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low-dose aspirin


Scientists have identified helicobacter pylori bacterium as being the real cause of stomach bleeding linked to aspirin, which makes thousands of patients to be unable to take the daily pill to prevent heart attack and stroke.

This new theory could transform the way many people with cardiovascular disease are treated.

It also opens up the possibility that otherwise healthy people, who are currently advised not to take a daily aspirin, because of the risk of bleeding, might be able to take it safely for its cancer-preventing benefits.

Low-dose daily aspirin is a lifesaver, helping to prevent blood clots in the arteries supplying the heart and brain.

Aspirin is also prescribed for problems such as atrial fibrillation, a common condition that causes an irregular heartbeat, as this can also lead to the formation of blood clots.

More recently, aspirin has also been linked to a lower risk of cancers.

However, it does carry the risk of abdominal pain and stomach bleeds, and for this reason many patients are advised not to take it.

This risk was thought to be due to aspirin directly irritating the stomach lining and causing an ulcer.

Scientists have identified helicobacter pylori bacterium as being the real cause of stomach bleeding linked to aspirin

Scientists have identified helicobacter pylori bacterium as being the real cause of stomach bleeding linked to aspirin

Now researchers from Nottingham University believe that helicobacter pylori bacterium (H. pylori), a common stomach bug, may in fact be responsible for the ulcers – and that aspirin merely exacerbates them.

The scientists think treating this problem at the source by eliminating the bacteria would leave more people able to tolerate aspirin, and so reduce their risk of heart attack and stroke.

One in four people is infected with H.pylori at some point, and though many people show no symptoms, it is thought to be the principal cause of stomach ulcers: about three in 20 people infected with it develop a stomach ulcer.

Now research has also linked the bacterium to bleeding from aspirin.

In a study by Nottingham University, 60% of patients who suffered internal bleeding while taking low-dose aspirin tested positive for the bacterium (H.pylori is detected using a breath test).

The researchers explained: “Our hypothesis is that H.pylori causes the ulcer, and aspirin, by thinning the blood, makes it bleed.

“If the bacterium is eradicated, the patient will not get an ulcer and therefore there is no increased bleeding risk with aspirin.”

Now a new trial of 40,000 patients in UK will investigate this. Doctors at five universities across the UK – Oxford, Durham, Southampton, Birmingham and Nottingham – will carry out the trial, the Helicobacter Eradication Aspirin Trial, starting next month and ending in March 2016.

In the study, patients aged 60 and over who are taking low-dose aspirin will first be given the breath test for the H.pylori bacterium.

Those found to be infected will receive a one-week course of eradication drug treatment of strong antibiotics, or a placebo treatment.

Commenting on the study, Dr. Jonathan Lyne, a consultant cardiologist who practices in London and at the Mater Private Hospital in Dublin, said: “Aspirin is a cornerstone of treatment in almost all patients with vascular disease.

“Concern in using this drug in those with a history of stomach ulceration and bleeding has always led to consideration of not using it in these patients, or using alternative drugs that may be more expensive and potentially not as effective.

“Furthermore, the potential cost savings in preventing hospital admissions, investigations and treatments related to ulcers and bleeding caused by aspirin and H.pylori would be welcome not just to patients but to the NHS as a whole.”

AstraZeneca today announced that AXANUM, a fixed dose combination of 81 mg low-dose ASA (acetylsalicylic acid) and 20 mg esomeprazole (Nexium), has received positive agreement for approval in 23 European Union member countries and in Norway.

 [googlead tip=”lista_mare” aliniat=”stanga”] AXANUM once-daily pill is a combination of low-dose ASA 81mg and esomeprazole 20mg.

Esomeprazole, which is the active ingredient in the proton pump inhibitor (PPI) Nexium, is approved for the risk reduction of peptic ulcer development in low-dose ASA patients and is the only PPI approved for the risk reduction of re-bleeding in peptic ulcer bleed patients.

Nexium

Nexium

AXANUM is indicated for prevention of cardiovascular (CV) events such as heart attack or stroke, in high-risk CV patients in need of daily low-dose ASA treatment and who are at risk of gastric ulcers.

Low-dose ASA (commonly known as aspirin) is recommended mainstay therapy for patients with high-risk for cardiovascular events. About one third of these patients are also at increased risk of gastro-duodenal ulcer. Low-dose ASA further increases the risk for gastric ulcers and gastrointestinal bleeding. In fact, the most common reason for stopping low-dose ASA treatment is upper gastrointestinal problems. The consequences of interrupting low-dose ASA treatment can be severe, increasing the risk of a heart attack or stroke as early as eight to 10 days later.

[googlead tip=”vertical_mare” aliniat=”stanga”] AXANUM is the only medicine that ensures every single pill of low-dose ASA comes with built-in protection against gastric ulcers.

That means AXANUM has the potential to provide continuous CV protection in this patient population.

The EU decision took place under the decentralized procedure (DCP), with Germany acting as reference member state. This process is now followed by national approvals and local pricing and reimbursement discussions.

AstraZeneca submitted a Marketing Authorization Application in the EU via the Decentralized Procedure for AXANUM on 30 April 2009. The EU Concerned Member States include: Austria; Belgium, Denmark, Luxemburg, Bulgaria, Cyprus, Czech Republic, Estonia, Germany, Greece, Finland, France, Italy, Lithuania, Latvia, Malta, Netherlands, Poland, Portugal, Romania, Sweden, Slovenia and Norway. The Member States will now work to pursue pricing/reimbursement and national approvals.

In 2010, AstraZeneca has obtained a complete response letter (CRL) from FDA for its new drug application Axanum. [googlead tip=”lista_mare” aliniat=”dreapta”]

Additionally it has also received a CRL for the supplemental new drug application (sNDA) for Nexium (esomeprazole magnesium).

AstraZeneca is currently evaluating the CRLs, and will continue discussions with the FDA to determine next steps with respect to both the AXANUM NDA as well as the NEXIUM sNDA and will respond to the agency’s request for additional information.

AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialization of prescription medicines for gastrointestinal, cardiovascular, neuroscience, respiratory and inflammation, oncology and infectious disease. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.