In its updated draft guideline on type II diabetes, NICE says an SGLT2 inhibitor, in addition to metformin, should be offered as first-line treatment in patients with type II diabetes who have congestive heart failure or established atherosclerotic cardiovascular disease. The combination of an SGLT2 inhibitor plus metformin should also be considered for patients at high risk of developing cardiovascular disease.
When starting dual therapy with metformin and an SGLT2 inhibitor, NICE recommends introducing the drugs sequentially, starting with metformin, to check their tolerability.
For first-line treatment if metformin is contraindicated or not tolerated, an SGLT2 inhibitor alone should be offered in patients with congestive heart failure or established atherosclerotic cardiovascular disease, and considered in patients at high risk of developing cardiovascular disease.
'High risk of developing cardiovascular disease' is defined as a QRISK2 score more than 10% in adults aged 40 and over, or clinical judgment of an elevated lifetime risk of cardiovascular disease (ie, presence of 1 or more cardiovascular risk factors in patients under 40).
NICE said the evidence showed that SGLT2 inhibitors as a class of drugs 'were effective at improving cardiovascular outcomes and were most likely to be cost-effective in combination with metformin', although the incremental cost-effectiveness ratio varied between drugs within the class.
The committee agreed there was more certainty of cardiovascular benefits in adults with type II diabetes and congestive heart failure or established atherosclerotic cardiovascular disease because they were participants in all of the included trials, while people at a high risk of developing cardiovascular disease were included in fewer trials. The committee therefore recommended dual therapy with an SGLT2 inhibitor in addition to metformin for both groups, but only as an option to consider for people without established cardiovascular disease, to reflect the lower certainty.
The committee highlighted some safety considerations to take into account before prescribing an SGLT2 inhibitor. To reduce the risk of diabetic ketoacidosis, it is important to check that the patient is not following a very low carbohydrate or ketogenic diet. In addition, SGLT2 inhibitors should be avoided in pregnancy and breastfeeding because in animal studies they have been shown to be toxic in pregnancy and present in breast milk. Finally, renal function should be monitored in all patients receiving SGLT2 inhibitors.
The publication of the draft guidance follows the approval last month of the SGLT2 inhibitor empagliflozin (Jardiance) to treat chronic heart failure in patients with or without type II diabetes. Dapagliflozin (Forxiga) is the only other SGLT2 inhibitor to be licensed for heart failure, and was approved by NICE earlier this year for use in this setting.