BIG news in the diabetes world this week – empagliflozin, a medication used to treat Type 2 Diabetes, is the first diabetes medication to show a reduction in cardiovascular risk in a rigorous clinical trial.
The EMPA-REG trial enrolled over 7,000 type 2 diabetic patients who were considered to be at high risk of cardiovascular events and had suboptimally controlled diabetes, and randomized them to received either empagliflozin 10mg, empagliflozin 25mg, or placebo. The primary outcome was time to first occurrence of cardiovascular death, non fatal heart attack, or non fatal stroke. Treatment with empagliflozin was in addition to usual standards of diabetes care.
The trial found that empagliflozin reduced the risk of cardiovascular events compared to placebo. I would love to look at further details today – but the data is embargoed until the European Association for the Study of Diabetes (EASD) meeting in Stockholm on September 17th. Data on just how much CV events are reduced, or which patients may benefit most, is not yet available.
Empagliflozin (trade name Jardiance) is one of a class of newer type 2 diabetes medications called SGLT2 inhibitors. They block the kidneys’ ability to reabsorb sugar from the urine back into the bloodstream, with the result that sugar is excreted in the urine (ie it causes you to pee sugar). In addition to reducing blood sugar and improving diabetes control, these medications also reduce blood pressure (they have a diuretic like activity) and also cause an average weight loss of around 10 lbs. Another excellent feature is that they do not cause low blood sugars as a side effect. While the details of the EMPA-REG trial haven’t been released yet, it is likely that all of these mechanisms of action contribute to the reduction in CV risk that was seen.
Empagliflozin has just been approved in Canada and will be available on shelves soon. Canagliflozin (trade name Invokana) and dapagliflozin (trade name Forxiga) are available already. The clinical trials of canagliflozin (called the CANVAS trial) and dapagliflozin (DECLARE trial) are currently underway, with results expected in a few years’ time. Clinical trials of other classes of type 2 diabetes medications are also underway, with results also rolling out over the next few years.
Until now, we have not had robust evidence that any particular diabetes medication clearly decreases the risk of CV events. Metformin has some less robust data behind it in this regard; this data is one of the main reasons why it is considered the first line treatment for type 2 diabetes worldwide. As the data and details of this study (and the other studies of medications in this class) become available to us, it will be interesting how these results may change the shape of how we approach type 2 diabetes treatment.
Disclaimer: I receive honoraria as a continuing medical education speaker and consultant from the makers of empagliflozin (Boehringer-Ingelheim and Eli Lilly). I am involved in research of SGLT2 inhibitors as a treatment of diabetes.