Dapagliflozin is one of the gliflozin group of hypoglycaemic drugs, which lower blood glucose levels by increasing excretion of glucose in the urine. In the European Union, the glifozins were first authorised for patients with type 2 diabetes. In that setting, their harm-benefit balance is unfavourable, mainly due to the risk of serious adverse effects with these drugs.

In 2019, dapagliflozin was granted marketing authorisation in Europe as an adjunct to insulin for overweight or obese adult patients with type 1 diabetes, in whom control of blood sugar levels is inadequate despite optimal insulin therapy.

In these patients, dapagliflozin has not been evaluated using meaningful clinical  outcomes, but only by a surrogate endpoint, which was the assessment of blood glucose control by measurement of glycated haemoglobin. 

The adverse effects profile of gliflozins includes, in particular, urogenital infections linked to the increased concentration of glucose in the urine. Serious, life-threatening infections of the perineum have been reported. Gliflozins also carry a risk of dehydration, renal failure, hypotension and ketoacidosis, which represent a serious complication of insulin deprivation.

During pregnancy, gliflozins expose the foetus to a risk of kidney damage.

As of 2020, when control of blood glucose levels is inadequate in patients with type 1 diabetes, it is preferable to seek other options or to revise the treatment targets, rather than to expose patients to the serious adverse effects of dapagliflozin.

©Prescrire 1 November 2020

Source: "Dapagliflozin (Forxiga°) and type 1 diabetes. Serious risks with no demonstrated clinical efficacy" Prescrire International 2020; 29 (220): 262-263. Subscribers only.

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