Patients and Methods
We randomly assigned 612 patients, aged 20 to 70 years, who met 1988 National Cholesterol Education Program guidelines for drug treatment of elevated LDL-C level and had not previously used cholesterol-lowering medication, to either a steppedcare regimen or initial therapy with lovastatin (both n=306). The study, conducted at Southern California Kaiser Permanente, was designed to approximate typical practice: provider compliance with treatment plans was encouraged but not enforced, and patients paid for medication as they customarily would.

Results
At 1 year, the decline in mean LDL-C level was significantly greater among patients assigned to initial treatment with lovastatin (22% vs 15% for stepped care; P<.001), as was the number who attained goal LDL-C level (4.14 mmol/L [160mg/dL],or3.36mmol/L [130mg/dL] if coronary heart disease or two or more risk factors were present) (40% vs 24%; P<.001). The increase in mean high-density lipoprotein cholesterol levels was significantly greater in the stepped-care group, however (8% vs 1% for lovastatin; P<.001). Patients who were randomized to stepped care were more likely to report substantial bother caused by side effects (30% vs 16% for lovastatin; P<.001) and discontinuation of therapy at 1 year (28% vs 18%, respectively; P<.01). Costs of care were $333 higher per patient in the lovastatin group ($786 vs $453; P<.001).

Conclusions
A stepped-care regimen beginning with niacin is less costly than initial therapy with lovastatin, but also less effective in lowering LDL-C level. While it is more effective in increasing high-density lipoprotein cholesterol levels, the tolerability of such a regimen may be a problem.

(Arch Intern Med. 1996;156:731-739)