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Study: Diabetes meds may harm some older patients

The Columbian
Published: January 12, 2015, 4:00pm

MILWAUKEE — Many older people with diabetes who have other health problems have been kept on intensive and potentially harmful blood sugar control regimens, according to a paper published Monday in JAMA Internal Medicine.

Diabetes is common in people 65 and older. However, it is questionable how much benefit they get from being kept on drugs that tightly control their blood sugar, the research found.

Doing so can actually cause harm, including dangerously low blood sugar.

“The risks appear to outweigh the benefits,” said lead author Kasia Lipska, an assistant professor of medicine and diabetes specialist at Yale School of Medicine. “We know that older people are at special risk.”

The paper echoes concerns raised last month in a Milwaukee Journal Sentinel/MedPage Today investigation of the diabetes drug industry. The investigation found all 30 diabetes drugs approved by the U.S. Food and Drug Administration over the past decade were OK’d based on the ability to lower blood-sugar levels, not proven benefits such as fewer heart attacks or strokes.

Type 2 diabetes — once known as adult-onset diabetes — is a serious problem in America, often requiring drugs. The condition can lead to cardiovascular disease, kidney failure, amputations and more immediate symptoms, especially in those with very high blood sugar levels.

The surging number of cases has closely paralleled increasing rates of obesity, sedentary living and an aging population.

But the number of people with diabetes or pre-diabetes and who are candidates for drugs has been magnified by organizations and doctors with financial ties to drug companies, the investigation found.

For the new study, researchers analyzed data collected from 1,288 people ages 65 and older for the years 2001 through 2010.

Depending on their health, they were put into three categories: relatively healthy; those with complex medical histories for whom self-care was difficult; and those with a very significant additional illness and functional impairment, many of whom had limited life expectancy.

Among those 65 and older in the United States, they represented 3.1 million relatively heathy Americans; 1.7 million with intermediate health; and 1.3 million with poor health.

Yet, there was little difference in how intensively their blood sugar was being controlled, the paper found.

About 60 percent of all three groups had blood sugar that was being kept low, based on a blood test known as hemoglobin A1C.

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“These vulnerable adults are unlikely to experience the benefits of intensive glycemic control and instead are likely to experience harms from treatment,” the authors wrote.

The study did not look at actual harms. Instead, it used a hemoglobin A1C level of less than 7 percent as the threshold for strict blood sugar control and an indicator of potential harm.

However, other research has found that tightly controlling blood sugar can be dangerous, especially for older people.

The new paper cited other research indicating that glucose-lowering drugs have been implicated in 25 percent of emergency hospitalizations in older people, nearly all for low blood sugar levels.

A 2014 study in JAMA Internal Medicine of people with an average age of 77 showed that 404,000 patients were admitted to the hospital because of dangerously low blood sugar levels between 1999 and 2011. Five percent, or 20,000 people, died within 30 days of their admission. The study was based on Medicare data.

“This squares well with the emerging data that diabetics now experience more emergencies from treatment than from the condition itself,” said David Newman, director of clinical research for emergency medicine at Icahn School of Medicine at Mount Sinai Hospital in New York.

Large data reviews have showed that lower glucose targets do considerably more harm than good, said Newman, an emergency room physician who founded NNT.com, an independent group of physicians who analyze the effectiveness of medical therapies.

“This is a classic example of how guidelines and quality measures are oversimplified and don’t do a good enough job of taking into account individual circumstances and instead tend to favor a ‘one size fits all’ approach to medicine,” said Sandeep Vijan, a physician with the Ann Arbor VA Health System who has studied diabetes drugs.

With diabetes it is worse because there has been a dramatic over-interpretation of the potential benefits of glucose lowering therapy, said Vijan, a professor of internal medicine at the University of Michigan.

“The problem is that for decades diabetes experts have drilled tight glycemic control into the mindset of physicians, and now evidence is suggesting that physicians need to de-implement some of this training,” said Christopher Carpenter, an associate professor of emergency medicine at Washington University School of Medicine.

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