CLAS Trial

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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]

Objective

To determine whether combined therapy with the lipid lowering agents colestipol hydrochloride (30g daily) plus niacin (3-12g daily) would produce significant change in coronary, carotid, and femoral artery atherosclerosis and coronary bypass graft lesions as determined by angiography. Also, to determine possible correlations between lesion changes and plasma lipid and lipoprotein cholesterol levels and to explore interrelationships of atherosclerosis change in femoral, coronary, and carotid arteries.

Methods

CLAS (Cholesterol Lowering Atherosclerosis Study) was a randomized, selectively blinded study wherein 188 men, with known previous coronary artery bypass grafts, were randomized to diet plus placebo or diet plus combined lipid lowering therapy consisting of colestipol and niacin and followed up at 2 years and 4 years.

Results

The following results were noted:[1]

  • Treatment group had a 37% raise in HDL-C levels and a 43% reduction in LDL-C levels.
  • Regression of atherosclerosis, as measured by angiography, was greater with combined drug treatment at 2 years and at 4 years.
  • Reduction in the percentage of subjects with new atheroma formation in native coronary arteries.
  • Significantly reduced percentage of subjects with new lesions or any adverse change in bypass grafts.
  • Atherosclerosis regression occurred in 16.2% of colestipol-niacin treated vs 2.4% placebo treated

Conclusion

The benefit of combined nicotinic acid and colestipol therapy was most prominent in patients with baseline plasma cholesterol levels above 240 mg/dL.[2][3][4][5]

References

  1. Blankenhorn DH, Nessim SA, Johnson RL, Sanmarco ME, Azen SP, Cashin-Hemphill L (1987). "Beneficial effects of combined colestipol-niacin therapy on coronary atherosclerosis and coronary venous bypass grafts". JAMA. 257 (23): 3233–40. PMID 3295315. Unknown parameter |month= ignored (help)
  2. Cashin-Hemphill L, Mack WJ, Pogoda JM, Sanmarco ME, Azen SP, Blankenhorn DH (1990). "Beneficial effects of colestipol-niacin on coronary atherosclerosis. A 4-year follow-up". JAMA. 264 (23): 3013–7. PMID 2243429. Unknown parameter |month= ignored (help)
  3. Azen SP, Mack WJ, Cashin-Hemphill L; et al. (1996). "Progression of coronary artery disease predicts clinical coronary events. Long-term follow-up from the Cholesterol Lowering Atherosclerosis Study". Circulation. 93 (1): 34–41. PMID 8616937. Unknown parameter |month= ignored (help)
  4. Blankenhorn DH, Johnson RL, Nessim SA, Azen SP, Sanmarco ME, Selzer RH (1987). "The Cholesterol Lowering Atherosclerosis Study (CLAS): design, methods, and baseline results". Control Clin Trials. 8 (4): 356–87. PMID 3327654. Unknown parameter |month= ignored (help)
  5. Blankenhorn DH, Azen SP, Crawford DW; et al. (1991). "Effects of colestipol-niacin therapy on human femoral atherosclerosis". Circulation. 83 (2): 438–47. PMID 1991366. Unknown parameter |month= ignored (help)