Smartphone-powered trial backs J&J's Invokana for heart failure
Johnson & Johnson's SGLT2 inhibitor Invokana has been shown to have a significant effect on heart failure symptoms in a clinical trial that relied entirely on remote monitoring of symptoms using a smartphone app.
The real-world CHIEF-HF study is said to be the first fully "decentralised, mobile, indication-seeking clinical study" with no need for patients to visit clinic, according to J&J's pharma division Janssen.
It enrolled patients with and without type 2 diabetes and heart failure, to see whether treatment with Invokana (canagliflozin) can improve their symptoms, function and quality of life compared to placebo.
The participants – who had had either preserved ejection fraction (HFpEF) or reduced ejection fraction (HFrEF) heart failure – recorded their progress by filling out the self-reported Kansas City Cardiomyopathy Questionnaire (KCCQ) on their smartphone.
Participants who received Invokana reported significantly greater improvements in their heart failure symptoms, beginning within two weeks that were sustained throughout the entire three months of the trial.
The benefits were seen in patients with both HFrEF or HFpEF, and regardless of whether they had type 2 diabetes, according to the investigators, who reported their results at the American Heart Association (AH) congress yesterday.
"We did not know if a completely 'virtual' clinical trial, especially one where randomised treatment was delivered to participants and the outcomes were collected through a smartphone app, could work," commented lead investigator John Spertus (pictured above) of the University of Missouri-Kansas City School of Medicine.
"Demonstrating the success of a decentralised clinical trial opens opportunities for applying this approach to the testing of other cardiovascular therapies that focus on health status," he told the meeting.
Updated labelling for Invokana has already been approved to include data showing that it can reduce the risk of hospitalisation for heart failure and diabetic kidney disease in patients with type 2 diabetes, based on the CREDENCE trial.
The drug is playing catch-up with other SGLT2 inhibitors as a heart failure therapy however, with AstraZeneca's Farxiga/Forxiga (dapagliflozin) and Eli Lilly/Boehringer Ingelheim's Jardiance (empagliflozin) both approved for HFrEF in patients with and without diabetes.
"These findings, together with the results of other SGLT2 inhibitor trials, are transformational and should have a significant impact on care," said Spertus.
"Since improvement in health status is such a key goal for many patients, these findings support increasing the use of SGLT2 inhibitors for people with heart failure," he added.
Invokana was the first SGLT2 inhibitor to reach the market for diabetes after it was cleared by the FDA in 2013, and sales accelerated to a peak of nearly $1.4 billion in 2016 before the product was linked to an increased risk of lower limb amputation.
The drug promptly went into reverse, with sales coming in at $738 million in the first nine months o 2021, a further 14% reduction on the same period of 2020.
