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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

Baseline of serum LDL-c of phase 1 and phase 2 of each group. Baseline 1, baseline LDL-c level before the start of active treatments in phase 1; baseline 2 LDL-c level after the washout period; Group 1, pravastatin then combination; Group 2, combination then pravastatin; Group 3, phytosterols then combination; Group 4, combination then phytosterols.
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Fig3: Baseline of serum LDL-c of phase 1 and phase 2 of each group. Baseline 1, baseline LDL-c level before the start of active treatments in phase 1; baseline 2 LDL-c level after the washout period; Group 1, pravastatin then combination; Group 2, combination then pravastatin; Group 3, phytosterols then combination; Group 4, combination then phytosterols.

Mentions: The changes in the LDL-c levels of the 4 groups are shown in Figure 3. After the wash-out period, the LDL-c levels returned to similar baseline levels of the first phase (data not shown) except in Group 2 in which the second baseline was slightly but significantly lower than the first baseline. (186.19 ± 26.18 vs. 170.95 ± 32.31 mg/dL, p = 0.042). The statistical difference of carryover effect was not observed in this study (Additional file 1).Figure 3


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)

Baseline of serum LDL-c of phase 1 and phase 2 of each group. Baseline 1, baseline LDL-c level before the start of active treatments in phase 1; baseline 2 LDL-c level after the washout period; Group 1, pravastatin then combination; Group 2, combination then pravastatin; Group 3, phytosterols then combination; Group 4, combination then phytosterols.
© Copyright Policy - OpenAccess
Related In: Results  -  Collection

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

Fig3: Baseline of serum LDL-c of phase 1 and phase 2 of each group. Baseline 1, baseline LDL-c level before the start of active treatments in phase 1; baseline 2 LDL-c level after the washout period; Group 1, pravastatin then combination; Group 2, combination then pravastatin; Group 3, phytosterols then combination; Group 4, combination then phytosterols.
Mentions: The changes in the LDL-c levels of the 4 groups are shown in Figure 3. After the wash-out period, the LDL-c levels returned to similar baseline levels of the first phase (data not shown) except in Group 2 in which the second baseline was slightly but significantly lower than the first baseline. (186.19 ± 26.18 vs. 170.95 ± 32.31 mg/dL, p = 0.042). The statistical difference of carryover effect was not observed in this study (Additional file 1).Figure 3

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