Plasma lipid lowering activity of acipimox in patients with type II and type IV hyperlipoproteinemia. Results of a multicenter trial.
A multicenter study was carried out in 130 out-patients to assess the plasma lipid lowering activity of acipimox in type IIa, IIb and IV hyperlipoproteinemia. The study consisted of two periods, an 8-week randomized, double-blind comparison of active drug versus placebo and a 16-week open follow-up with acipimox (400 mg and 250 mg t.i.d., respectively, in type II and IV patients). During the double-blind phase acipimox, compared to placebo, showed a highly significant triglyceride lowering effect in type IV patients (-43% vs. +4%, P less than 0.01), while reducing plasma cholesterol significantly in type II patients (-7% vs. -3%, P less than 0.05). Further reductions in plasma lipids were obtained in both types of hyperlipoproteinemia after the 16-week follow-up. In type II patients, total cholesterol fell by 9% in the former acipimox group and 17% in the former placebo group, whereas a 34% reduction in triglycerides was found in type IV patients previously treated with placebo. Treatment had to be discontinued in 4 patients during the double-blind phase and in 5 patients during follow-up, because of adverse events such as skin reactions and gastric disturbances. Statistical analysis of hematological and biochemical variables expressing safety did not show any significant change during treatment.
Crepaldi
G
G
Department of Internal Medicine, University of Padua, Italy.
Avogaro
P
P
Descovich
G C
GC
Di Perri
T
T
Postiglione
A
A
Sirtori
C R
CR
Strano
A
A
Ventura
S
S
Musatti
L
L
D000328:Adult; D000368:Aged; D002784:Cholesterol / Q000097:blood; D002986:Clinical Trials as Topic; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D006938:Hyperlipoproteinemia Type II / Q000097:blood*; D006953:Hyperlipoproteinemia Type IV / Q000097:blood*; D000960:Hypolipidemic Agents / Q000009:adverse effects / Q000494:pharmacology*; D008055:Lipids / Q000097:blood*; D008297:Male; D008875:Middle Aged; D011719:Pyrazines / Q000009:adverse effects / Q000494:pharmacology*; D014280:Triglycerides / Q000097:blood
D000960:Hypolipidemic Agents; D008055:Lipids; D011719:Pyrazines; D014280:Triglycerides; D002784:Cholesterol; C027696:acipimox