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Rosuvastatin versus pravastatin in dyslipidemic HIV-1-infected patients receiving protease inhibitors: a randomized trial

Aslangul, Elisabetha,b; Assoumou, Lambertc,d; Bittar, Randae,f; Valantin, Marc-Antoinec,d,g; Kalmykova, Olgac,d; Peytavin, Gillesh; Fiévet, Marie-Hélènei; Boccara, Franckj; Bonnefont-Rousselot, Dominiquee,f; Melchior, Jean-Claudek; Giral, Philippel; Costagliola, Dominiquec,d,g

doi: 10.1097/QAD.0b013e328331d2ab
Clinical Science

Background: HIV infection and its treatment with protease inhibitors, especially when boosted with ritonavir, can cause lipid disorders. Statins, with the exception of fluvastatin, pravastatin and rosuvastatin, interact with protease inhibitor metabolism via CYP450. Pravastatin is recommended for patients with protease inhibitor-associated dyslipidemia. Rosuvastatin is the statin most effective on low-density lipoprotein cholesterol (LDL-c) in non-HIV patients.

Methods: HIV-1-infected patients treated with boosted protease inhibitor were randomized to receive either rosuvastatin 10 mg/day or pravastatin 40 mg/day for dyslipidemia (LDL-c >4.1 mmol/l and triglycerides <8.8 mmol/l). The percentage change in LDL-c, triglyceride and high-density lipoprotein-cholesterol levels, measured in a central laboratory, was determined after 45 days of statin treatment.

Results: Eighty-eight patients were randomized and 83 took the study drugs, 41 rosuvastatin and 42 pravastatin. The median duration of prior antiretroviral treatment was 9 years. At baseline, the median LDL-c level was 4.93 mmol/l, the triglyceride level 2.29 mmol/l, and the high-density lipoprotein-cholesterol level 1.27 mmol/l. The median percentage changes in the rosuvastatin and pravastatin arms were −37 and −19% for LDL-c (P < 0.001), respectively, and −19 and −7% for triglycerides (P = 0.035), respectively. The change in the high-density lipoprotein-cholesterol level was not significantly different between the two arms. None of the four severe adverse events was attributed to the statins; in particular, there were no renal, hepatic or muscular events.

Conclusion: Rosuvastatin 10 mg/day was more effective than pravastatin 40 mg/day on LDL-c and triglyceride levels in HIV-1-infected patients receiving a boosted protease inhibitor.

aUniversité Paris Descartes, France

bAssistance Publique-Hôpitaux de Paris, Hôtel Dieu, Médecine Interne, France

cINSERM U943, France

dUPMC Univ Paris 06, UMR S 943, France

eBiochimie des Maladies Métaboliques, Service de Biochimie Métabolique, Groupe Hospitalier Pitié-Salpétrière Assistance Publique-Hôpitaux de Paris, France

fFaculté des Sciences Pharmaceutiques et Biologiques, EA 3617, Département de Biochimie, Université Paris Descartes, France

gAP-HP, Groupe Hospitalier Pitié-Salpétrière, Service des Maladies Infectieuses et Tropicales, France

hLaboratoire de Toxicologie et Pharmacocinétique, Groupe Hospitalier Bichat – Claude Bernard, Assistance Publique-Hôpitaux de Paris, France

iPharmacy, Groupe Hospitalier Pitié-Salpêtrière, France

jService de Cardiologie, Hôpital Saint Antoine, Assistance Publique-Hôpitaux de Paris, France

kService de Maladies Infectieuses, Hôpital Raymond Poincarré, Assitance Publique-Hôpitaux de Paris, Garches, France

lUnités de Prévention cardiovasculaire, Service d'Endocrinologie-Métabolisme, Groupe Hospitalier Pitié-Salpétrière, Assistance Publique-Hôpitaux de Paris, Paris, France.

Received 6 May, 2009

Revised 11 August, 2009

Accepted 11 August, 2009

Correspondence to Elisabeth Aslangul, MD, PhD, Service de Médecine Interne, Hôtel Dieu, 1 Place du Parvis Notre Dame, 75004 Paris, France. Tel: +33 1 42 34 80 84; fax: +33 1 42 34 85 88; e-mail: elisabeth.aslangul@htd.aphp.fr

© 2010 Lippincott Williams & Wilkins, Inc.