A Long-Term Study of Policosanol in the Treatment of Intermittent Claudication

Abstract

Policosanol is a cholesterol-lowering drug with concomitant antiplatelet effects. This study was undertaken to investigate the long-term effects of policosanol administered to patients with moderately severe intermittent claudication. The study consisted of a 6-week single-blind, placebo-controlled run in phase, followed by a 2-year double-blind, randomized treatment step. Fifty-six patients who met study entry criteria were randomized to receive placebo or policosanol 10 mg twice daily. Walking distances on a treadmill (constant speed 3.2 km/h, slope 10 degrees, temperature 25 degrees C) were assessed before and after 6, 12, 18, and 24 months of treatment. Both groups were similar at randomization. After 6 months of therapy, policosanol significantly increased (p < 0.01) the initial claudication distance from 125.9 +/- 8.7 m to 201.1 +/- 24.8 m and the absolute claudication distance from 219.5 +/- 14.1 m to 380.7 +/- 50.2 m. Both variables remained unchanged in the placebo group (p < 0.01). These effects did not wear off but improved after long-term therapy, so that final values were 333.5 +/- 28.6 m (initial claudication distance) and 648.9 +/- 54.1 m (absolute claudication distance); both significantly greater (p < 0.0001) than those obtained in the placebo group, which showed values of 137.9 +/- 21.8 m (initial claudication distance) and 237.7 +/- 28.1 m (absolute claudication distance), respectively. At study completion, 21 policosanol and 5 placebo patients attained increases in claudication distance values > 50% (p < 0.001). Policosanol, but not placebo, significantly increased the ankle/arm pressure index. In addition, from month 6 up to study completion, the frequency of patients reporting improvement of lower limb symptoms was greater in the policosanol group than in the placebo group. The treatment was tolerated well. There were 16 withdrawals (12 placebo, 4 policosanol) from the study. Eight patients in the placebo group experienced a total of 10 serious adverse events, 8 of which were vascular events, compared with none in the policosanol group (p < 0.01). In addition, 3 patients in the policosanol group and 3 patients in the placebo group reported mild adverse events during the study. The present results demonstrate the long-term usefulness of policosanol therapy to treat patients with intermittent claudication.

Role of dietary supplements in lowering low-density lipoprotein cholesterol: A review

“…In comparative trials with statins, policosanol showed similar or even greater improvement in lipid profiles. 115,116 There were also reports of improvement in clinical outcomes, including intermittent claudication 117 and cardiac ischemia. 118 Policosanol seems to be well tolerated.…”

Evaluation of cholesterol-lowering and antioxidant properties of sugar cane policosanols in hamsters and humans

“…The studies varied in duration and sample population, and consistently showed reductions in serum LDL-C and TC levels of up to 44% and 29%, respectively (Crespo et al, 1997). Significant increases in serum HDL-C as compared to placebo were only reported in a few studies (Menendez et al, 1999b;Castano et al, 2001a;Mirkin et al, 2001) and reductions in serum triglycerides in only two (Castano et al, 2002c;Mas et al, 2004).The lipid-lowering potential of SCP tended to increase in a dose-dependant manner up to 20 mg/day. Beyond this dose, no further cholesterol reductions were observed, as reported in 2001 by…”

“…No deleterious effects on fertility, reproductive performance or development of pups from three successive generations were observed as a result of any of the three doses administered as compared to control . In humans, policosanols effectively reduced serum LDL-C with no associated serious side effects and reported mild side effects were more common in the placebo group than in the policosanol group (Castano et al, 2001a;Mirkin et al, 2001). In studies comparing effects of SCP and statin drugs on the lipid profile Castano et al, 2003a) statins significantly increased levels of alanine aminotransferase (ALT), aspartate aminostransferase (AST) and creatinine phosphokinase (CPK).…”

“…Sugar cane policosanols (SCP) have repeatedly been shown to reduce plasma low density lipoprotein cholesterol (LDL-C), decreasing the risk of cardiovascular incidents (Pons et al, 1992;Pons et al, 1994a;Pons et al, 1994b;Aneiros et al, 1995;Canetti et al, 1995a;Canetti et al, 1995b;Batista et al, 1996;Canetti et al, 1997;Crespo et al, 1997;Ortensi et al, 1997;Castano et al, 1999;Castano et al, 2000b;Castano et al, 2001a;Castano et al, 2001b;Fernandez et al, 2001;Mas et al, 2001;Mirkin et al, 2001;Castano et al, 2002b; suggested that failure by other groups to observe cholesterol-lowering could be explained by differences in the policosanol ratios in the mixtures tested (Castano et al, 2002b). The purpose of the present study was to evaluate the original Cuban mixture of policosanols, as utilized in previous efficacy studies, as ingredients for cholesterol-lowering in moderately hypercholesterolemic individuals.…”

“…Animal and human studies have demonstrated that policosanol administration safely and significantly induced a cholesterol reduction comparable to that of statins Crespo et al, 1999;Fernandez et al, 2001;Castano et al, 2002c;Castano et al, 2003a;Castano et al, 2003b; and greater than other effective natural health products such as plant sterols . Complementing their lipid-lowering activity, policosanols were seen to be effective in the prevention of intermittent claudication and peripheral artery disease (PAD) through its inhibitory action on platelet aggregation Castano et al, 2001a). Based on these claimed benefits, policosanols can be considered as good alternatives to statins in the treatment of dyslipidemia and the prevention of CVD.…”