Guggulipid for the Treatment of Hypercholesterolemia - Guggulipid for the Treatment of Hypercholesterolemia

Description:

The goal of the trial was to evaluate the safety and efficacy of two doses of guggulipid, an herbal extract, compared with placebo for lipid-lowering therapy in patients with hypercholesterolemia.

Hypothesis:

Treatment with the herbal extract guggulipid would be associated with a reduction in low-density lipoprotein cholesterol (LDL-C) levels at eight weeks compared with placebo in patients with hypercholesterolemia.

Study Design

Study Design:

Patients Screened: 163
Patients Enrolled: 103
Mean Follow Up: 8 weeks
Mean Patient Age: mean age 51.5 years
Female: 49%

Patient Populations:

Age >18 years, LDL-C 130-200 mg/dl, and fasting triglycerides <400 mg/dl

Exclusions:

History of clinical cardiovascular disease, diabetes, untreated thyroid disorder, liver function test abnormalities, renal insufficiency, pregnant or lactating women, or use of lipid-lowering medication or dietary supplements in prior 30 days

Primary Endpoints:

Percent change from baseline in LDL-C at eight weeks

Secondary Endpoints:

Percent change from baseline in total cholesterol, HDL-C, very LDL-C, and triglycerides at four and eight weeks

Drug/Procedures Used:

Patients were randomized to standard-dose guggulipid (1000 mg 3x/day; n=33), high-dose guggulipid (2000 mg 3x/day; n=34), or matching placebo (n=36). All patients were to eat their usual diet.

Principal Findings:

LDL-C levels at eight weeks decreased by 4.9% in the placebo arm (from 160 mg/dl, p=0.06), but increased by 3.9% in the standard-dose guggulipid (from 156 mg/dl, p=0.10 vs. baseline and p=0.01 vs. placebo) and increased by 4.7% in the high-dose guggulipid (from 161, p=0.04 vs. baseline and p=0.006 vs. placebo) for a net increase of 9% and 10%, respectively.

There were no significant changes in other lipid measures at eight weeks, including total cholesterol (-2.45% for placebo vs. -0.98% for standard-dose [p=0.52] vs. +1.67% for high-dose [p=0.07]); high-density lipoprotein cholesterol (HDL-C) (+1.43% for placebo vs. -2.72% for standard-dose [p=0.06] vs. -2.71% for high-dose [p=0.06]); and triglycerides (+8.88% for placebo vs. -0.37% for standard-dose [p=0.26] vs. +5.79% for high-dose [p=0.58]).

Adverse event rates were similar in the three arms (p=0.77), but there were five patients in the high-dose guggulipid arm and one in the standard-dose arm who developed a hypersensitivity rash compared with none in the placebo group (p=0.02).

Interpretation:

Among patients with hypercholesterolemia, treatment with the herbal extract guggulipid was associated with an increase in the primary endpoint of LDL-C levels at eight weeks compared with placebo patients, which is the opposite of the prespecified hypothesis.

The authors note that previous studies of guggulipid have been conducted in India, and have shown a reduction in LDL-C in the 60-80% range, much higher than the 18% reduction observed in the present trial. Possible reasons for the discrepency may be differences between the Western diet and the Indian diet, as well as genetic differences and the nonrandomized nature of the prior studies.

References:

Szapary PO, Wolfe ML, Bloedon LT, et al. Guggulipid for the treatment of hypercholesterolemia: A randomized controlled trial. JAMA 2003;290:765-72.

Clinical Topics: Diabetes and Cardiometabolic Disease, Dyslipidemia, Prevention, Homozygous Familial Hypercholesterolemia, Lipid Metabolism, Nonstatins, Diet

Keywords: Cholesterol, Plant Gums, Hypercholesterolemia, Triglycerides, Fasting, Exanthema, Plant Extracts


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