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Bernard Chaitman

Publications and source records attributed to Bernard Chaitman.

11 recordsLinked to original sources

Gender comparison of efficacy and safety of ranolazine for chronic angina pectoris in four randomized clinical trials.

More women than men with myocardial infarction have previous stable angina pectoris. Women also have an increased incidence of angina after percutaneous coronary intervention and coronary artery bypass grafting. Data from 1,737 patients with stable angina pectoris in 4 international trials (Monotherapy Assessment of Ranolazine In Stable Angina [MARISA], Combination Assessment of Ranolazine In Stable Angina [CARISA], Ranolazine Versus Atenolol Comparison in Chronic Angina [RAN080], and Efficacy of Ranolazine in Chronic Angina [ERICA]) were used to compare efficacy and safety of ranolazine therapy for angina in women and men. MARISA, CARISA, and RAN080 included exercise testing; CARISA, RAN080, and ERICA assessed angina frequency and nitroglycerin consumption; and ERICA included quality-of-life assessment using the Seattle Angina Questionnaire. MARISA, CARISA, and ERICA used the extended-release formulation of ranolazine; RAN080 used ranolazine immediate release. All 4 studies showed overall efficacy and safety of ranolazine. In subgroup analyses, women showed less improvement than men in exercise testing. However, similar improvements for women and men were noted in angina frequency and nitroglycerin consumption, and in ERICA, in the angina frequency dimension of the Seattle Angina Questionnaire. In conclusion, explanations for the gender treatment differences for exercise parameters but comparable effects on decrease in angina frequency and nitroglycerin use are uncertain, but may include differences in patient demographics, reasons for stopping exercise, and type of exercise protocol used.

Acetanilides↗

Efficacy and safety of fasudil in patients with stable angina: a double-blind, placebo-controlled, phase 2 trial.

OBJECTIVES: This study sought to evaluate the efficacy and safety of fasudil, an orally available rho kinase inhibitor, in patients with stable angina. BACKGROUND: Several small, non-placebo-controlled trials suggest that fasudil reduces myocardial ischemia in patients with stable or vasospastic angina. METHODS: In a multicenter, double-blind, placebo-controlled, randomized trial, the efficacy and safety of fasudil were evaluated in stable angina patients. Of the 206 patients screened, 84 patients with reproducible exercise times were randomized 1:1 to fasudil or placebo. Nitroglycerin as needed and a beta- or calcium-channel blocker were allowed. Fasudil or matching placebo was force-titrated from 20 mg three times daily to 80 mg twice daily with 20 mg twice-daily increments every two weeks. Symptom-limited exercise testing was performed after two, four, six, and eight weeks of treatment. RESULTS: At peak, exercise duration was significantly improved at all visits in both groups, although exercise duration was numerically greater in patients receiving fasudil versus those receiving placebo. Time to > or =1 mm ST-segment depression was increased with fasudil at both peak and trough compared with placebo (172.1 s vs. 44.0 s, p = 0.001, and 92.8 s vs. 26.4 s, p = 0.02, respectively). Fasudil improved Seattle Angina Questionnaire scores. No significant differences in Canadian Cardiovascular Society class, time to angina, or frequency of angina or nitroglycerin use were noted between groups. Fasudil did not affect heart rate or blood pressure, and was well tolerated. CONCLUSIONS: Fasudil up to 80 mg three times daily significantly increased the ischemic threshold of angina patients during exercise with a trend toward increased exercise duration. Further investigation of fasudil doses >80 mg three times daily is indicated.

1-(5-Isoquinolinesulfonyl)-2-Methylpiperazine↗

Exercise treadmill testing using a modified exercise protocol in women with suspected myocardial ischemia: findings from the National Heart, Lung and Blood Institute-sponsored Women's Ischemia Syndrome Evaluation (WISE).

BACKGROUND: Exercise testing, a major diagnostic modality in individuals with suspected coronary artery disease (CAD), has in general demonstrated less overall diagnostic accuracy in women compared to men. As part of the WISE, a modified protocol was examined with the intention of improving reliability of exercise testing. METHODS: Criteria for entry in the WISE study include clinically indicated coronary angiography. Exercise testing was performed using a protocol modified to be more appropriate for women. The study population consisted of 96 women, mean age of 55.8 y (range 34-77), who completed exercise treadmill test (ETT). Most (78%) were postmenopausal; 96% had >or =2 risk factors for CAD. RESULTS: By core laboratory angiography, 29/96 women had stenosis > or =50% in at least one coronary artery. Of these 29 women, 9 had abnormal ETT, yielding overall sensitivity of 31%. The remaining 20 women had normal (12/29, 41%) or nondiagnostic (8/29, 28%) studies. Among the 67 women with minimal or no coronary stenosis, 35 had no ischemic ST-segment changes during ETT, yielding overall specificity of 52%. Analysis with exclusion of women with nondiagnostic studies yielded sensitivity and specificity of 43% and 66%, respectively. The presence of coronary artery stenosis and inability to perform ETT, but not results of testing, predicted the outcomes of myocardial infarction, heart failure, and death. CONCLUSIONS: Exercise treadmill test appears to be of limited diagnostic value in women with suspected myocardial ischemia referred for coronary angiography. Sensitivity and specificity remain poor even with modified exercise protocol and core laboratory angiographic analysis. These findings merit consideration in view of current guidelines that recommend exercise testing in women with suspected CAD.

Adult↗

Effects of angiotensin-converting enzyme inhibition on transient ischemia: the Quinapril Anti-Ischemia and Symptoms of Angina Reduction (QUASAR) trial.

OBJECTIVES: We sought to determine whether angiotensin-converting enzyme inhibition (ACE-I) (i.e., quinapril) prevents transient ischemia (exertional and spontaneous) in patients with coronary artery disease (CAD). BACKGROUND: It is known that ACE-I reduces the risk of death, myocardial infarction (MI), and other CAD-related outcomes in high-risk patients. Numerous studies have confirmed that ACE-I improves coronary flow and endothelial function. Whether ACE-I also decreases transient ischemia is unclear, because no studies have been adequately designed or sufficiently powered to evaluate this issue. METHODS: Using a randomized, double-blinded, placebo-controlled, multicenter design, we enrolled 336 CAD patients with stable angina. None had uncontrolled hypertension, left ventricular (LV) dysfunction, or recent MI, and all developed electrocardiographic (ECG) evidence of ischemia during exercise. They were randomly assigned to one of two groups: 40 mg/day quinapril (n = 177) or placebo (n = 159) for 8 weeks. Patients then entered an additional eight-week treatment phase to examine the full dose range. Those assigned to 40 mg quinapril continued that dose and those assigned to placebo were titrated to 80 mg/day. Treadmill testing, the Seattle Angina Questionnaire, and ambulatory ECG monitoring were used to assess responses at baseline and at 8 and 16 weeks. RESULTS: The groups did not differ significantly at entry or in terms of indexes assessing myocardial ischemia at 8 or 16 weeks of treatment. In this low-risk population, ACE-I was not associated with serious adverse events. CONCLUSIONS: Our findings suggest short-term ACE-I in CAD patients without hypertension, LV dysfunction, or acute MI is not associated with significant effects on transient ischemia.

Angina Pectoris↗

Impact of sodium-hydrogen exchange inhibition by cariporide on death or myocardial infarction in high-risk CABG surgery patients: results of the CABG surgery cohort of the GUARDIAN study.

OBJECTIVES: To evaluate the effects of cariporide on all-cause mortality or myocardial infarction at 36 days in patients at risk of myocardial necrosis after coronary artery bypass graft surgery. METHODS: In the coronary artery bypass graft cohort of the GUARD During Ischemia Against Necrosis trial, patients > or =18 years who required urgent coronary artery bypass graft, repeat coronary artery bypass graft, or had a history of unstable angina and > or =2 risk factors (age >65 years, female gender, diabetes mellitus, ejection fraction <35%, or left main or 3-vessel disease) were randomized to placebo (n = 743) or cariporide 20 mg (n = 736), 80 mg (n = 705), or 120 mg (n = 734). A 1-hour intravenous infusion was initiated shortly before surgery and administered every 8 hours for 2 to 7 days. Patients were followed up for 6 months. A nonparametric covariance analysis was used to calculate the primary efficacy endpoint. RESULTS: Baseline characteristics were similar between treatment groups. The cariporide 20- and 80-mg groups had event rates similar to placebo. The endpoint of all-cause mortality or myocardial infarction at day 36 was significant with cariporide 120 mg versus placebo (event rate 12.2% vs 16.2%; P =.027). The risk reduction was evident on postoperative day 1 (3.3% vs 6.5%; P =.005) and was maintained at 6 months (event rate 15.0% vs 18.6%; P =.033). Cariporide was well tolerated, and most adverse events were mild and transient in this high-risk population. CONCLUSIONS: Clinical benefit with cariporide 120 mg was observed early after treatment initiation and continued for 6 months postsurgery, suggesting that sodium-hydrogen exchange inhibition with cariporide is cardioprotective in patients undergoing high-risk coronary artery bypass graft surgery.

Adolescent↗