Wednesday 29 June, 2016 13.00 EDT
Statins—Overall many benefits and a few risks
Statins are a group of medicines that work in a particular way to reduce the body’s production of cholesterol. Examples of potent statins in common use include atorvastatin (Lipitor) and rosuvastatin (Crestor). As a result of their inhibition of cholesterol manufactured within a cell, and possibly other actions at the molecular level, statins have been found to reduce the risk for heart attacks and other cardiovascular complications in several clinical trials in HIV-negative people.
Analyses of data from clinical trials suggest that a minority of participants that take statins is at increased risk for the following side effects:
- muscle pain and weakness
- very rare cases of liver injury
- rising levels of blood sugar that approach the high end of the normal range—a prelude to developing pre-diabetes and diabetes
However, the risk for developing diabetes among statin users is not evenly distributed. In a recent analysis of data from a very large clinical trial called Jupiter, in which participants received either rosuvastatin or fake rosuvastatin (placebo), researchers found that only participants who had “one or more major diabetes risk factors were at highest risk of developing diabetes than those without a major risk factor.”
Furthermore, researchers found that the many benefits of taking a statin such as rosuvastatin outweighed the smaller risk of developing diabetes.
A note on side effects
Researchers at Harvard University conducted a review of hospital records from nearly 108,000 patients, focusing on their interruption of statin therapy. The researchers found that in about 18% of cases, patients likely discontinued statins because of side effects. This figure of 18% is not vastly different from the figures reported for side effects from rosuvastatin or placebo in the Jupiter study (between 15% and 16% of participants in Jupiter reported side effects, as mentioned in the report on that study that follows). What was interesting about the Harvard study is the following statement made by the researchers:
“We found that the majority—over 90%—of patients who were rechallenged with a statin after a statin-related event were ultimately able to tolerate one. Few of the rechallenged patients had another statin-related event, and serious reactions, such as rhabdomyolysis [the breakdown of muscle, causing the release of the protein myoglobin into the blood; myoglobin is broken down into substances that can injure the kidneys] were quite rare….” Indeed, the researchers also stated that “overt rhabdomyolysis was found in only 0.006% of the study patients.”
These findings are important and worth considering when trying to get a picture of statin safety in the everyday world of hospital clinics.
Statins also have anti-inflammatory activity, and clinical trials are planned or underway with HIV-positive people to explore their possible beneficial effect. It is therefore possible that statins may become more widely prescribed by doctors who care for HIV-positive people either as part of a plan to help protect them from complications of cardiovascular disease or to help reduce excess inflammation.
Caution with drug interactions
Care must be taken when selecting a statin because of the potential for drug interactions. A consultation with a doctor and pharmacist can be useful for uncovering potential interactions between statins and HIV medicines and other prescription and over-the-counter medicines.
Flying by Jupiter
As a service to our readers, we explore an in-depth analysis of the clinical trial Jupiter, which studied the use of a modern and potent statin—rosuvastatin—and its possible relationship to diabetes and other side effects and what these might mean for people who take the drug. The advantage of examining trial data from Jupiter is that it was a very well-designed study with HIV-negative people. We also explore the interim results of another study called Saturn—a placebo-controlled study of rosuvastatin with HIV-positive people.
—Sean R. Hosein
- Ng B, MacPherson P, Haddad T, et al. Heart failure in HIV infection: focus on the role of atherosclerosis. Current Opinion in Cardiology. 2014 Mar;29(2):174-9.
- Zhang H, Plutzky J, Skentzos S, et al. Discontinuation of statins in routine care settings: a cohort study. Annals of Internal Medicine. 2013 Apr 2;158(7):526-34.