Malaria drug that Trump and Bolsonaro praised as a Covid cure increased the chance of death, says study
The study calculated that there was an 11% increase in mortality associated with cases involving the use of hydroxychloroquine. The research was carried out with data from patients in Belgium, France, Italy, Spain, the United States and Turkey.
Chloroquine tablets produced at the Brazilian Army's Pharmaceutical Chemical Laboratory - Photo Reproduction
The drug used to treat malaria, hydroxychloroquine (HCQ), gained notoriety in 2020 when leaders such as the former president of the United States, Donald Trump, and the former president of Brazil, Jair Bolsonaro, praised it as a potential cure for SARS-CoV-2 (COVID-19). However, a recently published study has raised serious concerns about the safety of this medicine when used in the context of the pandemic.
According to research scientifically, people who used the medicine were 11% more likely to die from the virus.The researchers who conducted the study and shared their findings on revista Biomedicine & Pharmacotherapy, also calculated that around 17,000 individuals in six different nations, including the United States, where after contracting Covid-19 and using the antimalarial substance hydroxychloroquine, they died around 7.5 thousand people. The magazine, which has been edited by DM Townsend throughout its 67 years of existence, is linked to the Medical University of South Carolina, USA.
Medication
Hydroxychloroquine, an antimalarial drug, derived from chloroquine, which has immunomodulatory, anti-inflammatory, antibacterial and antiviral properties, in addition to being low cost and with a good safety profile, allowing its use in children, pregnant and lactating women, without suppressing the system immunological. However, it is imperative to undergo regular examinations to monitor the possible occurrence of retinopathy, a worrying adverse effect associated with the drug.
Widely used in dermatology, the drug demonstrates effectiveness in several conditions, such as lupus erythematosus, where it is a first-line therapy, and in several autoimmune/inflammatory diseases, such as lichen planus, polymorphic light eruption, porphyria cutanea tarda, granuloma annulare and sarcoidosis. One of the most feared toxicities of the drug is retinal, observed in 7.5% of patients, although it is extremely rare during the first 5 years of treatment. Doses greater than 5 mg/kg of actual body weight/day and a duration of more than 10 years of treatment are associated with an increased rate of retinopathy.
Gastrointestinal adverse effects are relatively common and include anorexia, heartburn, diarrhea and abdominal distension. The most common cutaneous adverse effects are: rash, hyperpigmentation and itching, which can cause photosensitivity. Other infrequent toxicities include cardiac, muscular and hematological. In 2020, the widespread prescription of HCQ for the prevention and treatment of COVID-19, caused by SARS-CoV-2, resulted in significant shortages and, in some cases, complete depletion of supplies. However, recent analyzes concluded that hydroxychloroquine is ineffective against COVID-19, advising against its use.
Indication in the Pandemic
In mid-2020, hydroxychloroquine became the target of intense debate and controversy. Some political leaders around the world have expressed optimism about the drug, contributing to a surge of global interest in the substance as a possible solution to the Covid-19 pandemic. Doctors who prescribed the drug during the peak of activity restrictions aimed at containing the spread of Covid-19 o did outside of approved indications and without substantial evidence of clinical benefit, as indicated by the authors of the recent study.
The study
A pooled analysis of randomized trials provided the conclusions of a published study. The researchers reported using public databases to determine the number of Covid-19 patients who were hospitalized in the early stages of the pandemic. In their systematic approach, they examined 44 cohort studies, reaching the conclusion that there was an 11% increase in the death rate associated with cases in which hydroxychloroquine It was used. This increase was related to approximately 16,990 hospital deaths in the United States, Belgium, France, Italy, Spain and Turkey.
Methodology
The study authors estimated the overall hospital mortality rate attributable to HCQ use by combining the mortality rate, HCQ exposure, number of hospitalized patients, and the increased relative risk of death associated with HCQ. We calculated the mortality rate in hospitalized patients for each country using a pooled prevalence estimated through a meta-analysis of published cohorts. HCQ exposure was estimated using both median and extreme estimates from a systematic review. We extracted the number of patients hospitalized during the first wave from dedicated databases. The systematic review encompassed 44 cohort studies.
Prescription rates for HCQ varied considerably from country to country, ranging from 16% to 84%. Using median estimates of HCQ use in each country, we estimate that 16,990 HCQ-related hospital deaths occurred in countries with available data, with a range of 6,267 to 19,256. The average number of HCQ-related deaths in Belgium, Turkey, France, Italy, Spain and the USA was, respectively, 240 (range not estimable), 95 (range 92-128), 199 (range not estimable), 1,822 (range 1,170 -2,063), 1,895 (range 1,475–2,094), and 12,739 (range 3,244–15,570).
Results
Study results showed that patients who received hydroxychloroquine had a significantly higher mortality rate compared to those who were not treated with the drug. Additionally, researchers have observed serious side effects associated with the drug's use, further raising concerns about its safety.
Observations regarding antimalarial medication have resulted in an increase in prescriptions for this medication. The Food and Drug Administration, which only approved the first vaccine against Covid-19 in December 2020, was forced to issue a warning that HCQ can cause irregular heartbeats and other heart problems. The researchers also cite a study by Brazilian colleagues that links the medication to side effects on the heart and liver.
The main outcome was the estimated number of excess deaths among patients hospitalized for COVID-19 during the first wave of the pandemic attributable to HCQ worldwide, the published study states.
According to research, HCQ toxicity in COVID-19 patients is in part associated with cardiac side effects, including conduction disturbances such as tachycardia, ventricular fibrillation and prolongation of the interval. In the RECOVERY study, the risk of serious drug-related cardiac arrhythmia in patients with COVID-19 was 8.2%, compared with 6.3% in the standard care group, with a 0.4% increase in the risk of death from cardiac causes.
The increased risk of death from cardiac causes in RECOVERY represents half the increase in all-cause mortality, suggesting that HCQ-related deaths may also have non-cardiac origins. In a trial conducted in Brazil, which tested hydroxychloroquine with or without azithromycin, an increase in hepatic and cardiac side effects was observed, mainly manifested by prolongation of the interval.
Despite the imprecision inherent in the estimates, the study concludes that these results highlight the danger associated with the use of medicines with low-level evidence when repurposed. The regulatory agency also clarified that the drug was only approved to treat malaria, lupus and rheumatoid arthritis.
