EMA has become aware of recent media reports and publications1 raising the question of whether certain medicinal products, for example, angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs or sartans), may worsen the course of COVID-19. ACE inhibitors and ARBs are most commonly used to treat patients with hypertension, heart failure, or kidney disease.
It is important that patients do not interrupt treatment with ACE inhibitors or ARBs, and there is also no need to switch to other medicinal products. At present there are no data from clinical or epidemiological studies establishing a link between ACE inhibitors or ARBs and a worsening course of COVID-19. Experts in the treatment of cardiac and blood pressure disorders, including the European Society of Cardiology, have already made this statement.2,3 To gather more evidence, the EMA is actively reaching out to researchers to obtain additional evidence in epidemiological studies.
As the public health crisis rapidly spreads around the world, scientific research continues to understand how severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) replicates in the body, interacts with the immune system, and causes disease, and whether continued treatment with ACE inhibitors and ARBs may affect the prognosis of COVID-19.
The assumption that treatment with ACE inhibitors or ARBs may worsen the course of infectious disease in the context of COVID-19 is not supported by clinical evidence. These medicinal products act by affecting the renin-angiotensin-aldosterone system (RAAS). The virus uses a target called angiotensin-converting enzyme 2 (ACE2), which is part of this system, to enter human cells. One hypothesis is that, by increasing ACE2, ACE inhibitors or ARBs may increase viral activity. However, the interaction of the virus with the RAAS in the body is complex and not fully understood.
The EMA is closely monitoring the situation and cooperating with stakeholders to coordinate epidemiological studies on the effect of ACE inhibitors and ARBs on individuals with COVID-19.
EMA is helping to coordinate urgent ongoing studies and undertakes to inform the public about any developments in this area. EMA is also aware of reports stating that corticosteroids and non-steroidal anti-inflammatory drugs may worsen COVID-19. EMA recently published information on this. 4 It is important that patients who have any questions about the medicinal products they use consult a doctor and do not stop their baseline treatment on their own.
Medicinal products must be prescribed and used in accordance with clinical indications, taking into account any warnings and other information contained in the approved instructions for medical use and in the clinical treatment protocols approved by the MoH of Ukraine.
More about medicinal products
Angiotensin-converting enzyme (ACE) inhibitors are medicinal products used to treat patients with high blood pressure, heart problems and other conditions. ACE inhibitors impede the production of angiotensin II, a hormone that constricts blood vessels. This constriction can cause high blood pressure and strain on the heart.
Angiotensin receptor blockers (ARBs, also known as angiotensin II receptor antagonists or sartans) are used to treat patients with high blood pressure, as well as patients with certain heart and kidney diseases and diabetic nephropathy. They also block the action of angiotensin II, preventing the narrowing of blood vessels so that blood pressure does not rise.
Corticosteroids (known as steroids) are anti-inflammatory drugs prescribed for a wide range of diseases, such as asthma, allergic rhinitis, chronic obstructive pulmonary disease (COPD), Crohn's disease, ulcerative colitis, and many others. Corticosteroids work in the same way as the hormones produced by the adrenal glands. They are mainly used to reduce inflammation and suppress the immune system.
Ibuprofen, a nonsteroidal anti-inflammatory drug, is an analgesic and antipyretic. Oral ibuprofen is used in adults, children and infants aged three months and older for short-term treatment of fever and/or pain. Ibuprofen is also prescribed for the treatment of arthritis and rheumatic conditions.
Link
https://www.ema.europa.eu/en/news/ema-advises-continued-use-medicines-hypertension-heart-kidney-disease-during-covid-19-pandemic
https://www.ema.europa.eu/en/documents/press-release/ema-advises-continued-use-medicines-hypertension-heart-kidney-disease-during-covid-19-pandemic_en.pdf
1 https://www.thelancet.com/pdfs/journals/lanres/PIIS2213-2600(20)30116-8.pdf
2 https://www.escardio.org/Councils/Council-on-Hypertension-(CHT)/News/position-statement-of-the-esc-council-onhypertension-on-ace-inhibitors-and-ang
3 https://www.acc.org/latest-in-cardiology/articles/2020/03/17/08/59/hfsa-acc-aha-statement-addresses-concerns-reusing-raas-antagonists-in-covid-19
4 this information was published on 19.03.2020 on the official website of the State Expert Center of the Ministry of Health https://dec.gov.ua/materials/ema-nadaye-porady-shhodo-vykorystannya-nesteroyidnyh-protyzapalnyh-zasobiv-dlya-covid-19/?role=applicant
