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Effects of pravastatin, phytosterols, and combination therapy on lipid profile in HIV-infected patients: an open-labelled, randomized cross-over study.

Kietsiriroje N, Leelawattana R - BMC Res Notes (2015)

Bottom Line: 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).

View Article: PubMed Central - PubMed

Affiliation: Division of Endocrinology and Metabolism, Department of Internal Medicine, Faculty of Medicine, Prince of Songkla University, Songkla, 90110, Thailand. knoppado@medicine.psu.ac.th.

ABSTRACT

Background: 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.

Methods: Thirty-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.

Results: The 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).

Conclusion: Pravastatin 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 effect

Trial registration: Thai Clinical Trial Registry: TCTR20150126002 date: January 23, 2015.

No MeSH data available.


Related in: MedlinePlus

Diagram of cross-over study.
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Fig1: Diagram of cross-over study.

Mentions: The flow of the trial is shown in Figure 1. In summary, the duration of the study was 12 weeks and was divided into 3 phases: 2 different active treatment phases separated by a wash-out phase. The medical history and physical examination of the patients taken at baseline included age, BMI, underlying diseases, duration of HIV infection, CD4 status and current ARVs. The biochemical tests at baseline and at the end of each intervention phase to determine the efficacy of each intervention included TC, TG, HDL-c, and LDL-c. Serum SGOT, SGPT, CPK, prothrombin time, and creatinine were collected at baseline and at the end of each intervention phase to determine the short-term safety of the interventions. Subject compliance was assessed by interviewing and counting residual pills and phytosterol products. Subjects who took pills or products less than 80% of the requirements were determined to be noncompliant. The subjects were asked to report any adverse effects at every follow-up time. All subjects were instructed to continue their usual lifestyle as well as dietary pattern.Figure 1


Effects of pravastatin, phytosterols, and combination therapy on lipid profile in HIV-infected patients: an open-labelled, randomized cross-over study.

Kietsiriroje N, Leelawattana R - BMC Res Notes (2015)

Diagram of cross-over study.
© Copyright Policy - OpenAccess
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4492082&req=5

Fig1: Diagram of cross-over study.
Mentions: The flow of the trial is shown in Figure 1. In summary, the duration of the study was 12 weeks and was divided into 3 phases: 2 different active treatment phases separated by a wash-out phase. The medical history and physical examination of the patients taken at baseline included age, BMI, underlying diseases, duration of HIV infection, CD4 status and current ARVs. The biochemical tests at baseline and at the end of each intervention phase to determine the efficacy of each intervention included TC, TG, HDL-c, and LDL-c. Serum SGOT, SGPT, CPK, prothrombin time, and creatinine were collected at baseline and at the end of each intervention phase to determine the short-term safety of the interventions. Subject compliance was assessed by interviewing and counting residual pills and phytosterol products. Subjects who took pills or products less than 80% of the requirements were determined to be noncompliant. The subjects were asked to report any adverse effects at every follow-up time. All subjects were instructed to continue their usual lifestyle as well as dietary pattern.Figure 1

Bottom Line: 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).

View Article: PubMed Central - PubMed

Affiliation: Division of Endocrinology and Metabolism, Department of Internal Medicine, Faculty of Medicine, Prince of Songkla University, Songkla, 90110, Thailand. knoppado@medicine.psu.ac.th.

ABSTRACT

Background: 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.

Methods: Thirty-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.

Results: The 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).

Conclusion: Pravastatin 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 effect

Trial registration: Thai Clinical Trial Registry: TCTR20150126002 date: January 23, 2015.

No MeSH data available.


Related in: MedlinePlus