Circulation
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Randomized Controlled Trial Multicenter Study Clinical Trial
Double-blind, dose-response, placebo-controlled multicenter study of nisoldipine. A new second-generation calcium channel blocker in angina pectoris.
Nisoldipine is a potent 1:4 dihydropyridine calcium channel antagonist, and doses of 5 or 10 mg administered either once or twice daily have been claimed to exert antianginal effects. There is, however, little information regarding the dose-response relation and whether the drug exerts any consistent effects throughout the dosing interval. In this placebo-controlled, parallel-design study, the dose-response relation of monotherapy with nisoldipine administered twice daily was studied in patients with stable angina pectoris. ⋯ Monotherapy with 2.5, 5, and 10 mg nisoldipine twice a day was not superior to placebo therapy in treating patients with angina pectoris, and the 10-mg-b.i.d. therapy resulted in a statistically insignificant but clinically important increase in the incidence of serious adverse events.
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In this article, the issues involved in the measurements of quality of life in clinical trials of cardiovascular drugs are discussed with emphasis on beta-blocker treatment. The extensive documentation available for beta-blockers makes it possible to evaluate different aspects of this class of drugs. Generally, beta-blockers have been shown to be safe with a low frequency of serious side effects. ⋯ Today there is increasing evidence that these can be quantitatively as well as qualitatively reduced by using beta-blockers in a low dose and avoiding high plasma peak concentrations. Considering effects on well-being and psychomotor tests, there seems to be no clinical difference between hydrophilic and lipophilic beta-blockers, when administered in comparable therapeutic dosages, whereas beta 1-selective blockers in clinically relevant doses seem to produce fewer and less severe adverse effects than nonselective blockers. Compared with other classes of cardiovascular drugs, there is no clear evidence of differences in well-being between selective beta-blockers and angiotensin converting enzyme inhibitors or calcium antagonists.
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Randomized Controlled Trial Comparative Study Clinical Trial
A prospective randomized study of a modified technique of ultrafiltration during pediatric open-heart surgery.
Conventional ultrafiltration (UF) fails to reverse satisfactorily hemodilution and the rise in total body water (TBW) seen after cardiopulmonary bypass (CPB). We have modified the technique, timing, and placement of UF in the CPB circuit and in pilot studies observed controlled elevation of hematocrit and a significantly reduced rise in TBW. We have carried out a prospective randomized study in 50 children undergoing open-heart surgery, comparing modified UF (MUF) with nonfiltered controls. ⋯ Percent rise of systolic blood pressure was 1 (-4 to +9) in controls versus 49 (5-81) in MUF (p = 0.0001); percent rise in diastolic blood pressure 0 (-5 to +8) in controls versus 28 (3-47) in MUF (p = 0.0001). UF reduced the rise in TBW and donor blood requirement associated with CPB in children. The blood pressure rise observed during UF is as yet unexplained, but if proven safe the technique may permit donor blood-free cardiac surgery and prevent the accumulation of potentially dangerous excess tissue fluid.
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Randomized Controlled Trial Comparative Study Clinical Trial
Hemostatic effects of tranexamic acid and desmopressin during cardiac surgery.
Desmopressin-induced release of tissue plasminogen activator from endothelial cells may explain the absence of its hemostatic effect in patients undergoing cardiac surgery. Prior administration of the antifibrinolytic drug tranexamic acid might unmask such an effect, and combination therapy might thereby improve postoperative hemostasis. ⋯ Desmopressin exerts no hemostatic effect, with or without prior administration of antifibrinolytic drug. Prophylactic tranexamic acid alone appears economical and safe in decreasing blood loss and transfusion requirement after cardiac surgery.
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The effect of diabetes on survival after coronary bypass surgery is uncertain. Also, although the overall clinical benefits of internal mammary artery (IMA) grafting are well established, the survival benefit attributable to IMA grafting in diabetics is not well characterized. To determine the influence of diabetes and IMA grafting on survival after bypass surgery in the current surgical era, characteristics related to subsequent outcome were analyzed in 5,654 consecutive patients undergoing surgery in the decade of the 1980s. ⋯ The magnitude of the survival benefit attributable to IMA grafting in the two groups did not differ (p = 0.4). Diabetes is an important risk factor for late cardiac mortality after bypass surgery and should be included in analyses of the efficacy of therapies for coronary artery disease. IMA grafting conveys a similar benefit to diabetic and nondiabetic patients but does not negate the adverse effect of diabetes on survival.