acipimox and Hyperlipoproteinemia-Type-II

An 8-week, randomized, double-blind study comparing the efficacy and tolerability of policosanol and acipimox was conducted in patients with type II hypercholesterolemia. Prior to entry into active treatment, all patients followed a standard cholesterol-lowering diet for 12 weeks. Sixty-three patients were randomized to receive either policosanol (10 mg/day) or acipimox (750 mg/day) tablets for 8 weeks under double-blind conditions. Both groups were similar at randomization. Policosanol significantly reduced total cholesterol (p < 0.0001) (15.8%), low-density lipoprotein (LDL)-cholesterol (21%) and the ratios of LDL-cholesterol to high-density lipoprotein (HDL)-cholesterol (15.8%) and cholesterol to HDL-cholesterol (11.5%). Acipimox significantly lowered both cholesterol and LDL cholesterol by 7.5%. The percent changes of total cholesterol, LDL-cholesterol and both ratios were larger in the policosanol group than in the acipimox group. Both drugs were well tolerated. Acipimox significantly increased (p > 0.001) aspartate amino transferase levels but only four patients showed increases above the normal limit. Policosanol significantly reduced creatinine values (p > 0.05) but no patients had values out of the normal range. Four patients withdrew from the study (two from each group) but none withdrew because of adverse effects. No adverse effects were reported in the policosanol group, while five patients on acipimox reported adverse effects (hot flushes, nausea, vomiting, headache, hypochondrial pain and leg edema). These results indicate that policosanol (10 mg/day) was more effective and well tolerated than was acipimox (750 mg/day) in this study population.

Topics: Aged; Anticholesteremic Agents; Double-Blind Method; Fatty Alcohols; Female; Humans; Hyperlipoproteinemia Type II; Hypolipidemic Agents; Male; Middle Aged; Pyrazines; Treatment Outcome

Acipimox, a derivative of nicotinic acid, lowers serum lipid levels by reducing the production of very-low-density and low-density lipoproteins (LDL).. We studied the additional lipid-lowering effect of high doses of acipimox in 12 patients with severe familial hypercholesterolemia (FH) who were on treatment with an HMG CoA reductase inhibitor, in some cases in combination with a resin.. There was a significant reduction in total serum cholesterol (-9%), LDL-cholesterol (-9%) and serum triglycerides (-21%) when the standard doses of acipimox (750 mg/day) was added to treatment with simvastatin (and a resin). However, higher doses had no further hypolipidemic effect. In concordance with the reduction of serum cholesterol and LDL-cholesterol there was a significant decrease in apolipoprotein (apo)-B (-11%). There was no change in HDL-cholesterol, apo-A1 and lipoprotein(a). Acipimox in high doses up to 2250 mg/d was well tolerated except for initial gastric complaints and of flushing; because of these side effects one patient dropped out of the study.. Acipimox in high doses, which were well tolerated, has no additional lowering effect on LDL-levels compared to the standard dose in patients with severe FH who are already treated with simvastatin.

Topics: Adult; Aged; Cholesterol, VLDL; Dose-Response Relationship, Drug; Drug Hypersensitivity; Drug Therapy, Combination; Female; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Hyperlipoproteinemia Type II; Hypolipidemic Agents; Lipoproteins, LDL; Male; Middle Aged; Pyrazines; Safety; Simvastatin

Serum and lipoprotein lipid levels, oral glucose tolerance and side-effects were compared in an open cross-over study of 31 non-diabetic patients with hypertriglyceridaemia (type II B and IV) before and after 6 weeks of treatment with nicotinic acid (3 g daily) and acipimox (0.75 g daily), a new nicotinic acid-like drug, respectively. Acipimox was about equally potent in reducing serum and VLDL lipid levels and in increasing HDL cholesterol levels. Acipimox had no significant negative effects on glucose metabolism measured by an oral glucose tolerance test compared with nicotinic acid, which decreased the late glucose tolerance as well as the area under the glucose curve (P less than 0.05 for the difference between the two treatments). The incidence and severity of flush or any other recorded side-effects was higher after nicotinic acid treatment than after acipimox. In addition, no effects on laboratory parameters such as liver enzymes and uric acid were seen after treatment with acipimox. The results of this study demonstrate that acipimox is a satisfactory alternative to nicotinic acid in patients with hypertriglyceridaemia.

Topics: Adult; Blood Glucose; Female; Glucose Tolerance Test; Humans; Hyperlipoproteinemia Type II; Hyperlipoproteinemia Type IV; Hypolipidemic Agents; Lipids; Male; Middle Aged; Niacin; Pyrazines

1. This study was designed to examine the effects of acipimox 250 mg three times daily and cholestyramine 4 g three times daily on plasma lipids and lipoproteins in 28 hypercholesterolaemic individuals in a prospective double-blind placebo controlled parallel group fashion. 2. Combined treatment with the two agents produced a mean reduction of 27% in plasma total cholesterol and a 32% fall in LDL cholesterol. Plasma triglyceride was reduced by 13% due to a 38% decrement in VLDL cholesterol. 3. In comparison treatment with cholestyramine alone resulted in a 12% fall in plasma cholesterol and a 15% fall in LDL cholesterol. In this group triglycerides and VLDL showed no significant change. 4. Studies of HDL subfraction mass showed that the addition of acipimox to resin therapy produced a mean increment of 45% in HDL2. 5. These results demonstrate the effectiveness of such a well tolerated low dosage combination therapy.

Topics: Cholesterol; Cholesterol, HDL; Cholesterol, LDL; Cholesterol, VLDL; Cholestyramine Resin; Double-Blind Method; Drug Therapy, Combination; Humans; Hyperlipoproteinemia Type II; Hypolipidemic Agents; Lipids; Lipoproteins; Patient Compliance; Pyrazines; Triglycerides

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.

Topics: Adult; Aged; Cholesterol; Clinical Trials as Topic; Double-Blind Method; Female; Follow-Up Studies; Humans; Hyperlipoproteinemia Type II; Hyperlipoproteinemia Type IV; Hypolipidemic Agents; Lipids; Male; Middle Aged; Pyrazines; Triglycerides

Hypolipaemic effectiveness and unfavourable effects of acipimox and fenofibrate were evaluated in patients with essential hyperlipoproteinaemia type II. The studies were carried out in two groups of 30 patients each. The studied patients were treated for three months with diet, and for another three months one group received acipimox (750 mg/day), and the other group was given fenofibrate (300 mg/day). After three months of pharmacological treatment in both groups a statistically significant decrease was seen of the concentrations of total cholesterol (by 13.8% and 19.3% respectively), LDL cholesterol (by 16.3% and 22.1%). TG (by 22.7% and 28.9%). The increase of HDL cholesterol concentration (twofold increase after fenofibrate) was non-significant. Desired LDL cholesterol values were achieved in eight patients (26.7%) treated with fenofibrate and in two patients (6.6%) receiving acipimox. Both drugs were well tolerated. Unfavourable effects were slight and did not require drug withdrawal.

Topics: Adult; Aged; Cholesterol; Female; Fenofibrate; Humans; Hyperlipoproteinemia Type II; Hypolipidemic Agents; Male; Middle Aged; Pyrazines; Treatment Outcome