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Health Bulletin: FDA Philippines approves new diabetes drug

AstraZeneca’s Dapagliflozin has been approved by the Philippine Food and Drug Administration for the prevention of new or worsening heart failure or cardiovascular death in adult patients with type 2 diabetes. 

Health Bulletin: FDA Philippines approves new diabetes drug
Clockwise from top left: Dr. Elizabeth Roasa, Dr. Erlyn Demerre, Dr. Cyril Tolosa, Professor Subodh Verma, Dr. Nemencio Nicodemus, and Dr. Alberto Pamplona make a ‘FIGHT’ sign at the recent ‘Dapagliflozin New Indication Virtual Media Briefing.’
“Heart failure is an often forgotten first manifestation of type 2 diabetes-related complications and is more frequent than heart attack or stroke,” said Dr. Erlyn Demerre, cardiologist at St. Luke’s Medical Center.

According to Dr. Nemencio Nicodemus, an endocrinologist at Philippine General Hospital, up to 50 percent of type 2 diabetes patients will develop heart failure and up to 40 percent will develop chronic kidney disease. 

Dapagliflozin is a first-in-class, oral medication that belongs to a class of drugs called SGLT2 inhibitors. The FDA approval of the drug is based on the results of DECLARE-TIMI 58, the largest, broadest, and longest SGLT2 inhibitor cardiovascular outcomes trial to date. The trial involved 17,160 type 2 diabetes patients, 60 percent of whom have cardiovascular risk factors and 40 percent have established cardiovascular disease. 

“The newly approved indication is a welcome development for local type 2 diabetes patients with multiple cardiovascular risk factors or established cardiovascular disease,” said AstraZeneca Philippines president Lotis Ramin. 

Dr. Cyril Tolosa, medical affairs director of the pharmaceutical company, added, “Dapagliflozin is the only type 2 diabetes treatment shown to reduce the risk of composite of cardiovascular death or hospitalization for heart failure in type 2 diabetes patients with multiple cardiovascular risks or established cardiovascular disease. Additionally, it has also been shown to reduce the risk of kidney events in these patient groups.”

Aside from its new indication, the diabetes drug is indicated as both monotherapy and as part of combination therapy to improve blood glucose control, with the additional benefits of weight loss and blood pressure reduction, as an adjunct to diet and exercise. 

“Using Dapagliflozin early in type 2 diabetes to assist with HbA1c control may also help to prevent progression of renal disease in patients with and without established cardiovascular disease,” noted Dr. Elizabeth Roasa, a nephrologist at University of Santo Tomas Hospital.

Topics: AstraZeneca , Dapagliflozin , Philippine Food and Drug Administration , heart failure
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