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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

CONSORT flow diagram.
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Fig2: CONSORT flow diagram.

Mentions: Thirty-nine HIV patients were screened and 36 HIV patients were enrolled into the study from 22 November 2012 to 27 February 2014. There were 34 subjects who completed the first phase and 33 patients who completed the second phase. Two subjects were lost to follow-up before the end of the first phase and one subject was excluded from the analysis due to adverse effects. Thirty-three subjects who completed the second phase were included into the primary outcome analysis and 34 subjects who completed the first phase were included into secondary outcome analysis (Figure 2). The baseline characteristics of each treatment group are summarized in Table 2. There were no differences in the baseline characteristics among the 4 treatment groups. The mean age of all patients was 44.68 ± 7.4 years old, mean BMI was 22.60 ± 2.83 kg/m2, mean HIV duration was 7.91 ± 5.4 years, and the mean CD4 status was 561.47 ± 316.10 cells/cmm. Of the 36 patients, 63.9% were male. One subject had diabetes, one subject had hypertension, four subjects were using PIs and three subjected had unsuppressed HIV viral load. The baseline means of the TC, TG, HDL-c, and LDL-c levels in the 36 HIV patients were 248.09 ± 34.73, 172.36 ± 125.44, 54.92 ± 16.67, and 175.13 ± 29.00 mg/dl, respectively. The baseline LDL-c levels in Groups 1–4 were 172.76 ± 43.23, 187.78 ± 26.46, 162.80 ± 11.29, and 180.68 ± 41.86 mg/dl, respectively. One subject was determined as noncompliant.Figure 2


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)

CONSORT flow diagram.
© Copyright Policy - OpenAccess
Related In: Results  -  Collection

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

Fig2: CONSORT flow diagram.
Mentions: Thirty-nine HIV patients were screened and 36 HIV patients were enrolled into the study from 22 November 2012 to 27 February 2014. There were 34 subjects who completed the first phase and 33 patients who completed the second phase. Two subjects were lost to follow-up before the end of the first phase and one subject was excluded from the analysis due to adverse effects. Thirty-three subjects who completed the second phase were included into the primary outcome analysis and 34 subjects who completed the first phase were included into secondary outcome analysis (Figure 2). The baseline characteristics of each treatment group are summarized in Table 2. There were no differences in the baseline characteristics among the 4 treatment groups. The mean age of all patients was 44.68 ± 7.4 years old, mean BMI was 22.60 ± 2.83 kg/m2, mean HIV duration was 7.91 ± 5.4 years, and the mean CD4 status was 561.47 ± 316.10 cells/cmm. Of the 36 patients, 63.9% were male. One subject had diabetes, one subject had hypertension, four subjects were using PIs and three subjected had unsuppressed HIV viral load. The baseline means of the TC, TG, HDL-c, and LDL-c levels in the 36 HIV patients were 248.09 ± 34.73, 172.36 ± 125.44, 54.92 ± 16.67, and 175.13 ± 29.00 mg/dl, respectively. The baseline LDL-c levels in Groups 1–4 were 172.76 ± 43.23, 187.78 ± 26.46, 162.80 ± 11.29, and 180.68 ± 41.86 mg/dl, respectively. One subject was determined as noncompliant.Figure 2

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