Anti-Diabetic Drug Dapagliflozin Associated with Important Cardiac & Renal Outcomes in Broad Type 2 Diabetes Patient Population in Landmark DECLARE-TIMI 58 Trial


Beirut, 28 November 2018: Results from DECLARE, the biggest clinical trial to assess a new class of diabetes pills called “SGLT-2 inhibitors” presented at the 2018 American Heart Association Congress, have shown that AstraZeneca’s Dapagliflozin cuts the risk of hospitalization for heart failure or cardiovascular (CV) death by 17%, provides positive renal outcomes, and has a good safety profile.

“Doctors have mainly been focused on lowering blood sugar levels among people living with diabetes, but the fact that diabetics are prone to complications that lead to other diseases including heart failure means that how we do that is very important,” said Dr. Paola Atallah, President of the Lebanese Society of Endocrinology, Diabetes, and Lipids. “We need to choose medications that improve overall health outcomes for patients.”


DECLARE-TIMI 58 (Dapagliflozin Effect on Cardiovascular Events) is a multi-national trial designed to assess the cardiovascular efficacy and safety profile of Dapagliflozin.

The trial includes approximately 17,160 Type 2 diabetes patients across 33 countries with multiple risk factors (60%) such as Dyslipidemia, Hypertension, or Smoking, or with established cardiovascular disease (40%) who were followed for 4.2 years, making it thelargest trial in its class to date, the longest in terms of patients follow up, and the broadest in terms of patient population representativeness.

“DECLARE patients are those whom we encounter in our every day practice,” said Professor Fady Haddad, former president of the Lebanese Society of Internal Medicine.

The trial is also unique as it is the first in its class of medications to assess hospitalization for heart failure or cardiovascular mortality in a dedicated primary endpoint.

Heart failure is a more common first CV event than myocardial infarction (MI) and stroke for patients with Type 2 diabetes and cardiovascular disease. Heart failure negatively impacts patient quality of life, leading to fatigue, breathlessness and frequent hospital admissions.

“Heart failure mortality rates might reach as high as 50% after only five years from diagnosis,” said Professor Antoine Sarkis, Lebanese Society of Cardiology President. “Reducing hospitalizations for heart failure by 27% in a broad population of whom only 10% had heart failure at baseline is a very important finding. This broadens our understanding of how to go beyond blood glucose control, so we better address this serious and often overlooked cardiovascular complication.”

About Diabetes and Cardio-Renal Disease

A close link exists between diabetes and cardiovascular disease, which is the most prevalent cause of morbidity and mortality in diabetic patients. Diabetes can also cause heart failure, a type of heart disease in which the heart no longer pumps sufficient blood to meet the body’s needs.

Sixty Eight percent of patients with Type 2 diabetes had evidence of left ventricular dysfunction as early as five years after initial diagnosis.

The heart and the kidney are closely linked, impact on one results in increased damage to the other. Chronic Kidney Disease (CKD) is an early and frequent complication of Type 2 diabetes, with studies showing that up to 40% of all Type 2 diabetes patients will develop CKD.

“AstraZeneca has ongoing research investigating the potential of Dapagliflozin to impact the progression of heart failure or Chronic Kidney Diseases in patients with or without Type 2 diabetes,” added Dr. Hiba Hajar Baroudi, Medical Lead, Cardiovascular, Renal & Metabolic Diseases, AstraZeneca Near East.

Diabetes in Lebanon

Eight percent of people living in Lebanon in 2017 are estimated to be diabetic, translating into 585,400 adults between 20 and 79 years old.