Glycemic Control Not Improved and Rates of Severe Hypoglycemia Unchanged, 2006–2013
abstract
This abstract is available on the publisher's site.
Access this abstract nowOBJECTIVE
To examine temporal trends in utilization of glucose-lowering medications, glycemic control, and rate of severe hypoglycemia among patients with type 2 diabetes (T2DM).
RESEARCH DESIGN AND METHODS
Using claims data from 1.66 million privately insured and Medicare Advantage patients with T2DM from 2006 to 2013, we estimated the annual 1) age- and sex-standardized proportion of patients who filled each class of agents; 2) age-, sex-, race-, and region-standardized proportion with hemoglobin A1c (HbA1c) <6%, 6 to <7%, 7 to <8%, 8 to <9%, ≥9%; and 3) age- and sex-standardized rate of severe hypoglycemia among those using medications. Proportions were calculated overall and stratified by age-group (18-44, 45-64, 65-74, and ≥75 years) and number of chronic comorbidities (zero, one, and two or more).
RESULTS
From 2006 to 2013, use increased for metformin (from 47.6 to 53.5%), DPP-4 inhibitors (0.5 to 14.9%), and insulin (17.1 to 23.0%) but declined for sulfonylureas (38.8 to 30.8%) and thiazolidinediones (28.5 to 5.6%; all P < 0.001). The proportion of patients with HbA1c <7% declined (from 56.4 to 54.2%; P < 0.001) and with HbA1c ≥9% increased (9.9 to 12.2%; P < 0.001). Glycemic control varied by age and was poor among 23.3% of the youngest and 6.3% of the oldest patients in 2013. The overall rate of severe hypoglycemia remained the same (1.3 per 100 person-years; P = 0.72), declined modestly among the oldest patients (from 2.9 to 2.3; P < 0.001), and remained high among those with two or more comorbidities (3.2 to 3.5; P = 0.36).
CONCLUSIONS
During the recent 8-year period, the use of glucose-lowering drugs has changed dramatically among patients with T2DM. Overall glycemic control has not improved and remains poor among nearly a quarter of the youngest patients. The overall rate of severe hypoglycemia remains largely unchanged.
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Additional Info
Disclosure statements are available on the authors' profiles:
Trends in Drug Utilization, Glycemic Control, and Rates of Severe Hypoglycemia, 2006-2013
Diabetes Care 2016 Sep 22;[EPub Ahead of Print], KJ Lipska, X Yao, J Herrin, RG McCoy, JS Ross, MA Steinman, SE Inzucchi, TM Gill, HM Krumholz, ND ShahFrom MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.
Diabetes Rx: Poor Return on Investment With Some Harm
The last 10 years have seen significant increases in pharmaceutical options for treating diabetes. These innovative treatments include DPP-4 inhibitors, GLP-1 agonists, and new forms of insulin. Billions of dollars have been invested, and the cost of treating a diabetic patient has doubled from 1987 to 2011, which is mainly a result of the drugs we prescribe.
The study by Lipska et al evaluated a large database of 1.66 million diabetics from 2006 to 2013.1 During this timeframe, metformin, DDP-4 inhibitor, GLP-1 agonist, and insulin use rose, while sulfonylurea and thiazolidinedione use decreased. This trend is in part related to the drive to reduce hypoglycemia risk while improving control, which these newer drugs were meant to accomplish.
Despite this significant investment, this study did not show improvement in diabetic control or a reduction in hypoglycemic events (hypoglycemia rates remained the same). Part of this may be related to less-stringent guidelines for HgA1c control, particularly in older diabetic populations. To be balanced, this study did not look at outcomes or mortality rates. It is possible that these new drugs are having a positive effect on lifespan.
“Return on investment” and “first do no harm” are common mantras in this age of value-driven care. Another study published in this issue of Diabetes Care examined the incidence of pancreatitis with one of these new classes of drugs, DPP-4 inhibitors.2 The authors found a 79% relative risk of acute pancreatitis compared with placebo. But, to put this in perspective, this was only a 0.13% absolute risk (1–2 cases over 2 years).
The challenge of treating a complex process such as diabetes, which involves thousands of chemical and hormonal pathways, with a drug that just addresses a few has always felt myopic. Imagine if we invested this much money in empowering a healthy lifestyle that increases movement and consumption of whole foods while educating how to reduce stress. These work on thousands of pathways that improve outcomes with an excellent return on investment and incur little harm.
Health is more about what we do than what we take. How do we pay for that?
References
Our once-simple messaging to primary care providers and people with diabetes, suggesting an A1c goal of <7% for almost everyone, has evolved over the past decade into more nuanced guidelines. Emerging evidence supports individualization of glycemic goals and choices of drug classes, and concerted efforts to avoid hypoglycemia in older or more complex patients. But are these evidence-based guidelines translating into improved outcomes? The analyses by Lipska and colleagues suggest, depressingly, that they may not be.
Using claims data from 1.66 million patients with type 2 diabetes, the researchers documented significant trends in drug utilization from 2006 to 2013. Thiazolidinedione use declined markedly, likely in part due to the rosiglitazone brouhaha that began in 2007. Sulfonylurea use declined from 39% to 31%, use of the relatively new DPP-4 inhibitors increased to 15% of patients, and insulin use increased from 17% to 23% of patients. Despite dramatic changes in drug therapy, average glycemic control was relatively stable. Most concerning was that rates of severe hypoglycemia were unchanged, although there was a modest reduction in those over 75 years of age.
The Lipska study is consistent with other studies showing that vulnerable patients are often over-treated and that rates of severe hypoglycemia remain too high. That this is occurring despite growing use of costly newer diabetes drugs suggests that pharmaceutical marketing messages are being heard, while our more nuanced guidelines are not.