The Pharmaceutical Journal Vol 267 No 7169 p506-509
13 October 2001

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Trials

Further insights into CURE study

From Dr M. Flather and Dr A. Bakhai

Some reservations have been raised in The Pharmaceutical Journal regarding the impact of the CURE trial and the cost effectiveness of clopidogrel in combination with aspirin (PJ, 25 August, p253). We would like to provide the following additional commentary.

The CURE study was powered to look at the difference in combined event rate of cardiac death, stroke and myocardial infarction. This outcome was significant with a p value of 0.00005. Using the absolute differences the number needed to treat to avoid one such event is 1 in 48. The trial was not powered to determine a difference in cardiac deaths alone.

If the conservative estimate for the number of acute coronary syndrome admissions in the UK alone is 120,000 then we would be avoiding between 3,000 and 10,000 deaths, strokes and myocardial infarctions with the addition of clopidogrel. This represents a considerable achievement and the reduction in the use of resources from this effect is substantial. Also, in the CURE trial there was a positive crossover from the placebo arm to the treatment arm for a large proportion of patients having coronary procedures. These patients all had open label clopidogrel for two to four weeks. This positive cross-over will considerably underestimate the benefits of the combination treatment and more importantly will select out the high risk patients in whom the treatment would have shown even higher benefits.

With respect to bleeding, for every 1,000 patients that would be treated with the combination, six would require blood transfusions and there was no increase in bleeds that would result in strokes, surgery or permanent disability, and is in keeping with the risk of aspirin itself.

Cost has been raised as a significant issue but the comments made so far provide only the cost of therapy and do not include the offsets from the benefits of treatment and a formal cost-effectiveness analysis is due to be presented shortly at AHA 2001. We anticipate that the cost-effectiveness of this therapy is considerably below that for the standard benchmark of the cost of dialysis treatment for one year in a patient with end stage renal failure.

Furthermore, there are a number of other benefits for clopidogrel that would reduce resource consumption such as the reduction in emergency operations and procedures, and the significant reduction in the complications of heart failure and intractable anginal pain while in hospital. For this group of patients being admitted with a suspected heart attack or severe angina, the addition of an effective, once a day, safe and affordable tablet represents a major breakthrough not matched since the use of aspirin in the 1980s.

Dr Marcus Flather
Director,
Clinical Trials and Evaluation Unit

Dr Ameet Bakhai
Senior Research Fellow,
Clinical Trials and Evaluation Unit,
Royal Brompton Hospital

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