Rosuvastatin (Crestor) is a safe and effective treatment for increased levels of cholesterol and triglycerides caused by protease inhibitors (PIs), according to the results of an Italian pilot study published in the July 1st edition of AIDS.
Hyperlipidaemia has been increasingly seen in HIV-positive individuals since the introduction of highly active antiretroviral therapy (HAART). Pravastatin (Lipostat), atorvastatin (Lipitor) and fluvastatin (Lescol) are currently recommended for the treatment of dyslipidaemia caused by protease inhibitors, although a low risk of interaction exists.
Rosuvastatin has been shown to be highly effective at lowering low-density lipoprotein (LDL)-cholesterol and pharamacokinetic studies have shown that it is not metabolised using the P450 pathway, and that there would therefore be a low risk of interaction with protease inhibitors.
In the early summer of 2004, 16 HIV-positive patients with persistently elevated blood lipids were enrolled onto a pilot study to evaluate the safety and efficacy of rosuvastatin for the treatment of dyslipidaemia caused by protease inhibitors.
All 16 patients had been taking a protease inhibitor-containing HAART regimen including a protease inhibitor for at least twelve months and had a viral load below 50 copies/ml.
Hypercholesterolaemia was defined as fasting cholesterol levels of 240mg/dl or greater and hypertriglyceridaemia as fasting triglycerides of 200mg/dl or greater.
All 16 patients had a six month history of elevated lipids and had unsuccessfully tried diet and exercise to reduce levels of blood fats before treatment with a 10mg daily dose of rosuvastatin was started. Treatment lasted 24 weeks.
“The addition of rosuvastatin led to a statistically significant reduction in plasma total cholesterol, LDL-cholesterol and triglyceride levels”, note the investigators.
After 24 weeks, total cholesterol was reduced by a median of 21% and triglycerides by 31%.
The drug was well tolerated, the only reported side-effects being mild and transient gastrointestinal problems by two patients. No laboratory abnormalities were reported.
“Therapy with rosuvastatin for 24 weeks proved effective in the management of hyperlipidaemia in protease inhibitor-treated patients, and was associated with a favourable tolerability profile”, conclude the investigators.
Caza L et al. Rosuvastatin for the treatment of hyperlipidaemia in HIV-infected patients receiving protease inhibitors: a pilot study. AIDS 19 (10): 1103 – 1105, 2005.