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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: 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 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.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

Effects of phytosterols on patients who had good response and poor response to pravastatin. Pravastatin, pravastatin monotherapy in Groups 1 and 2; combination combination therapy in Groups 1 and 2; poor response, subgroup pravastatin with an LDL-c reduction less than 25.6%; good response, subgroup pravastatin with an LDL-c reduction more than 25.6%.
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Fig5: Effects of phytosterols on patients who had good response and poor response to pravastatin. Pravastatin, pravastatin monotherapy in Groups 1 and 2; combination combination therapy in Groups 1 and 2; poor response, subgroup pravastatin with an LDL-c reduction less than 25.6%; good response, subgroup pravastatin with an LDL-c reduction more than 25.6%.

Mentions: When the HIV patients were separated according to the reduction of LDL-c by pravastatin into good and poor response using the mean value of 25.6%, a trend of interaction was demonstrated between the addition of phytosterols and the responsiveness to pravastatin. Phytosterols reduced LDL-c further from a mean of 17.54 ± 6.30 to 31.88 ± 14.68% (p = 0.052) in the poor response group while adding phytosterols to the good response patients possibly interfered with the LDL-c reducing efficacy of pravastatin (33.64 ± 6.81 to 24.36 ± 13.16% (p = 0.132) (Figure 5).Figure 5


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)

Effects of phytosterols on patients who had good response and poor response to pravastatin. Pravastatin, pravastatin monotherapy in Groups 1 and 2; combination combination therapy in Groups 1 and 2; poor response, subgroup pravastatin with an LDL-c reduction less than 25.6%; good response, subgroup pravastatin with an LDL-c reduction more than 25.6%.
© Copyright Policy - OpenAccess
Related In: Results  -  Collection

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

Fig5: Effects of phytosterols on patients who had good response and poor response to pravastatin. Pravastatin, pravastatin monotherapy in Groups 1 and 2; combination combination therapy in Groups 1 and 2; poor response, subgroup pravastatin with an LDL-c reduction less than 25.6%; good response, subgroup pravastatin with an LDL-c reduction more than 25.6%.
Mentions: When the HIV patients were separated according to the reduction of LDL-c by pravastatin into good and poor response using the mean value of 25.6%, a trend of interaction was demonstrated between the addition of phytosterols and the responsiveness to pravastatin. Phytosterols reduced LDL-c further from a mean of 17.54 ± 6.30 to 31.88 ± 14.68% (p = 0.052) in the poor response group while adding phytosterols to the good response patients possibly interfered with the LDL-c reducing efficacy of pravastatin (33.64 ± 6.81 to 24.36 ± 13.16% (p = 0.132) (Figure 5).Figure 5

Bottom Line: 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 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.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