Safety of nifedipine GITS in stable angina: The ACTION trial

Aim: We describe the safety profile of nifedipine GITS as assessed from adverse events reported in the ACTION trial in which 7,665 patients with stable, symptomatic coronary artery disease were randomly assigned nifedipine GITS or placebo and followed for a mean of 4.9 years. Methods: All adverse events were coded using the COSTART coding dictionary. The incidence rate for each event was calculated as the number of patients with the event concerned divided by the total time 'at risk'. Hazard ratios comparing nifedipine with placebo and their 95% confidence intervals were obtained by Cox proportional-hazards analysis. Results: As reported previously, nifedipine significantly reduced the incidence of cardiovascular events and procedures [hazard ratio (HR) 0.89, 95% confidence interval (CI) 0.83-0.95]. Apart from the known side effects of nifedipine, which include peripheral oedema, vasodilatation, hypotension, asthenia, constipation, leg cramps, non-specific respiratory complaints, impotence and polyuria, and which were reported more frequently in patients assigned nifedipine, the incidence rates of most other adverse events were similar. There were no differences in the occurrence of gastrointestinal haemorrhage, myocardial infarction and suicide. The rate of occurrence of death or new cancer excluding non-melanoma skin cancer for patients with no history of cancer at baseline was 2.53/100 patient years for patients assigned nifedipine and 2.37/100 patient years for patients assigned placebo (HR 1.06, 95% CI 0.93-1.22). Conclusion: Overall nifedipine GITS was well tolerated by patients with stable symptomatic angina

Comparison of costs of percutaneous transluminal coronary angioplasty and coronary bypass surgery for patients with angina pectoris

To determine the costs of a procedure, the total costs of the department that provides the service must be considered and, in addition, the direct cost of the specific procedure. Applying this principle to the cost accounting of angioplasty and bypass surgery results in a direct, i.e. procedural, cost, including the initial hospital stay, of respectively 8694 Dfl and 20,987 Dfl. A review of the follow-up data for the first year after the original intervention revealed a 2% reintervention rate for bypass surgery, while this percentage was 29% for angioplasty. Adding the first year costs involved with reinterventions to the procedural costs results in a 1-year cost of angioplasty and bypass operation of 13,625 Dfl and 21,363 Dfl, respectively. It is concluded that because of reinterventions in the first year, a mark up of 57% on the procedural cost of angioplasty must be added to cover 1-year costs, while for bypass surgery this is only 1%. Nevertheless, the 1-year cost for angioplasty is still 36% less than for bypass surgery. As reinterventions after PTCA may stay considerably higher than for CABG for several years, the mark-up per

Cost benefit analysis of early thrombolytic treatment with intracoronary streptokinase

The costs and benefits of early thrombolytic treatment with intracoronary streptokinase in acute myocardial infarction were compared in a randomised trial. All hospital admissions were recorded and the functional class was assessed at visits to the outpatient clinic during a 12 month follow up of 269 patients allocated to thrombolytic treatment and of 264 allocated to conventional treatment. Mean survival during the first year was calculated for patients with inferior and with anterior infarction and adjusted for impaired quality of life in cases where there were symptoms or hospital admission. In patients with inferior infarction mean survival was 337 days (out of a total follow up of 365 days) for patients allocated to thrombolytic treatment and 327 days for controls. Quality adjusted survival was seven days longer in the thrombolysis group (307 vs 300 days in controls). In patients with anterior infarction mean survival was significantly longer (35 days) in the thrombolysis group than in the control group as was quality adjusted survival (38 days) (304 vs 266 days in controls). The gain in life expectancy with thrombolytic treatment was 0.7 years for patients with inferior infarction, 2.4 years for patients with anterior infarction, and 3.6 years for the subset of patients with large anterior infarction who were admitted within two hours of the onset of symptoms.(ABSTRACT TRUNCATED AT 250 WORDS