CHANGES IN CARDIOVASCULAR RISK-FACTORS BY COMBINED PHARMACOLOGICAL AND NONPHARMACOLOGICAL STRATEGIES - THE MAIN RESULTS OF THE CELL STUDY

Objective. The objectives of the Cost Effectiveness of Lipid Lowering (CELL) study were twofold: (i) to evaluate the effect on overall cardi ovascular risk of two types of health care advice ('usual' and 'intens ive') given in primary care, with or without pharmacological medicatio n, with the target being to attain a moderate decrease in cholesterol; (ii) to evaluate the ritual of daily medication on compliance with th e health care advice. Design. A prospective, double-blind, randomized, controlled trial of 18 months' duration. Setting, The study was carri ed out in 32 health centres (out of a total of approximately 850) in S weden. Subjects. In all, 681 subjects, aged 30-59 years, were randomiz ed. They had at least two cardiovascular risk factors in addition to m oderate primary hyperlipidaemia (total cholesterol of at least 6.50 mm ol L(-1) on three occasions measured by Reflotron, triglycerides less than 4.0 mmol L(-1) and an LDL:HDL cholesterol ratio of more than 4.0) . Most (87%) of the subjects were males; 626 subjects (92%) completed the 18-month follow-up. Intervention: Half the subjects were randomize d to 'intensive advice' given in group sessions led by doctors and nur ses in primary care. The other half received 'usual advice'. In each o f the two advice groups, one-third received an active lipid-lowering d rug (pravastatin), one-third placebo, and one-third no drug at all. Th e tablets were titrated to achieve a 15% reduction in cholesterol. Mai n outcome measures. Changes in the overall framingham risk score, and the development of adverse events in each group. Results. The change i n Framingham risk score was significantly reduced only in subjects tak ing lipid-lowering medication (together with intensive advice -0.13; 9 5% CI -0.20,-0.06, and together with usual advice -0.16; 95% CI -0.23, -0.09). The other subjects receiving intensive advice tended to fare b etter than those on usual advice. Lifestyle was not influenced signifi cantly over the study period. The ritual of daily medication did not a ffect the outcome. Conclusion. As expected, lipid-lowering medication reduced serum cholesterol as well as overall cardiovascular risk in su bjects with several risk factors for cardiovascular disease. There was no additive effect of intensive advice to these subjects. However, th ere was a meagre but significant effect of intensive advice in subject s not receiving active lipid-lowering drugs. One explanation for this difference may be that those on active lipid-lowering medication who h ad substantial drops in cholesterol might have felt less inclined to c hange their lifestyle compared with those on other treatment regimens who had less successful drops in cholesterol. There was no benefit fro m the ritual of taking daily medication.