A widely used cholesterol-lowering medicine may carry a small but important risk for the kidneys, especially when taken at higher doses.
Researchers from Johns Hopkins University found that people taking rosuvastatin had higher rates of several kidney problems than people taking another common statin.
Rosuvastatin belongs to a family of medicines called statins. These drugs lower LDL cholesterol, often called “bad” cholesterol, and can greatly reduce the risk of heart attacks and strokes in people who need treatment.
Statins are among the most commonly prescribed medicines in the world and are generally considered safe. However, different statins are not identical, and researchers continue to study whether some may have particular risks for certain patients.
Questions about rosuvastatin and kidney health are not entirely new. When the U.S. Food and Drug Administration reviewed the medicine before approval, some patients taking it were found to have blood or protein in their urine.
Blood in the urine is known as hematuria, while protein in the urine is called proteinuria. Both can have many causes, but they may sometimes be warning signs that the kidneys are under stress or have been damaged.
To better understand the possible risk, the Johns Hopkins researchers examined electronic health records collected between 2011 and 2019. They compared more than 150,000 people who started rosuvastatin with nearly 800,000 people who started atorvastatin, another widely prescribed statin.
During about three years of follow-up, 2.9% of people taking rosuvastatin developed blood in their urine and 1% developed protein in their urine. Compared with atorvastatin users, rosuvastatin users had an 8% higher risk of hematuria and a 17% higher risk of proteinuria.
The researchers also found a 15% higher risk of serious kidney failure among people taking rosuvastatin. In these severe cases, kidney function had declined enough for patients to require treatments such as dialysis or a kidney transplant.
The difference became more concerning at higher doses. The study found that the risk of kidney problems increased as the dose of rosuvastatin rose, suggesting that patients receiving larger amounts of the medicine may require particular attention.
People who already had serious kidney disease were another concern. The kidneys help remove rosuvastatin from the body, so poor kidney function can increase exposure to the drug and is one reason dose limits are recommended for these patients.
Yet the researchers found that 44% of patients with severe kidney disease received rosuvastatin doses above the level recommended by the FDA for people with poor kidney function. This suggests that recommended dose adjustments may not always be followed in everyday medical care.
Importantly, rosuvastatin and atorvastatin provided similar heart-related benefits in the study. That finding raises the possibility that doctors could consider kidney safety along with cholesterol reduction when deciding which statin and dose are most suitable for an individual patient.
The study does not mean that people taking rosuvastatin should suddenly stop their medicine. Statins can prevent serious cardiovascular problems, and stopping treatment without medical advice could increase the risk of heart attack or stroke.
Instead, patients with kidney disease or concerns about their dose can discuss the issue with their doctor. Doctors may consider kidney function, the amount of cholesterol reduction needed and other health factors when choosing a statin.
The research was published in the Journal of the American Society of Nephrology. The findings highlight why medicines need continued study after approval, when researchers can examine their effects across much larger and more diverse groups of patients.
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