More Real-World Results Show A1C, Blood Pressure Decline With Canagliflozin

The findings are consistent with other results that have shown sizable drops in A1C, as well as the ability to control blood pressure in patients who previously failed to meet targets.

An analysis of more than 16,000 patient records shows that patients prescribed canagliflozin continue to see significant reductions in glycated hemoglobin (A1C), and that more than half achieved blood pressure goals.

The results, which appeared Wednesday in Current Medical Research and Opinion, are consistent with earlier results. They also show that 25% of the patients lost 5% of their weight after a year.1 More than half the patients (60%) were prescribed canagliflozin in a primary care setting, which is where most patients received care for type 2 diabetes (T2D).

Findings were announced in a statement from Janssen Pharmaceuticals, maker of canagliflozin (Invokana), which also highlighted results from 2 other recent retrospective studies. Highlights from these studies are:

· An analysis published in BMC Endocrine Disorders found that 80% of patients were taking other drugs their diabetes, and of these 20% were able to stop taking 1 or more other drugs after starting canagliflozin.2

· A study that looked at the specific effect of canagliflozin on Hispanic patients found that average A1C dropped more than it did in a comparable group of non-Hispanic patients; however, the Hispanic group started with a higher average A1C.3

Results published this week are consistent with a much smaller set of real-world results presented at the American Diabetes Association (ADA) meeting in Boston in June 2015. The paper in BMC Endocrine Disorders, which appeared in late 2015, was consistent with research across the class of drugs that include canagliflozin, called SGLT2 inhibitors, which have been shown to have anti-hypertensive effects and offer modest help with weight loss.

In 2015, Evidence-Based Diabetes Management reported on emerging research that showed the SGLT2 inhibitor class was having better results than some other anti-diabetic therapies on reducing A1C, but the drug’s effects were also allowing some to stop taking diuretics, which offered safety benefits for some patients.

“The A1C improvements and goal achievements shown in these analyses with Invokana across diverse patients with type 2 diabetes—including those with uncontrolled A1C and from different ethnic groups—are important metrics for providers, payers and reimbursement,” said Wing Chow, PharmD, MPH, of Janssen, who is listed as an author on each of the papers.

In the latest study, researchers examining prescription and lab data found among patients with a baseline A1C of 7% or more (and an average of 8.8%), there was an average drop of 0.8% to 8%, at 3 months, which is the goal recommended by Medicare. (The ADA recommends a goal of 7% or less across all age groups.) In addition, 59.5% brought A1C below 8% at 3 months, with 21.2% getting to the ADA goal of 7%. Patients’ A1C remained stable at the 6-, 9- and 12-month intervals.1

Among patients in this group who started with high blood pressure—a systolic and/or diastolic rate above 140/90 mmHg, 60% met the systolic target and 75.6% met the diastolic target after 3 months, and maintained these levels at future intervals.

Results from the trial published in November 2015 showed that of a larger group of 4017 patients, 826 had an available A1C baseline that with an average of 8.59%. Of this group, the average reduction was 0.81%. The share who achieved an A1C of less than 8% increased from 39% at baseline to 66% after 6 months, and the share with A1C less than 7% increased from 13% to 28%. The biggest A1C drops were for those who started with the highest A1C levels.

The comparison of canagliflozin’s effectiveness in Hispanic patients vs non-Hispanic ones found that after 6 months on the drug, both groups brought their A1C to an average of 7.8%. However, the Hispanic patients were starting with an average A1C of 8.9% compared with 8.5% for the others, even though more of the Hispanic patients were taking at least 3 drugs to control T2D.

Janssen is also conducting the CANVAS trial, (CANVAS and CANVAS-R) which is evaluating the long-term cardiovascular outcomes in a total of 10,000 patients taking either the 100 mg or the 300 mg version of canagliflozin. Results of this trial are expected in April 2017. Another drug in the class, empagliflozin, has already been shown to have cardiovascular benefits.

References

1 Lefebvre P, Pilon D, Robitalle MN, Lafeuille MH, Chow W, Pfeifer M, Duh MS. Real-world glycemic, blood pressure and weight control in patients with type 2 diabetes mellitus treated with canagliflozin—and electronic health-record based study [published online May 11, 2016]. Curr Med Res Opin. 2016; DOI: 10.1080/03007995.2016.1183604.

2. Buysman EK, Chow W, Henk HJ, Rupnow MFT. Characteristics and outcomes of patients

with type 2 diabetes mellitus treated with canagliflozin: a real-world analysis. BMC Endocrine Disorders. 2015; 15(1):67.

3. Chow W, Buysman E, Rupnow M, Aguilar R, Henk H. Canagliflozin treatment of Hispanic and non-Hispanic patients with type 2 diabetes in a US managed care setting. Curr Med Res Opin. 2016; 32(1):13-22.