AstraZeneca’s diabetes drug seen having heart-related benefits; firm to seek nod in India, too

PT Jyothi Datta Mumbai | Updated on September 06, 2019 Published on September 06, 2019

Company looks to get regulatory nod on these additional indicators in India, too

Upbeat over the positive results shown by AstraZeneca’s diabetes drug dapagliflozin in reducing the incidence of heart failure and death, the company is looking to get this additional benefit from the drug approved in India as well.

“The positive results from Dapa HF, which included patients from India in the study population, is an important development for heart failure patients with or without diabetes. In India, dapagliflozin is already approved and available for type-2 diabetes treatment. Given the benefits, it can potentially offer to heart failure patients, we look forward to bring this novel treatment solution for heart failure patients, subject to local regulatory approvals,” Gagandeep Singh, Managing Director of AstraZeneca Pharma India, said in an emailed response to BusinessLine.

Trial results

The DAPA-HF trial involving Forxiga, the brand name for AZ’s dapagliflozin, had shown that the medicine taken in addition to regular treatment or “standard of care” reduced incidence of cardiovascular death and the worsening of heart failure, the company said.

Over the weekend, detailed results from this trial were presented at the ESC Congress 2019 in Paris, France. The results showed that Forxiga reduced cardiovascular death or worsening of heart failure by 26 per cent, AZ said.

Besides the local participation in the study, the outcome from this trail was of interest because Indians, particularly women, show a greater risk of heart failure than their American or European counterparts, a company representative said.

The study was done on 4,700 patients across the United States, Canada, Latin America, Europe and Asian countries including China, Japan and India. A quarter of the patients on the trial were from Asia, including about 237 patients from India, he said.

Cardio connection

Explaining how the drug works to manage sugar levels in type-2 diabetics and yet not cause low-sugar levels in non-diabetics, Dr VK Chopra, Director-Heart Failure Programme at Medanta Medicity (Gurugram) said that it prevented the re-absorption of sugar being excreted through urine.

Chopra was the national lead investigator on the trial that was conducted on patients with a heart failure condition, with only half of them being diabetics. The drug has other additional benefits including helping the energy utilisation of the heart muscle, he said, among other things.

Dapagliflozin belongs to the “SGLT2 inhibitor” class of drugs and it has been around for sometime.

While the study on dapagliflozin’s impact on heart failure is out this year, another similar study on Boehringer Ingelheim’s Empagliflozin is expected next year, said Chopra, who is the national lead investigator on that study too.

On the downside for patients to watch out for on Dapagliflozin, he said side-effects included urinary infection, especially in women and dehydration.

Published on September 06, 2019
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