in 1367 patients (13.5%) in the telmisartan group and 1463 patients (14.4%) in the placebo group (hazard ratio, 0.94; 95% CI, 0.87 to 1.01; P=0.11). New-onset diabetes occurred in 1.7% of the telmisartan group and 2.1% of the placebo group (hazard ratio, 0.82; 95% CI, 0.65 to 1.04; P=0.10).CONCLUSIONS: Therapy with telmisartan initiated soon after an ischemic stroke and continued for 2.5 years did not significantly lower the rate of recurrent stroke, major cardiovascular events, or diabetes. (ClinicalTrials.gov number, NCT00153062.)",

keywords = "Aged, Angiotensin-Converting Enzyme Inhibitors, Benzimidazoles, Benzoates, Blood Pressure, Cardiovascular Diseases, Creatinine, Diabetes Mellitus, Female, Follow-Up Studies, Heart Failure, Humans, Kaplan-Meier Estimate, Male, Middle Aged, Myocardial Infarction, Potassium, Secondary Prevention, Stroke, Treatment Failure",

author = "Salim Yusuf and Hans-Christoph Diener and Sacco, {Ralph L} and Daniel Cotton and Stephanie Ounpuu and Lawton, {William A} and Yuko Palesch and Martin, {Rene{\'e} H} and Albers, {Gregory W} and Philip Bath and Natan Bornstein and Chan, {Bernard P L} and Sien-Tsong Chen and Luis Cunha and Bj{\"o}rn Dahl{\"o}f and {De Keyser}, Jacques and Donnan, {Geoffrey A} and Conrado Estol and Philip Gorelick and Vivian Gu and Karin Hermansson and Lutz Hilbrich and Markku Kaste and Chuanzhen Lu and Thomas Machnig and Prem Pais and Robin Roberts and Veronika Skvortsova and Philip Teal and Danilo Toni and Cam VanderMaelen and Thor Voigt and Michael Weber and Byung-Woo Yoon and {PRoFESS Study Group} and Iversen, {Helle Klingenberg}",

note = "2008 Massachusetts Medical Society",

year = "2008",

month = sep,

day = "18",

doi = "10.1056/NEJMoa0804593",

language = "English",

volume = "359",

pages = "1225--37",

journal = "New England Journal of Medicine",

issn = "0028-4793",

publisher = "Massachusetts Medical Society",

number = "12",

}

TY - JOUR

T1 - Telmisartan to prevent recurrent stroke and cardiovascular events

AU - Yusuf, Salim

AU - Diener, Hans-Christoph

AU - Sacco, Ralph L

AU - Cotton, Daniel

AU - Ounpuu, Stephanie

AU - Lawton, William A

AU - Palesch, Yuko

AU - Martin, Reneé H

AU - Albers, Gregory W

AU - Bath, Philip

AU - Bornstein, Natan

AU - Chan, Bernard P L

AU - Chen, Sien-Tsong

AU - Cunha, Luis

AU - Dahlöf, Björn

AU - De Keyser, Jacques

AU - Donnan, Geoffrey A

AU - Estol, Conrado

AU - Gorelick, Philip

AU - Gu, Vivian

AU - Hermansson, Karin

AU - Hilbrich, Lutz

AU - Kaste, Markku

AU - Lu, Chuanzhen

AU - Machnig, Thomas

AU - Pais, Prem

AU - Roberts, Robin

AU - Skvortsova, Veronika

AU - Teal, Philip

AU - Toni, Danilo

AU - VanderMaelen, Cam

AU - Voigt, Thor

AU - Weber, Michael

AU - Yoon, Byung-Woo

AU - PRoFESS Study Group

AU - Iversen, Helle Klingenberg

N1 - 2008 Massachusetts Medical Society

PY - 2008/9/18

Y1 - 2008/9/18

N2 - BACKGROUND: Prolonged lowering of blood pressure after a stroke reduces the risk of recurrent stroke. In addition, inhibition of the renin-angiotensin system in high-risk patients reduces the rate of subsequent cardiovascular events, including stroke. However, the effect of lowering of blood pressure with a renin-angiotensin system inhibitor soon after a stroke has not been clearly established. We evaluated the effects of therapy with an angiotensin-receptor blocker, telmisartan, initiated early after a stroke.METHODS: In a multicenter trial involving 20,332 patients who recently had an ischemic stroke, we randomly assigned 10,146 to receive telmisartan (80 mg daily) and 10,186 to receive placebo. The primary outcome was recurrent stroke. Secondary outcomes were major cardiovascular events (death from cardiovascular causes, recurrent stroke, myocardial infarction, or new or worsening heart failure) and new-onset diabetes.RESULTS: The median interval from stroke to randomization was 15 days. During a mean follow-up of 2.5 years, the mean blood pressure was 3.8/2.0 mm Hg lower in the telmisartan group than in the placebo group. A total of 880 patients (8.7%) in the telmisartan group and 934 patients (9.2%) in the placebo group had a subsequent stroke (hazard ratio in the telmisartan group, 0.95; 95% confidence interval [CI], 0.86 to 1.04; P=0.23). Major cardiovascular events occurred in 1367 patients (13.5%) in the telmisartan group and 1463 patients (14.4%) in the placebo group (hazard ratio, 0.94; 95% CI, 0.87 to 1.01; P=0.11). New-onset diabetes occurred in 1.7% of the telmisartan group and 2.1% of the placebo group (hazard ratio, 0.82; 95% CI, 0.65 to 1.04; P=0.10).CONCLUSIONS: Therapy with telmisartan initiated soon after an ischemic stroke and continued for 2.5 years did not significantly lower the rate of recurrent stroke, major cardiovascular events, or diabetes. (ClinicalTrials.gov number, NCT00153062.)

AB - BACKGROUND: Prolonged lowering of blood pressure after a stroke reduces the risk of recurrent stroke. In addition, inhibition of the renin-angiotensin system in high-risk patients reduces the rate of subsequent cardiovascular events, including stroke. However, the effect of lowering of blood pressure with a renin-angiotensin system inhibitor soon after a stroke has not been clearly established. We evaluated the effects of therapy with an angiotensin-receptor blocker, telmisartan, initiated early after a stroke.METHODS: In a multicenter trial involving 20,332 patients who recently had an ischemic stroke, we randomly assigned 10,146 to receive telmisartan (80 mg daily) and 10,186 to receive placebo. The primary outcome was recurrent stroke. Secondary outcomes were major cardiovascular events (death from cardiovascular causes, recurrent stroke, myocardial infarction, or new or worsening heart failure) and new-onset diabetes.RESULTS: The median interval from stroke to randomization was 15 days. During a mean follow-up of 2.5 years, the mean blood pressure was 3.8/2.0 mm Hg lower in the telmisartan group than in the placebo group. A total of 880 patients (8.7%) in the telmisartan group and 934 patients (9.2%) in the placebo group had a subsequent stroke (hazard ratio in the telmisartan group, 0.95; 95% confidence interval [CI], 0.86 to 1.04; P=0.23). Major cardiovascular events occurred in 1367 patients (13.5%) in the telmisartan group and 1463 patients (14.4%) in the placebo group (hazard ratio, 0.94; 95% CI, 0.87 to 1.01; P=0.11). New-onset diabetes occurred in 1.7% of the telmisartan group and 2.1% of the placebo group (hazard ratio, 0.82; 95% CI, 0.65 to 1.04; P=0.10).CONCLUSIONS: Therapy with telmisartan initiated soon after an ischemic stroke and continued for 2.5 years did not significantly lower the rate of recurrent stroke, major cardiovascular events, or diabetes. (ClinicalTrials.gov number, NCT00153062.)

KW - Aged

KW - Angiotensin-Converting Enzyme Inhibitors

KW - Benzimidazoles

KW - Benzoates

KW - Blood Pressure

KW - Cardiovascular Diseases

KW - Creatinine

KW - Diabetes Mellitus

KW - Female

KW - Follow-Up Studies

KW - Heart Failure

KW - Humans

KW - Kaplan-Meier Estimate

KW - Male

KW - Middle Aged

KW - Myocardial Infarction

KW - Potassium

KW - Secondary Prevention

KW - Stroke

KW - Treatment Failure

U2 - 10.1056/NEJMoa0804593

DO - 10.1056/NEJMoa0804593

M3 - Journal article

C2 - 18753639

SN - 0028-4793

VL - 359

SP - 1225

EP - 1237

JO - New England Journal of Medicine

JF - New England Journal of Medicine

IS - 12

ER -

Telmisartan to prevent recurrent stroke and cardiovascular events

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