Foot care reminder for canagliflozin prescribing

Healthcare professionals have been reminded of the importance of routine preventive foot care in patients with diabetes receiving canagliflozin (Invokana/Vokanamet), after an increased incidence of lower-limb amputation was observed in a study of the SGLT2 inhibitor.

Healthcare professionals should follow diabetes treatment guidelines for routine preventive foot care in patients receiving canagliflozin. | iStock
Healthcare professionals should follow diabetes treatment guidelines for routine preventive foot care in patients receiving canagliflozin. | iStock

Lower-limb amputation (primarily of the toe) occurred at a rate of 6 per 1000 patient-years in patients treated with canagliflozin in the ongoing CANVAS trial, compared with an incidence of 3 per 1000 patient-years in those who received placebo, a letter from the manufacturer advises.

This increased risk was observed independent of predisposing factors, although the absolute risk was higher in patients with previous amputations, existing peripheral vascular disease or neuropathy. No dose response was observed.

Further information
View canagliflozin drug record
Letter to healthcare professionals
MIMS Diabetes Clinic

The finding of the CANVAS study is currently under investigation, and any mechanism behind a possible link between canagliflozin treatment and an increased risk of amputation is as yet unknown.

In the meantime, healthcare professionals treating patients with canagliflozin are reminded of the need to:

  • follow standard diabetes treatment guidelines for routine preventive foot care
  • carefully monitor patients with risk factors for amputation events (eg, previous amputations, existing peripheral vascular disease or neuropathy)
  • initiate early treatment for foot problems such as ulceration, infection, new pain or tenderness
  • consider, as a precautionary measure, stopping canagliflozin treatment in patients who develop a significant complication, such as a lower-extremity skin ulcer, osteomyelitis or gangrene, at least until the condition has resolved
  • monitor patients for signs and symptoms of loss of body water and salt and ensure that hydration is sufficient to prevent volume depletion

Healthcare providers should also remind patients to maintain routine preventive foot care; report ulceration, discoloration, new lower extremity pain or tenderness; and remain well hydrated.

Amputation rates in other studies

The CANVAS study enrolled patients with a history or high risk of cardiovascular disease. In the ongoing CANVAS-R study, which involves a similar population to CANVAS, there was a numerical imbalance in amputation events between the canagliflozin and placebo groups (16 events in the canagliflozin group and 12 events in the placebo group). No increase in the incidence of amputation was observed across 12 other completed phase III/IV clinical trials with a mean follow-up of 0.9 years (0.6 per 1000 patient-years in the canagliflozin groups and 2 per 1000 patient-years in control groups).

Want news like this straight to your inbox?
Sign up for our bulletins

Have you registered with us yet?

Register now to enjoy more articles and free email bulletins

Already registered?
Sign in

MIMS Product Slides

Product overviews prepared by the MIMS team, in a handy slide format.

Click here

Slides are initiated, funded & reviewed by the companies specified.

Register or Subscribe to MIMS

GPs can get MIMS print & online and GPonline for free when they register online – take 2 minutes, and make sure you get your free MIMS access! If you're not a GP, you can subscribe to MIMS for full access.

Register or subscribe

MIMS Dermatology

Read the latest issue online exclusively on MIMS Learning.

Read MIMS Dermatology

MIMS Adviser

Especially created for prescribing influencers.

Request free copy

Mobile apps

MIMS: access the full drug database and quick-reference tables on the go

MIMS Diagnosis and Management: concise information on signs and symptoms, investigations and diseases