Predicting the Adverse Risk of Statin Treatment: An Independent and External Validation of Qstatin Risk Scores in the UK

Study Questions:

How do the QStatin scores perform for predicting the 5-year risk of developing acute renal failure, cataract, liver dysfunction, and myopathy in men and women in England and Wales receiving statins?

Methods:

This was a prospective cohort study to evaluate the performance of four statin risk prediction models. Three hundred and sixty-four practices in the United Kingdom contributed to the Health Improvement Network database. A total of 2.2 million patients ages 35–84 years registered with a general practice surgery between January 1, 2002 and June 30, 2008, with 2,037 incident cases of acute renal failure, 25,692 incident cataract cases, 14,756 cases of liver dysfunction, and 1,209 incident cases of myopathy included in the analysis. The main outcome measures were first recorded occurrence of acute renal failure, cataract, moderate or severe liver dysfunction, and moderate or severe myopathic events, as recorded in general practice records.

Results:

Results from this independent and external validation of QStatin scores indicate that models predicting the 5-year statin risk of developing acute renal failure, cataracts, and myopathy perform well with areas under the receiver operating characteristic curve ranging from 0.73 to 0.87. Calibration plots for the three models also indicated close agreement between observed and predicted risks. Poor performance was observed for the model predicting the 5-year statin risk of developing liver dysfunction, with areas under the receiver operating characteristic curve of 0.64 and 0.60 for women and men, respectively.

Conclusions:

The authors concluded that the QStatin scores for predicting the 5-year statin risk of developing acute renal failure, cataract, and myopathy appear to be useful models with good discriminative and calibration properties.

Perspective:

This study reports very good performance for the models predicting the 5-year statin risk of acute renal failure and cataracts, and moderately good performance data supporting the model for myopathy. However, the results also highlight the poor performance in calibration and discrimination for the model predicting the 5-year statin risk for liver dysfunction and, as such, should not be routinely used in practice. Clinicians can use these scores during a clinic visit to discuss with their patients the balance between risks and benefits of starting statin treatment.

Clinical Topics: Dyslipidemia, Nonstatins, Novel Agents, Statins

Keywords: Outcome Assessment (Health Care), Hydroxymethylglutaryl-CoA Reductase Inhibitors, Acute Kidney Injury, Cardiovascular Diseases, Cataract, ROC Curve, Risk Assessment, Muscular Diseases, Liver Diseases, England


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