15 December 2015
Gain Your Inhibitions
Today, we enter happily into the secret world (as far as NICE is concerned) of SGLT2 inhibitors. These clever drugs increase glucose excretion by the kidney thereby reducing blood glucose levels.
When manufacturers produce new drugs they have to show, by research, that they do not do any harm. Usually, in Type 2 diabetes, this means that there is no increase in cardiovascular disease. This in itself is a little strange in that our main aim in treating diabetes is to prevent our patients dying due to cardiovascular disease.
Way back in 2010, the manufacturers of one of the SGLT2 inhibitors, Boehringer Ingelheim and empagliflozin respectively, set up a large study of over 7,000 patients. They chose patients who were at very high risk of cardiovascular disease because they had either already had a myocardial infarction, coronary artery by-pass, stroke, peripheral vascular disease or renal failure and split into three cohorts. Two of these received different doses of empagliflozin and the remaining third a placebo.
The trial was concluded in 2015 and the results discovered. The astonishing and brilliant finding was that major adverse coronary events and hospitalisation for heart failure were all reduced by a third. To my knowledge, this is the first time that anyone has shown a reduction in these terrible events by glucose lowering alone.
Immediately the fur has started to fly. It is hardly surprising that Astra-Zeneca/Bristol Myers Squibb (dapagliflozin) and Janssen Pharmaceuticals (canagliflozin) have rushed to claim that this is a class effect of all similar drugs (thereby saving themselves the expense of doing their own research). Funnily enough, if the research had shown a rise in cardiovascular disease, they would be claiming exactly the opposite.
But, the people with most egg on their face are NICE who produced their recent Guidelines on the Management of Type 2 Diabetes. Despite dapagliflozin having been prescribed in the UK by GP’s and Practice Nurses for over three years, there is not a mention of the drug in the guidelines. To completely ignore an innovative class of drugs after over three years of experience is strange, to say the least.
This is in guidelines which, in certain situations, advocates prescribing drugs off licence; that is outside their strict indications.
Incidentally, for those GP’s and Nurses who do not have the time to wade through over 50 pages of rather turgid prose, the recommendations can be summarised as follows:
a] Drugs… Metformin
b] Insulin… Isophane
In the meantime, it is time for rejoicing at the introduction of a drug which really does seem to make a difference.