The Covid-19 pandemic raging across the globe has a multitude of implications across healthcare sectors and disease indications. The cardiovascular and metabolic disorder (CVMD) space is no exception, as Covid-19 has a significant impact on patients with pre-existing conditions, many of which fall under the CVMD category. The current uncertainty regarding treatment with certain cardiovascular (CV) drugs, supply chain, and clinical trials is also notable. Overall, the pandemic is already impacting the CVMD healthcare landscape, and there will undoubtedly be further developments as more data become available.
Covid-19 patients with CV disease or diabetes are at higher risk of developing more severe symptoms and have a higher fatality rate than patients without comorbidities. 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. These can include strain on the heart due to interference with the ability of the lungs to deliver oxygen and disruption in narrowed arteries, which can then lead to artery blockage and CV events.
There is also concern over reports on the implications of angiotensin-converting enzyme (ACE) inhibitors/angiotensin receptor blocker (ARB) treatment, as the SARS-CoV-2 virus is known to bind to ACE2, an enzyme that has increased expression following treatment with these drugs. Both ACE inhibitors and ARBs are highly prescribed for patients with hypertension and heart failure, and diabetics may also take ACE inhibitors for the nephroprotective effects they confer. Thus, the hypothesis is that patients who are being treated with ACE inhibitors/ARBs could face an increased risk to and severity from Covid-19. However, paradoxically, animal studies have suggested that ACE inhibitors and ARBs might actually provide protection against lung complications in Covid-19 patients.
The concerns have spurred the European Society of Cardiology to publish a statement on 13 March advising against patients discontinuing ACE inhibitor or ARB treatment, as evidence indicating adverse outcomes among Covid-19 patients treated with these drugs remains insufficient. Subsequently, on 17 March, the American Heart Association, the American College of Cardiology, and the Heart Failure Society of America followed suit with a similar recommendation.
Pharmaceutical companies are also 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. GlobalData believes that disruptions in the CVMD space may appear outside of the supply chain, primarily affecting clinical trials.
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). However, 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.
The situation surrounding the Covid-19 pandemic is ever-evolving, including emerging findings and implications that are relevant to the CVMD space. In countries that are experiencing high numbers of confirmed Covid-19 cases, the risks remain high for patients with CV disease or diabetes. These risks mainly depend on the containment measures being taken and whether or not the outbreak is brought under control. Pharmaceutical companies will also continue to play a role in this changing landscape, especially by taking appropriate mitigation measures in order to avoid supply chain disruptions, which would otherwise have devastating consequences for those being treated for CV disease and diabetes.