Millions of patients with a high risk of a fatal heart attack can take a medicine that may not even be effective, top doctors warned.
Anti-clotting pill ticagrelor was approved for use on the NHS in 2011 after testing claimed that it could prevent one in five dead after a heart attack.
The twice-day pill, sold as Brilinta, is given to people with acute coronary syndrome-a sudden reduction of blood to the heart-worth the risk of deadly clots and strokes is provided.
Since then, studies have wondered whether the AstraZeneca medication is as good as its rivals, such as Clopidogrel, with some people even suggest that it can even increase the risk of bleeding.
Now experts in two clinical tests have ‘discovered proof of seriously wrong reports’, crucial to get the drug approved in the UK and the US, ‘doubting the approval’.
The BMJ research Claimed the results of ‘primary end point’ – the most important measure to determine whether a treatment is effective – for both studies, the leading cardiology journal circulation was reported inaccurately.
It also said that about a quarter of the lectures of machines used in the tests were not included in the data sets, the Regulator of American Medicine, the Food and Drug Administration (FDA) that was used to approve the medicine.
Dr. Victor Serebruany, an expert in cardiovascular pharmacology at Johns Hopkins University in Maryland, who has been critical of the medicine for more than ten years: ‘It has been clear for years that something is wrong with the data.
The twice-day pill, sold as Brilinta, is given to people with an acute coronary syndrome-a sudden reduction of blood to the heart-worth the risk of deadly clots and strokes is provided
Since then, studies have wondered whether the AstraZeneca -Medicrow is as good as its rivals, such as Clopidogrel, where some even suggest that it can even increase the risk of bleeding
‘That the leadership of the FDA could look beyond all these problems – the many problems that their own reviewers identified and are now discovered by the BMJ – is unconsciously.
‘We all have to know how and why that happened.
“If doctors had known what happened in these tests, they would never have started using TicaGrelor.”
To get Ticagrelor approved, clinical tests had to prove that it was a better medicine than competitors in a 3 -study phase.
After phase 3 and approval of medicines, the FDA and MHRA will keep an eye on in the UK in phase 4 investigations, to see if there are additional problems with the medicine.
But the BMJ analysis of two phase 2 research results showed that there were cases of patients who dramatically increase blood pictures aggregation. “
This is where platelets – a type of blood cell – fall together to form lumps that can lead to blood clots, exactly what the medicine wants to prevent.
It “suggests incorrect laboratory values,” said the BMJ.
Although some warning signals are easy to recognize, such as serious chest pain, others are more vagient and difficult to locate
Assessment of the measurements of platelet machines used at the two test locations, led by cardiologist Dr. Paul Gurbel, they also thought that more than 60 of the 282 measurements were not included in the data sets submitted to the FDA.
“The non -supplied platelet levels were significantly higher than those used in the circulation documents and FDA data sets,” they claimed.
“It is unclear whose blood was sampled and why those measurements did not contribute to data in both examinations.”
A spokesperson for the Sinai Center for Trombosis Research and Drug Development, which Dr. Gurbel leads, said: “Any accusations of misconduct of research in the two studies are unfounded and incorrect.”
In the UK, the drug is prescribed on the NHS about 45,000 times a month.
According to Medicine Wakhond the National Institute for Health and Care Excellence (Nice), patients are advised to take the medicine twice a day with 90 mg for about a year after a heart attack.
A lower dose of 60 mg can then be prescribed by doctors for another three years.
It can also be taken by those who have sustained a small stroke or a passing ischemic attack on 90 mg in addition to aspirin.
Symptoms of a stroke are often remembered under this acronym of four letters, fast. Patients experiencing a stroke can often drop their faces on one side, struggle to lift both arms and have an unclear speech, while time is essential, as immediate treatment for a passing ischemic attack (TIA) or a small stroke can significantly reduce the risk of a much more deadly large stroke
Other – just as usual – meaningful signs of a threatening stroke, often fall under the radar. These include sudden numbness on one side of the body, sudden dizziness and swallowing problems
The body naturally forms blood clots to patch wounds and stop bleeding.
But over time, things such as age, smoking and excessive weight gain blood clots can occur more often.
These types of clots are also more common after someone has a heart attack or blood vessel disorder, coronary artery disease.
When someone transforms these clots, they can hide blood vessels, interrupt blood flow or weaken the walls of blood vessels, causing aneurysmas and heart attacks.
Circulation and AstraZeneca did not respond to a request for comments from the BMJ. MailOnline has also approached AstraZeneca for comment.
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