Home
Hard-fought progress comes with dose of skepticism
The number of type 2 diabetes drugs that have a proven cardiovascular benefit jumped from one to three this year, highlighting the changing landscape for diabetes treatments.
In June it was reported that liraglutide (Victoza) -- a glucagon-like peptide 1 (GLP-1) analogue -- was associated with a 13% relative risk reduction in a composite of cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke (P=0.01) in the 3-year LEADER trial. Those results were reported at the annual American Diabetes Association scientific meeting.
And an investigational GLP-1 analogue known as semaglutide was shown in September to also have a cardiovascular benefit, becoming the third diabetes drug to do so after empagliflozin (Jardiance) did so last year. Researchers writing in The New England Journal of Medicine said that semaglutide lowered the rate of death from the cardiovascular composite to 6.6%, compared with 8.9% in the placebo group, in the SUSTAIN-6 trial.
A spokesperson from semaglutide's maker, Novo Nordisk, which also markets liraglutide, said in an email to MedPage Today that the company hopes to file an application to the FDA for approval by the end of the year. "If all goes well, approval could be in 2017," the spokesperson wrote.
But despite the outward progress in the field of type 2 diabetes treatments, significant questions remain about how the findings will translate into clinical practice. For starters, liraglutide comes at a hefty cost: $702 for a single carton of three pens (each pen can deliver 10-30 daily doses). For empagliflozin, one month of the drug cost $405 for 30 25-mg tablets, according to data from GoodRx, which tracks drug prices for consumers.
In exchange, the number needed to treat to prevent one coronary event over a 3-year period was 66. The number needed to prevent one death? Ninety-eight, if the numbers from the LEADER trial are correct.
For semaglutide, the number needed to treat from the SUSTAIN-6 trial for a 2-year period to prevent one instance of the primary endpoint events was 45.
"It's a challenge to push these drugs in the absence of adequate insurance coverage," Robert Eckel, MD, at the University of Colorado Denver of the University of Colorado School of Medicine, told MedPage Today earlier this year. "I am not going to make somebody broke by giving them an agent that has a number to treat of 1 in 60."
A separate piece of promising news surfaced in September: In a 21-year follow-up of the Steno-2 trial, researchers found that type 2 diabetes patients who had undergone intensive behavioral and pharmacological treatments lived eight years longer than those who received conventional therapy.
Taken together, the stories from this year constitute "rare excellent news," said Joel Zonszein, MD, an endocrinologist at the Albert Einstein College of Medicine, in an email to MedPage Today. "We now have the opportunity to select a better regimen for our patients. The important message is that we can treat effectively and prevent complications by using early combination therapy."
He added that he sees no reason why the positive trend won't continue.
Researchers also developed a relatively accurate scoring system to determine which patients who underwent bariatric surgery would see remission of type 2 diabetes. The tool -- known as DiaRem -- was straightforward and based on four variables: age, insulin dependence, diabetes medication use, and HbA1c levels. In a MedPage Today video exclusive, clinicians also discussed how to best use bariatric surgery to treat type 2 diabetes patients.
And this year has seen growing public sentiment for policies that tax consumers or producers of sugar-sweetened beverages thought to contribute to type 2 diabetes risk. Experts have debated whether or not there should be a tax, but voters in Berkeley, Calif. and Philadelphia have voted to pass taxes, and the November elections saw more citiesadopt them.
In Berkeley, early evidence suggested that sales of sugar-sweetened beverages were slightly down, but that overall beverage and store revenue sales remained steady. In Mexico, which is facing an epidemic of type 2 diabetes -- patients aged 35-59 with diabetes there had an all-cause mortality rate that was more than five times higher than in non-diabetic patients -- there has been a significant decrease in consumption after a soda tax was passed there.
Elsewhere, the American Diabetes Association published a newly updated recommendation in October for diabetes patients, suggesting that patients break up long periods of sitting with at least three minutes of light physical activity.
http://www.medpagetoday.com/Endocrinology/Diabetes/61774
The number of type 2 diabetes drugs that have a proven cardiovascular benefit jumped from one to three this year, highlighting the changing landscape for diabetes treatments.
In June it was reported that liraglutide (Victoza) -- a glucagon-like peptide 1 (GLP-1) analogue -- was associated with a 13% relative risk reduction in a composite of cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke (P=0.01) in the 3-year LEADER trial. Those results were reported at the annual American Diabetes Association scientific meeting.
And an investigational GLP-1 analogue known as semaglutide was shown in September to also have a cardiovascular benefit, becoming the third diabetes drug to do so after empagliflozin (Jardiance) did so last year. Researchers writing in The New England Journal of Medicine said that semaglutide lowered the rate of death from the cardiovascular composite to 6.6%, compared with 8.9% in the placebo group, in the SUSTAIN-6 trial.
A spokesperson from semaglutide's maker, Novo Nordisk, which also markets liraglutide, said in an email to MedPage Today that the company hopes to file an application to the FDA for approval by the end of the year. "If all goes well, approval could be in 2017," the spokesperson wrote.
But despite the outward progress in the field of type 2 diabetes treatments, significant questions remain about how the findings will translate into clinical practice. For starters, liraglutide comes at a hefty cost: $702 for a single carton of three pens (each pen can deliver 10-30 daily doses). For empagliflozin, one month of the drug cost $405 for 30 25-mg tablets, according to data from GoodRx, which tracks drug prices for consumers.
In exchange, the number needed to treat to prevent one coronary event over a 3-year period was 66. The number needed to prevent one death? Ninety-eight, if the numbers from the LEADER trial are correct.
For semaglutide, the number needed to treat from the SUSTAIN-6 trial for a 2-year period to prevent one instance of the primary endpoint events was 45.
"It's a challenge to push these drugs in the absence of adequate insurance coverage," Robert Eckel, MD, at the University of Colorado Denver of the University of Colorado School of Medicine, told MedPage Today earlier this year. "I am not going to make somebody broke by giving them an agent that has a number to treat of 1 in 60."
A separate piece of promising news surfaced in September: In a 21-year follow-up of the Steno-2 trial, researchers found that type 2 diabetes patients who had undergone intensive behavioral and pharmacological treatments lived eight years longer than those who received conventional therapy.
Taken together, the stories from this year constitute "rare excellent news," said Joel Zonszein, MD, an endocrinologist at the Albert Einstein College of Medicine, in an email to MedPage Today. "We now have the opportunity to select a better regimen for our patients. The important message is that we can treat effectively and prevent complications by using early combination therapy."
He added that he sees no reason why the positive trend won't continue.
Researchers also developed a relatively accurate scoring system to determine which patients who underwent bariatric surgery would see remission of type 2 diabetes. The tool -- known as DiaRem -- was straightforward and based on four variables: age, insulin dependence, diabetes medication use, and HbA1c levels. In a MedPage Today video exclusive, clinicians also discussed how to best use bariatric surgery to treat type 2 diabetes patients.
And this year has seen growing public sentiment for policies that tax consumers or producers of sugar-sweetened beverages thought to contribute to type 2 diabetes risk. Experts have debated whether or not there should be a tax, but voters in Berkeley, Calif. and Philadelphia have voted to pass taxes, and the November elections saw more citiesadopt them.
In Berkeley, early evidence suggested that sales of sugar-sweetened beverages were slightly down, but that overall beverage and store revenue sales remained steady. In Mexico, which is facing an epidemic of type 2 diabetes -- patients aged 35-59 with diabetes there had an all-cause mortality rate that was more than five times higher than in non-diabetic patients -- there has been a significant decrease in consumption after a soda tax was passed there.
Elsewhere, the American Diabetes Association published a newly updated recommendation in October for diabetes patients, suggesting that patients break up long periods of sitting with at least three minutes of light physical activity.
http://www.medpagetoday.com/Endocrinology/Diabetes/61774
