COVID-19 has a significant impact on patients with pre-existing conditions, many of which fall under the cardiovascular (CV) and metabolic disorder (CVMD) category. The current uncertainty regarding treatment with certain CV drugs, the supply chain and clinical trials is also notable. Overall, the pandemic is already impacting the CVMD healthcare landscape, and leading data and analytics company GlobalData believes that disruptions in the CVMD space may appear outside of the supply chain, primarily affecting clinical trials, says GlobalData, a leading data and analytics company.
Jesse Cuaron, Ph.D., PPM, Associate Director of CVMD and Gender Health at GlobalData, comments:
According to GlobalData’s clinical trials database, there has been an overall increase in trials that have pushed back their estimated start dates since the beginning of January, largely due to the COVID-19 pandemic. One such example in the CVMD space is the temporary halt of randomization of newly diagnosed type 1 diabetic patients for Provention Bio’s Phase III PROTECT study of PRV-031 (teplizumab).
GlobalData anticipates that some studies, such as Apple and Johnson & Johnson’s remote Heartline study in atrial fibrillation, may hold an advantage during the pandemic through the use of the Heartline Study’s app and Apple Watch.
Although the exact mechanisms by which COVID-19 adversely impacts patients with CV disease are unknown, there has been a growing general consensus that the disease can place significant stress on the CV system. There is also concern that patients who are being treated with angiotensin-converting enzyme (ACE) inhibitors/angiotensin receptor blockers (ARBs) could face increased risk to and severity from COVID-19.
The concerns have spurred the European Society of Cardiology, the American Heart Association, the American College of Cardiology, and the Heart Failure Society of America to publish statements advising against patients discontinuing ACE inhibitor or ARB treatment, as evidence indicating adverse outcomes among COVID-19 patients treated with these drugs remains insufficient.
Pharmaceutical companies are currently facing uncertain times, as they address concerns over the impact of the COVID-19 pandemic on the CVMD medicine supply. A number of developers with a dedicated CVMD portfolio have already announced that they do not anticipate any drug shortages at this time. These companies include, but are not limited to, AstraZeneca, Eli Lilly, Johnson & Johnson, Mylan, Novartis, Sanofi, Takeda and Teva.”