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Canagliflozin safe, effective for longer-term use in type 2 diabetes
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In patients with type 2 diabetes, longer-term exposure to the SGLT2 inhibitor canagliflozin was generally well tolerated alone or combined with other agents, according to a pooled analysis of active- and placebo-controlled studies.
Rong Qiu, MD, PhD, of Janssen Research and Development in Raritan, New Jersey, and colleagues analyzed data from 5,598 patients with type 2 diabetes enrolled in seven completed placebo- and active-controlled, phase 3 studies of 52 to 104 weeks’ duration. All studies assessed the safety and effectiveness of 100 mg and 300 mg canagliflozin (Invokana, Janssen) vs. either placebo, sitagliptin (Januvia, Merck) or glimepiride as monotherapy or combined with other agents (mean duration with 100 mg, 65.1 weeks; mean duration with 300 mg, 59.4 weeks; mean duration with non-canagliflozin agents, 56.4 weeks). Data from the ongoing CANVAS study and from the study of canagliflozin in patients with chronic kidney disease were not included in this analysis.
Overall, adverse events were similar across 100 mg, 300 mg and non-canagliflozin treatment groups (73.7%, 74.5% and 73.7%, respectively). Serious adverse events were similar across treatment groups: 6.6 per 100 patient-years for both 100 mg and 300 mg canagliflozin; 8.2 per 100 patient-years for non-canagliflozin, respectively.
Adverse events related to the mechanism of SGLT2 inhibitors, including genital mycotic infections, urinary tract infections and volume depletion-related events, were higher with canagliflozin vs. non-canagliflozin; events were generally mild or moderate and occurred mostly within the first 3 months of initiating therapy, according to researchers
The rate of fracture was similar across 100 mg, 300 mg and non-canagliflozin treatment groups (1.2, 1.4 and 1.1 per 100 patient-years, respectively). Overall incidence of diabetic ketoacidosis was also low across groups; one patient in each of the three groups experienced diabetic ketoacidosis requiring hospitalization. Renal-related adverse events were similar across 100 mg, 300 mg and non-canagliflozin groups (2.1, 2.5 and 2.6 per 100 patient-years, respectively).
Documented hypoglycemia occurred more often in patients assigned canagliflozin who were on background agents already associated with hypoglycemia, such as insulin, glinide or sulfonylurea.
“As [type 2 diabetes] is a chronic disease requiring continued treatment with [antihyperglycemic agents], the longer-term safety of treatment options is an important consideration,” the researchers wrote. “In this pooled analysis, canagliflozin 100 and 300 mg were generally well tolerated in studies ranging in duration from 52 to 104 weeks in a broad population of patients with [type 2 diabetes] inadequately controlled with diet and exercise or other [antihyperglycemic agents].”
The researchers noted that the ongoing CANVAS, CANVAS-R and CREDENCE trials will provide more insight into the longer-term safety of canagliflozin, including cardiovascular outcomes, fracture risk and renal outcomes in patients with an elevated risk for CVD or with renal impairment. – by Regina Schaffer
Disclosure: Janssen Research and Development sponsored this research. All of the researchers are employees of Janssen Research and Development or Janssen Scientific Affairs.
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