Julio Fernández

Effects of policosanol in patients with type II hypercholesterolemia and additional coronary risk factors.

This study was undertaken to evaluate the efficacy, safety, and tolerability of policosanol, a new cholesterol‐lowering drug, in patients with type II hypercholesterolemia and additional coronary risk factors.

Treatment of Hypercholesterolemia in NIDDM With Policosanol

OBJECTIVE To determine whether elevated levels of cholesterol and low-density lipoprotein (LDL) cholesterol in non-insulin-dependent diabetes mellitus (NIDDM) patients could be decreased by policosanol, a new cholesterol-lowering drug. NIDDM predisposes patients to coronary artery disease (CAD) through the direct action of hyperglycemia on the arteries as well as the dyslipidemia induced by NIDDM. RESEARCH DESIGN AND METHODS This double-blind placebo-controlled trial was performed in 29 patients with NIDDM and hypercholesterolemia. After stable glycemie control was achieved by diet and/or oral Hypoglycemic drugs, patients were instructed to follow a cholesterol-lowering diet for 6 weeks. Patients who met entry criteria received, under double-blind conditions, policosanol (5 mg) or placebo tablets twice a day for 12 weeks. RESULTS Policosanol (10 mg/day) significantly reduced total cholesterol by 17.5% and LDL cholesterol by 21.8% compared with baseline and placebo. Furthermore, high-density lipoprotein (HDL) cholesterol was raised by 11.3% (not significant), and triglycerides showed a statistically nonsignificant decrease of 6.6%. These changes in lipid profile were similar to those induced by policosanol in nondiabetic patients with type II hyperlipoproteinemia. CONCLUSIONS Glycemie control was unaffected by treatment. No clinically or biochemically adverse effects attributable to treatment were observed. Only one patient (placebo) withdrew from the trial because of an adverse experience (erythema). We concluded that policosanol is effective and safe in patients with NIDDM and hypercholesterolemia.

Effect of policosanol in lowering cholesterol levels in patients with type II hypercholesterolemia

Abstract A randomized double-blind, placebo-controlled study was conducted in 45 patients with type II hypercholesterolemia to investigate the efficacy and safety of policosanol administered at 10 mg daily (5 mg twice daily). After adhering to a cholesterol-lowering diet-only period, 45 outpatients in whom serum cholesterol and LDL-C values were not controlled sufficiently b diet alone were randomized to receive policosanol or placebo at the evening and the morning meal for 6 weeks. Policosanol significantly decreased total cholesterol by 162% and low-density lipoprotein cholesterol (LDL-C) by 21.5%. Ratios of total cholesterol to high-density lipoprotein cholesterol (HDL-C) and of LDL-C to HDL-C were also significantly reduced by 17.7% and 22.3%, respectively. HDL-C values increased by 14% in the policosanol-treated group, but this increase was not significant ( P = 0.07). No significant changes in triglycerides were observed compared with baseline or placebo. No clinically significant differences in clinical and biochemical safety indicators were observed in policosanol-treated patients compared with those receiving placebo. No patient withdrew from the study becasue of adverse experiences, and there were no clinically significant drug-related adverse effects. These data indicate that polico sanol (5 mg twice daily) is effective and well tolerated in patients with type II hypercholesterolemia.

Efficacy and safety of policosanol in patients with primary hypercholesterolemia

Abstract A double-blind, placebo-controlled study was conducted in patients with primary hypercholesterolemia to examine the effects of policosanol on plasma lipids and lipoproteins. After adhering to a cholesterol-lowering diet for 6 weeks, 56 patients were randomized to receive placebo or policosanol 5 mg once daily in the evening for 8 weeks. Total cholesterol and low-density lipoprotein cholesterol decreased significantly, by an average of 13.1% and 17.7%, respectively. No significant changes were observed for triglycerides, very-low-density lipoprotein cholesterol, or high-density lipoprotein cholesterol. No significant differences in clinical and biochemical safety indicators were seen in the treated patients compared with those receiving placebo. There were no adverse effects attributable to treatment, and no patient was withdrawn from the trial. These data indicate that policosanol therapy is effective and very well tolerated.

Effects of policosanol on postmenopausal women with type II hypercholesterolemia.

This randomized, double-blind, placebo-controlled study was conducted to investigate the efficacy, safety and tolerability of policosanol, a cholesterol-lowering drug purified from sugar-cane wax, in postmenopausal women with type II hypercholesterolemia. A total of 244 women who had experienced the menopause and showed elevated serum total cholesterol and low-density lipoprotein cholesterol (LDL-C) levels despite 6 weeks on a standard lipid-lowering diet were randomized to receive placebo or policosanol 5 mg/day for 12 weeks, after which the dose was doubled to 10 mg/day for the next 12 weeks. Policosanol (5 and 10 mg/day) significantly lowered LDL-C levels (17.7% and 25.2%, respectively) and total cholesterol (12.6% and 16.7%, respectively), as well as the ratios of LDL-C to high-density lipoprotein cholesterol (HDL-C) (17.0% and 29.3%, respectively) and total cholesterol to HDL-C (16.7% and 27.2%, respectively), compared to the baseline and placebo; at the same time, policosanol significantly raised HDL-C levels by 16.5% and 29.3%, respectively. The drug was safe and well tolerated. No drug-related adverse events were observed, and even the extent of adverse events was less in the policosanol group than in the placebo group. Four serious adverse events occurred in the placebo group (one myocardial infarction, two cases of hypertensive status and one surgical intervention) compared to none in the policosanol group. In conclusion, policosanol is effective, safe and well tolerated in hypercholesterolemic postmenopausal women.

One-year efficacy and safety of policosanol in patients with type II hypercholesterolemia

Abstract A 12-month, double-blind, placebo-controlled study was conducted in patients with type II hypercholesterolemia to ascertain the efficacy, safety, and tolerability of policosanol (5 mg once daily). After adhering to a cholesterol-lowering diet for 12 weeks, 59 patients were randomized to receive either placebo or policosanol (5 mg) tablets for 12 months. Tablets were taken once daily before the evening meal. Two months after the start of therapy, policosanol had significantly reduced total cholesterol and low-density lipoprotein cholesterol (LDL-C) levels. These changes were maintained, or increased, throughout the study. After 12 months, total cholesterol levels had decreased by 15.3% and LDL-C by 23.7%. In the placebo group a significant increase in both values was detected 9 months after the start of therapy. No significant changes in triglycerides and high-density lipoprotein cholesterol (HDL-C) were reported compared with baseline or placebo. LDL-C:HDL-C and cholesterol:HDL-C ratios were significantly reduced in the policosanol-treated group: decreases were 25.3% (LDL-C:HDL-C) and 17.0% (cholesterol:HDL-C) after 12 months. Of the seven patients who discontinued the trial (five from the placebo group and two from the policosanol group), only one (placebo group) withdrew because of side effects. The adverse effects reported were mild and transient; no significant differences were seen in the treated patients compared with those receiving placebo. No drug-related clinical, biochemical, or ophthalmologic adverse effects were observed. The study indicates that policosanol 5 mg administered once daily for 12 months results in maintained efficacy as well as good safety and tolerability in patients with type II hypercholesterolemia.

Effects of policosanol on patients with non—insulin-dependent diabetes mellitus and hypercholesterolemia: a pilot study

Abstract A randomized, double-masked, 12-week, placebo-controlled pilot study was conducted to determine the efficacy and tolerability of policosanol 5 mg twice daily, a new cholesterol-lowering drug, in patients with non—insulin-dependent diabetes mellitus (NIDDM) and hypercholesterolemia. After glycemic control was achieved through treatment with diet and oral hypoglycemic drugs, patients were instructed to follow a lipid-lowering diet and to discontinue all lipid-lowering drugs for 6 weeks. Subsequently, patients who met the entry criteria received policosanol or placebo tablets to be taken twice daily for 12 weeks. When compared with baseline, policosanol significantly reduced total cholesterol by 28.9%, low-density lipoprotein cholesterol (LDL-C) by 44.4%, and total cholesterol:high-density lipoprotein cholesterol (HDL-C) ratio by 38.3% and LDL-HDL-C ratio by 51.6%. Significant between-group differences were also seen: policosanol treatment raised HDL-C levels by 23.5% compared with placebo. Levels of triglyceride, glucose, and glycated hemoglobin were not significantly changed after therapy. No patient withdrew from the trial because of adverse experiences. Only two patients, both from the placebo group, reported mild adverse experiences (nervousness). It is concluded that policosanol is effective and well tolerated in the treatment of patients with NIDDM, and hypercholesterolemia.

One-year study of the efficacy and safety of policosanol (5 mg twice daily) in the treatment of type II hypercholesterolemia

Abstract This study reports the results of a 12-month, randomized, double-blind, placebo-controlled study to investigate the efficacy, safety, and tolerability of policosanol (5 mg twice daily) in patients with type II hypercholesterolemia. After a low-fat, low-cholesterol diet for at least 12 weeks, 74 patients were randomized to receive placebo or policosanol (5 mg) tablets for 12 months. Tablets were taken twice daily before the morning and evening meals. Lipid profile and safety indicators were controlled regularly throughout the study. Significant reductions of serum total cholesterol and low-density lipoprotein cholesterol (LDL-C) were achieved after 2 months of therapy. The treatment effect continued during the 12-month follow-up. After 12 months, total cholesterol had decreased by 17.2% and LDL-C by 26.4%. Similarly, ratios of LDL-C to high-density lipoprotein cholesterol (HDL-C) and total cholesterol to HDL-C were also significantly reduced in the policosanol group, decreasing by 33.3% (LDL-C:HDL-C) and 25.3% (cholesterol:HDL-C) after 12 months. In addition, a significant, sustained increase in HDL-C of 13% to 15% occurred in the policosanol-treated group. No significant changes in triglycerides were observed compared with baseline or placebo. Nine patients discontinued the trial (five from the placebo group and four from the policosanol group), none of them because of adverse effects. The adverse experiences reported were mild and transient. No significant differences were obtained compared with those reported by the placebo group. No drug-related clinical or biochemical adverse effects were detected. It is concluded that policosanol administered at 5 mg twice daily for 12 months shows a persistent efficacy and is safe and well tolerated in patients with type II hypercholesterolemia.

A COMPARATIVE STUDY OF POLICOSANOL VERSUS PRAVASTATIN IN PATIENTS WITH TYPE II HYPERCHOLESTEROLEMIA

Abstract This randomized, double-masked study compared the short-term efficacy and tolerability of policosanol and pravastatin in patients with type II hypercholesterolemia. After following a step I cholesterol-lowering diet for 6 weeks, 24 patients with type II hypercholesterolemia were randomly assigned to receive policosanol or pravastatin administered at the same dose (10 mg/d) for 6 weeks. Both groups were statistically similar at randomization. Policosanol significantly reduced total cholesterol (15.7%), low-density lipoprotein (LDL) cholesterol (24.2%), and triglycerides (8.7%), as well as the atherogenic ratios of total cholesterol to high-density lipoprotein (HDL) cholesterol (25.7%), and LDL cholesterol to HDL cholesterol (33.0%). Pravastatin significantly lowered total cholesterol by 15.3%, LDL cholesterol by 19.6%, triglycerides by 13.9%, and the atherogenic ratios of total cholesterol to HDL cholesterol (18.7%) and LDL cholesterol to HDL cholesterol (22.8%). Mean values of HDL cholesterol were significantly increased by 13.6% after treatment with policosanol, and were increased by 4.7% after treatment with pravastatin. Comparisons between groups showed that the percentage change in LDL and HDL cholesterol levels, and in atherogenic ratios were significantly higher in the policosanol group than in the pravastatin group. Both drugs were well tolerated. A significant increase in mean aspartate aminotransferase level was observed in the pravastatin group, but individual values remained within the normal range. No patient withdrew from the study because of adverse events. Four moderate adverse events (nausea, dizziness, abdominal pain, and pruritus) were reported by pravastatin-treated patients. The other adverse events reported (five in each group) were classified as mild. These results suggest that both policosanol and pravastatin are suitable alternatives for treating type II hypercholesterolemia, but that policosanol administered of 10 mg/d shows modest advantages compared with pravastatin administered at the same dose.

EFFECTS OF POLICOSANOL IN HYPERTENSIVE PATIENTS WITH TYPE II HYPERCHOLESTEROLEMIA

Abstract The results of a 1-year, multicenter, randomized, double-masked, placebo-controlled study of the efficacy and tolerability of policosanol administered at 10 mg daily in patients with type II hypercholesterolemia and hypertension treated with beta-blockers, diuretics, or calcium antagonists are reported. The trial included 58 patients with total cholesterol and low-density lipoprotein cholesterol (LCL-C) levels not controlled sufficiently during a 12-week diet-only period. Two months after initiating therapy, treatment with policosanol significantly reduced total cholesterol, LDL-C, and ratios of LDL-C:high-density lipoprotein cholesterol (HDL-C) and total cholesterol:HDL-C. The treatment effect on these efficacy variables was maintained during the 1-year follow-up. Thus 12 months after therapy reductions of 19.1% in LDL-C, 13.0% in total cholesterol, 20.0% in total cholesterol: HDL-C, and 24.2% in LDL-C:HDL-C had been obtained. No changes in any lipid profile variables were seen in the placebo group throughout the study. At the end of the therapy, policosanol had increased HDL-C significantly (17.1%), while triglycerides did not change significantly. No patient withdrew from the study and no drug-related clinical or biochemical side effects were observed. Only two patients (one in each group) reported mild adverse events.