Abstract
BackgroundTo determine the effects of 40 mg of pravastatin, 2 g of phytosterols, and combination therapy on lipid profiles and to compare the reduction of LDL cholesterol between combination therapy and monotherapy.MethodsThirty-six HIV-infected patients treated with ARVs who had high LDL cholesterol levels but no current usage of any lipid-lowering agents were enrolled into the open-labelled, randomized, cross-over study. All patients were assigned randomly into one of four intervention groups: (1) pravastatin 40 mg cross-over to the combination of pravastatin 40 mg and phytosterols 2 g (combination group), (2) the combination group cross-over to pravastatin 40 mg, (3) phytosterols 2 g cross-over to the combination group, and (4) the combination group cross-over to phytosterols 2 g. Each active treatment lasted 4 weeks with a wash-out period of 4 weeks.ResultsThe baseline mean TC, TG, HDL-c, and LDL-c levels in 36 HIV patients were 248.09 ± 34.73, 172.36 ± 125.44, 54.92 ± 16.67, and 175.13 ± 29.00 mg/dl, respectively. Pravastatin, phytosterols, and combination therapy reduced TC and LDL-c but TG and HDL-c were not significantly different from the baselines. The mean LDL-c reductions in the pravastatin, phytosterols, and the combination groups were 28.76 ± 9.32, 9.12 ± 7.84, and 27.08 ± 15.58%, respectively. The LDL-c levels in the pravastatin and combination groups were reduced more than in the phytosterols group (p < 0.01). There was no difference in the LDL-c reduction between the combination and pravastatin monotherapy groups (−25.61 ± 10.43 vs. −28.12 ± 14.07%, p = 0.555).ConclusionPravastatin had moderate potency on LDL-c lowering in HIV patients but could not bring LDL-c to goal. Adding phytosterols to pravastatin for a 4-week duration could not demonstrate any additional lipid-lowering effectTrial registration: Thai Clinical Trial Registry: TCTR20150126002 date: January 23, 2015Electronic supplementary materialThe online version of this article (doi:10.1186/s13104-015-1225-6) contains supplementary material, which is available to authorized users.
Highlights
To determine the effects of 40 mg of pravastatin, 2 g of phytosterols, and combination therapy on lipid profiles and to compare the reduction of LDL cholesterol between combination therapy and monotherapy
Mechanisms of abnormal lipid profile in highly active antiretroviral therapy (HAART)-treated human immunodeficiency virus (HIV) patients included increased de novo hepatic lipogenesis, increased secretion of very low-density lipoprotein (VLDL) and decreased clearance of VLDL, increased synthesis and decreased catabolism of apolipoprotein (Apo) B, and increased atherogenic low-density lipoprotein cholesterol (LDL-c) level including small dense LDL-c and oxidized LDL-c [5]
This unmet LDL-c target may be from the small dosage of potent statins used or the weak potency of an allowed statin to be used in patients taking HAART
Summary
To determine the effects of 40 mg of pravastatin, 2 g of phytosterols, and combination therapy on lipid profiles and to compare the reduction of LDL cholesterol between combination therapy and monotherapy. The most recent guideline suggests the use of pravastatin, atorvastatin, and fluvastatin to lower cholesterol in HIV patients but with the known pharmacokinetics of pravastatin was chosen mainly from its safety profile [8]. This unmet LDL-c target may be from the small dosage of potent statins used or the weak potency of an allowed statin to be used in patients taking HAART. Phytosterols, which are plant sterols/stanols and are classified as food, lower cholesterol by competitively binding with the Niemann-Pick C1-like 1 (NPC1L1) intestinal sterol transporter and lead to reduced gut cholesterol absorption This mechanism of action is very similar to ezetimibe. There is no study report of their efficacy and safety in patients taking HAART
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