Lilia 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.

Comparison of the Efficacy and Tolerability of Policosanol with Atorvastatin in Elderly Patients with Type II Hypercholesterolaemia

BackgroundHypercholesterolaemia is a risk factor for coronary heart disease (CHD). Clinical studies have shown that lowering elevated serum total cholesterol (TC) levels, and particularly low density lipoprotein-cholesterol (LDL-C) levels, reduces the frequency of coronary morbidity and deaths, whereas high serum levels of high density lipoprotein-cholesterol (HDL-C) protect against CHD. Policosanol is a cholesterol-lowering drug purified from sugar cane wax with a therapeutic dosage range from 5–20 mg/day. Atorvastatin is an HMG-CoA reductase inhibitor which across its dosage range (10–80 mg/day) has shown significantly greater lipid-lowering effects than all previously marketed statins.ObjectiveThis study was undertaken to compare the efficacy and tolerability of policosanol with atorvastatin in older patients with type II hypercholesterolaemia.Patients and methodsThis randomised, single-blind, parallel-group study was conducted in older patients (60–80 years) with type II hypercholesterolaemia. After 4 weeks on a cholesterol-lowering diet, 75 patients were randomised to policosanol or atorvastatin 10mg tablets taken once daily with the evening meal for 8 weeks. An interim and final check-up were performed at 4 and 8 weeks, respectively, after treatment was initiated.ResultsAt 4 (p < 0.0001) and 8 (p < 0.00001) weeks, policosanol 10 mg/day significantly lowered serum LDL-C levels by 17.5 and 23.1%, respectively compared with baseline; corresponding values for atorvastatin were 28.4 and 29.8%. At study completion, policosanol significantly (p < 0.0001) reduced serum TC (16.4%), LDL-C/HDL-C ratio (25.5%) and TC/HDL-C ratio (19.3%), as well as (p < 0.001) triglyceride levels (15.4%). Atorvastatin significantly (p < 0.0001) decreased serum TC (22.6%), LDL-C/HDL-C (26.2%) and TC/HDL-C (19.8%) ratios, as well as (p < 0.001) triglyceride levels (15.5%). Atorvastatin was significantly more effective than policosanol in reducing LDL-C and TC, but similar in reducing both atherogenic ratios and triglyceride levels. Policosanol, but not atorvastatin, significantly (p < 0.05) increased serum HDL-C levels by 5.3%. Both treatments were well tolerated. At study completion, atorvastatin mildly, but significantly (p < 0.05) increased creatine phosphokinase (CPK) and creati-nine, whereas policosanol significantly reduced AST and glucose (p < 0.01) and CPK (p < 0.05) levels. All individual values, however, remained within normal limits. Three atorvastatin but no policosanol patients withdrew from the study because of adverse events: muscle cramps (1 patient), gastritis (1 patient) and uncontrolled hypertension, abdominal pain and myalgia (1 patient). Overall, no policosanol and seven atorvastatin patients (18.9%) reported a total of nine mild or moderate adverse events during the study (p < 0.01).ConclusionsThis study shows that policosanol (10 mg/day) administered for 8 weeks was less effective than atorvastatin (10 mg/day) in reducing serum LDL-C and TC levels in older patients with type II hypercholesterolaemia. Policosanol, but not atorvastatin, however, significantly increased serum HDL-C levels, whereas both drugs similarly reduced atherogenic ratios and serum triglycerides. Policosanol was better tolerated than atorvastatin as revealed by patient withdrawal analysis and overall frequency of adverse events. Nevertheless, further studies must be conducted in larger sample sizes and using dose-titration methods to achieve target lipid levels in order to reach wider conclusions.

Effects of Policosanol and Lovastatin in Patients with Intermittent Claudication: A Double-Blind Comparative Pilot Study

Policosanol is a cholesterol-lowering drug with concomitant antiplatelet effects. The present study was undertaken to compare the effects of policosanol and lovastatin on patients with moderately severe intermittent claudication. The study had a 4-week baseline step, followed by a 20-week double blinded, randomized treatment period. Twenty-eight patients who met study entry criteria were randomized to policosanol 10 mg or lovastatin 20 mg tablets once daily. Walking distances in a treadmill (constant speed 3.2 km/hr, slope 10°, temperature 25°C) were assessed before and after 20 weeks of treatment. Both groups were similar at random ization. Compared with baseline, policosanol increased significantly (p<0.01) the initial claudi cation distance (ICD) from 160.39 ±15.82 m to 211.31 ±21.48 m (+33.7%) and the absolute claudication distance (ACD) (p<0.001) from 236.39 ±25.44 m to 288.09 ±28.47 m (+24.3%); meanwhile both variables remained unchanged after lovastatin therapy. Changes in ICD and ACD were significantly larger in the policosanol than in the lovastatin group (p<0.01). Policosanol, but not lovastatin, significantly increased (p < 0.05) the ankle/arm index, although between-group differences were not significant. The frequency of patients reporting improve ment on quality of life domains was greater in the policosanol than in the lovastatin group. Policosanol significantly (p< 0.00 1 ) lowered total cholesterol (TC) and low-density lipoprotein- cholesterol (LDL-C) by 17.5% and 31.0%, respectively, and meanwhile increased (p<0.01) high- density lipoprotein-cholesterol (HDL-C) levels by 31.5%. Lovastatin reduced (p<0.01) TC (18.0%), LDL-C (22.6%), and (p<0.05) triglycerides (9.8%). In addition, policosanol, but not lovastatin, moderately, but significantly, reduced (p < 0.05) fibrinogen levels, so that final values and percent changes in both groups were different (p<0.01). Treatments were well tolerated. Only 1 lovastatin patient withdrew from the study because of a nonfatal myocardial infarction. Five lovastatin patients, but none from the policosanol group, experienced 6 adverse events (AE) (p<0.01). The present results indicate that policosanol, but not lovastatin, is a suitable alternative to manage patients with intermittent claudication because of pleiotropic properties beyond its cholesterol-lowering effects.

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.

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.

Effects of policosanol on hypercholesterolemic patients with abnormal serum biochemical indicators of hepatic function

Abstract Forty-six patients with primary hypercholesterolemia and abnormal serum biochemical indicators of hepatic function were included in a 12-week, randomized, double-masked, placebo-controlled study of the efficacy and tolerability of policosanol 5 or 10 mg/d. Patients followed a standard cholesterol-lowering diet for at least 6 weeks and were then randomized to receive policosanol or placebo tablets. All groups were statistically similar at randomization. The study of the 5-mg dose comprised 24 patients. In this study, policosanol significantly reduced total cholesterol (13.6%), low-density lipoprotein cholesterol (LDL-C) (19.1%), and the ratios of cholesterol:high-density lipoprotein cholesterol (HDL-C) (21.1%) and LDL-C:HDL-C (25.5%). HDL-C increased significantly by 11.5%, while triglycerides did not change significantly. The study of the 10-mg dose comprised 22 patients. Policosanol significantly lowered total cholesterol (15.4%), LDL-C (22.3%), and the cholesterol:HDL-C (26.1%) and LDL-C:HDL-C (32.2%) ratios. The increase in HDL-C levels (17.9%) tended toward significance, while the changes in triglyceride levels were not significant. The lipid profile of the placebo group was not changed significantly; no clinical, biochemical, or hematologic adverse effects were observed; and the liver function indicators that were abnormal at baseline had not deteriorated further. No patient withdrew from the study because of adverse events. Seven patients (four from the placebo group and three from the policosanol group) reported at least one adverse experience, all of which were mild and transient. The comparisons between groups did not show any significant differences. The results demonstrate that policosanol is effective and well tolerated in patients with type II hypercholesterolemia and abnormal serum biochemical indicators of hepatic function.