Title : Are Newer Diabetes Drugs Improving Glycemic Control?
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Are Newer Diabetes Drugs Improving Glycemic Control?
Neither glycemic control nor severe hypoglycemia rates improved between 2006 and 2013 among US adults with diabetes type 2, despite a dramatic shift on the use of newer glucose-lowering drugs during that interval, new information shows.
The findings, from an analysis of claims data from 1.66 million privately insured and Medicare Advantage patients, were published online September 22 in Diabetes Care by endocrinologist Kasia J Lipska, MD, of Yale University, New Haven, Connecticut, and colleagues.
"We use a great number of medications to decrease glucose levels in people with diabetes. Our findings declare that we adopted them in this clinical practice when they became that you can purchase. However, we wouldn't find population-level improvements in glycemic control or rate of severe hypoglycemia. These effects were somewhat disappointing, ever since the newer agents cost additional and don't typically cause hypoglycemia," Dr Lipska told Medscape Medical News.
However, she says that this results ought not discourage prescribing of newer medications, especially in the recent comes from the cardiovascular end-point trials EMPA-REG, LEADER, and SUSTAIN-6 suggesting cardiovascular benefit which might be independent of glucose-lowering.
"We need more outcomes studies, including to the available older and cheaper agents, and we all can understand their impact beyond just glycemic control," she stressed.
Asked to comment, Michael A Bush, MD, an endocrinologist using the University of California, Los Angeles Geffen School of Medicine and coauthor from the American Association of Clinical Endocrinologists' type two diabetes management algorithm, points out which the period studied reflects any time when the dipeptidyl peptidase-4 (DPP-4) inhibitors were just becoming widely adopted as alternatives to your thiazolidinediones pursuing the reported concerns around the latter's cardiovascular safety, even so the data include very little usage of glucagonlike peptide 1 (GLP-1) receptor agonists no sodium glucose cotransporter-2 (SGLT2) inhibitors, which emerged later and therefore are now increasingly used.
"It's always interesting to discover the trends in pharma utilization with this country.…This paper represents 2006 to 2013. An endocrinologist would view 'new medications' for diabetes as GLP-1 agonists and SGLT2 inhibitors," Dr Bush told Medscape Medical News.
"I'd be very interested to discover, after SGLT2 inhibitors tend to be solidly employed in the diabetes world — and I think are going to — how that influences drug utilization on the next several years and what type of data may come out in relation to its both A1c attainment and hypoglycemia risk," he added.
Dramatic Shift in Drug Utilization
For your research, Dr Lipska and colleagues conducted a retrospective analysis of medical and pharmacy claims at a large database (OptumLabs Data Warehouse) that also includes more than 100 million enrollees within private insurance and Medicare Advantage plans through the entire United States. Study subjects were 1,657,610 adults with diabetes type 2 enrolled for a minimum of 1 year during 2006–2013.
From 2006 to 2013, there was clearly increases in the utilization of metformin (from 47.6% to 53.5%), DPP-4 inhibitors (0.5% to 14.9%), GLP-1 agonists (3.3% to.0%), and insulin (17.1% to 23.0%). Over the same time frame, declines were affecting the by using sulfonylureas (38.8% to 30.8%) and thiazolidinediones (28.5% to.6%). All changes were significant (P < .001).
The increased insulin use was driven primarily by uptake of insulin analogs, with increases in basal analogs from 10.9% to 19.3% and rapid-acting analogs from 6.7% to 11.6% (both P < .001).
Worsening of Glycemic Control Seen; Hypoglycemia Rates Unchanged
Laboratory testing for HbA1c was readily available for 26% on the total sample.
From 2006 to 2013, the proportion of patients with HbA1c quantities of 9% or greater rose from 9.9% to 12.2%, and also the proportion of such with HbA1c levels 8% to 9% increased from 9.9% to 10.6% (P for trend < .001).
At once, the proportion with HbA1c 7% to 8% didn't change significantly (23.8 to 23.0%, P = .31), while those achieving HbA 1c below 7% declined from 56.4% in 2006 to 54.2% in 2013 (P < .001).
Poor glycemic control (HbA1c> 9%) was most commonly encountered among the youngest patients but increased slightly after a while across all age ranges.
The finding of worsening glycemic control may need to do together with the 2008 publication on the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial data, which raised concerns in regards to a possible adverse cardiovascular mortality risk from intensive glycemic control, Dr Lipska and colleagues postulate.
Meanwhile, age- and sex-standardized rates of severe hypoglycemia requiring a hospital visit (emergency, admission, or observation) among people using diabetes medications were 1.3 events per 100 person-years both in years, 2006 and 2013 (P for trend as time passes 0.72).
Severe hypoglycemia was more common one of several oldest patients and others with multiple comorbidities in contrast to younger, healthier adults.
Cost vs Benefit
Dr Bush indicates that in addition for the need for new glycemic data for patients using GLP-1 agonists and SGLT2 inhibitors, an examination with the costs vs benefits also need to include the recent clinical study findings of cardiovascular benefit with many of these newer agents.
"If congratulations, you look at that inside the context on the new data on CV protection — which obviously should be confirmed by other studies plus other medications — you'll need a broader a sense of what is cost-effective, because effectiveness in diabetes means not merely blood glucose control but prevention of serious complications."
In their paper, Dr Lipska and colleagues input it this way: "Although the by using newer plus much more expensive agents can have other important benefits, further studies are required to define the significance and cost-effectiveness of current therapies."
This study was funded to some extent by the National Center for Advancing Translational Sciences, a component with the National Institutes of Health. Dr Lipska receives support from your National Institute on Aging plus the American Federation of Aging Research from the Paul Beeson Career Development Award and also the Yale Claude D Pepper Older Americans Independence Center. Disclosures with the coauthors are listed inside article. Dr Bush is for the speaker's bureau for Lilly, Novo Nordisk, AstraZeneca, Boehringer Ingelheim, and Janssen and is particularly a consultant for Janssen and Lilly.
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