Search

Background: Despite successful coronary angioplasty (PTCA), patients may have ischemia after the procedure because of the overall coronary disease and luminal renarrowing at the lesion sites. The aim of this study was to examine the effects of the calcium-channel blocker amlodipine on post-PTCA ischemia., Methods: In a prospective, double-blind design, patients were randomized to receive 10 mg of amlodipine or placebo 2 weeks before angioplasty. Exercise tests and 48-hour ambulatory electrocardiography recordings were performed in 405 patients, 2 weeks before and 2 and 20 weeks (early and late) after PTCA., Results: There were no differences in clinical and angiographic baseline characteristics between the treatment groups. Ischemia and angina were equally distributed before PTCA, and no difference in restenosis was found between the groups at follow-up. The incidence of angina was significantly lower in the amlodipine group compared with the placebo group both early and late after PTCA (P =.04 and.03). Exercise-induced ischemia was reduced by 40% (P =.009) early and 34% (P =.02) late after PTCA in the amlodipine group, and ischemia on ambulatory electrocardiography was reduced by 18% early and 28% late after PTCA compared with placebo (P =.06 and P =.009)., Conclusion: Ischemia and angina occurred after successful PTCA and were significantly reduced by amlodipine.

Introduction: The objective of this analysis was to evaluate the health economic benefits of using amlodipine in patients undergoing angioplasty procedures in Canada and Norway., Methods: A decision tree model was constructed to find the total expected cost per patient for a 4-month time period following an initial angioplasty. The model used clinical data from the Coronary Angioplasty Amlodipine Restenosis Study (CAPARES), a prospective, randomized, double blind, placebo-controlled trial conducted to investigate the effects of amlodipine on restenosis and clinical events in patients undergoing percutaneous transluminal coronary angioplasty (PTCA). Outcomes of interest to this analysis included MI, repeat PTCA, CABG, and all-cause mortality. Clinical experts from Canada and Norway were enlisted and a modified Delphi study approach was used to quantify healthcare resources consumed for each clinical outcome., Results: The use of amlodipine decreased the rates of MI, PTCA, and CABG by 2.0, 4.7, and 2.7%, respectively. The total expected cost per patient using amlodipine was $6,398.30 (US$4,323) in Canada and kr 59,993.27 (US$6,846) in Norway. The total expected cost per patient not using amlodipine was $6,519.37 (US$4,405) in Canada and kr 64,292.17 (US$7,337) in Norway. The model demonstrated potential cost-savings over a 4-month follow up period resulting from the improved clinical outcomes for patients using amlodipine with PTCA--$121,071 (US$81,844) per 1000 patients in Canada and kr 4,298,899 (US$490,074) per 1000 patients in Norway., Conclusions: The adjunctive use of amlodipine is a cost-effective therapeutic strategy to achieve more favorable clinical outcomes in patients undergoing PTCAs in Canada and Norway.

The Coronary AngioPlasty Amlodipine REStenosis Study (CAPARES) is a multicentre, double-blind, placebo controlled restenosis trial investigating the effect of amlodipine on angiographic and clinical endpoints in patients undergoing routine percutaneous transluminal coronary angioplasty (PTCA) for stable angina pectoris. A total of 635 patients were randomized to amlodipine or placebo two weeks before PTCA and were followed for four months after PTCA. There were 451 nonstented patients who completed the study with angiographic follow-up. Quantitative coronary angiography revealed that the loss in minimal luminal diameter from immediately after PTCA to the four-month follow-up was unaffected by amlodipine treatment. However, the incidence of repeat PTCA and composite clinical events were significantly lower in patients treated with amlodipine.

Objectives: Our intent was to investigate the effect of the dihydropyridine calcium channel blocker amlodipine on restenosis and clinical outcome in patients undergoing percutaneous transluminal coronary angioplasty (PTCA)., Background: Amlodipine has sustained vasodilatory effects and relieves coronary spasm, which may reduce luminal loss and clinical complications after PTCA., Methods: In a prospective, double-blind design, 635 patients were randomized to 10 mg of amlodipine or placebo. Pretreatment with the study drug started two weeks before PTCA and continued until four months after PTCA. The primary angiographic end point was loss in minimal lumen diameter (MLD) from post-PTCA to follow-up, as assessed by quantitative coronary angiography (QCA). Clinical end points were death, myocardial infarction, coronary artery bypass graft surgery and repeat PTCA (major adverse clinical events)., Results: Angioplasty was performed in 585 patients (92.1%); 91 patients (15.6%) had coronary stents implanted. Follow-up angiography suitable for QCA analysis was done in 236 patients in the amlodipine group and 215 patients in the placebo group (per-protocol group). The mean loss in MLD was 0.30 +/- 0.45 mm in the amlodipine group versus 0.29 +/- 0.49 mm in the placebo group (p = 0.84). The need for repeat PTCA was significantly lower in the amlodipine versus the placebo group (10 [3.1%] vs. 23 patients [7.3%], p = 0.02, relative risk ratio [RR]: 0.45, 95% confidence interval [CI]: 0.22 to 0.91), and the composite incidence of clinical events (30 [9.4%] vs. 46 patients (14.5%), p = 0.049, RR: 0.65, CI: 0.43 to 0.99) within the four months follow-up period (intention-to-treat analysis)., Conclusions: Amlodipine therapy starting two weeks before PTCA did not reduce luminal loss, but the incidence of repeat PTCA and the composite major adverse clinical events were significantly reduced during the four-month follow-up period after PTCA with amlodipine as compared with placebo.

In this multicentre, double-blind trial in 461 patients with essential hypertension, amlodipine (5-10 mg once daily) and enalapril (10-40 mg once daily) were compared in terms of quality of life, efficacy and tolerability after 1 year of treatment (part 1). In part 2, 177 patients successfully treated with amlodipine in part 1 continued in an open evaluation of efficacy and safety of antihypertensive treatment with amlodipine for a further 2 years. In part 1, both drugs were similarly effective in lowering blood pressure (BP) (although significantly more enalapril patients required a diuretic) while maintaining quality of life. Apart from class-typical effects, such as oedema for calcium antagonists and cough for angiotensin-converting enzyme inhibitors, both drugs were equally well tolerated, with few adverse effects of clinical significance. Only a few patients (eight amlodipine (4%), nine enalapril (4%)) were withdrawn from the trial because of drug-related adverse events, demonstrating that the tolerability was good. Neutral to slightly beneficial effects were found in blood lipid concentrations after treatment with amlodipine. The BP reduction seen in the amlodipine patients after part 1 was maintained during part 2. Also, blood lipids and safety variables remained virtually constant. It is concluded that, at similar BP reduction, quality of life is equally well maintained on amlodipine and enalapril therapy. Thus, amlodipine compares favourably with enalapril as an effective and well-tolerated anti-hypertensive agent over the first year. Additionally, amlodipine patients evaluated over a 2-year extension maintained good BP control and the drug was well tolerated.

Objectives: This study was carried out to determine the effect of the once-daily calcium channel blocking agent amlodipine (half-life 35 to 50 h) on the circadian pattern of myocardial ischemia in patients with chronic stable angina., Background: Myocardial ischemia during normal daily life, both symptomatic and asymptomatic, has been associated with increased risk of cardiovascular morbidity and mortality, and the circadian pattern parallels that for myocardial infarction and sudden death., Methods: The Circadian Anti-Ischemia Program in Europe (CAPE) was a large, 10-week international (63 sites), double-blind, parallel study. After a 2-week, single-blind placebo phase, during which stable doses of antianginal treatment were maintained (beta-adrenergic blocking agents in 65% of patients), patients with chronic stable angina with at least three attacks of angina per week, with at least four ischemic episodes or > or = 20 min of ST segment depression in 48 h of Holter monitoring, were randomized to receive treatment with either 5 mg/day of amlodipine or placebo (2:1 randomization). The dose was increased to 10 mg/day after 4 weeks. During week 7 of treatment, 48-h ambulatory ECG monitoring was repeated., Results: Three hundred fifteen of 1,160 patients screened were eligible, and 250 had complete evaluable data. Compared with placebo, amlodipine significantly reduced both the frequency of ST segment depression episodes (60% for amlodipine vs. 44% for placebo, p = 0.025) and total integrated ST ischemic area (62% mm-min vs. 50% mm-min, p = 0.042). Amlodipine reduced ischemia over the 24 h with the intrinsic circadian pattern maintained. In addition, diary data showed a significant reduction in angina (70% for amlodipine vs. 44% for placebo, p = 0.0001) and in nitroglycerin consumption (67% vs. 22%, respectively, p = 0.0006). Amlodipine and placebo demonstrated similar safety profiles (adverse events 17.3% for amlodipine and 13.3% for placebo; discontinuation rates due to adverse events were 2% vs. 4.4%, respectively)., Conclusions: Once-daily amlodipine, when added to background treatment, significantly reduced both symptomatic and asymptomatic ischemic events over 24 h in patients with chronic stable angina.

The efficacy, tolerability and impact on quality of life of amlodipine and enalapril were compared in a multicentre, double-blind, general practice study in 461 mild and moderate hypertensives over a 50-week active treatment period. Amlodipine (5-10 mg, once daily) and enalapril (10-40 mg, once daily) were found to be similarly effective in lowering blood pressure while not adversely affecting quality-of-life parameters. However, 20% of the enalapril group compared with 11% of the amlodipine group required the addition of hydrochlorothiazide for blood pressure control (P < 0.01). Diastolic blood pressure was normalised or reduced by 10 mmHg in 204 (90%) patients on amlodipine and in 190 (85%) patients on enalapril. Side-effects were, in general, mild or of little clinical significance. The major side-effects recorded were class-typical of ACE inhibitors and calcium antagonists, namely cough (enalapril) and oedema (amlodipine), respectively. Tolerability was very good, with only 17 patients (8 amlodipine, 4%; 9 enalapril, 4%) being withdrawn from the study due to side-effects definitely related to treatment. Amlodipine monotherapy produced a slightly beneficial effect on blood lipid concentration, and both drugs reduced the calculated 10-year risk of coronary heart disease. It was concluded that the calcium antagonist amlodipine compared favourably with the ACE inhibitor enalapril in terms of antihypertensive efficacy, tolerability and impact on quality of life.

In this multicentre trial in general practice the effect of one year of therapy with amlodipine or enalapril on quality of life and blood pressure was studied in 461 hypertensive patients. Quality of life was evaluated by means of a questionnaire administered on five occasions during the study. A total of 125 questions were distributed between psychological general well-being, own perception of health, social relations, sexual and cognitive functioning, and a combined index for frequency and intensity of symptoms. Both drugs were equally effective in reducing blood pressure, from 162/106 to 142/91 mm Hg, and had the same effect on quality of life. Neither of the drugs reduced quality of life, and in some of the variables a slight improvement (2-5%) was observed. The two compounds were tolerated equally well. Apart from class-typical effects (coughing for enalapril and edema for amlodipine) no clinically significant side effects were experienced.

Objective: To compare tolerance, antihypertensive efficacy and impact on quality of life of amlodipine and enalapril in patients with mild or moderate hypertension., Design: Multicentre, double-blind, double-dummy, comparative trial in general practice. Three phases were conducted: 4 weeks on placebo, 12 weeks of dose adjustment (amlodipine or enalapril) and a 38-week maintenance period., Patients: Four hundred and sixty-one patients of both sexes were enrolled; 451 were available for efficacy evaluation at the end of the trial., Treatment: The patients were allocated to either amlodipine (231) or enalapril (230) treatment. If at the end of dose adjustment (amlodipine 5-10 mg/day, enalapril 10-40 mg/day) diastolic blood pressure was > or = 95 mmHg, hydrochlorothiazide (25-50 mg/day) was added (27 amlodipine patients and 45 enalapril patients)., Main Outcome Measures: Blood pressure changes after 1 year of treatment; between- and within-group changes in quality of life as assessed by psychological general well-being, social and sexual functioning, health-risk perception, alertness, behaviour, and impact of symptom and side effects., Results: Indices on quality of life were unchanged or increased (2-9%) in both groups. Blood pressure was normalized or reduced by > or = 10 mmHg in 204 (90%) and 190 (85%) patients on amlodipine and enalapril, respectively. Cough was the most frequently reported adverse event in the enalapril group (13%) and oedema in the amlodipine group (22%). Only eight (4%) patients on amlodipine and nine (4%) on enalapril were withdrawn because of drug-related adverse events., Conclusion: At similar blood pressure reduction in mild and moderate hypertension, quality of life is equally well maintained on amlodipine and enalapril therapy.

Amlodipine (5-10 mg, once daily) and enalapril (10-40 mg, once daily) were compared in terms of quality of life, efficacy, and tolerability, in a multicenter, double-blind trial lasting for 50 weeks in 461 mild or moderate hypertensive patients. Both drugs were similarly effective in lowering blood pressure while maintaining quality of life. Apart from class-typical effects, such as edema for calcium antagonists, and cough for angiotensin-converting enzyme inhibitors, both drugs were equally well tolerated, with few adverse effects of clinical significance. Only a few patients [eight amlodipine (4%); nine enalapril (4%)] were withdrawn from the trial due to drug-related adverse events, demonstrating that tolerability was good. Neutral to slightly beneficial effects were found in blood lipid concentrations after treatment with amlodipine. Both drugs reduced the calculated risk of coronary heart disease over the next 10 years. It was concluded that amlodipine compared favorably with enalapril as an effective and well-tolerated antihypertensive drug.