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 bli...

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Veröffentlicht in:Angiology 2003-01, Vol.54 (1), p.25-38
Hauptverfasser: Castaño, Gladys, Más, Rosa, Fernández, Lilia, Gámez, Rafael, Illnait, José
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creator Castaño, Gladys
Más, Rosa
Fernández, Lilia
Gámez, Rafael
Illnait, José
description 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
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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.]]></description><identifier>ISSN: 0003-3197</identifier><identifier>EISSN: 1940-1574</identifier><identifier>DOI: 10.1177/000331970305400104</identifier><identifier>PMID: 12593493</identifier><identifier>CODEN: ANGIAB</identifier><language>eng</language><publisher>Thousand Oaks, CA: SAGE Publications</publisher><subject>Adult ; Aged ; Aged, 80 and over ; Biological and medical sciences ; Double-Blind Method ; Fatty Alcohols - therapeutic use ; Female ; General and cellular metabolism. 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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. 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Drug treatments</topic><topic>Pilot Projects</topic><topic>Platelet Aggregation Inhibitors - therapeutic use</topic><topic>Policosanol</topic><topic>Severity of Illness Index</topic><topic>Time Factors</topic><topic>Walking - physiology</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Castaño, Gladys</creatorcontrib><creatorcontrib>Más, Rosa</creatorcontrib><creatorcontrib>Fernández, Lilia</creatorcontrib><creatorcontrib>Gámez, Rafael</creatorcontrib><creatorcontrib>Illnait, José</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Health &amp; Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Health &amp; Medical Complete (Alumni)</collection><collection>Health &amp; Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><jtitle>Angiology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Castaño, Gladys</au><au>Más, Rosa</au><au>Fernández, Lilia</au><au>Gámez, Rafael</au><au>Illnait, José</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Effects of Policosanol and Lovastatin in Patients with Intermittent Claudication: A Double-Blind Comparative Pilot Study</atitle><jtitle>Angiology</jtitle><addtitle>Angiology</addtitle><date>2003-01</date><risdate>2003</risdate><volume>54</volume><issue>1</issue><spage>25</spage><epage>38</epage><pages>25-38</pages><issn>0003-3197</issn><eissn>1940-1574</eissn><coden>ANGIAB</coden><abstract><![CDATA[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.]]></abstract><cop>Thousand Oaks, CA</cop><pub>SAGE Publications</pub><pmid>12593493</pmid><doi>10.1177/000331970305400104</doi><tpages>14</tpages></addata></record>
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subjects Adult
Aged
Aged, 80 and over
Biological and medical sciences
Double-Blind Method
Fatty Alcohols - therapeutic use
Female
General and cellular metabolism. Vitamins
Heart diseases
Humans
Hydroxymethylglutaryl-CoA Reductase Inhibitors - therapeutic use
Intermittent Claudication - drug therapy
Intermittent Claudication - physiopathology
Lovastatin - therapeutic use
Male
Medical sciences
Middle Aged
Pharmacology. Drug treatments
Pilot Projects
Platelet Aggregation Inhibitors - therapeutic use
Policosanol
Severity of Illness Index
Time Factors
Walking - physiology
title Effects of Policosanol and Lovastatin in Patients with Intermittent Claudication: A Double-Blind Comparative Pilot Study
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