Tag Archives: Azithromycin

Health service providers urge to stop using hydroxycholoroquine for COVID-19 | Instant News


The sacred oaths taken by doctors during graduation from medical school to “First do no harm,” the first words of the Hippocratic Oath, provide a powerful impetus for comments that have just been published in The American Journal of Medicine.

Researchers from Florida Atlantic University’s Schmidt School of Medicine and collaborators from the University of Wisconsin School of Medicine and Public Health urge all health care providers to prioritize compassion with reliable evidence about efficacy and security.

They recommend a moratorium on prescription chloroquine or hydroxychloroquine, with or without azithromycin, to treat or prevent COVID-19, with the exception of getting the evidence needed in randomized trials and loving use.

Despite the fact, or maybe partly due to the fact that there are no therapeutic or preventative measures for the COVID-19 pandemic in the United States, which accounts for less than 5 percent of the world’s population and about 30 percent of cases and deaths, prescription drugs are widespread nine times bigger than in the last few years.

This widespread use leads to national deficiencies in patients with lupus and rheumatoid arthritis, for whom hydroxychloroquine has been an approved indication for decades. These patients cannot fill their prescriptions.

On March 28, the US Food and Drug Administration (FDA) issued an emergency use permit for chloroquine and chloroquine hydroxy for the treatment of COVID-19. However, on April 24, the FDA issued a drug safety communication warning regarding chloroquine hydroxy disorders and heart rhythm disorders that can cause sudden cardiac death.

If this drug needs to be prescribed for patients with COVID-19, initial evaluation and serial monitoring are an absolute necessity. “

Richard D. Shih, M.D, Study First Author and Professor of Emergency Medicine, Florida Atlantic University

Shih is also a division director and founding program director for emergency medicine residency programs at FAU’s Schmidt College of Medicine.

Furthermore, the authors suggest that the convincing safety profile of chloroquine may be more real than it really is.

Data on safety comes from decades of prescription by healthcare providers, especially for their patients with lupus and rheumatoid arthritis, both of which have a greater prevalence in young and middle-aged women, whose risk of fatal cardiac outcomes due to hydroxychloroquine is very convincing. low.

In contrast, the risk of hydroxychloroquine for patients with COVID-19 is significantly higher because of fatal cardiovascular complications due to these drugs is much higher in older patients and those who have heart disease or risk factors, both of which are mostly male .

In basic research, hydroxychloroquine and chloroquine are structurally related and have similar mechanisms to inhibit the virus that causes COVID-19. Despite their structural similarities, in vitro, hydroxychloroquine seems to be more effective.

Additionally, when used for lupus and rheumatoid arthritis, hydroxychloroquine has fewer side effects, less drug interactions and is less toxic in overdoses.

The authors note that the evidence currently available is limited to eight published studies, five on hydroxychloroquine alone; two in chloroquine hydroxy plus azithromycin; and one in both in combination or alone.

Of these only three were randomized trials enrolling 225, 62, and 30 patients – all of them too small to provide reliable evidence. All three tested hydroxychloroquine alone versus the standard of care in China.

One showed no significant difference in cleansing the virus at 28 days, second, there was no difference in cleansing the virus at seven days, and third, some improvements in fever, coughing and chest computed with tomographic findings.

“With regard to hypothesis testing, only large-scale randomized trials with sufficient size, dosage and duration can reliably detect the most reasonable small to moderate effects, which can have enormous clinical and public health impacts,” said Charles H. Hennekens, MD, Dr.PH, senior writer, first professor Sir Richard Doll and senior academic advisor at FAU’s Schmidt College of Medicine.

Source:

Journal reference:

Shin, R D., et al. (2020) Hydroxychloroquine for Coronavirus: Urgent Need for Prescription Moratorium. American Journal of Medicine. doi.org/10.1016/j.amjmed.2020.05.005.

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HealthDay Report: NIH Launches Trial of Hydroxychloroquine, Azithromycin for COVID-19 | Instant News


Researchers from the University of Central Florida are looking to develop a special cough medicine that can help control the spread of COVID-19 by changing one’s saliva.

The idea is that COVID-19 transmission will drop because the specially designed cough drops made with candy or corn flour will make saliva heavier and stickier, which will help sneeze and cough particles fall instead of floating in the air, according to the press. release on the project.

The team recently received the National Science Foundation’s Rapid Response Research Award for $ 200,000 for their project.

“Based on our preliminary data, combining face masks with saliva mixed with corn flour will potentially make us go from six feet to two feet for social distance,” said Kareem Ahmed, assistant professor in the Department of Mechanical and Aerospace Engineering at UCF and co. -The main investigator, in a press release about the project.

This will be very helpful in areas where social distance is not always easy, such as offices, grocery stores and public transportation.

They use special high-speed cameras to see patterns and distances of sneezing and cough drops, including those altered by candy or starch. The team’s initial results show that changing the nature of saliva can cause a significant reduction in how long the droplets remain in the air.

Read more about this research.

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The UK funded three major Covid-19 clinical trials in the race for healing | Instant News


LONDON: Although there is no clinically proven drug in the world to treat Covid-19, three new novel coranvirus clinical trials funded by the British government are racing to find a cure. Antiviral drug remdesevir, which has undergone clinical trials in the US and China, is not among the drugs that are being evaluated in Britain.
The Recovery Trial, coordinated by Oxford University researchers working with hospital doctors in the UK, is currently the largest potential randomized clinical trial in the world corona virus care. It is testing several drugs in pre-critical adult Covid-19 patients who are hospitalized in the UK.
Now underway with more than 9,000 adult inpatients who have tested positive for Covid-19 in more than 130 NHS hospitals, are being tested whether existing or new drugs – a mixture of injections and tablets – can help patients treated in hospitals with Covid – confirmed. 19. The outcome of whether this treatment is safe and effective is expected in five to seven weeks, potentially benefiting hundreds of thousands of patients worldwide.
A large-scale randomized hospital-based trial, which has received £ 2.1 million in British government funding, is evaluating lopinavir-ritonavir (a drug commonly used to treat HIV that has shown activity against SARS and MERS CoVs); dexamethasone steroids, which are used in various conditions to reduce inflammation; hydroxychloroquine (treatment for malaria which has shown antiviral activity against SARS-CoV-2 in cell culture); and azithromycin (A commonly used antibiotic that has shown benefits in inflammatory lung disease.) Tocilizumab (an anti-inflammatory treatment given by injection) is being used in patients with progressive Covid-19 (as evidenced by hypoxia and inflammatory conditions).
“Recovery is a major trial similar in concept and design to the WHO ‘Solidarity’ international clinical trial for Covid-19 treatment, unless remdesivir is not part of it,” a senior adviser to the British government told TOI.
Another British experiment is the Principle Trial, also administered by Oxford University, which tests drugs in people over 65 and those over 50 with underlying health conditions who have Covid-19 symptoms. This trial, which has already received £ 1.7 million in UK government funding, initially tested hydroxychloroquine through general practice to see whether doctors could stem the development of Covid-19 symptoms in the elderly and prevent hospitalization.
The third major UK trial, which also takes place in 12 other countries, is called the Remap-Cap trial. This global clinical trial is for Covid-19 patients who are critically ill in the ICU. It uses an innovative adaptive trial design to evaluate a number of treatment options simultaneously.
“In the space around re-used drugs, the possibility of a dramatic treatment effect is relatively low and there may not be an absolute game modifier in registered drugs even though individually it might be very helpful. Therefore the government formed Accord, others learned, and that started recruiting patients last week, “the adviser said.
Accord will accelerate clinical trials in the UK on drugs that have not been licensed and are still in phase 2 for other diseases, if, after a small randomized control trial with Covid-19 patients, there is an early signal that they can become game changers. If so, these medicines will be included in one of these large scale Covid studies.

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Hydroxychloroquine is combined with azithromycin and abnormal heart rhythms in COVID-19 patients | Instant News


A new study shows that a combination of drugs that were initially praised for COVID-19 – Hydroxychloroquine and Chloroquine combined with azithromycin, can cause abnormal and life-threatening heart rhythms. In patients who are hospitalized with new coronavirus infections or SARS CoV-2, this combination can cause prolonged QT intervals as can be detected on an ECG. The study, entitled, “Risks of QT Interval Extensions Related to the Use of Hydroxychloroquine With or Without Azithromycin Concurrent Among Inpatients Who Test Positive for Coronavirus 2019 (COVID-19),” is published in the latest issue of the journal JAMA Cardiology.

What is this research about?

Research led by Dr. Howard S. Gold of Beth Israel Deaconess Medical Center and Harvard Medical School in Boston is basically observational research. The first author of this study was Nicholas J. Mercuro. The study authors wrote that this combination of drugs was initially cited as a treatment for people who had been diagnosed with COVID-19-associated pneumonia. The main objective of this study was to “characterize the risk and extent of QT prolongation in patients with COVID-19 in connection with their use of hydroxychloroquine with or without concurrent azithromycin.” They measured the correct QT interval for study participants.

QT interval in 3d illustration of ECG signaling. Image Credit: sciencepics / Shutterstock

What was done

This observational cohort study was conducted at a tertiary care center in Boston, Massachusetts. Participants are patients who have been detected at least once with a viral infection. One of their nasopharyngeal swabs has at least tested positive in the polymerase chain reaction test (PCR test) for SARS CoV-2. All of these participants were clinically diagnosed with pneumonia and had received at least 1 day of hydroxichloroquine between 1st March 2020 and 7th April 2020.

Electrocardiogram (ECG) records of patients were measured. On an ECG, several waves are recorded – P, Q, R, S, and T. Intervals between waves are measured. Two significant waves measured include the PR interval and the QT interval. Other potential side effects of the drug or its combination are also noted.

What was found?

For this study, a total of 90 participants who received hydroxychloroquine were included. Of these, 53 have received azithromycin in combination. Among participants, 48.9 percent (total 44) were women, and the average body mass index was 31.5 for all participants. Among patients, 53.3 percent had high blood pressure (48 patients), and 28.9 percent had diabetes mellitus (26 patients). Both of these conditions are most often found among patients.

The results revealed that at the start of the study, the median initial QTc was 455 (430-474) milliseconds. The median QTc for those using hydroxychloroquine is 473 milliseconds (ranging from 454 milliseconds to 487 milliseconds). Among those using hydroxychloroquine and azithromycin, the median QTc was 442 milliseconds (ranging from 427 milliseconds to 461 milliseconds). The extension after administration of a combination of drugs was found to be statistically significant.

The researchers wrote, “Those who received concurrent azithromycin had a greater median (interquartile range) in the QT interval (23). [10-40] milliseconds) compared to those who received hydroxychloroquine alone (5.5 [−15.5 to 34.25] millisecond. “

Serious heart rhythm arrhythmias have been found in some patients. Of the participants, seven (19 percent) who had received hydroxychloroquine alone had a QTc interval that lasted 500 milliseconds or more. Three of the patients had a difference of 60 milliseconds from the start. Among those who received azithromycin, 21 percent (11 of 53 who received the combination) had a QTc interval of more than 500 milliseconds. The change is 60 milliseconds or more between 13 percent (7 out of 53 participants).

The researchers also noted that patients given loop diuretics such as furosemide had a higher risk of extending the QTc interval compared to those who did not receive the drug. The chance ratio was found by the researchers, developing a prolonged QTc among those who received this combination was 3.38. Risk is increased for those who have an initial QTc interval of 450 milliseconds or more (odds ratio 7.11).

One participant developed a severe heart rhythm abnormality called torsades de pointes. Ten patients had to stop hydroxychloroquine due to drug side effects, including nausea and low blood sugar.

Conclusions and importance of research

The researchers concluded that participants who were diagnosed with COVID-19 pneumonia given hydroxychloroquine were at a higher risk for prolongation of QTc. This risk increases with the addition of azithromycin. They also wrote that one of their cases of torsades de pointes was the first case reported with this combination of drugs. They called for more detailed research to assess the risks and benefits of using this drug among patients diagnosed with COVID-19. They recommend that all patients require “routine electrocardiogram, and electrolyte monitoring” during therapy.

The authors write, “Doctors must carefully consider the risks and benefits when considering hydroxychloroquine and azithromycin, with close monitoring of QTc and concurrent drug use.”

Editorial accompanying

In accompanying editorial titled “Hydroxychloroquine, Coronavirus Disease 2019, and QT Prolongation,” by Robert O. Bonow, Adrian F. Hernandez, and Mintu Turakhia talk about the complexity of decision making when treating COVID-19 patients.

They emphasize the fact that there is no proven treatment strategy for this infection. They wrote, “Lacking strong trial evidence, doctors are forced to consider all options based on preclinical and small observational studies, often in the heartbreaking arrangement of patients who worsen in the upheaval of severe pneumonia …”

The authors write that hydroxychloroquine is able to extend the QT interval due to “inadequate cellular potassium flow.” Azithromycin also carries a similar risk. They called this finding “welcome and important.” They added, however, that in intensive care settings, it was easy to monitor the patient’s ECG, and if proven useful, the drug could be used.

The authors say that there are two ongoing trials – “Results Associated with COVID-19 Treated with Hydroxychloroquine Among Inpatients With Symptoms of Disease (ORCHID) (NCT04332991) 12 and Randomized evaluation of COVID-19 Therapy (RECOVERY) (ISRCTN50189673) ) “. This will provide a detailed drug safety profile.

They concluded, “Until then, treatment decisions for this disease will remain based on clinical judgment and, ideally, in the context of enrolling patients in clinical trials to provide definitive answers.”

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The use of anti-malaria drugs for COVID-19 is associated with an increased risk of cardiac arrhythmias | Instant News


Since the World Health Organization declared COVID-19 as a Public Health Concern for Global Interests on January 30, more than one million tested positive for illness in the United States, and more than 62,000 have died. In the absence of FDA-approved treatments to date, the anti-malaria drug, hydroxychloroquine, has emerged as a potential therapy for pneumonia associated with COVID-19, with or without the antibiotic azithromycin.

In a short report published today at JAMA Cardiology, a team of pharmacists and doctors at Beth Israel Deaconess Medical Center (BIDMC), part of Beth Israel Lahey Health, found evidence that showed patients who received hydroxychloroquine for COVID-19 were at an increased risk of electrical changes in the heart and cardiac arrhythmias. The combination of hydroxychloroquine with azithromycin is associated with greater changes compared to hydroxychloroquine alone.

While hydroxychloroquine and azithromycin are generally well-tolerated drugs, increased use in the context of COVID-19 is likely to increase the frequency of adverse drug events (ADE). This is particularly concerning given that patients with underlying cardiac comorbidities appear to be disproportionately affected by COVID-19 and that the virus itself can damage the heart. “

Nicholas J. Mercuro, PharmD, first co-author, pharmaceutical specialist in infectious diseases at BIDMC

Hydroxychloroquine and azithromycin can respectively cause electrical disturbances in the heart known as QTc extension, shown by a longer distance between certain peaks on the electrocardiogram. The extension of QTc indicates that the heart muscle takes milliseconds longer than usual to refill between beats. Delay can cause cardiac arrhythmia, which in turn increases the chance of a heart attack, stroke, or death.

In this observational, retrospective, single center study, Mercuro and colleagues evaluated 90 adults with COVID-19 who were hospitalized at BIDMC between March 1 and April 7, 2020, and received at least one day of hydroxychloroquine. More than half of these patients also have high blood pressure, and more than 30 percent have diabetes.

Seven patients (19 percent) who received hydroxychloroquine alone developed QTc lasting 500 milliseconds or more, and three patients experienced changes in QTc of 60 milliseconds or more. Of the 53 patients who also received azithromycin, 21 percent had QTc that lasted 500 milliseconds or more, and 13 percent experienced a change in QTc of 60 milliseconds or more.

In our study, patients who were hospitalized and received hydroxychloroquine for COVID-19 often experienced extended QTc and adverse drug events. One participant who used a combination of drugs experienced a potentially lethal tachycardia called torsades de pointes, which to our knowledge has not been reported elsewhere in the COVID-19 literature reviewed by peers. “

Christina F. Yen, MD, first co-author, BIDMC Medical Department

In 2003, preliminary data showed that hydroxychloroquine might be effective against SARS-CoV-1, a fatal but difficult-to-transmit respiratory virus associated with coronavirus that causes COVID-19. Recently, a small study of patients with COVID-19 appears to benefit from anti-malaria drugs. However, subsequent studies failed to confirm both of these findings. Regarding their data, Gold and his colleagues urge caution and careful consideration before giving hydroxychloroquine as a treatment for COVID-19.

“When considering the use of hydroxychloroquine, specifically combined with azithromycin, doctors must carefully weigh the risks and benefits, and monitor QTc – especially considering the patient’s co-morbidity and concurrent drug use,” said senior author Howard S. Gold, MD, a specialist infectious disease at BIDMC and assistant professor of medicine at Harvard Medical School. “Based on our current knowledge, hydroxychloroquine for the treatment of COVID-19 may have to be limited to clinical trials.”

Source:

Journal reference:

Mercuro, N.J., et al. (2020) The risk of prolongation of the QT interval associated with the use of hydroxychloroquine with or without concurrent azithromycin among inpatients who tested positive for Coronavirus 2019 (COVID-19). JAMA Cardiology. doi.org/10.1001/jamacardio.2020.1834.

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