CardioExchange Archive

CardioExchange, an NEJM practice community for medical professionals dedicated to improving cardiac patient care, was active from 2009 to 2015. CardioExchange fostered discussion between clinicians from across the globe.

March 29th, 2013

FDA Approves First SGLT2 Inhibitor for Diabetes

The FDA said today that it had approved canaglifozin (Invokana, Johnson & Johnson), the first of a new class of diabetes drugs known as sodium-glucose co-transporter 2 (SGLT2) inhibitors. Canaglifozin is indicated, in conjunction with diet and exercise, to improve glycemic control in adults with type 2 diabetes. The drug has been studied as monotherapy and in combination with other common treatments for type 2 diabetes, including metformin, sulfonylurea, pioglitazone, and insulin.

The FDA said it was requiring J&J to perform five postmarketing studies with canaglifozin, including a cardiovascular outcomes trial; an enhanced pharmacovigilance program to monitor for malignancies, serious cases of pancreatitis, severe hypersensitivity reactions, photosensitivity reactions, liver abnormalities, and adverse pregnancy outcomes; and a bone safety study.

Vaginal yeast infections and urinary tract infections are the most common side effects associated with canaglifozin. The FDA said canaglifozin should not be used to treat people with type 1 diabetes or in people with diabetic ketoacidosis or severe renal disease.

In clinical trials in over 10,000 patients with type 2 diabetes, canaglifozin was shown to improve hemoglobin A1c levels and fasting plasma glucose levels.

Categories: General, Prevention
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2 Responses to “FDA Approves First SGLT2 Inhibitor for Diabetes”

  1. Jean-Pierre Usdin, MD says:
    April 5, 2013 at 3:40 am

    yes but!

    As I remember as a studient or intern/resident having high glycosuria was judjed to be harmful for the kidney and hydro electrolytic balance.
    infection of urinary tract and the very severe Papilla necrosis was said to be a (dramatic) complication of high content of sugar in the urine. probably related to infection if my memory is good.
    the surprise for me is: we do not treat really the diabetes but one of his important consequence that is accentuated on a detrimental way.
    what about dehydratation? what about Natremia, blood osmolarity?
    and what kind of cardio vascular complications are under the eyes of FDA during post marketing?
    I would appreciate comments of my colleagues diabetologists concerning the long term effects.
    however the picture choosen for the ad. is marvellous (see on end page of last NEJM issue!) “a bottle half-full of sugar with the tap in the middle of the bottle to regulate blood sugar” really good
    will this serve the prescription of the drug? probably but safety first is not it?

  2. Hiteshi K.C. Chauhan, MD says:
    April 6, 2013 at 2:46 am

    Evaluating the pros and cons, the FDA approval of Canaglifozin seems a bit ‘post-haste’.