Effectiveness of Colestipol Tablets vs Granules in Patients with Moderate to Severe Hypercholesterolaemia

Summary

This study compared a new tablet form of colestipol with colestipol granules in patients with moderate to severe hypercholesterolaemia, in a double-blind, double-dummy, randomised multicentre trial conducted at hospital medical or lipid clinics. The subjects, 102 men and 93 women with serum low density lipoprotein (LDL) levels ≥ 4.3 mmol/L and triglyceride levels ≤ 3.0 mmol/L, followed a diet equivalent to the American Heart Association step I diet for 8 weeks. They were subsequently randomised to twice-daily 4g doses of colestipol tablets and 2 packets of placebo granules or to 2 packets of colestipol granules (4g twice daily) and placebo tablets for 8 weeks. The main outcome measures were lipid levels, compliance and adverse effects. Reductions in LDL cholesterol levels of 17.4% in the tablet group and 18.6% in the granules group were highly statistically significant (p = 0.0001), and did not differ between the tablet and granules groups. Increases in levels of triglycerides and high density lipoprotein cholesterol were small, not statistically significant and similar in both groups. Compliance was 89.4% in the tablet group and 87.3% in the granules group. Mild gastrointestinal adverse effects were frequent (> 50%) and similarly prevalent in both groups, but serious gastrointestinal adverse effects, such as obstruction, did not occur. This study demonstrated that low-dose colestipol tablets are as effective and safe as colestipol granules during short term treatment of moderate to severe hypercholesterolaemia.