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Original Investigation |

Effect of Patients’ Risks and Preferences on Health Gains With Plasma Glucose Level Lowering in Type 2 Diabetes Mellitus

Sandeep Vijan, MD, MS1,2; Jeremy B. Sussman, MD, MS1,2; John S. Yudkin, MD, FRCP3; Rodney A. Hayward, MD1,2
[+] Author Affiliations
1Center for Clinical Management Research, Ann Arbor Veterans Affairs Hospital, Ann Arbor, Michigan
2Department of Internal Medicine, University of Michigan, Ann Arbor
3Department of Medicine, University College London, London, England
JAMA Intern Med. 2014;174(8):1227-1234. doi:10.1001/jamainternmed.2014.2894.
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Importance  Type 2 diabetes mellitus is common, and treatment to correct blood glucose levels is standard. However, treatment burden starts years before treatment benefits accrue. Because guidelines often ignore treatment burden, many patients with diabetes may be overtreated.

Objective  To examine how treatment burden affects the benefits of intensive vs moderate glycemic control in patients with type 2 diabetes.

Design, Setting, and Participants  We estimated the effects of hemoglobin A1c (HbA1c) reduction on diabetes outcomes and overall quality-adjusted life years (QALYs) using a Markov simulation model. Model probabilities were based on estimates from randomized trials and observational studies. Simulated patients were based on adult patients with type 2 diabetes drawn from the National Health and Nutrition Examination Study.

Interventions  Glucose lowering with oral agents or insulin in type 2 diabetes.

Main Outcomes and Measures  Main outcomes were QALYs and reduction in risk of microvascular and cardiovascular diabetes complications.

Results  Assuming a low treatment burden (0.001, or 0.4 lost days per year), treatment that lowered HbA1c level by 1 percentage point provided benefits ranging from 0.77 to 0.91 QALYs for simulated patients who received a diagnosis at age 45 years to 0.08 to 0.10 QALYs for those who received a diagnosis at age 75 years. An increase in treatment burden (0.01, or 3.7 days lost per year) resulted in HbA1c level lowering being associated with more harm than benefit in those aged 75 years. Across all ages, patients who viewed treatment as more burdensome (0.025-0.05 disutility) experienced a net loss in QALYs from treatments to lower HbA1c level.

Conclusions and Relevance  Improving glycemic control can provide substantial benefits, especially for younger patients; however, for most patients older than 50 years with an HbA1c level less than 9% receiving metformin therapy, additional glycemic treatment usually offers at most modest benefits. Furthermore, the magnitude of benefit is sensitive to patients’ views of the treatment burden, and even small treatment adverse effects result in net harm in older patients. The current approach of broadly advocating intensive glycemic control should be reconsidered; instead, treating patients with HbA1c levels less than 9% should be individualized on the basis of estimates of benefit weighed against the patient’s views of the burdens of treatment.

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Figure 1.
Quality-Adjusted Life Years (QALYs) Gained or Lost by Age and Treatment Burden

Quality-adjusted life years gained or lost by a treatment that leads to a 1% reduction in hemoglobin A1c level (from 8.5% to 7.5%) across 4 age groups and views of the burden of treatment.

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Figure 2.
Sensitivity Analysis: Changes in Quality-Adjusted Life Years (QALYs) per 100 Treatment Years

Variability in gains in QALYs from a 1% reduction in hemoglobin A1c (HbA1c) level for various age, utility, and starting HbA1c values.

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