Combination therapy with colestipol and psyllium mucilloid in patients with hyperlipidemia.
OBJECTIVE
To test whether combining psyllium mucilloid with half the usual dose of colestipol reduces the adverse effects associated with colestipol and maintains or increases its efficacy in the treatment of hyperlipidemia. This strategy might make bile acid sequestrants, which are seldom used because they cause adverse effects such as bloating and constipation, more tolerable and less expensive.


METHODS
A randomized, parallel-group, double-blind, controlled trial.


METHODS
An outpatient clinic in a tertiary care hospital.


METHODS
121 patients who had moderate primary hypercholesterolemia (total cholesterol level > 6 mmol/L and < 8 mmol/L; triglyceride level < 3 mmol/L) after following a low-fat diet for 1 year (National Cholesterol Education Program Step Two diet).


METHODS
5 g of cellulose placebo; 5 g of colestipol; 2.5 g of colestipol plus 2.5 g of psyllium; or 5 g of psyllium three times daily before meals for 10 weeks.


METHODS
At baseline and at weeks 4 and 10, fasting blood lipid levels and apoprotein concentrations were measured and a quality-of-life instrument was completed.


RESULTS
A combination of 2.5 g of psyllium and 2.5 g of colestipol was better tolerated than and as effective as either 5 g of colestipol alone or 5 g of psyllium alone. The combination therapy and colestipol alone did not differ significantly with respect to changes in individual lipid values. The ratio of total cholesterol to high-density lipoprotein cholesterol (HDL) was reduced by 18.2% (95% CI, 12.3% to 24%) with the combination therapy; by 10.6% (CI, 2.0% to 15.4%) with colestipol alone; by 6.1% (CI, 1.5% to 10.6%) with psyllium alone; and by 0.1% (CI, -4.8% to 7%) with placebo (P = 0.0002). Combination therapy reduced the ratio of total cholesterol to HDL significantly more than did colestipol alone or psyllium alone (P < 0.05).


CONCLUSIONS
These findings suggest that adding psyllium to half the usual dose of bile acid sequestrant resins maintains the efficacy and improves the tolerability of these resins.
Spence
J D
JD
Victoria Hospital, Robarts Research Institute, London, Ontario, Canada.
Huff
M W
MW
Heidenheim
P
P
Viswanatha
A
A
Munoz
C
C
Lindsay
R
R
Wolfe
B
B
Mills
D
D
D000328:Adult; D000368:Aged; D001794:Blood Pressure / Q000502:physiology; D003084:Colestipol / Q000008:administration & dosage / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D016527:Drug Costs; D004359:Drug Therapy, Combination; D005260:Female; D006339:Heart Rate / Q000502:physiology; D006801:Humans; D006937:Hypercholesterolemia / Q000097:blood / Q000188:drug therapy* / Q000503:physiopathology; D008055:Lipids / Q000097:blood; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance; D011620:Psyllium / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use*; D011788:Quality of Life
D008055:Lipids; D011620:Psyllium; D003084:Colestipol