Daijiworld Media Network – New York
New York, Feb 15: A major global analysis has found that the vast majority of commonly cited side effects linked to cholesterol-lowering statins are not supported by high-quality evidence, offering reassurance to millions who rely on the drugs.
Statins are among the most widely prescribed medications worldwide, with an estimated 200 million adults using them globally. In the United States alone, over 92 million adults take statins to manage high cholesterol. Despite their proven cardiovascular benefits, concerns about potential side effects often lead patients to hesitate or discontinue treatment.
The new meta-analysis, published on February 5 in The Lancet, was conducted by the Cholesterol Treatment Trialists’ Collaboration. Researchers reviewed data from 23 double-blind randomized controlled trials involving more than 150,000 participants — a methodology widely considered the gold standard for establishing cause and effect.
Participants had a mean age of 63 years, 72% were men, nearly half had existing cardiovascular disease, and about one in five had diabetes — a profile typical of patients prescribed statins.
Only 4 of 66 reported side effects linked to Statins
Out of 66 potential side effects examined across multiple organ systems — including gastrointestinal issues, respiratory problems, neurological symptoms and sleep disorders — only four were found to be attributable to statin use:
• Abnormal liver transaminases (indicating liver stress)
• Other liver function abnormalities
• Altered urinary composition (possible kidney-related changes)
• Edema (fluid buildup, usually in ankles or legs)
Experts emphasised that these side effects are uncommon and manageable.
Dr Donald Lloyd-Jones, past president of the American Heart Association and section chief of preventive medicine at Boston University School of Medicine, noted that drug labels often list all adverse events reported during trials — even those not caused by the medication.
“Just because something happened while a patient was taking a drug does not mean it was caused by it,” he explained.
He also pointed out that while relative risk increases may appear significant, the absolute event rates remain low.
What about muscle pain and diabetes?
Muscle pain (myopathy), one of the most frequently cited statin-related complaints, was not part of the primary four outcomes because it had been analysed separately in earlier research.
A 2022 review by the CTT Collaboration found that while there was a small increase in reported muscle symptoms, over 90% of cases were not actually caused by statins. Experts estimate that only about 5% of patients experience muscle aches directly attributable to the drug, and most cases can be managed with dose adjustments or switching medications.
Rare complications such as rhabdomyolysis — severe muscle breakdown — can occur but are considered extremely uncommon.
Another 2024 study by the same collaboration found a modest increase in new-onset type 2 diabetes, particularly with high-intensity statin regimens. However, experts stressed that this risk mainly affects individuals already predisposed to diabetes.
Importantly, untreated high cholesterol significantly raises the risk of heart attack and stroke — outcomes statins are proven to prevent.
Benefits outweigh the risks
Cardiologists say the findings should reassure both physicians and patients.
Experts highlighted that statins have been studied for decades and remain one of the most effective tools for preventing cardiovascular events.
The overarching message from researchers is clear: while statins are not entirely free of side effects, their risks are limited, well-defined, and far outweighed by their life-saving benefits in appropriately selected patients.
Clinicians are encouraged to have transparent conversations with patients — acknowledging real risks while placing them in proper context against the dangers of untreated cardiovascular disease.