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Clinical trials in cardiovascular medicine: are we looking for statistical significance or clinical relevance?
R Willenheimera, B Dahlöfb, A Gordonc
a Department of
Cardiology, Malmö University Hospital, S-20502 Malmö, Sweden, b Clinical Research
Institute, Göteborg University, Göteborg, Sweden, c Department of Cardiology, Huddinge Hospital,
Karolinska Institute, Stockholm, Sweden
Correspondence to: Dr Willenheimer email: ronnie.willenheimer@medforsk.mas.lu.se
| The first 150 words of the full text of this article appear below. |
 |
Introduction |
|---|
During
the last two decades several large clinical trials have documented
beneficial effects of different pharmacological interventions on
morbidity and mortality in various cardiovascular conditions. Based on
the results of these trials physicians in general feel convinced that
there is a considerable reduction of mortality and morbidity as a
result of treatment with: (a) 
receptor blockers in patients with
acute myocardial infarction as well as in the postinfarction period;
(b) acetylsalicylic acid (ASA; aspirin) and thrombolytic drugs in
patients with acute myocardial infarction; (c) angiotensin converting
enzyme (ACE) inhibitors in patients with left ventricular systolic
dysfunction irrespective of symptoms of heart failure and, as recently
shown in the HOPE study, in patients with high cardiovascular risk but
without heart failure or obvious left ventricular systolic dysfunction;
(d) receptor blockers and spironolactone in addition to an ACE
inhibitor in patients with chronic heart failure; (e) diuretics, receptor blockers, calcium channel blockers,
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