Patients taking the type 2 diabetes medication Invokana had a reduced risk of kidney disease progression over the course of six years, according to new clinical data. However, the medication still carries warnings that it can cause kidney damage.
The study, pulled from the landmark CANVAS clinical trial program, pitted patients taking Invokana against those treated with a placebo. It showed that patients taking Invokana had significantly reduced urinary albumin excretion and stable estimated glomerular filtration rate over the six-year study period.
The CANVAS program is the longest, largest and broadest completed cardiovascular outcomes study among all the type 2 diabetes drugs in a class known as sodium glucose cotransporter2 (SGLT2) inhibitors. It involves more than 10,000 patients with type 2 diabetes who either have a history of cardiovascular disease or at least two cardiovascular risk factors.
While the CANVAS data showed Invokana proved beneficial in reducing the risk of kidney disease progression, Invokana (as well as the similar drug Invokamet and Invokamet XR), along with SGLT2 inhibitors Farxiga and Xigduo, carry warnings for an increased risk of acute kidney injury or kidney damage. The warnings were placed on the drugs in June 2016.
In May 2015 – just two years after Invokana hit the market – the FDA required the medication to add warnings for serious urinary tract infections that in some cases resulted in a serious blood infection called urosepsis, or a kidney infection called pyelonephritis. The FDA also ordered new warnings for ketoacidosis, a condition in which too much acid builds up in the blood. Ketoacidosis can lead to diabetic coma or death if left untreated.
In May 2017, a review of CANVAS data also showed that patients taking canagliflozin were at an increased risk of lower leg amputations. The FDA order black box warnings to be placed on the safety labels of Invokana, Invokamet, and Invokamet XR.