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1. Direct thrombin inhibitors in acute coronary syndromes: principal results of a meta-analysis based on individual patients' data

Author

Yusuf, S, Granger, C, Eikelboom, J, Mehta, S, Pogue, J, Tait, P, Behar, S, Benderly, M, Hod, H, Kaplinsky, E, Barrett, N, Bilke, R, Luz, M, Marhoefer, M, Roi, L, Trenery, D, Bittl, JA, Boersma, H, Flather, M, Baigent, C, Simoons, ML, Califf, R, Pieper, K, Topol, EJ, Weitz, J, Serruys, PW, White, HD, Neuhaus, KL, Zeymer, U, Simes, J, Close, P, Edwards, S, Gallo, P, Henis, M, Anand, S, Kimball, W, Meanwell, C, Villiger, J, Antman, EM, Braunwald, E, Gibson, M, Murphy, S, Grip, L, Held, P, Trialist, DTI, and Cardiology

Subjects
medicine.medical_specialty, medicine.medical_treatment, Hirudin, Glycine, Myocardial Infarction, Pharmacology, Arginine, Argatroban, Antithrombins, Piperidines, Hirudin Therapy, Internal medicine, medicine, Bivalirudin, Humans, Myocardial infarction, Angina, Unstable, Randomized Controlled Trials as Topic, Sulfonamides, business.industry, Heparin, Thrombin, Percutaneous coronary intervention, General Medicine, Hirudins, medicine.disease, Peptide Fragments, Recombinant Proteins, Survival Rate, Direct thrombin inhibitor, Pipecolic Acids, Cardiology, business, Oligopeptides, medicine.drug, Discovery and development of direct thrombin inhibitors
Abstract

BACKGROUND: To obtain more reliable and precise estimates of the effect of direct thrombin inhibitors in the management of acute coronary syndromes, including patients undergoing percutaneous coronary intervention, we undertook a meta-analysis based on individual patients' data from randomised trials comparing a direct thrombin inhibitor (hirudin, bivalirudin, argatroban, efegatran, or inogatran) with heparin. METHODS: We included trials that involved at least 200 patients. The primary efficacy outcome was death or myocardial infarction, and the primary safety outcome was major bleeding. Data from individual trials were combined by use of a modified Mantel-Haenszel method. FINDINGS: In 11 randomised trials, 35,970 patients were assigned up to 7 days' treatment with a direct thrombin inhibitor or heparin and followed up for at least 30 days. Compared with heparin, direct thrombin inhibitors were associated with a lower risk of death or myocardial infarction at the end of treatment (4.3% vs 5.1%; odds ratio 0.85 [95% CI 0.77-0.94]; p=0.001) and at 30 days (7.4% vs 8.2%; 0.91 [0.84-0.99]; p=0.02). This was due primarily to a reduction in myocardial infarctions (2.8% vs 3.5%; 0.80 [0.71-0.90]; p

Published
2002
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2. Characteristics of 15314 Hypertensive Patients at High Coronary Risk. The VALUE Trial

Author

Kjeldsen, S. E., Julius, S., Brunner, H., Hansson, L., Henis, M., Ekman, S., Laragh, J., Mcinnes, G., Smith, B., Weber, M., Zanchetti, A., and Portaluppi, Francesco

Subjects
medicine.medical_specialty, education.field_of_study, business.industry, Population, General Medicine, medicine.disease, Essential hypertension, Angiotensin II, Surgery, Blood pressure, Valsartan, Heart failure, Internal medicine, Internal Medicine, Medicine, Myocardial infarction, Amlodipine, Cardiology and Cardiovascular Medicine, business, education, medicine.drug
Abstract

Valsartan is an orally active, selective antagonist of the angiotensin II-1 (AT1) receptor developed for the treatment of hypertension. The Valsartan Antihypertensive Long-term Use Evaluation (VALUE) Trial of Cardiovascular Events in Hypertension is a double-blind, randomized prospective, parallel group study designed to compare the effects of valsartan with those of the calcium-antagonist amlodipine on the reduction of cardiac morbidity and mortality. Patients with essential hypertension, aged 50 years and older, and at particularly high risk of coronary events were enrolled. 18,119 patients were screened and 15,314 patients in 31 countries were randomized mainly between January 1998 and December 1999. These hypertensives had a mean blood pressure of 154.7/87.5 mmHg at the time of their randomization to blinded medication. The population comprises both genders (men 57.6%), Caucasians (89.1%), mean age 67.2 years, mean body mass index 28.6 kg/m2, coronary heart disease (45.8%), high cholesterol (33.0%), type 2 diabetes mellitus (31.7%) and smokers (24.0%). More than 92% of the randomized participants had been treated for high blood pressure for at least 6 months when screened for the study. The randomized population is now being treated (goal blood pressure < 140/90 mmHg) in adherence with the protocol until at least 1450 patients experience primary cardiac endpoint defined as clinically evident or aborted myocardial infarction, hospitalization for heart failure or death caused by coronary heart disease.

Published
2001
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4. Valsartan, captopril, or both in myocardial infarction complicated by heart failure, left ventricular dysfunction, or both.

Author

Pfeffer MA, McMurray JJV, Velazquez EJ, Rouleau J, Køber L, Maggioni AP, Solomon SD, Swedberg K, Van de Werf F, White H, Leimberger JD, Henis M, Edwards S, Zelenkofske S, Sellers MA, Califf RM, Valsartan in Acute Myocardial Infarction Trial Investigators, Pfeffer, Marc A, McMurray, John J V, and Velazquez, Eric J

Abstract

Background: Angiotensin-converting-enzyme (ACE) inhibitors such as captopril reduce mortality and cardiovascular morbidity among patients with myocardial infarction complicated by left ventricular systolic dysfunction, heart failure, or both. In a double-blind trial, we compared the effect of the angiotensin-receptor blocker valsartan, the ACE inhibitor captopril, and the combination of the two on mortality in this population of patients.Methods: Patients receiving conventional therapy were randomly assigned, 0.5 to 10 days after acute myocardial infarction, to additional therapy with valsartan (4909 patients), valsartan plus captopril (4885 patients), or captopril (4909 patients). The primary end point was death from any cause.Results: During a median follow-up of 24.7 months, 979 patients in the valsartan group died, as did 941 patients in the valsartan-and-captopril group and 958 patients in the captopril group (hazard ratio in the valsartan group as compared with the captopril group, 1.00; 97.5 percent confidence interval, 0.90 to 1.11; P=0.98; hazard ratio in the valsartan-and-captopril group as compared with the captopril group, 0.98; 97.5 percent confidence interval, 0.89 to 1.09; P=0.73). The upper limit of the one-sided 97.5 percent confidence interval for the comparison of the valsartan group with the captopril group was within the prespecified margin for noninferiority with regard to mortality (P=0.004) and with regard to the composite end point of fatal and nonfatal cardiovascular events (P<0.001). The valsartan-and-captopril group had the most drug-related adverse events. With monotherapy, hypotension and renal dysfunction were more common in the valsartan group, and cough, rash, and taste disturbance were more common in the captopril group.Conclusions: Valsartan is as effective as captopril in patients who are at high risk for cardiovascular events after myocardial infarction. Combining valsartan with captopril increased the rate of adverse events without improving survival. [ABSTRACT FROM AUTHOR]

Published
2003

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