Abstract
This paper is a review of the scientific and economic (when possible) impact of 15 randomized clinical trials of lipid intervention for atherosclerotic cardiovascular disease. No effort has been made to be all-inclusive and certain smaller and first generation studies have been omitted. No effort has been made to offer detailed analyses of protocols; we have limited discussion to summaries of the salient features of each study presented. After stating the data, we introduce certain reflections and raise some of the more obvious questions that emerge.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 271-283 |
| Number of pages | 13 |
| Journal | Controlled clinical trials |
| Volume | 3 |
| Issue number | 3 |
| DOIs | |
| State | Published - Sep 1982 |
Bibliographical note
Funding Information:9. Is rigid, recurrent peer review and investigator-initiated grants a proper mechanism for the funding of intervention trials or should such under-takings be given a protected, privileged status under contract and overall NIH control?
Funding Information:
POSCH is an investigator-initiated randomized secondary prevention clinical trial funded by a grant from the National Heart, Lung, and Blood Institute \[18\].I nitial work (pilot phase) began in 1973. There are a total of four clinical centers, with one centralized lipid lab. All support facilities are located at the University of Minnesota, the originating center. One thousand subjects are planned for the trial; the trial is still in the recruitment phase. Subjects are male and female volunteers, between the ages of 30 and 64 years, who have sustained one (and only one) documented myocardial infarction within the preceding five years, and who have serum cholesterol levels of 220 mg/100 ml or greater or low density lipoprotein cholesterol levels of at least 140 mg/ 100 ml if the serum cholesterol level is between 200 and 219 mg/100 ml. Subjects are not accepted into the trial with secondary hyperlipidemia; individuals with hypertension, diabetes, obesity, and other major diseases are excluded. The mode of intervention is partial ileal bypass, a surgical procedure designed to lower circulating blood cholesterol levels by an average of 40% and provide essentially obligatory intervention protocol adherence, i.e., minimal dropout from treatment. Up to 500 subjects will be randomized to the control group and up to 500 subjects will be randomized to the surgical intervention group; all subjects are to be followed a minimum of 5 years. The primary end point of the trial is death from all causes; secondary end points are fatal and nonfatal myocardial infarction, serial coronary arteriography changes, doppler assessment of peripheral occlusive disease, and new ECG abnormalities. Although the trial is still in progress, the reported serum cholesterol reduction in the surgical group at three years is 31% \[19,20\].S ignif-icantly, the LDL-cholesterol fraction is reduced 44% at three years (p ~ 0.05) and there was a net 10% difference in the HDL-cholesterol between the surgery (-1.1%) and the control (-11.1%) groups. This trial is scheduled for completion in 1988.
Keywords
- atherosclerotic cardiovascular disease
- lipid intervention
- randomized clinical trials
