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Statin use linked to few side effects

drugs_pillsStatins — the popular class of cholesterol-lowering drugs used widely to prevent recurrent heart disease and a first event — appear to cause few side effects, according to new research conducted by Huseyin Naci from LSE Health, Jasper Brugts from Erasmus Medical Center and Professor Tony Ades from the University of Bristol.

In their paper, published in Circulation: Cardiovascular Quality and Outcomes, Naci and colleagues conducted the largest meta-analysis on statin side effects to date, reviewing data from 135 previous drug studies to evaluate the safety of the seven statins on the market. They concluded that “as a class, adverse events associated with statin therapy are not common.”

The researchers noted that simvastatin and pravastatin, the generic names of the brands Zocor and Pravachol, were found to have the best safety profile in the class. This is particularly true when patients were prescribed low to moderate doses of those statins, said the study’s lead author Huseyin Naci, a doctoral candidate at the London School of Economics and Political Science and research fellow at Harvard Medical School’s Department of Population Medicine.

Researchers also noted a nine per cent increased risk of diabetes among statin users. But according to a previous landmark study, 250 patients need to be treated with a statin for one case of diabetes to be diagnosed. Naci said: “I am concerned that patients may misunderstand this small increase in risk and stop adhering to their medications.”

The proven ability of statins to significantly cut the rate of death and hospitalization in patients who have heart disease outweighs the “small increase in diabetes risk,” he said.

Researchers reviewed trials published between 1985 and early 2013, which included a total of almost 250,000 patients. On average, the trials lasted a bit longer than a year. Some compared one statin to another, while others compared a statin to an inactive placebo, which is often called a sugar pill or dummy pill.

The study also found that statins were not linked to an increase in cancer risk. However, the drugs were associated with a typically reversible increase in liver enzymes, which, Naci said, still resulted in a very low rate of actual liver toxicity in statin patients.

“Although the benefits of statins clearly outweigh risks at the population level, individualising such benefits and risks is more difficult,” he said. “This brings into sharp focus the importance of correctly identifying the set of individuals who stands to benefit from statin therapy.”

The results, Naci said, should be used to help doctors determine the best course of treatment for certain patients. For example, patients who have elevated cholesterol levels but not heart disease don’t reap the same benefits from taking statins as those with heart disease.

“Caution is warranted before prescribing statins to individuals at low risk of developing cardiovascular disease. Statins are only modestly effective in reducing mortality and morbidity in individuals with low risk of developing cardiovascular disease. Although the risk of developing diabetes is low, what this risk would amount to over time is simply not known based on the existing evidence,” Naci said.

'Comparative Tolerability and Harms of Individual Statins' is co-authored by Huseyin Naci from LSE Health, Jasper Brugts from Erasmus Medical Center and Professor Tony Ades from the University of Bristol. The study, which was conducted at the London School of Economics and Political Science, received no funding.

Ends

Contact: Huseyin Naci at h.naci@lse.ac.uk|

Jess Winterstein, LSE Press Office, 020 7107 5025, j.winterstein@lse.ac.uk|

10 July 2013

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