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Controlled trial of acifran in type II hyperlipoproteinemia
Author(s) -
Hunninghake Donald B,
Edwards K David G,
Sopko George S,
Tosiello Robert L
Publication year - 1985
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1038/clpt.1985.177
Subject(s) - placebo , dosing , medicine , lipoprotein , double blind , gastroenterology , clinical trial , clinical pharmacology , cholesterol , randomized controlled trial , endocrinology , pharmacology , alternative medicine , pathology
The hypolipidemic effects of acifran were evaluated in a randomized, double‐blind, placebo‐controlled study of 30 patients with type IIa hyperlipoproteinemia. Plasma lipid and lipoprotein values were determined at baseline (mean of three values), again after a 2‐week single‐blind period of acifran dosing, and at 2‐week intervals during a 10‐week period of double‐blind drug dosing. At week 8, subjects who received the lower dose of acifran (100 mg t.i.d.) showed significantly lower levels of total and low‐density lipoprotein cholesterol and triglycerides compared with their baseline levels (P < 0.01) or the placebo group (P < 0.05). At week 12, subjects who received the higher dose of acifran (300 mg t.i.d.) had an increase in high‐density lipoprotein levels of 16% (P < 0.01) and a decrease in the ratio of low‐ to high‐density lipoproteins of 22% compared with their baseline levels (P < 0.01). There were no significant differences in lipid responses between the two groups receiving acifran. Transient mild flushing and pruritus were experienced by some subjects, but no subject failed to complete the study because of drug intolerance or side effects. The safety and efficacy demonstrated in this short‐term therapeutic trial justify additional long‐term studies with acifran. Clinical Pharmacology and Therapeutics (1985) 38, 313–317; doi: 10.1038/clpt.1985.177