Study highlights lack of guidance on deintensifying diabetic regimens

Patients with Type 2 diabetes often receive unnecessarily intensive treatment for long durations, increasing their risk of severe hypoglycaemia, research shows.

Rozalina McCoy (Mayo Clinic, Rochester, Minnesota, USA) and colleagues found that 25.5% of 31,542 diabetes patients identified in an administrative database received treatment that was more intensive than recommended in the guidelines for their particular glycated haemoglobin (HbA1c) level.

And this total included "nearly 20% of patients with clinical complexity whose advanced age and comorbidities placed them at risk for treatment-related adverse events without substantial long-term benefit", the team writes in JAMA Internal Medicine.

In all, 26.5% of patients with low clinical complexity and 18.7% of those with high clinical complexity were receiving intensive treatment. Furthermore, 76.0% of patients on an intensive regimen continued on the same medications even after they had achieved their target HbA1c level.

Intensive treatment came at a cost, especially in the complex cases. Among patients with low clinical complexity, the 2-year incidence of severe hypoglycaemia was 1.02% with standard treatment and increased nonsignificantly to 1.30% with intensive treatment. But among those with high clinical complexity, the corresponding incidences were 1.74% and 3.04%.

Complex cases had a significant 1.72-fold increased risk of severe hypoglycaemia versus low-complexity cases even with standard treatment, rising to a 3.05-fold increased risk with intensive treatment.

Being placed on a sulfonylurea or a meglitinide/glinide more than doubled patients' risk of having severe hypoglycaemia, but this did not underlie the increased risk associated with high clinical complexity.

In a related commentary, Eve Kerr and Timothy Hofer (University of Michigan Medical School, Ann Arbor, USA) say that the findings underline the lack of guidance on when intensive treatment should be stopped or reduced.

While noting that clinical trials of deintensification are needed, they stress that "we cannot wait for new evidence to accrue before we act."

The commentators say: "When guidelines are silent on the limits of generalization, the default in clinical practice and pharmaceutical marketing is often to generalize to the entire population all treatment benefits in the absence of definitive proof of harm."

They therefore call on guideline makers to specify the extent to which clinical trial findings can be generalised and to "be willing to make recommendations to avoid or stop treatment in cases in which the evidence for benefit is sparse and that for harms is more likely."

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