First real-world study comparing SGLT2i therapies also showed patients taking INVOKANA 300 mg significantly less likely to discontinue treatment or switch to another diabetes medicine.
The Janssen Pharmaceutical Companies of Johnson & Johnson announced the results of a real-world study showing that adults with type 2 diabetes initiated on INVOKANA®(canagliflozin) 300 mg had significantly better blood glucose control, based on A1C goal attainment and reduction, compared to similar patients initiated on Farxiga® (dapagliflozin) 10mg. Also of interest was the facts that patients on INVOKANA were also less likely to discontinue treatment or switch to another medicine to treat their type 2 diabetes.
Lawrence Blonde, MD, director of the Ochsner Diabetes Clinical Research Unit in the Frank Riddick Diabetes Institute, Department of Endocrinology, Diabetes and Metabolism at the Ochsner Medical Center in New Orleans, Louisiana added that, “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….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.”
About half of patients with type 2 diabetes do not meet individualized targets for blood glucose control, measured by A1C. 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. And the AACE organization of endocrinologists recommend an A1c of 6.5% or below. All of these different goals from the different organizations make it difficult for health care professionals and patients to determine which recommendation to follow.
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).
Paul Burton, MD, PhD, FACC, vice president of Medical Affairs at Janssen Pharmaceuticals, stated that, “These findings are an important addition to the large and growing body of real-world evidence supporting INVOKANA. 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.”
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 that patients on INVOKANA 300 mg had a 29 percent greater reduction in A1C compared to patients initiated on dapagliflozin 10 mg.
More results from the study showed 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. Also, 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. When looking at just the average A1c levels, they determined that the 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.
When looking at the average A1c reduction, they found that it was 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). Plus, 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.
- Patients on INVOKANA 300 mg had a 29 percent greater reduction in A1C compared to patients initiated on dapagliflozin 10mg.
- A significantly higher proportion of patients on INVOKANA than those on dapagliflozin 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 patients taking INVOKANA than dapagliflozin 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.
Findings were recently published online April 20, 2018 in Current Medical Research and Opinion.