PMID- 24678094 OWN - NLM STAT- PubMed-not-MEDLINE DCOM- 20140328 LR - 20240420 IS - 0011-393X (Print) IS - 0011-393X (Linking) VI - 67 IP - 3 DP - 2006 May TI - Effects of combination treatment with policosanol and omega-3 fatty acids on platelet aggregation: A randomized, double-blind clinical study. PG - 174-92 LID - 10.1016/j.curtheres.2006.06.004 [doi] AB - BACKGROUND: Policosanol is a mixture of long-chain primary aliphatic alcoholspurified from sugar cane wax that has cholesterol lowering and antiplatelet effects. Omega-3 fatty acids (FA) have triglyceride lowering and antiplatelet effects. Combination treatment with policosanol and omega-3 FA (Omega23FA) has been associated with significant inhibition of platelet aggregation in rabbits compared with either drug alone. OBJECTIVE: The aim of this study was to investigate the effects of combination treatment with Omega3FA (1 g/d) and policosanol (Omega3FA+Poli) compared with Omega3FA (1 g/d) plus placebo (Omega3FA+Pla) on platelet aggregation in human patients with hypercholesterolemia. METHODS: This randomized, double-blind, clinical study at the Surgical Medical Research Center (Havana City, Cuba) recruited outpatients from lipid clinics, with some atherosclerotic risk factors. Outpatients of both sexes aged 20 to 75 years with serum total cholesterol (TC) levels >/=5 and <6 mmol/L were eligible to enroll. They were included in the study at the end of a 4-week diet stabilization period if their platelet aggregation to arachidonic acid (AA) was >/=50% and serum TC level remained >/=5 mmol/L. Patients were then evenly randomized to receive Omega3FA (1 g/d) + placebo or Omega3FA (1 g/d) + policosanol (10 mg/d) to be taken PO with the evening meal for 21 days. Treatment was assigned according to a randomization code using balanced blocks and a 1:1 allocation ratio. Inhibition of platelet aggregation to AA was the primary efficacy variable, while effects on platelet aggregation to collagen and epinephrine and on lipid profile were secondary variables. Drug compliance and adverse events (AEs) were monitored. Tolerability was assessed using physical examinations and laboratory test results. RESULTS: Sixty-four subjects were initially enrolled. Fifty-four patients (30 women, 24 men; mean [SD] age, 58.4 [12] years, [range, 40-70 years]) met the inclusion criteria and were randomized to treatment; 2 groups of 27. After 21 days, platelet aggregation to AA was significantly inhibited in the 2 groups. Omega3FA+Poli inhibited platelet aggregation to all agonists by >/=20%. Platelet aggregation to AA 1.0 and 1.5 mM was inhibited with combination treatment (39.6% and 33.9%, respectively; both P < 0.001 vs baseline; P < 0.001 and P < 0.01, respectively, vs Omega3FA+Pla) and with Omega3FA+Pla (11.0% and 13.3%; both, P < 0.001). Combination treatment was more effective in inhibiting platelet aggregation to AA 1.0 and 1.5 mM in 28.6% (P < 0.001) and 20.6% (P < 0.01), respectively. Platelet aggregation to collagen 1 mug/mL was significantly inhibited with combination treatment and with Omega3FA+Pla compared with baseline (43.2% and 15.1%, respectively; both, P < 0.001), but the effects of combination treatment were significantly greater (P < 0.01). Platelet aggregation to epinephrine 0.1 mM was inhibited with Omega3FA+Poli and Omega3FA+Pla (34.8% and 20.1%; both, P < 0.001), with similar results for both groups. Bleeding time did not change significantly for either group and Omega3FA+Pla did not significantly change the lipid profile. Combination treatment did significantly reduce levels of low-density lipoprotein cholesterol (LDL-C) (17.4%; P < 0.001 vs baseline, P < 0.05 vs Omega3FA+Pla) and TC (10.1%; P < 0.001 vs baseline, P < 0.05 vs Omega3FA+Pla), increase high-density lipoprotein cholesterol (HDL-C) levels (18.0%; P < 0.001 vs baseline), but did not significantly change triglyceride levels. Three patients (2 from the Omega3FA+Poli group and 1 from the Omega3FA+Pla group) withdrew from the trial, though none were due to AEs. Two patients receiving combination treatment reported mild AEs (headache). All treatments were well tolerated. CONCLUSIONS: In these patients, policosanol (10 mg/d) administered concomitantly with Omega3FA (1 g/d) enhanced the inhibition of platelet aggregation to AA and collagen, but not to epinephrine, compared with Omega3FA+Pla, without significantly affecting bleeding time. Concomitant treatment was also associated with reduced levels of LDL-C and TC and raised HDL-C levels. All treatments were well tolerated. FAU - Castano, Gladys AU - Castano G AD - Surgical Medical Research Center, Havana City, Cuba. FAU - Arruzazabala, Maria L AU - Arruzazabala ML AD - Center of NaturalProducts, National Center of Scientific Research, Havana City, Cuba. FAU - Fernandez, Lilia AU - Fernandez L AD - Center of NaturalProducts, National Center of Scientific Research, Havana City, Cuba. FAU - Mas, Rosa AU - Mas R AD - Center of NaturalProducts, National Center of Scientific Research, Havana City, Cuba. FAU - Carbajal, Daisy AU - Carbajal D AD - Center of NaturalProducts, National Center of Scientific Research, Havana City, Cuba. FAU - Molina, Vivian AU - Molina V AD - Center of NaturalProducts, National Center of Scientific Research, Havana City, Cuba. FAU - Illnait, Jose AU - Illnait J AD - Surgical Medical Research Center, Havana City, Cuba. FAU - Mendoza, Sarahi AU - Mendoza S AD - Surgical Medical Research Center, Havana City, Cuba. FAU - Gamez, Rafael AU - Gamez R AD - Surgical Medical Research Center, Havana City, Cuba. FAU - Mesa, Melbis AU - Mesa M AD - Surgical Medical Research Center, Havana City, Cuba. FAU - Fernandez, Julio AU - Fernandez J AD - Center of NaturalProducts, National Center of Scientific Research, Havana City, Cuba. LA - eng PT - Journal Article PL - United States TA - Curr Ther Res Clin Exp JT - Current therapeutic research, clinical and experimental JID - 0372621 PMC - PMC3965964 OTO - NOTNLM OT - antiplatelet drugs OT - cholesterol-lowering drugs OT - omega-3 fatty acids OT - platelet aggregation OT - policosanol EDAT- 2006/05/01 00:00 MHDA- 2006/05/01 00:01 PMCR- 2006/05/01 CRDT- 2014/03/29 06:00 PHST- 2006/01/30 00:00 [accepted] PHST- 2014/03/29 06:00 [entrez] PHST- 2006/05/01 00:00 [pubmed] PHST- 2006/05/01 00:01 [medline] PHST- 2006/05/01 00:00 [pmc-release] AID - S0011-393X(06)00045-2 [pii] AID - 10.1016/j.curtheres.2006.06.004 [doi] PST - ppublish SO - Curr Ther Res Clin Exp. 2006 May;67(3):174-92. doi: 10.1016/j.curtheres.2006.06.004.