BOSTON – Malaria drugs encouraged by President Donald Trump because treatment for the corona virus did not help and were associated with a greater risk of death and heart rhythm problems in a new study of nearly 100,000 patients worldwide.
Friday report in the journal Lancet is not a strict chloroquine or chloroquine hydroxy test, but by far the biggest display of its use in real-world settings, which includes 671 hospitals on six continents.
“Not only is there no benefit, but we see a very consistent danger signal,” said a study leader, Dr. Mandeep Mehra, cardiologist at Brigham and Women’s Hospital in Boston.
The researchers estimate that the death rate due to drug use, with or without antibiotics such as azithromycin, is approximately 13% compared to 9% for patients who do not take it. The risk of developing serious heart rhythm problems is more than five times greater.
Although only observational, the size and scope of the study had many impacts, said Dr. David Aronoff, head of infectious diseases at Vanderbilt University Medical Center.
“This really gives us a level of confidence that we might not see the great benefits of this drug in the treatment of COVID-19 and might be harmful,” said Aronoff, who was not involved in the study.
Trump has repeatedly encouraged malaria drugs, and said he was using hydroxychloroquine to try to prevent infection or minimize the symptoms of coronavirus.
These drugs are approved to treat lupus and rheumatoid arthritis and to prevent and treat malaria, but there are no rigorous large tests that find them safe or effective to prevent or treat COVID-19. People who are sick enough to be hospitalized with coronavirus are not the same as healthy people who take drugs in other situations, so safety cannot be assumed from previous use, Mehra said.
These drugs also have the potential to cause serious side effects. Food and Drug Administration has warned oppose the use of hydroxychloroquine with antibiotics and say the malaria drug should only be used for coronavirus in formal studies.
A pharmaceutical technology holding Hydroxychloroquine pills at Rock Canyon Pharmacy in Provo, Utah, on May 20, 2020. President Donald Trump announced on May 18 that he had used hydroxychloroquine for almost two weeks as a precautionary measure against COVID-19.
Lacking the results of more stringent tests, “people need to see real-world evidence” to measure safety or effectiveness, Mehra said. The results for these patients, from a long-standing global research database, are “the real world as can be obtained by the database,” he said.
His study looked at nearly 15,000 people with COVID-19 getting one malaria drug with or without one of the recommended antibiotics and more than 81,000 patients not getting these drugs.
Overall, 1,868 took chloroquine alone, 3,783 took it plus antibiotics, 3,016 took hydroxychloroquine alone and 6,221 took it plus antibiotics.
About 9% of patients who don’t take drugs die in the hospital, compared to 16% in chloroquine, 18% in hydroxychloroquine, 22% in chloroquine plus antibiotics, and 24% in hydroxychloroquine plus antibiotics.
After calculating age, smoking, various health conditions, and other factors that affect survival, the researchers estimated that the use of these drugs might contribute 34% to 45% of the risk of excess death they observed.
About 8% of those using hydroxychloroquine and antibiotics developed heart rhythm problems vs. 0.3% of patients who did not use the drug in this study. More of this problem is seen with other drugs too.
The results show these drugs are “useless and possibly dangerous” in people treated in hospitals with COVID-19, professor Christian Funck-Brentano, from the Sorbonne University in Paris, wrote in comments published by the journal. He has no role in this research.
Experiments are being conducted now to test these drugs in a strict manner “needs to be completed and should not be stopped prematurely,” Aronoff said.
Despite the large Lancet study, counter-observations such as these “cannot control every factor that may be responsible for the observed results,” he said.
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