In a trial called Saturn, researchers randomly assigned users of potent combination anti-HIV therapy (ART) to receive one of the following daily interventions:
Participants were mostly middle-aged men and had blood tests suggestive of heightened inflammation.
On average, levels of bad cholesterol (LDL-C) in blood samples of participants taking rosuvastatin fell between 20% and 25% during the first six months of the study. This was sustained for the duration of the trial. Furthermore, participants taking rosuvastatin developed only a very modest narrowing of their arteries compared to placebo users. In some assessments, rosuvastatin appeared to reduce HIV-related immune activation.
Researchers recruited HIV-positive adults taking ART who did not have coronary artery disease or uncontrolled diabetes. Blood tests revealed that participants had elevated levels of inflammation and immune activation. Participants also underwent high-resolution CT scans of the chest. This imaging technique can reveal deposits in arteries. Arteries that have more deposits become narrow and less flexible and less able to help blood flow. Narrowing of the arteries is a well-established measure of cardiovascular disease.
Researchers randomly assigned 72 people to receive rosuvastatin and 75 people to receive placebo.
The average profile of participants at the start of the study was as follows:
In total, 28 participants prematurely left the study, distributed as follows:
None of the 19 people left because of perceived or actual side effects. One person could not be assessed because of a poor CT scan. This left 118 people whose data could be assessed at week 96.
On average, participants who took rosuvastatin had their levels of bad cholesterol (LDL-C) fall between 20% and 25%. This change was statistically significant compared to placebo users and was maintained throughout the study.
Changes in levels of good cholesterol (HDL-C) and triglycerides were not statistically significant between rosuvastatin and placebo users.
Arteries carry fresh oxygen-rich blood to tissues and organs. In both aging and cardiovascular disease, arteries narrow as substances are deposited in them.
Participants who used rosuvastatin appeared to have only very minor and slow narrowing of the arteries over the course of the study compared to placebo users. This occurred regardless of age, gender, use of protease inhibitors or if participants had pre-diabetes or diabetes.
According to tests that are generally used in studies of immune activation and inflammation in HIV, rosuvastatin did not reduce such activation on T-cells. However, it did reduce the level of activation on another group of the immune system's cells called monocytes. As these cells play a role in the formation of blood clots, their reduced activation by rosuvastatin may prove to be beneficial in the long term
Rosuvastatin was able to significantly reduce levels of bad cholesterol in ART users. Its impact on other lipids was relatively modest.
Rosuvastatin was able to reduce levels of some activated cells of the immune system.
There were no heart attacks in this study -- it only lasted for two years and contained a relatively small number of participants, none of whom had a history of cardiovascular disease.
Other analyses from Saturn show that rosuvastatin has no harmful effect on bone density. It may help to slightly increase leg muscle mass.
A major question that remains unanswered is this: Will rosuvastatin significantly reduce heart attacks in the long term among HIV-positive people? Unfortunately, Saturn was not designed to answer this question; the study focused on lab and other test results rather than a hard endpoint such as heart attacks. The reason for this focus on lab and other tests is that heart attacks are not common events. A much larger and longer study is needed to provide answers about the use of a statin and hard endpoints such as heart attacks and stroke. Such a study (called Reprieve) has been designed and will take place in Canada using a different statin called pitavastatin. The next report in TreatmentUpdate focuses on the Reprieve study.
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