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Concerns about heart risk are heightened by the use of chloroquine to treat Covid-19

 


There were early indications that these drugs might be effective in treating or preventing Covid-19, but drug therapy has not endured extensive clinical trial due diligence and is closely associated with chloroquine. There is growing concern about the effects of hydroxychloroquine, especially in the mind.

Currently, there is no cure for Covid-19 approved by the US Food and Drug Administration, but government agencies Emergency use permit Chloroquine and hydroxychloroquine for treating patients hospitalized with Covid-19.

“In a better world, if we don’t panic about this virus so much, we’ll declare this drug to have some value other than the president and see if it declares it to have any value.” Ofit said. “If someone is sick, you can hurt them.”

The drug chloroquine is similar to hydroxychloroquine, but hydroxychloroquineLess toxic derivativeOf chloroquine.
“Hydroxychloroquine is very widely used in the treatment of lupus and other diseases, at least in more developed regions of the world, and is much safer,” said Dr. William Schaffner, a professor of preventive medicine and infectious diseases. Vanderbilt University School of Medicine In Nashville.

“But this concern remains,” he added.

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World Health Organization officials said on Mondays that chloroquine and hydroxychloroquine were Covid-19 treatment options as much as possible because the drug was used “off label” to treat some patients, especially in certain countries. “I’m looking forward to” the results of a study to evaluate the use of.

“The medical and research community takes the potential of hydroxychloroquine and chloroquine really seriously,” said Dr. Mike Ryan, executive director of the World Health Organization’s Emergency Medicine Program. During a media briefing in Geneva on Monday.

Now, “there is no evidence of efficacy from the randomized controlled trials, and clinicians are first warned to look out for side effects of the drug to ensure we do no harm.” Said Ryan. “We look forward to the outcome of the ongoing trial.”

Small chloroquine test ends early in Brazil due to death

A preliminary study in Brazil on the use of chloroquine diphosphonate to treat patients with Covid-19 symptoms ended early after the death of a few patients, and researchers found that high doses of drugs were severe. It has been found to be associated with arrhythmias or irregular heartbeat.

Although the study has not been published in a peer-reviewed medical journal, Published on online medical server medRxiv Dr Marcus Lacerda, principal investigator of the study and researcher at the Brazilian facility Fiocruz, submitted to and published in a medical journal on Saturday, told CNN by email on Monday.

The preprint study included 81 patients admitted with severe respiratory syndrome in Manaus, Amazon, Brazil. Patients were enrolled in the lab prior to receiving Covid-19 confirmation, but Lacerda said 75% of patients were finally confirmed and other patients were “very likely” It came out negatively.

In this study, patients received high doses of chloroquine at 600 mg twice daily for 10 days for a total of 12 g, or low doses of 450 mg for 5 days twice daily, only on the first day, for a total of 2.7 g. All patients were also given antibiotics Ceftriaxone and azithromycin as part of treatment. The limitation of the study was that no patients received placebo.

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By day 6 of the trial, researchers discontinued the study after 11 patients died-more deaths were counted in the study’s updated data.

In a new update of the study submitted for publication, “16 of 41 high doses and 6 of 40 low doses die. This is significantly different,” Lacerda said in an email. Stated.

“Patients are also using azithromycin and oseltamivir, which are also cardiotoxic drugs,” he said. “The lower doses seem to be safer in these patients, but they are more effective due to their lack of local control (no drug use) as they are routinely used in Brazil. I need to do a test. “

The Data Safety Oversight Committee for the study “recommended immediate discontinuation of the high-dose group and unmasking all patients in it to return to the low-dose group,” the researchers said in a preprint study. wrote.

Overall, at least 2 patients in the high dose group occurred Ventricular tachycardiaData from preprint studies showed that it was a type of arrhythmia that could lead to sudden cardiac death, and none of the low dose groups developed this condition.

The researchers pointed out that their study size was small, but higher doses showed “no apparent benefit” to Covid-19.

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“The main difference between the high-dose and low-dose groups was in the first 3 days and the actual toxicity. Two patients in the high-dose chloroquine group developed ventricular tachycardia before death. “Said Schaffner from Vanderbilt University, who was not involved. the study.

“So it’s clear that the higher doses are more toxic, but the low doses weren’t without concern, and a large study may find some issues with the low doses.” He said.

While researchers have shown that chloroquine drugs have been safely used for over 70 years in their trials, For malaria, “It could be toxic” when used in high doses to treat Covid-19, they called for further study of the drug.

“In conclusion, the high CQ dose scheme (12g) given for 10 days was not safe enough to warrant the continuity of that particular study group,” the researchers noted in the study, indicating that this dose was no longer available. It is used to treat severe Covid-19 with a strong addition that is not recommended.

Swedish hospital instructed Covid-19 not to use chloroquine

Swedish hospitals are receiving guidance instructing physicians not to use chloroquine to treat Covid-19 patients outside of clinical trials.

Magnus Gisren, a professor and senior doctor at Sahlgrenska University Hospital in Gothenburg, Sweden, told CNN last week that the guidance also applies to its related drug, hydroxychloroquine.

Guidance states that chloroquine is not recommended for use outside clinical trials, given the very low evidence of significant effects on Covid-19 and the exclusion of serious side effects.

“I stopped using it a few weeks ago with very limited use,” Gisslén said. “We advised all hospitals in our area to stop using it. I think almost every hospital in the country has stopped using it.

“This drug is not as effective as we could see in the treatment of Covid-19.”

Mr Gislen and his colleagues have seen “serious effects on the heart” associated with the use of this drug, he said. Patients with impaired renal function also struggled to take this drug.

The highest-risk patients are those with a history of the heart, Gislen said. “They are often elderly patients,” he said. “But too high a dose can affect people who have no underlying illness at all.”

In the United States, the drug is commonly used in combination with the antibiotic azithromycin. Gislen said it was not combined with antibiotics in Sweden.

“ The use of chloroquine and hydrochloroquine has been tested in clinical trials in Covid-19 patients, ” said Urawenderliminga, science director of pharmacovigilance at the Swedish Medical Products Agency, who has not published any specific guidance on medicines. Should only be used. “

Last week, Liminga counted about five incident reports of serious side effects in Swedish Covid-19 patients.

“These side effects are mostly well known and are primarily about the heart. In the worst case, the side effects are cardiac arrest, which can eventually lead to death,” she said.

The agency is not aware of the death from cardiac arrest due to chloroquine, but has identified one death with an unclear drug relationship.

“I don’t know how much this drug was used in Sweden,” Liming said. “But there is no evidence that it has any positive effects when used as a prophylactic. We say this should only be used in clinical trials with Covid-19 patients. That’s why. “

Cardiologist group to consider

Last week, American Heart Association, American College of Cardiology, Heart Rhythm Society Issued guidance For important cardiovascular considerations for using hydroxychloroquine and azithromycin to treat new coronaviruses, physicians must consider “potentially serious consequences for people with pre-existing cardiovascular disease”. Said no
“The urgency of COVID-19 must not diminish the scientific rigor of working with COVID-19,” said Robert Harrington, chairman of the American Heart Association and professor and professor of medicine at Stanford University. Dr. Said in last week’s news release About guidance.

Harrington said, “While these medications may be effective against COVID-19, either individually or in combination, we recommend that patients with cardiovascular disease be alert to these medications. I will. “

Minali Nigram of CNN contributed to this report.

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