Tendon complications, though rare, linked to statins

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Tendon complications, though rare, linked to statins

http://www.eurekalert.org/pub_releases/2008-02/w-tct022708.phpTendon

complications, though rare, linked to statins

Statins, the most effective treatment for lowering cholesterol, are

widely used and have been demonstrated to be safe in large clinical

trials. Although side effects are usually mild, more severe side

effects, especially musculoskeletal complications, have been

reported. Tendon impairment has been reported anecdotally but has not

been included in large-scale studies. A new study published in the

March issue of Arthritis Care & Research

(http://www.interscience.wiley.com/journal/arthritiscare) found that,

although rare, tendon complications are linked to the use of statins.

Led by Noblet, of Rouen University Hospital in Rouen Cedex,

France, researchers identified 96 cases of tendon complications from

the French Pharmacovigilance database between 1990 and 2005 that were

attributed to statins. Tendon conditions included tendonitis and

tendon rupture. Patient data retrieved from computer database were as

follows: medical history, other medications they were taking

(especially those known to increase statin concentrations),

information about the onset, pattern and severity of their condition,

and the dosage and type of statin they took.

The results showed that of the 4,597 side effects associated with

statins, about two percent were attributed to tendon complications.

Symptoms usually occurred within 8 months of beginning statin

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. Seventeen of the patients had symptoms severe enough to

warrant hospitalization. The researchers were able to link the tendon

problems to statin use based on the fact that the symptoms appeared

after the statins were started, they improved when the statins were

stopped and they recurred in all of the patients who restarted the

therapy.

The authors note that tendon complications due to statins may be

largely unreported; no cases were reported during the large

therapeutic trials that included more than 30,000 patients, but this

may have been due to controlling for factors that predisposed

patients to tendon conditions. In this study, an increasing number of

patients with complications was seen with the increasing number of

prescriptions between 1990 and 2005. They also note that although the

prevalence of tendon problems in connection with statins is low, all

types of statins could potentially cause tendon problems, which

occurred at the recommended dosages.

" Our study suggests that regular tendinous clinical examination may

be required in statin-treated patients, particularly during the first

year following statin therapy initiation, " the authors state. They

also suggest that it is worth considering interrupting statin therapy

before strenuous physical activity such as marathon running.

Although it is not known how statins may produce tendon injury, there

are several theories. It may be that blocking cholesterol synthesis

reduces the cholesterol content of tendon cell membranes, making them

unstable, or that statins either reduce the levels of proteins

involved in maintaining tendon cells or destroy vascular smooth

muscle cells.

The authors suggest that although statins are effective, physicians

should be aware that their side effects 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 state, adding that postmarketing surveillance

appears to be a major tool for early detection of safety problems

with a new drug.

Article: " Tendinous Disorders Attributed to Statins: A Study on

Ninety-Six Spontaneous Reports in the Period 1990-2005 and Review of

the Literature, " Isabelle Marie, Hélène Delafenêtre, Nathalie Massy,

Christian Thuillez, Noblet, the Network of the French

Pharmacovigilance Centers, Arthritis Care & Research, March 2008.

Statins, the most effective treatment for lowering cholesterol, are

widely used and have been demonstrated to be safe in large clinical

trials. Although side effects are usually mild, more severe side

effects, especially musculoskeletal complications, have been

reported. Tendon impairment has been reported anecdotally but has not

been included in large-scale studies. A new study published in the

March issue of Arthritis Care & Research

(http://www.interscience.wiley.com/journal/arthritiscare) found that,

although rare, tendon complications are linked to the use of statins.

Led by Noblet, of Rouen University Hospital in Rouen Cedex,

France, researchers identified 96 cases of tendon complications from

the French Pharmacovigilance database between 1990 and 2005 that were

attributed to statins. Tendon conditions included tendonitis and

tendon rupture. Patient data retrieved from computer database were as

follows: medical history, other medications they were taking

(especially those known to increase statin concentrations),

information about the onset, pattern and severity of their condition,

and the dosage and type of statin they took.

The results showed that of the 4,597 side effects associated with

statins, about two percent were attributed to tendon complications.

Symptoms usually occurred within 8 months of beginning statin

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. Seventeen of the patients had symptoms severe enough to

warrant hospitalization. The researchers were able to link the tendon

problems to statin use based on the fact that the symptoms appeared

after the statins were started, they improved when the statins were

stopped and they recurred in all of the patients who restarted the

therapy.

The authors note that tendon complications due to statins may be

largely unreported; no cases were reported during the large

therapeutic trials that included more than 30,000 patients, but this

may have been due to controlling for factors that predisposed

patients to tendon conditions. In this study, an increasing number of

patients with complications was seen with the increasing number of

prescriptions between 1990 and 2005. They also note that although the

prevalence of tendon problems in connection with statins is low, all

types of statins could potentially cause tendon problems, which

occurred at the recommended dosages.

" Our study suggests that regular tendinous clinical examination may

be required in statin-treated patients, particularly during the first

year following statin therapy initiation, " the authors state. They

also suggest that it is worth considering interrupting statin therapy

before strenuous physical activity such as marathon running.

Although it is not known how statins may produce tendon injury, there

are several theories. It may be that blocking cholesterol synthesis

reduces the cholesterol content of tendon cell membranes, making them

unstable, or that statins either reduce the levels of proteins

involved in maintaining tendon cells or destroy vascular smooth

muscle cells.

The authors suggest that although statins are effective, physicians

should be aware that their side effects 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 state, adding that postmarketing surveillance

appears to be a major tool for early detection of safety problems

with a new drug.

Article: " Tendinous Disorders Attributed to Statins: A Study on

Ninety-Six Spontaneous Reports in the Period 1990-2005 and Review of

the Literature, " Isabelle Marie, Hélène Delafenêtre, Nathalie Massy,

Christian Thuillez, Noblet, the Network of the French

Pharmacovigilance Centers, Arthritis Care & Research, March 2008.