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Rare Tendon Complications Linked to Statin Use
NEW YORK -- March 24, 2008 -- According to study results published in the March 2008 issue of Arthritis Care & Research, tendon complications, although rare, may be linked to statin use.
Although statin-related adverse events usually are mild, more severe side effects, such as musculoskeletal complications, have been reported. Tendon impairment has been reported anecdotally, but it has not been included in large-scale studies.
Catherine Noblet, University Hospital, Rouen Cedex, France, and colleagues identified 96 cases of tendon complications (eg, tendonitis, tendon rupture) that were attributed to statin use between 1990 and 2005 from the French pharmacovigilance database. They retrieved data on patients' medical histories; other medications they were taking, particularly those known to increase statin concentrations; onset, pattern, and severity of their condition; and the dosage and type of statin they were given.
The results indicated that 4,597 adverse events were associated with statin use, and nearly 2% of those were attributed to tendon complications. Symptoms usually occurred within 8 months of initiating statin therapy.
The authors were able to ascertain that the tendon problems were associated with statin use because symptoms appeared after statin therapy was initiated, but they improved when the use of statins ceased; symptoms also recurred in patients who restarted the therapy.
Most patients had tendonitis, but some also suffered ruptured tendons. The most common tendon affected was the Achilles tendon, with pain, swelling, warmth, and stiffness as the most common symptoms. Some patients (n = 17) had symptoms severe enough to warrant hospitalization.
Tendon complications due to statin use may go largely unreported. There were no reported cases during large therapeutic trials that included more than 30,000 patients, but the authors suggested that controlling for factors that predispose patients to tendon conditions may have caused that result.
In this study, an increasing number of patients with complications was seen in tandem with the increasing number of prescriptions between 1990 and 2005. The prevalence of tendon problems in connection with statin use is low, but the researchers suggested that all types of statin use, even at the recommended dosages, could potentially cause tendon problems.
"Our study suggests that a regular tendinous clinical examination may be required in statin-treated patients, particularly during the first year following statin therapy initiation," the authors stated. Interrupting statin therapy before strenuous physical activity such as marathon running may also be considered.
It is not entirely known how statin use may produce tendon injury, but blocking cholesterol synthesis may reduce the cholesterol content of tendon cell membranes and make them unstable. The researchers also suggested that statins may either reduce the levels of proteins involved in maintaining tendon cells or destroy vascular smooth muscle cells.
The authors suggested that physicians should be aware of the adverse events of statins, which may include tendon complications. "We also suggest that patients who are at risk of developing statin-associated tendon manifestations and who require statins be routinely questioned about symptoms consistent with tendon involvement," they stated. Postmarketing surveillance, they added, could be a major tool for early detection of safety problems with a new drug.
SOURCE: Arthritis Care & Research, March 2008
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