TITUSVILLE, N.J., April 27, 2018 — The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the results of a real-world study showing that adults with type 2 diabetes initiated on INVOKANA® (canagliflozin) 300mg had significantly better blood glucose control, based on A1C goal attainment and reduction, compared to similar patients initiated on Farxiga®(dapagliflozin) 10mg. Patients on INVOKANA® were also less likely to discontinue treatment or switch to another medicine to treat their type 2 diabetes. Findings were recently published in Current Medical Research and Opinion.
"Controlling blood glucose levels is central to diabetes treatment because it can reduce the risk of diabetes-related complications, such as kidney disease, retinopathy and potentially cardiovascular disease,” said Lawrence Blonde, MD, Director, Ochsner Diabetes Clinical Research Unit, Frank Riddick Diabetes Institute, Department of Endocrinology, Diabetes and Metabolism, Ochsner Medical Center, New Orleans, Louisiana. "This first real-world analysis comparing SGLT2i therapies in adults with type 2 diabetes showed that canagliflozin (INVOKANA®) 300mg each day allowed more patients to achieve blood glucose control [A1C <7%] than did a daily dose of dapagliflozin (Farxiga®) 10mg."
Up to half of patients with type 2 diabetes do not meet individualized targets for blood glucose control, measured by hemoglobin A1C, which reflects a person's average blood glucose over the past two to three months. The Healthcare Effectiveness Data and Information Set (HEDIS) recommends an A1C of less than 8.0 percent as a goal for most people with type 2 diabetes, while the American Diabetes Association (ADA) recommends less than 7.0 percent.
In the analysis, which matched INVOKANA® and dapagliflozin patients based on demographic and clinical characteristics including A1C, a significantly greater proportion of INVOKANA® patients achieved the HEDIS A1C goal of less than 8.0 percent (70.8 vs. 59.1 percent, p=0.0001), as well as the ADA goal of less than 7.0 percent (36.7 vs. 25.1 percent, p<0.0001).
"These findings are an important addition to the large and growing body of real-world evidence supporting INVOKANA®," said Paul Burton, MD, PhD, FACC, Vice President, Medical Affairs, Janssen Pharmaceuticals, Inc. "Because the significant benefits of INVOKANA® shown in this study were based on data from everyday clinical practice, they are especially relevant for physicians to consider when choosing an SGLT2i therapy for their patients."
Study and Findings
The analysis was based on Optum Clinformatics™ claims data and looked at 558 INVOKANA® patients and an equal number of matched dapagliflozin patients, beginning 12 months before initiating the medications until six months afterwards. The primary outcome was the proportion of patients who achieved the HEDIS-recommended A1C goal of less than 8.0 percent. Secondary outcomes included the proportion of patients who achieved the ADA-recommended A1C goal of less than 7.0 percent, the proportion of patients with A1C greater than 9.0 percent (poor control of type 2 diabetes, as defined by HEDIS), the absolute change in A1C, and treatment patterns indicative of adherence. Analyzing data at six months after patients initiated the medications, the investigators found:
- Patients on INVOKANA® 300mg had a 29 percent greater reduction in A1C compared to patients initiated on dapagliflozin 10mg.
- A significantly higher proportion of INVOKANA® patients than dapagliflozin patients achieved A1C less than 8.0 percent (primary endpoint): 70.8 percent vs. 59.1 percent; odds ratio (OR) 1.60, 95 percent confidence interval (CI): 1.26, 2.04; p=0.0001.
- A significantly higher proportion of INVOKANA® patients than dapagliflozin patients achieved A1C less than 7.0 percent: 36.7 percent vs. 25.1 percent; OR 1.75, CI: 1.34, 2.27; p<0.0001.
- Average A1C levels were significantly lower in INVOKANA® vs. dapagliflozin patients: 7.57 percent vs. 7.85 percent, difference of -0.28 percent; p=0.0003.
- Average A1C reduction was significantly greater in INVOKANA® vs. dapagliflozin patients: 1.17 percent vs. 0.91 percent, difference of -0.26 percent; p=0.0049.
- A similar proportion of INVOKANA® and dapagliflozin patients had A1C levels above 9.0 percent (12.0 percent vs. 15.1 percent; OR 0.77, CI: 0.55, 1.09; p=0.1386).
- INVOKANA® patients were significantly less likely than dapagliflozin patients to discontinue treatment (OR 0.75, CI: 0.57, 0.99; p=0.0400) or switch medication (OR 0.72, CI: 0.54, 0.96; p=0.0229), and approximately as likely to have add-on therapy (OR 1.30, CI: 0.96, 1.74; p=0.0865).
Real-world data have the potential to supplement randomized controlled trial data by providing additional information about how a medicine performs in routine medical practice; however, they have limitations and cannot be used as stand-alone evidence to validate the efficacy and/or safety of a treatment.
WHAT IS INVOKANA®?
INVOKANA® (canagliflozin) is a prescription medicine used along with diet and exercise to lower blood sugar in adults with type 2 diabetes. INVOKANA® is not for people with type 1 diabetes or with diabetic ketoacidosis (increased ketones in blood or urine). It is not known if INVOKANA® is safe and effective in children under 18 years of age. The recommended starting dose is 100 mg once daily, taken before the first meal of the day. The dose can be increased to 300 mg once daily in patients tolerating INVOKANA® 100 mg once daily who have an eGFR of 60 mL/min/1.73 m2 or greater and require additional glycemic control.
Janssen Pharmaceuticals, Inc. and its affiliates have rights to canagliflozin through a license agreement with Mitsubishi Tanabe Pharma Corporation, including in the United States.