Poll finds less than half of health care professionals aware of newest drug up for FDA approval.
In the past two years, more than 30 medications have come to the market, and more than 475 additional diabetes drugs are in the works to get approved.
To test the knowledge of endocrinologists, 149 endocrinologists responded to a survey about a new drug that the FDA is looking to approve shortly. The drug, ertugliflozin, met the primary outcomes in two year-long phase 3 trials, VERTIS SU and VERTIS SITA2 and only 45% of the physicians said they had heard of the drug. Of those, 20% knew it only by name and only 5% were “very familiar” with it.
Ertugliflozin is an investigational oral sodium-glucose co-transporter 2 (SGLT-2) inhibitor aimed at improving glycemic control in adults. It is expected to be approved before the end of the year, which would make it the fourth drug in its class to market.
Respondents were asked, after reading the clinical trial data provided about the drug and assuming ertugliflozin is approved and performs as described, how long they thought it would take for them to start prescribing. Only 7% answered that they would start prescribing within the first week, another 18% said they would prescribe it in the first month, and nearly half (46%) said they would prescribe it within 2 to 6 months. Just more than 1 in 5 (21%) said they would likely wait at least 9 months before prescribing.
Among the 113 endocrinologists who anticipated prescribing ertugliflozin, the main reason given was efficacy (58% answered that way). Other reasons included expected insurance coverage (42%), safety profile (36%), and mode of administration (24%).
It is critically important that medical professionals who deal with patients with diabetes are knowledgeable about the drugs available for the treatment of diabetes. According to the ADA, treatments for patients with diabetes must be individualized. That means because there are no two patients with diabetes who are exactly alike, we need to be knowledgeable about the different drug classes and the differences between drugs within a certain class.
As an example, when looking at ertugliflozin, what do we know from the studies that have been published?
The investigational sodium/glucose cotransporter 2 (SGLT2) inhibitor ertugliflozin (Merck), being developed to improve glycemic control in adults with type 2 diabetes, met the primary outcomes in two year-long phase 3 trials, VERTIS SU and VERTIS SITA2. In the VERTIS SITA2 trial, HbA1c was reduced by 0.6% with 15-mg/day ertugliflozin and patients in both ertugliflozin arms had improved glycemic control and reduced body weight and blood pressure at 52 weeks compared with those in the placebo arm, which were generally consistent with the 26-week findings from the same study.
Ertugliflozin has similar characteristics to the other drugs in this class — canagliflozin (Invokana, Janssen), dapagliflozin (Farxiga/Formia, AstraZeneca), and empagliflozin (Jardiance, Boehringer Ingelheim). The drug class has been boosted by positive cardiovascular-outcomes data from the EMPA-REG trial with empagliflozin and the CANVAS study with canagliflozin.
Patients who were taking at least 1,500 mg/day metformin for at least 8 weeks and still had HbA1c between 7% and 9% were randomized to remain on metformin and also take 5-mg/day ertugliflozin (448 patients), 15-mg/day ertugliflozin (440 patients), or the sulfonylurea glimepiride up to 6 or 8 mg/day (437 patients). At 52 weeks, in patients with type 2 diabetes inadequately controlled with metformin, ertugliflozin 15 mg was non-inferior to glimepiride in lowering HbA1c, provided greater body-weight reduction relative to glimepiride, and was associated with less hypoglycemia compared with glimepiride.
On average, with glimepiride, patients had gained 0.9 kg, whereas with the two ertugliflozin doses combined they had lost 3.0 or 3.4 kg, at 1 year (P < .001). The rate of symptomatic hypoglycemia (requiring help) was 19% in the glimepiride group but only 5.2% in the group that received 15-mg/day ertugliflozin and 4.0% in the group that received 5-mg/day ertugliflozin (P < .001).
Both doses of ertugliflozin were generally well-tolerated, rates of urinary-tract infections and hypovolemia were similar in the three groups, but men and women who received either dose of ertugliflozin had higher rates of genital mycotic infection than those who received glimepiride.
The sulfonylurea brought down the HbA1c quite effectively by 26 weeks and only at 52 weeks was there no difference between the SGLT2 inhibitor (both doses) and glimepiride. But the patients on the sulfonylurea had a much greater rate of symptomatic hypoglycemia and weight gain, and patients taking ertugliflozin had better blood pressure. “Sulfonylurea brought down HbA1c, but it is very important to stop focusing only at HbA1c and to also look at the bigger picture.
So now, what would you recommend for as a 2nd treatment therapy for a patient not meeting goals on metformin, a sulfonylurea or an SGLT2 inhibitor? Understanding the differences in the different drug classes and the differences between those within that class can be the difference in your success in the treatment of your patients with diabetes.
- Sulfonylurea brought down HbA1c effectively but with a greater risk of hypoglycemia and weight gain.
- Ertugliflozin showed weight loss and blood pressure drops.
- Knowing the positives and negatives of the drugs prescribed can truly help in individualizing treatment options.
Stay tuned in 2018 for our new series on how technology may soon make it easier for doctors to find the best treatment for each patient.
DiabetesinControl.com. Ertugliflozin, An SGLT-2, Meets Goals in Two Phase 3 Trials
Medscape. Few Endocrinologists Know Ertugliflozin Beyond Name: Poll