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M Farkouh

Publications and source records attributed to M Farkouh.

5 recordsLinked to original sources
PubMed2004

Therapeutic arthritis research and gastrointestinal event trial of lumiracoxib - study design and patient demographics.

BACKGROUND: Cyclooxygenase-2 selective inhibitors were developed in order to reduce the incidence of life-threatening gastrointestinal ulcer complications compared with non-selective non-steroidal anti-inflammatory drugs. Previous outcomes studies have, variously, lacked power to investigate this endpoint, focused on broader outcomes, or been too small to quantify the influence of aspirin. AIM: To evaluate lumiracoxib, a novel cyclooxygenase-2 selective inhibitor, vs. non-selective non-steroidal anti-inflammatory drugs in an outcomes study of considerably increased size. This paper describes the study's methodology. METHODS AND PATIENTS: The Therapeutic Arthritis Research and Gastrointestinal Event Trial was a randomized, double-blind, 52-week study of lumiracoxib 400 mg once daily (two to four times the recommended dose for osteoarthritis) versus naproxen 500 mg twice daily or ibuprofen 800 mg three-times daily in patients with osteoarthritis. Randomization was stratified for low-dose aspirin use and age (< or = 64, 65-74, > or= 75 years). The study was powered to investigate upper gastrointestinal ulcer complications (primary endpoint) in patients not taking aspirin and in the overall study population; other endpoints included cardiovascular, renal and hepatic measures. CONCLUSIONS: Therapeutic Arthritis Research and Gastrointestinal Event Trial was designed to provide definitive answers concerning the gastrointestinal safety of lumiracoxib, addressing the controversial issues arising from outcomes studies with other cyclooxygenase-2 selective inhibitors.

Adult↗
PubMed2001

Clinical risk stratification correlates with the angiographic extent of coronary artery disease in unstable angina.

OBJECTIVES: We sought to determine whether clinical risk stratification correlates with the angiographic extent of coronary artery disease (CAD) in patient with unstable angina. BACKGROUND: The Agency for Health Care Policy and Research (AHCPR) guidelines stratify patients with unstable angina according to short-term risk of myocardial infarction or death. Whether these guidelines are useful in predicting the extent of CAD is unknown. METHODS: All residents of Olmsted County, Minnesota, undergoing emergency department evaluation from January 1, 1985 through December 31, 1992 for unstable angina without a history of prior coronary artery bypass grafting, and who underwent early angiography (within seven days of presentation) were classified into low, intermediate and high risk subgroups based on AHCPR criteria. RESULTS: Seven hundred ninety-five patients underwent early angiography: 159 high risk, 572 intermediate risk and 64 low risk patients. Logistic regression analysis demonstrated that low risk patients had a greater likelihood of normal or mild CAD relative to intermediate risk (odds ratio [OR], 4.67; 95% confidence interval [CI], 2.70-8.06; p < 0.001) and high risk (OR, 11.1; 95% CI, 5.71-22.2; p < 0.001). Significant 1-, 2-, 3-vessel coronary disease or left main coronary disease was more likely in high relative to low risk (OR, 8.09; 95% CI, 4.22-15.5; p < 0.001), intermediate relative to low risk (OR, 4.11; 95% CI, 2.34-7.22; p < 0.001), and high relative to intermediate risk (OR, 1.97; 95% CI, 1.31-2.96; p = 0.0012). CONCLUSIONS: Among patients with unstable angina undergoing early coronary angiography, risk stratification according to the AHCPR guidelines correlates with the angiographic extent of CAD.

Adult↗
PubMed1995

The antioxidant vitamins and cardiovascular disease. A critical review of epidemiologic and clinical trial data.

PURPOSE: To review prospective epidemiologic studies and randomized trials regarding the role of antioxidant vitamins (vitamins E and C and beta-carotene) in the prevention of cardiovascular disease, with emphasis on differences in results obtained by these two types of studies. DATA SOURCES: Computerized and manual searches of the literature on antioxidant vitamins and cardiovascular disease. STUDY SELECTION: Prospective epidemiologic studies and randomized trials that included 100 or more participants and provided quantified estimates of antioxidant vitamin intake. DATA SYNTHESIS: Comparisons of relative risk reductions (RRR) across observational studies and randomized trials, including assessment of dose-response relations. RESULTS: All three large epidemiologic cohort studies of vitamin E noted that high-level vitamin E intake or supplementation was associated with a significant reduction in cardiovascular disease (RRR range, 31% to 65%), as measured by various fatal and nonfatal cardiovascular end points. To obtain these reductions, vitamin E supplementation must last at least 2 years. Less consistent reductions were seen in studies of beta-carotene (RRR range, -2% to 46%) and vitamin C (RRR range, -25% to 51%). Considerable biases in observational studies, such as different health behaviors of persons using antioxidants, may account for the observed benefit. By contrast, none of the completed randomized trials showed any clear reduction in cardiovascular disease with vitamin E, vitamin C, or beta-carotene supplementation. The trials were not specifically designed to assess cardiovascular disease, did not provide data on nonfatal cardiovascular end points, may have had insufficient treatment durations, and used suboptimal vitamin E doses. The completed trials were of adequate size to indicate that the true therapeutic benefit of vitamin E and other antioxidants in reducing fatal cardiovascular disease (a survival benefit as long as 5 years) is probably more modest than the epidemiologic data suggest. CONCLUSION: The epidemiologic data suggest that antioxidant vitamins reduce cardiovascular disease, with the clearest effect for vitamin E; however, completed randomized trials do not support this finding. Much of this controversy should be resolved by the ongoing large-scale and long-term randomized trials designed specifically to evaluate effects on cardiovascular disease.

Antioxidants↗
PubMed1993

Maximizing benefits of therapies in acute myocardial infarction.

Major advances in the management of acute myocardial infarction have been achieved by a combination of careful experimental work and development of effective pharmacologic and interventional strategies in conjunction with the conduct of large, reliable randomized trials. Current trials indicate that a combination of thrombolytic therapy, aspirin, and intravenous followed by oral beta blockers reduces mortality. There are a number of additional promising interventions, such as intravenous magnesium, nitrates, and the newer antithrombin agents. However, before these agents are used widely in clinical practice, clear proof of benefit and adequate safety should be available from the ongoing randomized trials. Following discharge from the hospital, long-term therapy with aspirin and beta blockers should be considered in all patients. In patients with heart failure and low ejection fraction, angiotensin-converting enzyme (ACE) inhibitors have been shown to reduce mortality, reinfarction, and the need for further hospitalizations for heart failure. Therefore, these therapies, in conjunction with risk factor modification (cessation of cigarette smoking, treatment of hypercholesterolemia, treatment of hypertension), should be considered in all appropriate patients. A number of new strategies for the prevention of atherosclerosis and its complications are currently being evaluated in prospective randomized trials. These include the natural antioxidant vitamins, estrogen replacement therapy, tamoxifen therapy, and ACE inhibitors in patients without evidence of heart failure or left ventricular dysfunction.

Humans↗