Treatment Intensification Required, Sooner if Possible, for Many Type 2 Diabetics

A new analysis of patient records published in Diabetes Care supports rapid treatment intensification when metformin monotherapy fails in patients with type 2 diabetes mellitus (T2DM), but finds that intensification is often delayed in practice.

Investigators used the Cleveland Clinic’s electronic health record to identify 5,239 patients diagnosed with T2DM between 2005 and 2013 who used metformin monotherapy for 3 months but never met initial goals for HbA1c goals. They then compared outcomes for patients who waited more than 6 additional months to intensify treatment with outcomes for patients who intensified treatment sooner.

Treatment was intensified early (i.e. within 6 months of metformin failure and 9 months of initial diagnosis) in 62% of patients whose HbA1c exceeded a 7% target, 69% of patients whose HbA1c exceeded a 7.5% target and 72% of patients whose HbA1c exceeded an 8% target at the 3-month mark.

Analysis showed that early treatment intensification was significantly associated with faster HbA1c control, regardless of whether a patient’s target was 8%, 7.5% or 7% (p < 0.05 for all). Analysis also showed that early intensification reduced the risk that a patient’s condition would never be controlled.

The new analysis is not the first to find evidence of delayed treatment intensification.

A study published earlier this year in Diabetes, Obesity and Metabolism used an insurance claims database to follow 11,525 patients whose HbA1c still exceeded 8% after 3 months on metformin. Just 37% of patients had their treatment intensified in the next 6 months, and just 11% had their treatment intensified in the 6 months after that. Some 52% did not have their treatment intensified a full year after the index date.

The authors of the Cleveland Clinic study called for further research to see whether rapid treatment intensification reduces the long-term risk of diabetic complications, but there is already some evidence that it does.

A 2015 study published in Cardiovascular Diabetology used the United Kingdom Clinical Practice Research Datalink to follow 105,477 patients diagnosed with T2DM between 1990 and 2012. Some 26% of patients whose HbA1c consistently exceeded 7% and 22% of those whose HbA1c consistently exceeded 7.5% went more than 2 years without treatment intensification. Analysis of those patients showed that a 1-year delay in intensification was associated with significantly increased risk of myocardial infarction (HR, 1.67; 95% CI, 1.39-2.01), stroke (HR, 1.51; 95% CI, 1.25-1.83), heart failure (HR, 1.64; 95% CI, 1.40-1.91) a composite of macrovascular events (HR, 1.62; 95% CI, 1.46-1.80).

A 2015 study published in Diabetes Research and Clinical Practice surveyed physicians to see why some of them stick with monotherapy when guidelines from the American Association of Clinical Endocrinologists (AACE) advise them to use combination therapy.

Some 1,235 primary care physicians and 290 specialists reviewed medical charts (which all qualified patients for combination therapy) and rated the relevance of 22 reasons for sticking with monotherapy.

Among the answers that participants consistently deemed most relevant were “Monotherapy is easier to handle than dual therapy” and “I believe that monotherapy and changes in lifestyle are enough for hyperglycemia control” and “Patient has mild hyperglycemia.”