In a double-blind, randomized, placebo-controlled study comparing verapamil and placebo in late secondary intervention after acute myocardial infarction, the physicians were asked to try to identify the treatment in 100 consecutive patients. The assessment of the presumed treatment was based upon the presence of effects and side effects. It was only possible correctly to group 36% (95%: 26.7-46.2) of the patients. 35 patients were grouped as indeterminable. In 65 a treatment was proposed, correctly in 55%, and thus ideal blindedness had been achieved.
The effect of verapamil on major events in patients with impaired cardiac function recovering from acute myocardial infarction. The Danish Study Group on Verapamil in Myocardial Infarction.
In the Danish Verapamil Infarction Trial II (DAVIT II) intervention with verapamil significantly decreased the first major event rate (i.e. reinfarction or death) in patients recovering from acute myocardial infarction. As calcium channel antagonists might have a detrimental effect in patients with heart failure, the effect of verapamil on major events in patients with and without impaired left ventricular function was analysed. Eight hundred and seventy-eight patients were randomized to verapamil 120 mg t.i.d. and 897 to placebo. Patients were followed up to 18 months. The endpoint was the first major event while on trial medication. In patients treated for heart failure during the acute phase of myocardial infarction, the lowest 18-month event rate was seen in the verapamil group (21.2% vs 22.2%) (absolute numbers: events/patients verapamil 47/291; placebo 60/323) (ns). Similarly, in patients treated with diuretics at randomization, the lowest 18-month event rate was seen in those randomized to verapamil (22.4 vs 24.3%) (absolute numbers: events/patients verapamil 57/349; placebo 76/375 (ns). When patients were subdivided according to New York Heart Association functional classes, verapamil reduced the event rate in all classes, but none of these differences was statistically significant. In patients without heart failure during the acute phase and in patients without diuretic treatment at randomization, treatment with verapamil caused a significant reduction in major events (hazard ratio (95% confidence limits): 0.66 (0.47, 0.92); 0.66 (0.45, 0.96) respectively). Long-term treatment with verapamil after acute myocardial infarction caused a significant reduction in major events.(ABSTRACT TRUNCATED AT 250 WORDS)
Effect of verapamil on reinfarction and cardiovascular events in patients with arterial hypertension included in the Danish Verapamil Infarction Trial II. The Danish Study Group on Verapamil in Myocardial Infarction.
An increased incidence of reinfarction and cardiovascular events has been reported in patients with hypertension recovering from acute myocardial infarction. We studied the effect of intervention with verapamil on the development of myocardial infarction and cardiovascular events in 301 patients with hypertension enrolled in the Danish Verapamil Infarction Trial II. During the second week after the index infarct, patients were randomly assigned to treatment with verapamil 360 mg per day (n = 149) or placebo (n = 152) and followed-up to 18 months (mean 16 months). The 18 months first reinfarction rates were 12.5% in verapamil and 19.8% in placebo treated patients (hazard ratio 0.53, 95% confidence limits 0.28-1.00, P = 0.04). The first cardiovascular event rates were 21.8% in the verapamil and 29.3% in the placebo group (hazard ratio 0.66, 95% confidence limits 0.41-1.06, P = 0.07). In this retrospective analysis of patients with hypertension included in the Danish Verapamil Infarction Trial II, intervention with verapamil reduced cardiovascular events primarily due to a substantial reduction in reinfarctions.
Rigshospitalet, Copenhagen University Hospital and Institute of Preventive Medicine, The Copenhagen Trial Unit, Center for Clinical Intervention Research, Copenhagen, Denmark.
To elucidate potential mechanisms for the clarithromycin-induced excess mortality observed in the CLARICOR trial during 2.6 year follow-up of patients with stable coronary artery disease.
Cox analyses using out-of-hospital death as a proxy for sudden death compared to in-hospital (nonsudden) death.
In 100 of 189 (53%) cardiovascular (CV) deaths in which it was possible to examine the question, there was a strong association between place of death and the classification of CV death as sudden or not-sudden. The excess mortality in the clarithromycin group was confined to sudden CV death in patients not on statins at trial entry (HR: 2.61, 95% CI: 1.69-4.05, p
A first-aid station was established at the Midtfyn Music Festival in 1988. A total of 174 patients were treated. The diseases and casualties are described according to numbers, distribution, course and causes. Orthopaedic casualties constituted approximately 60%, sprains, infections, contusions and open wounds being the commonest. Respiratory diseases were the commonest conditions among the non-orthopaedic conditions. Treatment could be completed in approximately 60% of the cases. Most of the casualties were caused by broken glass, deliberate violence or failure to comply with maintenance medication. Various suggestions are made to reduce the number of casualties.
In clinical trials, agreement on outcomes is of utmost importance for valid estimation of intervention effects. As there is limited knowledge about adjudicator agreement in cardiology, we examined the level of agreement among three cardiology specialists adjudicating all possible events in a randomized controlled clinical trial of patients with stable coronary heart disease.
All information (hospital records, death certificates, etc.) was forwarded to two randomly selected blinded adjudicators. If they disagreed, the third arbiter had to choose the more likely of the two alternatives. Files of 5,475 nonfatal and 362 fatal events were evaluated.
For nonfatal outcomes, pairwise kappa values ranged from 0.75 to 0.80. The three adjudicators had 4.3%, 9.5%, and 6.1% of their nonfatal outcome classifications overruled by their arbiter. If stable angina pectoris, unstable angina pectoris, and acute myocardial infarction were treated as one, agreement increased minimally. For fatal outcomes, the pairwise kappa values ranged from 0.65 to 0.90. The three adjudicators had 12%, 9%, and 10% of their death classifications overruled.
Specialists in cardiology can attain a reasonably high agreement on outcomes in patients with stable coronary heart disease.
High-sensitivity C-reactive protein and N-terminal pro-B-type natriuretic peptide in patients with stable coronary artery disease: a prognostic study within the CLARICOR trial.
Patients with stable coronary artery disease (CAD) have a poor prognosis. The aim of the study was to evaluate the extent to which serum high-sensitivity C-reactive protein (hs-CRP) and N-terminal pro-B-type natriuretic peptide (NT-proBNP) measurement alone or together could be prognostic biomarkers in patients with stable CAD.
During the 2.6-year follow-up period 270 patients among the 4264 patients with stable CAD in the CLARICOR trial suffered myocardial infarction (MI) and 377 died (187 cardiovascular deaths (CVD)).
Serum NT-proBNP was significantly associated with MI (hazard ratio (HR), 1. 65 (refers to a 2.72 fold increase in serum level, p = 0.0005), CVD (HR, 2.42, p
BACKGROUND: Angina pectoris accompanied by transient ST-segment changes during the in-hospital phase of acute myocardial infarction (AMI) is a well established marker of subsequent cardiac death and reinfarction. HYPOTHESIS: This study was undertaken to record the prognostic significance of angina pectoris experienced during the first month following discharge from AMI. METHODS: In all, 803 patients included in the placebo arm of the Danish Verapamil Infarction Trial II were followed up for 18 months in 20 coronary care units in Denmark. The patients were randomized to placebo and were still on study treatment 1 month after discharge. Of these patients, 311 (39%) reported chest pain during the first month following discharge. RESULTS: Patients with angina pectoris had a significantly increased risk of reinfarction [hazard 1.71; 95%-confidence limit (CL): 1.09, 2.69] and increased mortality risk which, however, only reached borderline statistical significance (hazard 1.52; 95%-CL: 0.96, 2.40). When patients were subdivided according to both angina pectoris and heart failure, those with one or both of these risk markers had significantly increased mortality (p 0.03) and reinfarction (p 0.02) rates compared with patients free of both angina pectoris and heart failure. CONCLUSION: Patients with postinfarction angina pectoris have a significantly increased morbidity risk.
The prognostic significance of post-infarction angina pectoris and the effect of verapamil on the incidence of angina pectoris and prognosis. The Danish Study Group on Verapamil in Myocardial Infarction.
The prognostic significance of angina pectoris and the effect of intervention with verapamil on the incidence of angina pectoris were studied in patients recovering from myocardial infarction and included in the Danish Verapamil Infarction Trial II. During the second week after admission patients were doubly-blindly randomized to treatment with verapamil 360 mg.day-1 or placebo. Treatment was continued for up to 18 months. At discharge angina pectoris was reported in 11% of 869 patients randomized to verapamil and in 12% of 888 randomized to placebo (ns). One month after discharge a significant increase in the prevalance of angina pectoris was reported in both the verapamil (33%) (P
