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Titolo:
Comparison of two regimens of policosanol administered at 20 mg/d in patients with type II hypercholesterolemia: A randomized, double-blind, placebo-controlled study
Autore:
Castano, G; Mas, R; Fernandez, L; Illnait, J; Gamez, R; Fernandez, JC;
Indirizzi:
Natl Ctr Sci Res, Ctr Nat Prod, Havana 6880, Cuba Natl Ctr Sci Res Havana Cuba 6880 i Res, Ctr Nat Prod, Havana 6880, Cuba Natl Ctr Sci Res, Ctr Med Surg Res, Havana 6880, Cuba Natl Ctr Sci Res Havana Cuba 6880 s, Ctr Med Surg Res, Havana 6880, Cuba
Titolo Testata:
CURRENT THERAPEUTIC RESEARCH-CLINICAL AND EXPERIMENTAL
fascicolo: 3, volume: 62, anno: 2001,
pagine: 194 - 208
SICI:
0011-393X(200103)62:3<194:COTROP>2.0.ZU;2-9
Fonte:
ISI
Lingua:
ENG
Soggetto:
CORONARY-HEART-DISEASE; EUROPEAN-ATHEROSCLEROSIS-SOCIETY; DEPENDENT DIABETES-MELLITUS; AVERAGE CHOLESTEROL LEVELS; SUCCESSIVE DOSE INCREASES; LIPID PROFILE; RISK-FACTORS; CARDIOVASCULAR-DISEASE; DENSITY LIPOPROTEIN; PRIMARY-PREVENTION;
Keywords:
policosanol; cholesterol-lowering drugs; lipid-lowering therapy; hypercholesterolemia; higher aliphatic primary alcohols;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Clinical Medicine
Life Sciences
Citazioni:
53
Recensione:
Indirizzi per estratti:
Indirizzo: Mas, R Natl Ctr Sci Res, Ctr Nat Prod, POB 6880 6990, Havana 6880, Cuba Natl Ctr Sci Res POB 6880 6990 Havana Cuba 6880 Havana 6880, Cuba
Citazione:
G. Castano et al., "Comparison of two regimens of policosanol administered at 20 mg/d in patients with type II hypercholesterolemia: A randomized, double-blind, placebo-controlled study", CURR THER R, 62(3), 2001, pp. 194-208

Abstract

Background: Policosanol is a mixture of higher primary aliphatic alcohols purified from sugar cane wax that has demonstrated dose-dependent cholesterol-lowering effects in patients with type II hypercholesterolemia and dyslipidemia associated with non-insulin-dependent diabetes mellitus. The 20 mg/d dosage is particularly useful for patients at high coronary risk and to date this dosage has been administered as two 10-mg tablets once daily. Objective: This 8-week study was undertaken to compare the cholesterol-lowering effects and tolerability of 2 dosing regimens of policosanol 20 mg/d:two 10-mg tablets versus one 20-mg tablet taken once daily with the evening meal. Methods: In this randomized, double-blind. placebo-controlled study, after4 weeks of dietary stabilization, 62 patients with type II hypercholesterolemia were randomly assigned in a 1:1:1 ratio to receive 2 placebo tablets,2 policosanol 10-mg tablets, or 1 policosanol 20-mg tablet plus 1 matched placebo tablet. Physical examinations were performed and lipid profiles andblood samples were obtained at baseline and after 4 and 8 weeks of therapy. The incidence of adverse events (AEs) and compliance with study medications were also evaluated at week 4 and week 8 of treatment. Results: The 2 policosanol 20 mg/d regimens were similarly effective. Policosanol administered as two 10-mg tablets significantly reduced total cholesterol (TC) (16.0%, P< 0.001 vs baseline), low-density lipoprotein cholesterol (LDL-C) (35.9%, P< 0.001), as well as the TC:high-density lipoprotein cholesterol (HDL-C) ratio (37.3%, P< 0.001) and LDL-C:HDL-C ratio (52.4%, P<0.001). The regimen significantly increased HDL-C levels (38.0%, P< 0.001 vs baseline). The 20-mg policosanol tablet also significantly decreased TC (20.0%), LDL-C (37.8%), TC:HDL-C ratio (39.9%), and LDL-C:HDL-C ratio (52.4%) (all P < 0.001), whereas it significantly raised HDL-C levels (39.4%, P < 0.001). Triglyceride levels did not change significantly in either group. The differences between treatment groups were not significant. No significant changes in lipid profile variables were observed in the placebo group. Both policosanol 20 mg/d regimens were well tolerated. No drug-related clinical or blood biochemistry abnormalities were observed after 8 weeks of treatment. Five patients (8.1%) withdrew from the study, 2 from the placebo group, 2 from the 10-mg tablet group, and 1 from the 20-mg tablet group. One of these patients (in the placebo group) withdrew from the study because ofan AE (duodenal ulcer). The other AEs reported during the study were mild,and the frequency of AE reports was similar in all the groups. Conclusions: These results demonstrate that policosanol 20 mg/d is an effective and well-tolerated cholesterol-lowering regimen whether administered as a 20-mg tablet once daily or two 10-mg tablets once daily with the evening meal.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 04/04/20 alle ore 14:59:51