Cardiac Events Potentially Associated to Remdesivir

[mdpi-res.com]

If you get covid something to weigh if you want to risk any 8.4% cardiac reactions

“ Abstract: Remdesivir was recommended for hospitalized patients with COVID-19. As already reported in the Summary of Product Characteristics, most of remdesivir’s safety concerns are hep- atoxicity and nephrotoxicity related. However, some cases have raised concerns regarding the potential cardiac events associated with remdesivir; therefore, the Pharmacovigilance Risk Assess- ment Committee of the European Medicines Agency requested to investigate all available data. Therefore, we analyzed all Individual Case Safety Reports (ICSRs) collected in the EudraVigilance database focusing on cardiac adverse events. From April to December 2020, 1375 ICSRs related to remdesivir were retrieved from EudraVigilance, of which 863 (62.8%) were related to male and (43.3%) adult patients. A total of 82.2% of all AEs (N = 2604) was serious and one third of the total ICSRs (N = 416, 30.3%) had a fatal outcome. The most frequently reported events referred to hep- atic/hepatobiliary disorders (19.4%,), renal and urinary disorders (11.1%) and cardiac events (8.4%). Among 221 cardiac ICSRs, 69 reported fatal outcomes. Other drugs for cardiovascular disorders were reported as suspected/concomitant together with remdesivir in 166 ICSRs (75.1%), 62 of which were fatal. Moreover, the mean time to overall cardiac event was 3.3 days (±2.2). Finally, dispropor- tionality analysis showed a two-fold increased risk of reporting a cardiac adverse event associated with remdesivir compared to both hydroxychloroquine and azithromycin. This study showed that remdesivir could be associated to risk of cardiac events, suggesting a potential safety signal which has not been completely evaluated yet. Further studies are needed to confirm these findings.”

Here's an assessment of what Remdesivir is good for, by Dr. Daniel Griffin. Dr. Griffin is a senior clinician in New York City who has treated or consulted on several thousand Covid patients. He is the senior clinician in a system where there are thousands of doctors. This is an excerpt from a hastily transcribed partial transcript of This Week in Virology podcast 808: COVID-19 clinical update #81 with Dr. Daniel Griffin

Basically, he says if you get treated with Remdesivir very early in your infection, great. But if it is given at a later stage, say when you arrive in the hospital with severe symptoms, it doesn't do anything. The chances you get treated early enough are fairly slim given that you tend to not get tested until you feel symptoms, then you need confirmation with a test that takes time and by then if you are one of the unlucky ones and you get a severe case, Remdesivir arrives too late to help you.

So, if the concern is Remdesivir cardiac, or any other serious side effects, a person wouldn't want to take chances unless they were offered Remdesivir in the very early stage of a Covid-19 infection.

Dr. Griffin;

"Remdesivir does significantly reduce risk of hospitalization in high-risk patients with covid 19. This data is going to be presented in detail next week . I'm going to be doing a presentation. This data is from a phase 3 randomized double blind placebo control trial to evaluate the efficacy and safety of a three-day course of Remdesivir for intravenous use for the treatment of covid19 in non-hospitalized patients at high risk for disease progression.

So this is let's give Remdesivir not during that second week when they're being admitted for an early inflammatory process let's give it in that first week during the viral phase. In an analysis of 562 participants randomly assigned a one-to-one ratio to receive Remdesivir or placebo demonstrated a statistically significant 87% reduction in risk for the composite primary endpoint of related hospitalization or all-cause death - um there were no deaths. The results also show this 81 reduction for the composite secondary endpoint [which is] no medical visits at all, so 87 reduction 81 percent reduction um great p values p 0.008 p 0.002 um but Remdesivir early on during those first few days of illness is starting to look like the monoclonal, an efficacious intervention….

…All right what if you wait… to when people get hospitalized and then you decide to give them Remdesivir. I think I've related over time I've been less than impressed. There was another publication in The Lancet Infectious Diseases. Remdesivir plus standard of care versus standard of care alone for the treatment of patients admitted to hospital with covid19. So this is the DisCoVeRy study… This is a phase three randomized controlled open label trial um it's adaptive multi-center it was conducted in 48 sites in Europe - so France, Belgium, Austria, Portugal, Luxembourg. There were a number of different agents that were in this trial so it's a one to one to one to one to one um to receive different agents. One of those um was the Remdesivir. So let's just talk about the Remdesivir versus control data. [There was] no significant difference in the occurrence of serious adverse events between treatment groups. There was no noted benefit. There were three deaths that were considered related to Remdesivir by the investigators but only one by the sponsors safety team… so really not showing any significant difference here….

We will we will probably be moving on hopefully to more exciting agents in the coming weeks."