Soluble-fiber breakfast cereals were examined for their cholesterol-lowering ability in 58 male patients with mild to moderate hypercholesterolemia in a randomized, double-blind, placebo-controlled study. Patients followed a step 1 diet for a minimum of 6 wk, then were randomly assigned to groups incorporating either corn flakes or one of two soluble-fiber cereals (pectin enriched or psyllium enriched) in the diet for an additional 6 wk. During the diet-only phase, total cholesterol dropped 3.8%. During the cereal-plus-diet phase, total and LDL cholesterol values of the pectin-enriched cereal group dropped an additional 2.1% (P = 0.243) and 3.9% (P = 0.16), respectively, and they dropped 5.9% (P = 0.005) and 5.7% (P = 0.034), respectively, in the psyllium-enriched cereal group. During the cereal-plus-diet phase, no significant effects on HDL cholesterol, triglyceride, or body weight were found within or between any cereal groups. These results support use of soluble-fiber cereals as an effective and well-tolerated part of a prudent diet in the treatment of mild to moderate hypercholesterolemia.

This article presents an overview of the process and organisational aspects required to support the collection of pharmacoeconomic (PE) data during phase II and phase III clinical trials of pharmaceutical products. The process described requires early involvement of the PE study team in clinical trials design and planning, as well as continuing close collaboration between the PE study team and the clinical study team as the data collection plans are implemented. Adequate resources must be made available for staffing and funding the PE component of data collection and analysis. If the suggested procedures are adequately resourced and implemented, the result should be a comprehensive, complete and accurate database that will allow the PE study team to characterise the economic value of the new drug at the same time as the clinical study team characterise its safety and efficacy. Integrated clinical and economic evaluations are essential for the appropriate use of pharmaceutical products in rapidly changing markets.

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Psyllium hydrophilic mucilloid was examined for its ability to lower serum cholesterol levels in hypercholesterolemic patients. Seventy-five patients with mild to moderate hypercholesterolemia were evaluated in this randomized, double-blind, placebo-controlled parallel study. Patients were treated with a Step I diet for 12 weeks before receiving placebo or 3.4 g of psyllium (equivalent to 1 teaspoon) three times per day for 8 weeks. Compared with placebo, psyllium achieved an additional 4.8% reduction in total cholesterol level, 8.2% reduction in low-density lipoprotein cholesterol level, and 8.8% reduction in apolipoprotein B level. Psyllium did not significantly affect blood pressure or levels of high-density cholesterol, triglycerides, serum glucose, or iron. Reported adherence to diet and treatment was excellent, and no significant adverse side effects were noted. These results indicate psyllium hydrophilic mucilloid is an effective and well-tolerated adjunct to diet in the management of mild to moderate hypercholesterolemia.

We present the prospective economic evaluation that served as a secondary endpoint for the FIRST study, a randomized international multicenter trial of patients with severe congestive heart failure. Although the clinical results of this study were disappointing, we demonstrated the feasibility of incorporating prospective economic evaluation in phase III clinical trials.