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Randomized Controlled Trial
. 2016 Jun 15;11(6):e0157531.
doi: 10.1371/journal.pone.0157531. eCollection 2016.

Effects of Pitavastatin on Lipid Profiles in HIV-Infected Patients with Dyslipidemia and Receiving Atazanavir/Ritonavir: A Randomized, Double-Blind, Crossover Study

Asita Wongprikorn  1 , Chonlaphat Sukasem  2   3 , Apichaya Puangpetch  2   3 , Pawin Numthavej  4 , Ammarin Thakkinstian  4 , Sasisopin Kiertiburanakul  1
Affiliations
Randomized Controlled Trial

Effects of Pitavastatin on Lipid Profiles in HIV-Infected Patients with Dyslipidemia and Receiving Atazanavir/Ritonavir: A Randomized, Double-Blind, Crossover Study

Asita Wongprikorn et al. PLoS One. .

Abstract

Background: Dyslipidemia as a risk factor of cardiovascular disease is common especially in HIV-infected patients who are using protease inhibitors (PIs) including atazanavir. Pitavastatin has less drug-drug interactions and demonstrable efficacy in decreasing lipid levels in non HIV-infected individuals.

Materials and methods: This study was a randomized, double-blind, crossover study comparing the safety and efficacy of pitavastatin vs placebo in HIV-infected patients with dyslipidemia and receiving atazanavir/ritonavir (ATV/r). Patients were randomized to receive either placebo or pitavastatin for 12 weeks. The follow-up visits were every 4 weeks until the end of the study.

Results: A total of 12 HIV-infected patients were enrolled to each study group. Of all, 14 (58%) patients were men and mean (standard deviation, SD) age was 48.1 (1.8) years. At 12 weeks of treatment with pitavastatin compared to placebo; mean [95% confidence interval (CI)] total cholesterol (TC) was 207 (187.3, 226.8) mg/dL vs 246.3 (226.5, 266) mg/dL (p <0.001); mean (95% CI) triglyceride (TG) was 351.3 (193.2, 509.4) mg/dL vs 279.1 (121, 437.2) mg/dL (p = 0.269); mean (95% CI) high density lipoprotein (HDL) was 45.3 (40.4, 50.2) mg/dL vs 44.2 (39.3, 49.1) mg/dL (p = 0.354); and mean (95% CI) low density lipoprotein (LDL) was 113.2 (100.4, 126) mg/dL vs 145.6 (132.8, 158.4) mg/dL (p <0.001). Mean liver enzyme and median creatine phosphokinase levels were not statistically significant between patients receiving placebo and pitavastatin.

Conclusions: Pitavastatin decreases TC and LDL level at 12 weeks significantly and shows indifferent in hepatotoxicity and creatine phosphokinase levels compared to those of placebo. Thus, pitavastatin can be a good option of lipid-lowering agent in HIV-infected patients who are receiving ATV/r.

Trial registration: ClinicalTrials.gov NCT02442700.

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Conflict of interest statement

Competing Interests: All authors in this study have no relationship with Kowa Company Limited (Japan). Kowa Company Limited (Japan) supported only pitavastatin and its corresponding placebo, with no role in study design; data collection, analysis, and interpretation of data; writing of the paper; preparation of the manuscript; and/or decision to submit for publication. This does not alter the authors' adherence to PLOS ONE policies on sharing data and materials.

Figures

Fig 1
Fig 1. Flowchart of Subjects Participating in the Different Phases of Randomized Crossover Trial.
See this image and copyright information in PMC

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