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


CONCLUSIONS
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.
Université Paris Descartes, France. elisabeth.aslangul@htd.aphp.fr
Elisabeth
E
Aslangul
Lambert
L
Assoumou
Randa
R
Bittar
Marc-Antoine
MA
Valantin
Olga
O
Kalmykova
Gilles
G
Peytavin
Marie-Hélène
MH
Fiévet
Franck
F
Boccara
Dominique
D
Bonnefont-Rousselot
Jean-Claude
JC
Melchior
Philippe
P
Giral
Dominique
D
Costagliola
D000328:Adult; D000924:Anticholesteremic Agents / Q000627:therapeutic use*; D008078:Cholesterol, LDL / Q000097:blood; D050171:Dyslipidemias / Q000139:chemically induced / Q000188:drug therapy*; D005260:Female; D005464:Fluorobenzenes / Q000627:therapeutic use*; D015658:HIV Infections / Q000097:blood / Q000188:drug therapy*; D017320:HIV Protease Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D015497:HIV-1; D006801:Humans; D008297:Male; D008875:Middle Aged; D017035:Pravastatin / Q000627:therapeutic use*; D011743:Pyrimidines / Q000627:therapeutic use*; D000068718:Rosuvastatin Calcium; D013449:Sulfonamides / Q000627:therapeutic use*; D016896:Treatment Outcome; D019562:Viral Load
D000924:Anticholesteremic Agents; D008078:Cholesterol, LDL; D005464:Fluorobenzenes; D017320:HIV Protease Inhibitors; D011743:Pyrimidines; D013449:Sulfonamides; D000068718:Rosuvastatin Calcium; D017035:Pravastatin