Canagliflozin Reference

Plain English

What it is

Canagliflozin is a prescription pill sold under the brand name Invokana. It is an FDA-approved type 2 diabetes medicine in a group called SGLT2 inhibitors, which lower blood sugar by making the kidneys pass extra sugar out in the urine.

What people use it for

It is approved to improve blood sugar in adults and in children age ten and older who have type 2 diabetes. In adults it is also approved to lower the chance of major heart problems in those who also have heart disease, and to protect the kidneys in those who also have diabetic kidney disease. People in the diabetes community know it as the first medicine of its kind shown to help the heart.

What the science shows

A large trial called CANVAS, with more than ten thousand people who had type 2 diabetes and high heart risk, found it modestly lowered the rate of serious heart events compared with a dummy pill. A later trial showed it also helps protect the kidneys. This evidence comes from large human trials, which is strong.

The catch

This is a real prescription drug with real risks, not a casual supplement, and it needs a doctor's supervision. Like others in its class it can cause genital yeast infections, urinary tract infections, dehydration, and a rare but serious buildup of acid in the blood called diabetic ketoacidosis. Canagliflozin also stood out for more toe and foot amputations in its main trial, a concern serious enough that its label once carried the strongest type of warning, which was removed in 2020 though the raised amputation risk still remains.

Reference summary

CANVAS (Neal 2017 NEJM, integrated analysis of CANVAS and CANVAS-R, n=10,142 adults with T2D and high CV risk) reported a 14 percent relative reduction in the primary MACE composite over a mean 188 weeks. CREDENCE subsequently established renal-outcome benefit in T2D patients with CKD. The CANVAS program also identified a 1.97-fold increased risk of lower-extremity amputation (toes / feet) that prompted an initial boxed warning, later removed in 2020 after additional data review.

Regulatory and posture

Categories

Metabolic

Aliases

Invokana, SGLT2 inhibitor (small molecule, not a peptide)

Evidence posture

human - CANVAS identified an amputation risk signal that distinguishes canagliflozin from empagliflozin and dapagliflozin in class-comparative discussion. The initial boxed warning was removed in 2020.

Regulatory status

FDA-approved as Invokana for type 2 diabetes (2013), reduction in major adverse cardiovascular events in adults with T2D and established cardiovascular disease (2018), and treatment of diabetic kidney disease in adults with T2D (2019). Fixed-dose combination with metformin (Invokamet) is also approved.

Content review status

label verified