New combo therapy to be listed


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A new combination therapy for type 2 diabetes, which can be prescribed alongside metformin, is set to be listed on the PBS from 1 April

Glyxambi, a new oral, fixed-dose combination of the SGLT2 empagliflozin inhibitor (Jardiance) and DPP4 inhibitor linagliptin (Trajenta) will become available on the PBS from 1 April 2018.

Glyxambi (empagliflozin/linagliptin) can be prescribed on the PBS alongside metformin to treat patients with type 2 diabetes requiring additional glycaemic control despite treatment with metformin and any SGLT2 inhibitor, or metformin and any DPP4 inhibitor.

“With growing evidence for and use of agents like Jardiance, we welcome the ability to prescribe this agent in combination with Trajenta in a single pill,” says Professor Mark Cooper, Head of Department of Diabetes, Central Clinical School, Monash University.

“Glyxambi is an important treatment option for patients struggling with blood glucose control.

“Affordable access to Glyxambi is an important development for the thousands of people with type 2 diabetes who find that dual oral therapy does not provide adequate glucose control. Diabetes is a progressive disease and we need more intensive treatment options to help patients achieve their HbA1c target,” said Professor Cooper.

“Glyxambi works to lower blood glucose levels by simultaneously producing more insulin, decreasing glucose production and expelling excess glucose from the body. Significantly, the combination therapy has a low rate of hypoglycaemia.”

Nearly half (47%) of Australians with Type 2 diabetes being managed with non-insulin glucose-lowering therapy have HbA1c levels above their recommended target of 7%, according to a recent nine-year cohort study published in Diabetes Research and Clinical Practice.

“Good diabetes management necessitates that glucose-lowering therapy is vigorously intensified as the condition progresses in order to achieve improved glycaemic control and to prevent or slow down a range of diabetic complications,” says Professor Cooper.

“We know that the risk of microvascular complications like eye, nerve or kidney damage jumps up to 40% with every one percentage point increase in HbA1c above recommended levels,” he explained.

“The combination of empagliflozin and linagliptin provides complementary modes of action to lower blood glucose, without significantly increasing side-effects.

“Pharmacists are ideally placed to reinforce the importance of monitoring blood glucose levels and discussing treatment adjustments with a doctor if glycaemic control is not being achieved,” said Professor Cooper.

“Pharmacists can explain to patients that triple oral therapy is now available through the PBS and that this may delay the need for injectable therapy for many people.”

Glyxambi will be reimbursed for use in combination with metformin in patients with type 2 diabetes:

  • Who have an HbA1c measurement greater than 7% despite treatment with dual oral combination therapy with metformin and a DPP4 or a SGLT2 inhibitor; OR
  • Where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation of triple oral therapy with an SGLT2 inhibitor, metformin and a DPP4.

The recommended starting dose is empagliflozin 10mg / linagliptin 5mg once daily.

For patients who tolerate the recommended starting dose and require additional glycemic control, the dose can be increased to empagliflozin 25 mg / linagliptin 5mg once daily.

Potential side effects include a low risk of hypoglycaemia and increased risk of genital/urinary tract infections.

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