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Here comes a Novel Solution for Type 2 Diabetes

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Here comes a Novel Solution for Type 2 Diabetes

08th Aug 2018

We at MIOT International always strive to introduce to you, new technologies and medications that are shattering conventions and making rapid strides across the global healthcare landscape. As a responsible healthcare provider in the country, we believe that such proactive initiatives are necessary to create awareness among the general public and healthcare professionals as well.

At MIOT International, the curiosity to learn never stops.

In pursuit of the latest advancement in the world of diabetes (type 2), we have observed that a new class of medication is defying the life threatening consequences of a deadlier combination – diabetes and heart failure.

So we had Ms. Anna Maria Langkilde (MD, PhD), Global Clinical and Scientific Lead, from Sweden to enlighten us more on that.

And from what we learnt at this enriching session, we believe that this new class of medication is here to stay.
It is a sweet revenge against diabetes.

Seen in the photograph from left to right: Mrs. Mallika Mohandas, Chairman, MIOT International, Anna Maria Langkilde, Global Clinical and Scientific Lead for dapagliflozin (FORXIGA) at AstraZeneca
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The global prevalence of Diabetes Mellitus (DM) was 415 million in 2015 and is expected to rise to 642 million by 2040. Diabetes is prevalent in India on an epidemic scale with more than 63 million people being affected.

Types of Diabetes

Insulin deficiency & resistance is quite common after prolonged duration of diabetes.

  • Type 1 Diabetes or T1D (lack of insulin production) – It occurs when insulin-producing cells are damaged or destroyed and stops producing insulin
  • Type 2 Diabetes or T2D (insulin resistance) – It occurs when the pancreas produces excess insulin to overcome body resistance. And when the cells wear out, the insulin production slows down, leaving too much glucose in the blood

There is a close relationship between uncontrolled diabetes and cardiac and kidney problems. 27 per 1000 diabetics die of cardiovascular diseases each year. 

How Type 2 Diabetes (T2D) Affects the Heart and Kidneys?

  • Heart –
  • Atherosclerosis (hardening and narrowing of the arteries due to build-up of plaque)
  • Myocardial Infarction or MI (heart attack)
  • Peripheral Vascular Disease or PVD (blood circulation disorder outside the heart)
  • Kidney –
  • Damaged blood vessels
  • High blood pressure

Diabetes (T2D) and Heart Failure – A Cancer-like Syndrome

Having both diabetes (T2D) and heart failure is a nightmare. Survival chances in such a scenario are as low as in cancer. Heart failure can occur within five years of being diagnosed with diabetes (T2D). And it doesn’t necessarily have to be a result of heart attack.

1 in every 4 diabetic patients is known to have undiagnosed heart failure.

Summary of the co-relation between Diabetes (T2D) & Heart Failure –

  • Diabetes (T2D) is commonly known to increase the risk of heart failure, independent of other traditional risk factors. The presence of several biochemical and molecular changes associated with diabetes (T2D) leads to HFpEF or heart failure with preserved ejection fraction
  • Heart failure is commonly thought to be an early indication of diabetes-related cardiovascular disease
  • Signs of myocardial (relating to the muscular tissue of the heart) damage are known to appear even before the diagnosis of diabetes (T2D)
  • Heart failure may or may not be a result of atherosclerosis (hardening and narrowing of the arteries due to build-up of plaque)
  • Despite the absence of coronary artery disease, diabetes patients have echocardiographic evidence of LV (left ventricle) dysfunction in as little as 5 years post diagnosis for diabetes (T2D)
  • The survival rate of diabetes patients with heart failure is significantly lower compared to diabetes patients without heart failure

Heart failure continues to remain undiagnosed in diabetes patients. So, when choosing an anti-diabetic therapy, the possibility of heart failure in the long term and its prevention must be considered very seriously.

Currently Used Medication – oGLDs

Other glucose-lowering drugs or oGLDs are the most commonly used form of medication by diabetes patients. But since long, they have failed to address the complications that arise from the heart and kidneys, as these oGLDs-based anti-diabetic drugs are insulin-dependent, hence requiring a functioning pancreas.

In the CVD-REAL (cardiovascular disease) study (an observational study on people with Type 2 Diabetes), it was found that oGLDs did not reduce hHF (hospitalization for heart failure) cases, as compared to the new class of drugs – SGLT2 indicators such as canagliflozin, empagliflozin and dapagliflozin.

Here comes the Novel Solution….

Welcome the New Class of Diabetes Medication – SGLT2i

In 2007, the USFDA (U.S. Food and Drug Administration) has made it mandatory for all antidiabetic drugs to have high safety standards and produce favorable cardiovascular outcomes. After extensive research and detailed clinical studies, a new class of diabetes medication was introduced – SGLT2 (sodium glucose cotransporter – 2) inhibitors.

One such SGLT2 inhibitor is Dapagliflozin.

Dapagliflozin

Dapagliflozin is a unique drug that has an insulin-independent mode of action, which helps in removing glucose via urine.

At times, the contemporary anti-diabetic medication leads to hypoglycemia (very low sugar level), which can have serious consequences. But remarkably, this new drug has a lower incidence of hypoglycemia along with the added benefits of weight loss and reduction in blood pressure.

Post various clinical studies to re-confirm its safety and efficiency, Dapagliflozin was approved in over 50 countries in 2015, including in India by DGCI (Drugs Controller General of India) a year ago.

SGLT2i vs oGLDs

With the arrival of SGLT2i, there was a lower risk of all-cause death, hHF (hospitalization for heart failure), heart attack and stroke in all the clinical studies.

Compared to oGLDs, SGLT2i was associated with –

  • 39% reduction in hHF
  • 19% in MI (myocardial infarction)
  • 49% in all cause death
  • 32% in stroke
Among all the SGLT2 indicators that were put to test, it was only Dapagliflozin that displayed the highest proportion of exposure time in all the countries.
  • Dapagliflozin – 75%
  • Empagliflozin – 9%
  • Canagliflozin – 4%
Conclusion:
  • SGLT2 inhibitors like Dapagliflozin is proven to reduce chances of heart failure and kidney problems
  • It is also known to reduce cardiovascular mortality
  • The safety and efficacy profile of these newer drugs makes them an automatic initial choice or as an add-on drug in the management of diabetes (T2D)
  • Positive and successful results from the longest and largest clinical study conducted by DECLARE-TIMI 58 are expected to address many issues in diabetes management
About Anna Maria Langkilde

We have with us Ms. Anna Maria Langkilde (MD, PhD), Global Clinical and Scientific Lead for Dapagliflozin (FORXIGA) at AstraZeneca. She has led many development projects in the Cardiovascular, Metabolic and Chronic Kidney Diseases Therapeutic Area, Sweden.

Having also served as one of the lead study directors on DECLARE TIMI 58, who better to have with us at MIOT International today to enlighten us on Dapagliflozin. She is also here to explain why all the doctors and diabetes patients must choose SGLT2 indicators naturally, along with their prescribed medication.