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Changes in lipid-lowering therapies suggest intolerance common in type 2 diabetes
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In patients with type 2 diabetes at high risk for cardiovascular disease, index statin treatment adjustments suggesting statin intolerance and/or inadequacy appear to be common, according to recent findings.
Ruben G. W. Quek , PhD, of Amgen Inc., and colleagues identified 6,063,446 adults with type 2 diabetes with outpatient pharmacy claims for statins and/or Zetia (ezetimibe, Merck) between Jan. 1, 2007 and June 30, 2011, from the IMS LifeLink Pharmetrics Plus commercial claims database.
Participants were divided into three high-risk categories: history of cardiovascular event (n = 9,823; mean age, 59 years; 66% men), two risk factors (older age, hypertension; n = 62,049; mean age, 57 years; 62% men) and age 40 years or older (n = 128,691; 55% men).
The researchers defined the study’s primary outcomes as intensity of index statins, treatment alterations (dose escalation, reduction, augmentation, switching to nonindex statin, reinitiation or permanent discontinuation), potential related issues of statin/nonstatin tolerance or ineffectiveness (based on type of treatment adjustment) and time-to-treatment alteration among the three groups. Participants were also grouped by age: younger than 65 years, or 65 years and older.
Researchers found that among participants younger than 65 years in all three groups, 65.6% to 77.6% of participants began treatment with a moderate-intensity statin, and 7.7% to 25.2% of patients initiated a regimen of high-intensity statins with similar patterns seen annually from 2007 to 2011.
Among participants younger than 65 years, the percentages of participants with at least one treatment modification were as follows for the three groups: history of CV event, 81.4%; two risk factors, 75.6%; and aged 40 years or older, 77.9%. The most common first treatment adjustment among all three groups was reinitiation, followed by switches to a nonindex statin. Among participants in all three groups, the average number of days to the first treatment adjustment ranged from 131 to 394 days. The average interval to reinitiation was the longest in all cohorts (> 1 year), while time-to-augmentation was the shortest interval.
In participants younger than 65 years, at least one second treatment modification was seen in the following percentages of each group: history of CV event, 51.8%; two risk factors, 44.4%; and aged 40 or more years, 47.1%. Reinitiation was the most prevalent second treatment adjustment. The average number of days from index treatment to second treatment adjustment across all cohorts ranged from 307 to 607 days.
According to researchers, this study is the first to employ a real-world, retrospective, claims-based approach to demonstrate the prevalence of lipid-lowering treatment modifications implying potential treatment intolerance/ineffectiveness in type 2 diabetes with high CVD risk.
“Low use of high-intensity statin found in this study also indicates gaps in the management of hyperlipidemia among patients with type 2 diabetes and possible remaining unaccounted lipid residual risk,” the researchers wrote. “Better management of these patients with diabetes is warranted to reduce their CVD risk.” – by Jennifer Byrne
Disclosure: Quek reports being an employee and stockholder of Amgen Inc. Please see the full study for a list of all other authors’ relevant financial disclosures.
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