Initial Combination of Empagliflozin and Linagliptin for treating Type 2 Diabetes
Diabetes Care: American Diabetes Association Journal
The standard pharmacotherapy for management of type 2 diabetes mellitus (T2DM) involves initiation with monotherapy (usually metformin) unless there are contraindications or intolerance, followed by sequential addition of other single agents, when target glycaemic control is not achieved or maintained for 3 months.
Combination therapy as first line is a treatment option when glycated haemoglobin (HbA1c) at entry is well above target.
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Dual sodium glucose co-transporter 2 (Empagliflozin) /dipeptidyl peptidase-4 inhibitor (Linagliptin) combination in a single-tablet combination (STC) represents a new therapeutic option for patients with type 2 diabetes. Empagliflozin/linagliptin has been approved by the US Food and Drug Administration for the treatment of type 2 diabetes mellitus (T2DM).
Empagliflozin, a (SGLT2) inhibitor and linagliptin, a (DPP-4) inhibitor, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both empagliflozin and linagliptin is appropriate.
Empagliflozin removes glucose through the urine by blocking blood glucose re-absorption in the kidney, and linagliptin exerts glucose-lowering activity by increasing hormones that stimulate the pancreas to produce more insulin and decreasing the levels of glucagon in the circulation.
In addition, this combination therapy modestly reduces body weight and blood pressure without significant safety issues. A fixed dose combination (FDC) of empagliflozin and linagliptin as add on therapy to metformin or as initial treatment lowered the HbA1c by approximately 1.1% and reduced the body weight by 2.0-3.0 kg. The hypoglycemia risk was not significantly increased.
Advantage of Empagliflozin/Linagliptin Combination therapy:
Treatment with this fixed-dose combination of empagliflozin and linagliptin is suitable for people who don’t benefit enough from taking one of the commonly used sulfonylureas or metformin, and also for people who are already taking empagliflozin and linagliptin separately.
The aim of this treatment in type 2 diabetes is to avoid strong fluctuations in blood sugar levels and the effects of high and low blood sugar.
Results of randomized controlled trials of 52 weeks’ duration in adults with T2D demonstrated that empagliflozin/linagliptin improved glycaemic control significantly more than linagliptin when administered as initial therapy and significantly more than linagliptin or empagliflozin when administered as an add-on therapy to metformin. In addition to glycaemic control, empagliflozin/linagliptin provided significant weight loss compared with linagliptin alone in both trials.
Empagliflozin has recently proved to reduce cardiovascular risk in type 2 diabetes and cardiovascular high risk situations.
Empagliflozin was associated with significant and clinically meaningful reductions in BP, body weight and HbA1c versus placebo and was well tolerated in patients with type 2 diabetes and hypertension.
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The joint position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) recommends initial combination therapy in patients with baseline HbA1c ≥ 9% and who are less likely to achieve treatment goals on monotherapy.
The American Association of Clinical Endocrinologists’ and American College of Endocrinology's (AACE/ACE) comprehensive diabetes management algorithm recommends initial dual therapy when HbA1c is ≥ 7.5%, and combination therapy with insulin (symptomatic hyperglycaemia) or without insulin (asymptomatic hyperglycaemia) when HbA1c is ≥ 9%.
Initial combination therapy potentially offers advantages such as rapid reduction in HbA1c, avoidance of extended periods of hyperglycaemic state and harmful effects of glucotoxicity, and avoidance of maximal doses of monotherapy which may augment adverse effects associated with that monotherapy.
Patients with type 2 diabetes and established atherosclerotic cardiovascular disease:
Among patients with type 2 diabetes who have established atherosclerotic cardiovascular disease or established kidney disease, a sodium–glucose cotransporter 2 inhibitor (Empagliflozin) or glucagon-like peptide 1 receptor agonist (Semaglutide, Liraglutide) with demonstrated cardiovascular disease benefit is recommended as part of the comprehensive cardiovascular risk reduction and/or glucose-lowering regimens.
In patients with type 2 diabetes and established atherosclerotic cardiovascular disease, multiple atherosclerotic cardiovascular disease risk factors, or diabetic kidney disease, a sodium–glucose cotransporter 2 inhibitor with demonstrated cardiovascular benefit is recommended to reduce the risk of major adverse cardiovascular events and/or heart failure hospitalization.
In patients with type 2 diabetes and established heart failure with reduced ejection fraction, a sodium–glucose cotransporter 2 inhibitor with proven benefit in this patient population is recommended to reduce risk of worsening heart failure and cardiovascular death.
For patients with type 2 diabetes and diabetic kidney disease:
For patients with type 2 diabetes and diabetic kidney disease, use of a sodium–glucose cotransporter 2 inhibitor (Empagliflozin) in patients with an estimated glomerular filtration rate ≥25 mL/min/1.73 m2 and urinary albumin ≥300 mg/g creatinine is recommended to reduce chronic kidney disease progression and cardiovascular events.
In patients with type 2 diabetes and chronic kidney disease, consider use of sodium–glucose cotransporter 2 inhibitors additionally for cardiovascular risk reduction when estimated glomerular filtration rate and urinary albumin creatinine are ≥25 mL/min/1.73 m2 or ≥300 mg/g, respectively.
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