Anvisa approves new medicine that benefits 383 thousand in ES

Anvisa approves new medicine that benefits 383 thousand in ES
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Patients with chronic kidney disease (CKD) will have another treatment option: empagliflozin, a medicine indicated for the treatment of type 2 diabetes, which was approved for use by the National Health Surveillance Agency (Anvisa) to treat CKD.

In the State, the estimate by the Department of Health (Sesa) is that 10% of the population, around 383 thousand, have the disease. This is the number of patients who can benefit from the new indication, which occurred at the end of April and published in the Official Gazette of the Union.

The approval was based on the EMPA-KIDNEY study, with adults, conducted by the University of Oxford, in partnership with pharmaceutical companies Boehringer Ingelheim and Eli Lilly, and found that the molecule reduced the risk of progression of kidney disease or death from a problem by 28%. cardiovascular disease in patients with chronic kidney disease compared to those who did not receive the drug.

With an average price of around R$200, the medicine is not yet available in the Unified Health System (SUS), but can now be prescribed by a specialist, if the patient has an indication, according to the president of the Brazilian Society of Nephrology – Espírito Regional Santo, Alice Pignaton Naseri.

“All medications in the gliflozin class have been shown to be beneficial in reducing the loss of kidney function in people with CKD, according to published clinical trials, and we have seen this in practice.”

She highlights that the medication prolongs the functioning time of the kidneys, preventing fibrosis and chronic damage, postponing the process of needing dialysis or transplantation.

According to nephrologist Adriana Borel, until recently the number of medications was limited and had little effect on reducing the progression of chronic kidney disease.

Nephrologist André Potratz warns that chronic kidney disease is caused by a set of comorbidities prevalent in the country, such as diabetes and hypertension, but there are other less common causes such as chronic nephritis.

“Chronic kidney disease is asymptomatic. Most of the time, it will only have symptoms in more advanced stages. It is important that blood pressure is measured regularly and that creatinine measurement is done as part of the laboratory tests at check-up.”

The numbers

– 2.4 million deaths per year are caused by chronic kidney disease

– 1.1 million is the number of hospitalizations for CKD in the State last year


know more

There is no cure for chronic kidney disease

– Medicine

Empagliflozin is a medicine indicated for the treatment of type 2 diabetes mellitus. Its use had already been approved for the treatment of chronic kidney failure and has now been approved for the treatment of chronic kidney disease (CKD).

The new indication, made by the National Supplementary Health Agency (Anvisa), occurred at the end of April and was published in the Official Gazette of the Union.

The approval was based on the EMPA-KIDNEY study, with adults, conducted by the University of Oxford, in partnership with pharmaceutical companies Boehringer Ingelheim and Eli Lilly. The research showed that the molecule reduced the risk of progression of kidney disease or death from cardiovascular problems by 28% in patients with chronic kidney disease compared to those who did not receive the medication.

– Chronic kidney disease

general term for heterogeneous changes that affect both kidney structure and function, with multiple causes and multiple risk factors.

– Risk factors

Chronic kidney disease is associated with two diseases with a high incidence in the Brazilian population: high blood pressure and diabetes.

As the kidney is responsible for controlling blood pressure, when it does not function properly, pressure levels change. Changing pressure levels also put stress on the kidneys. Therefore, hypertension can be the cause or consequence of kidney dysfunction, and its control is essential for preventing the disease.

Diabetes can damage the blood vessels of the kidneys, interfering with the functioning of these organs, which are unable to filter the blood correctly. More than 25% of people with type I diabetes, and 5% to 10% of people with type II diabetes develop kidney failure.

In addition, obesity, cardiovascular diseases, smoking, nephritis (inflammation of the kidneys), hereditary cysts, frequent urinary infections that damage the urinary tract and congenital diseases are also among the risk factors.

– Symptoms

In many cases, patients may be asymptomatic until they completely lose function. The most common symptoms are nausea, vomiting, leg swelling, shortness of breath, weakness and reduced urine output.

– Diagnosis

Kidney dysfunction can be identified through two tests: a urine test and a blood test. The first identifies the presence of a protein (albumin) in the urine, and the blood test checks the presence of another, creatinine.

– Treatment

There is no cure for chronic kidney disease, although treatment can slow or stop the progression of the disease and prevent the development of other serious conditions.

In Brazil, according to data from the Brazilian Society of Nephrology for 2022, the number of patients with advanced chronic kidney disease is growing and, currently, more than 140 thousand patients undergo dialysis in the country.

Source: Ministry of Health, experts consulted and AT research.


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The article is in Portuguese

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