Posted on 07/28/2020 6:38:36 AM PDT by Red Badger
According to new research published in the preprint server medRxiv* in July 2020, the use of hydroxychloroquine (HCQ) among outpatients in clinical trials, without high-risk factors for cardiac arrhythmia, is safe, with gastrointestinal side-effects being the most common side effects and no fatal adverse outcomes.
As the COVID-19 pandemic continues all around the world, with over 630,000 deaths so far, scientific research has focused on finding effective medications against the virus. A strong contender, right from the very beginning, has been HCQ, mainly because of the heavy backing given by political heavyweights. Positive Profile, Negative Side Effects
HCQ has been demonstrated to have in vitro antiviral activity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19 disease, and hinders its replication. However, correspondingly strong evidence of its activity in the treatment or prevention of this disease has not been found so far.
For this reason, the World Health Organization and several other health organizations are conducting studies on the safety and efficacy of this drug in both asymptomatic or mildly symptomatic cases, as well as sicker patients in hospitals.
Earlier research has reported an increase in the reported incidence of cardiac side effects with the use of HCQ and azithromycin in combination. This led to the revocation of the Emergency Authorization issued by the US Food and Drug Authority (FDA) for the use of HCQ in severely ill COVID-19 patients.
Instead, it said, “Hydroxychloroquine and chloroquine can cause abnormal heart rhythms such as QT interval prolongation and…ventricular tachycardia,” especially among those using HCQ with azithromycin or those who already had kidney or heart problems.
The issue with QT prolongation is the risk of ventricular arrhythmias. Most of these episodes in the context of HCQ use have been when the drug was used with another arrhythmogenic drug, used for an extended period or at excessive doses. Long and Fruitful History of HCQ in Medicine
However, HCQ has been in clinical use, and when used as per the guidelines, for people without such issues, it is a useful drug in multiple disciplines and has been used in autoimmune rheumatic conditions. Baseline laboratory tests or ECG monitoring are rarely carried out in most cases.
However, health organizations have drawn attention to its ability to cause sudden deaths, especially when coupled with azithromycin. In most cases, safety issues have arisen in sicker, hospitalized patients who have severe disease, or other coexisting disease conditions, where multiple medications are taken at the same time. Reasons for Increased Risk of Arrhythmia with HCQ in COVID-19
There are reasons to suspect that this may not reflect the normal course of events following the use of HCQ. For instance, the current virus may gain entry into cardiac cells and cause damage, and even arrhythmias, as reported in many cases.
Another potential cause of arrhythmias may be the elevated cytokines, especially in patients who already have heart damage. HCQ in current trials is also used at much higher doses than for the conditions it is currently approved for.
Finally, there may be significant disruption of normal electrolyte levels, which, in combination with kidney failure, makes the individual more prone to arrhythmias. This means that separate safety tests need to be carried out specifically for COVID-19 patients. HCQ is thought to be safer in outpatients with COVID-19 compared with hospitalized patients. The Study: Safety of HCQ in COVID-19 Outpatients
The current study focuses on the safety evaluation of HCQ in outpatients, compiling data from three randomized controlled trials, where HCQ was used as pre-exposure prophylaxis, post-exposure prophylaxis, and early treatment, respectively. The researchers excluded all participants with contraindications to the use of this drug.
The study included approximately 2,800 individuals, with a median age of 40 years. About 60% of them were in good health. The researchers found that side effects were reported in around 85% of the participants, and 27% had one or more side effects related to the medication.
When the dosage frequency was compared, they found that about 30%, 35%, 30%, and 20% had side effects when the drug was administered daily, twice a week, once a week or when a placebo was used. Important Side-Effects
Around 30% of patients reported side effects in the trials where the drug was administered post-exposure or post-infection.
The most common side effects reported were gastrointestinal, namely, stomach upset or nausea, diarrhea, vomiting, or abdominal pain. Overall, these symptoms were reported in a quarter of patients on daily dosage (about 20% and 15% with twice-weekly or weekly dosage), and in 10% of those on placebo.
However, in the post-exposure placebo vs. treatment groups, the rate of gastrointestinal side effects was comparable. The side effects were rated as tolerable and not requiring the cessation of medication.
Other reported side effects included lightheadedness or dizziness and allergic reactions.
There were only two instances of cardiac arrhythmias in the whole patient population, one of which occurred in the placebo group, the other in a patient taking HCQ twice a week. There were no reported deaths in this low-risk population. Implications and Future Directions
The current study excluded hospitalized, presumably sicker, patients, who were mostly older. Most of the participants were health workers, and reasonably well-informed about health. Therefore, the safety of HCQ concerning its use in severely ill COVID-19 patients remains unclear.
Ongoing clinical trials can safely continue with research participants and regulatory bodies reassured as to the general safety of hydroxychloroquine when using appropriate exclusion criteria.”
*Important Notice
medRxiv publishes preliminary scientific reports that are not peer-reviewed and, therefore, should not be regarded as conclusive, guide clinical practice/health-related behavior, or treated as established information. Journal reference:
Lofgren, S. M. et al. (2020). Safety of Hydroxychloroquine among Outpatient Clinical Trial Participants for COVID-19. medRxiv preprint. doi: https://doi.org/10.1101/2020.07.16.20155531. https://www.medrxiv.org/content/10.1101/2020.07.16.20155531v1
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Yet Twitter has reported the opposite.
It makes me wonder.
HCQ has been used for DECADES to treat other illnesses, malaria, Lupus, Rheumatoid Arthritis, etc. and it’s side effects are well known, and people use it every day for these maladies. And it’s very inexpensive.
If it is cheap, plentiful and well tolerated by most people, then why restrict its use by doctors, even if it doesn’t work well, or not work at all, there is no harm done.................
By the time it’s approved for general use COVID-19 will be gone.
Hydroxychloroquine and chloroquine can cause abnormal heart rhythms such as QT interval prolongation and…ventricular tachycardia especially among those using HCQ with azithromycin or those who already had kidney or heart problems. Most of these episodes (ventricular arrhythmia) in the context of HCQ use have been when the drug was used with another arrhythmogenic drug, used for an extended period or at excessive doses.
...health organizations have drawn attention to its ability to cause sudden deaths, especially when coupled with azithromycin.
In most cases, safety issues have arisen in sicker, hospitalized patients who have severe disease, or other coexisting disease conditions, where multiple medications are taken at the same time.
THEN, FINALLY, you get to the bottom line at the end of the article..."There were only two instances of cardiac arrhythmias in the whole patient population, one of which occurred in the placebo group, the other in a patient taking HCQ twice a week. There were no reported deaths in this low-risk population.
So ONE arrhythmia incident with HCQ in 1,400 people AND one in the placebo group. They don't say if the patients experience arrhythmia were taking azithromycin.
“why restrict its use?”
Because Donald Trump is President and the nation is completely unhinged. There is no other reason.
It has been used safely for 51 years as a malarial treatment. Why is this a headline? If it is because someone on Twitter doesn’t believe the facts? Why is Twitter a reference source?
Where is the Twitter medical science officer with an Ivy League degree in virology?
Or is he just some punk with a empty skull and a computer?...............
So ... when is PDJT going to sign an EO to allow HCQ to be sold OTC?
A relative of mine had all the symptoms and had tested positive for COVID-19 4 days before, went to the ER with breathing difficulty. Oxygen saturation down to 86%. The ER only gave fluids and a cat-scan. The next day they found a doctor who prescribed the “Trump Cocktail” plus a steroid in a nebulizer. They saw an immediate turn around, said it was like a miracle.
What I want to know is how many have died or suffered needlessly because doctors are too cowardly to prescribe one of these cheaper treatments such as hydroxychloroquine, budesonide, or dexamethasone?
Now I understand why Rush Limbaugh says Twitter is a sewer.
It is the voice of the Left..............
To answer you question, ... the dems can’t let a simple cheap drug / regimen make their “pandemic” go away. The wuhan flu has to last until November to show how Trump is not able to protect the US citizens. How else will the sheeple vote him out of office. They have tried everything else and nothing has worked. So this HAS to work. They have nothing left.
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