Nifedipine therapy for patients with threatened and acute myocardial infarction: a randomized, double-blind, placebo-controlled comparison.

Muller, James E.; Morrison, John; Stone, Peter H.; Rude, Robert E.; Rosner, B.; Roberts, Robert; Pearle, David L.; Turi, Zoltan G.; Schneider, Jingjing; Serfas, D H

doi:10.1161/01.cir.69.4.740

Cited by 247 publications

(38 citation statements)

References 51 publications

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“…Nifedipine might be expected to be of benefit in limiting infarct size in these patients, but a study of nifedipine therapy for threatened and acute myocardial infarction conducted in parallel with the present study did not show such a beneficial effect. 39 The lack of benefit in the infarction study could have been due to a delay in initiation of therapy (mean interval from onset of pain to treatment, 4.6 + 0.1 hr), which would not occur in the unstable angina setting. However, the number of patients with infarction in the unstable angina study is far too small to detect a beneficial effect, if present.…”

Section: Discussionmentioning

confidence: 99%

Nifedipine and conventional therapy for unstable angina pectoris: a randomized, double-blind comparison.

Muller¹,

Turi²,

Pearle³

et al. 1984

Circulation

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142

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To characterize the potential of nifedipine in the therapy of unstable angina pectoris we implemented a blinded, randomly assigned, titrated schedule of conventional therapy (propranolol, if not contraindicated, and isosorbide dinitrate) or nifedipine for 14 days in 126 patients hospitalized in a coronary care unit for ischemic chest pain of less than 45 min duration. There were no significant differences between conventionally and nifedipine-treated patients with regard to (1) the time to relief of pain as judged by life table analysis, (2) the decrease in anginal attacks per 24 hr from day 0 to day 2 ( -2.5 + 0.4 for conventional therapy vs; -2.8 + 0.3 for nifedipine), (3) the decrease in the number of nitroglycerin tablets consumed per 24 hr ( -2.0 ± 0.5 for conventional vs -2.1 ± 0.4 for nifedipine therapy), (4) the percentage of patients requiring morphine on day 1 (1 3% for conventional vs 21 % for nifedipine therapy), or (5) the percentage of patients who developed infarction (1 4% in both groups). Among the 27 patients who did not respond to initial conventional (n = 13) or nifedipine therapy (n = 14), five in each group became pain free when the opposite therapy (either nifedipine or conventional therapy) was added. In the subgroup of 67 patients who were receiving propranolol before randomization, addition of nifedipine was more effective in controlling pain than was an increase in conventional therapy (p = .026). In the subgroup of 59 patients not receiving prior propranolol, initiation of conventional therapy produced more rapid pain relief than initiation of nifedipine therapy alone (p < .001), which tended to increase heart rate. Thus, for the study population as a whole therapy with nifedipine alone was equivalent to conventional therapy for unstable angina, although this overall equivalence may result from a combination of superiority of nifedipine therapy in patients previously receiving ,/-blocker therapy and superiority of /3-blocker therapy in patients not previously receiving ,3-blockers. Circulation 69, No. 4, 728-739, 1984. UNSTABLE ANGINA, a syndrome intermediate in severity between stable angina pectoris and acute myocardial infarction, is well recognized. Heberden,' in his classic description of angina pectoris, noted that in some cases the pain occurred in patients at rest. Her-

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Section: Discussionmentioning

confidence: 99%

Nifedipine and conventional therapy for unstable angina pectoris: a randomized, double-blind comparison.

Muller¹,

Turi²,

Pearle³

et al. 1984

Circulation

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142

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“…28 In 1436 patients with AMI randomly assigned to verapamil or placebo, there was no effect of the drug on 6 month survival and infarct size was also similar in a subgroup of 100 patients in whom it was assessed by serial creatine kinase analysis. 29 In a recent double-blind study, Muller et al 30 investigated the effects of nifedipine in 191 patients with threatened or established AMI. Their dosage of nifedipine was larger than that in the present study, but the effects on infarct size and 6 month mortality were similar.…”

Section: Discussionmentioning

confidence: 99%

“…A patient was considered to be included in the trial when he or she took the first capsule sublingually. Subsequent doses were 10 mg orally and were begun 30 min after the first dose unless systolic blood pressure was below 90 mm Hg. For the first 2 days 10 mg was given five Estimation of sample size.…”

mentioning

confidence: 99%

Evolution of infarct size during the early use of nifedipine in patients with acute myocardial infarction: the Norwegian Nifedipine Multicenter Trial.

Sirnes¹,

Overskeid²,

Pedersen³

et al. 1984

Circulation

130

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In a multicenter double-blind study, 227 THE CALCIUM ANTAGONIST nifedipine has been shown during the last decade to be effective in the treatment of angina pectoris' and more recently in the treatment of hypertension2 and heart failure.3 A cardioprotective effect of nifedipine has also been demonstrated after experimental coronary occlusion.4 6 There are several reasons why nifedipine might limit myocardial damage in patients with acute myocardial infarction (AMI). By reducing systemic vascular resistance, nifedipine might improve left ventricular unloading and reduce left ventricular workload.7 Dilatation of coronary arteries9 10 might enhance collateral flow to the ischemic region and possibly restore blood flow in situations in which spasm contributes to the ischemia. " Furthermore, nifedipine might inhibit detrimental cellular uptake of Ca ++ during ischemia. 2 This trial was primarily designed to investigate MethodsPatient selection and recruitment. All patients who were admitted to the four participating hospitals with suspected AMI during the trial period (885 patients) were screened for inclusion. Inclusion criteria were (1) severe central chest pain for at least 30 min, continuing on admission or until an analgesic was given, or (2) electrocardiographic changes suggesting an AMI (not previously recognized ST segment elevation >0.2 mV in precordial leads or >0.1 mV in extremity leads, or a Q wave >-0.04 sec that had not been previously recognized). These inclusion criteria were fulfilled by 623 patients, 396 (64%) of whom were excluded (table 1).Allocation and treatment. After informed consent was obtained, eligible patients of both sexes were randomly assigned to treatment with either nifedipine (10 mg capsules) or placebo. Patients at each center were assigned in blocks of 10 and given capsules from prenumbered bottles. A patient was considered to be included in the trial when he or she took the first capsule sublingually. Subsequent doses were 10 mg orally and were begun 30 min after the first dose unless systolic blood pressure was below 90 mm Hg. For the first 2 days 10 mg was given five CIRCULATION

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“…In our retrospective data base,1' patients meeting the age and extent score criteria listed in Table 1 had an 80% probability of coronary disease progression in 2-4 years. Thus, these criteria Placebo (n = 191) 50.0+8.4 157 (82) 61 (32) 3 (1.6) 135 (71) 46 (24) (26) 32 (17) 90 (47) 60 (31) 9 (4.7) 6.98 +1.47 1.05+0.26 114 (60) 10 (5.2) 29 (15) 4 (2.1) 28 (15) 14 (7.3) 35 (18) 54 (28) 73 (38) 29 (15) 30.6±38. 6 97 (25) 65 (17) 160 (42) 146 (38) (16) 21 (5.5) 56 (15) 108 (28) 146 (38) 73 (19) …”

Section: Patient Selectionmentioning

confidence: 99%

A controlled clinical trial to assess the effect of a calcium channel blocker on the progression of coronary atherosclerosis.

et al. 1990

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To determine whether calcium channel blockers influence the progression of coronary atherosclerosis, 383 patients age 65 years or less with 5-75% stenoses in at least four coronary artery segments were selected at random within 1 Ninety-two nicardipine patients (55%) and 95 placebo patients (57%) had progression at one or more sites (p=NS). Regression, that is, an improvement by l1o0 or more in diameter stenosis, was seen in 140 of 2,323 lesions (6.0%) overall, with no significant intergroup difference. Among the 217 patients with 411 stenoses of 20% or less in the first study, such minimal lesions progressed in only 15 of 99 nicardipine patients compared with 32 of 118 placebo patients (15% versus 27%, p =0.046). In this subgroup, 16 of 178 minimal lesions in nicardipine patients and 38 of 233 minimal lesions in placebo patients progressed (p=0.038). By stepwise logisticregression analysis, baseline systolic blood pressure (p=0.04) and the change in systolic blood pressure between baseline and 6 months (p=0.002) correlated with progression of minimal lesions. This suggested blood pressure reduction may account for the beneficial action of nicardipine. These results suggested nicardipine has no effect on advanced coronary atherosclerosis but may retard the progression of minimal lesions. (Circulation 1990;82:1940-1953 Several calcium channel blockers have been shown to retard the development of athero-1, sclerosis in rabbits fed cholesterol-rich diets.1-7 The mechanism through which these drugs exert their antiatherogenic effects is not known, but is being From the

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Nifedipine therapy for patients with threatened and acute myocardial infarction: a randomized, double-blind, placebo-controlled comparison.

Cited by 247 publications

References 51 publications

Nifedipine and conventional therapy for unstable angina pectoris: a randomized, double-blind comparison.

Nifedipine and conventional therapy for unstable angina pectoris: a randomized, double-blind comparison.

Evolution of infarct size during the early use of nifedipine in patients with acute myocardial infarction: the Norwegian Nifedipine Multicenter Trial.

A controlled clinical trial to assess the effect of a calcium channel blocker on the progression of coronary atherosclerosis.

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