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Heart Disease
Brilique the New Blood Thinning Drug is Hardly Ground-Breaking...
Date: 10/12/10
‘AstraZeneca gets the green light in Europe for its oral blood thinner, Brilique’. That’s the headline which dominated the news this week.
Brilique’s European approval follows the positive opinion from the Committee for Medicinal Products for Human Use, earlier in September. The drug will be prescribed along with aspirin to prevent blood clots in people who've had a heart attack or who suffer from acute coronary syndromes (ACS).
Lesser of two evils... or not
This may sound like a positive development...
But hang on...
The approval is principally based on the 18,642-patient PLATO study, which compared Brilique with Plavix — the drug currently used as a ‘gold standard’ to prevent second heart attacks.
Regular readers of the Daily Health will know that we’ve highlighted the dangerous side effects of Plavix (clopidogrel) a few times in the past. These include major bleeding, flu-like symptoms, headaches, dizziness, pain, diarrhoea, dyspepsia, bruising, bloody nose, black and tarry stools, blood in the urine or stools, vomiting blood, red or purple spots on the skin and itchy skin or rash.
Based on that list of side effects, perhaps it’s not a bad thing that a new drug has come along to replace Plavix... however, if you look at the results of the PLUTO study, I am not sure whether the new candidate, Brilique, will prove to be any better...
PLUTO results showed that treating 54 ACS patients with Brilique instead of Plavix for one year prevented one atherothrombotic event and treating 91 patients prevented one cardiovascular death, with no increase in overall major or fatal bleeding over the course of one year of treatment.
Basically, Brilique prevented 0.54 people (just more than a half) of having a second heart attack and 0.91 (almost 1) cardiovascular death... Great, that’s very reassuring!
It gets better... there was also ‘no increase in overall major or fatal bleeding’... Meaning, Brilique causes the same amount of bleeding as Plavix...
In fact, AstraZeneca (the makers of Brilique) states on their website that ‘BRILIQUE can cause side effects... The most common side effects reported with BRILIQUE were bleeding and shortness of breath... Other uncommonly reported side effects include headache, dizziness, abdominal pain, diarrhoea, rash, itching, and upset stomach.’
Brilique’s list of side effects seems very similar to those of Plavix. Which leads me to ask, did AstraZeneca set out to develop a drug to out-perform Plavix (doesn’t look like they succeeded judging by the results), or did they simply create a bit of competition for a drug that is currently dominating the market in the hopes of cashing in on Plavix’s success?
If past Pharma history is anything to go by, I reckon it’s the latter.
Not a good track record
Obviously a lot more needs to be taken into consideration when it comes to assessing a new drug other than simply looking at the study results.
Things like, the track record of the drug manufacturer... What drugs have they produced previously, how willing they are to publish negative study results, how often they fund studies of their own drugs, how big are they in the Pharma market and how safe their drugs are in general?
These are all valid and important considerations before you start popping pills.
AstraZeneca, for instance, also manufacture the cholesterol- lowering statin Crestor — the most powerful statin on the market... and funded a two year drug trial, called JUPITER, involving 18, 000 patients which was designed to see if Crestor reduced heart attacks and strokes in patients with high inflammation in the blood stream, but with low-to- normal cholesterol levels.
The initial results, released in 2008, showed that heart attacks were cut by 54 per cent, strokes by 48 per cent and the need for a bypass cut by 46 per cent, compared with a placebo... Actually, things went so well for Crestor that the trial ended early when a provisional analysis showed a 44 per cent reduction in all the risk factors... The logic probably was that with such positive results, why continue the study?
Earlier this year, controversy struck when researchers took a second look at the findings of JUPITER and said that the results were flawed.
Dr. Michel de Lorgeril, wrote in the Archives of Internal Medicine, that there were major discrepancies between the reductions in non-fatal stroke and heart attacks reported by JUPITER and the results of numerous other research trials... He also stated that the JUPITER results were clinically inconsistent and should not be used to change medical practice or clinical guidelines.
On top of this, 9 of the 14 researchers in the JUPITER trial had financial relationships with AstraZeneca... who funded the study...
Add to this the numerous side effects linked to Crestor like muscle problems, anaemia, sexual dysfunction, pancreas or liver dysfunction, and cataracts... it’s no wonder I am more than a little sceptical about Brilique.
The fact that Brilique will be prescribed along with aspirin which is also known to increase the risk of internal bleeding, is alarming to say the least.
If it was me, I’d much rather explore safer alternatives to prevent a second heart attack, like adopting a healthy lifestyle and eating habits, quitting smoking, exercising and reducing stress.
Related Articles:
Nattokinase the Natural Alternative to Harmful Prescription Blood Thinners
Reduce Your Stroke Risk With These Little-Known Tips
Studies Show Meditation Can Benefit Your Heart
Sources:
‘AstraZeneca's Brilique gets OK in Europe for ACS’ by Kevin Grogan, published online 07,12,10, pharmatimes.com
Plavix Side Effects published online, stroke.emedtv.com
‘Crestor : The Super Strong Statin Drug’ published online 14.11.08, thehealthierlife.co.uk
‘Crestor Statin Controversy: Results of Major Statin Trial are Biased and Flawed’ published online 23.07.10, thehealthierlife.co.uk
Back to topBrilique’s European approval follows the positive opinion from the Committee for Medicinal Products for Human Use, earlier in September. The drug will be prescribed along with aspirin to prevent blood clots in people who've had a heart attack or who suffer from acute coronary syndromes (ACS).
Lesser of two evils... or not
This may sound like a positive development...
But hang on...
The approval is principally based on the 18,642-patient PLATO study, which compared Brilique with Plavix — the drug currently used as a ‘gold standard’ to prevent second heart attacks.
Regular readers of the Daily Health will know that we’ve highlighted the dangerous side effects of Plavix (clopidogrel) a few times in the past. These include major bleeding, flu-like symptoms, headaches, dizziness, pain, diarrhoea, dyspepsia, bruising, bloody nose, black and tarry stools, blood in the urine or stools, vomiting blood, red or purple spots on the skin and itchy skin or rash.
Based on that list of side effects, perhaps it’s not a bad thing that a new drug has come along to replace Plavix... however, if you look at the results of the PLUTO study, I am not sure whether the new candidate, Brilique, will prove to be any better...
PLUTO results showed that treating 54 ACS patients with Brilique instead of Plavix for one year prevented one atherothrombotic event and treating 91 patients prevented one cardiovascular death, with no increase in overall major or fatal bleeding over the course of one year of treatment.
Basically, Brilique prevented 0.54 people (just more than a half) of having a second heart attack and 0.91 (almost 1) cardiovascular death... Great, that’s very reassuring!
It gets better... there was also ‘no increase in overall major or fatal bleeding’... Meaning, Brilique causes the same amount of bleeding as Plavix...
In fact, AstraZeneca (the makers of Brilique) states on their website that ‘BRILIQUE can cause side effects... The most common side effects reported with BRILIQUE were bleeding and shortness of breath... Other uncommonly reported side effects include headache, dizziness, abdominal pain, diarrhoea, rash, itching, and upset stomach.’
Brilique’s list of side effects seems very similar to those of Plavix. Which leads me to ask, did AstraZeneca set out to develop a drug to out-perform Plavix (doesn’t look like they succeeded judging by the results), or did they simply create a bit of competition for a drug that is currently dominating the market in the hopes of cashing in on Plavix’s success?
If past Pharma history is anything to go by, I reckon it’s the latter.
Not a good track record
Obviously a lot more needs to be taken into consideration when it comes to assessing a new drug other than simply looking at the study results.
Things like, the track record of the drug manufacturer... What drugs have they produced previously, how willing they are to publish negative study results, how often they fund studies of their own drugs, how big are they in the Pharma market and how safe their drugs are in general?
These are all valid and important considerations before you start popping pills.
AstraZeneca, for instance, also manufacture the cholesterol- lowering statin Crestor — the most powerful statin on the market... and funded a two year drug trial, called JUPITER, involving 18, 000 patients which was designed to see if Crestor reduced heart attacks and strokes in patients with high inflammation in the blood stream, but with low-to- normal cholesterol levels.
The initial results, released in 2008, showed that heart attacks were cut by 54 per cent, strokes by 48 per cent and the need for a bypass cut by 46 per cent, compared with a placebo... Actually, things went so well for Crestor that the trial ended early when a provisional analysis showed a 44 per cent reduction in all the risk factors... The logic probably was that with such positive results, why continue the study?
Earlier this year, controversy struck when researchers took a second look at the findings of JUPITER and said that the results were flawed.
Dr. Michel de Lorgeril, wrote in the Archives of Internal Medicine, that there were major discrepancies between the reductions in non-fatal stroke and heart attacks reported by JUPITER and the results of numerous other research trials... He also stated that the JUPITER results were clinically inconsistent and should not be used to change medical practice or clinical guidelines.
On top of this, 9 of the 14 researchers in the JUPITER trial had financial relationships with AstraZeneca... who funded the study...
Add to this the numerous side effects linked to Crestor like muscle problems, anaemia, sexual dysfunction, pancreas or liver dysfunction, and cataracts... it’s no wonder I am more than a little sceptical about Brilique.
The fact that Brilique will be prescribed along with aspirin which is also known to increase the risk of internal bleeding, is alarming to say the least.
If it was me, I’d much rather explore safer alternatives to prevent a second heart attack, like adopting a healthy lifestyle and eating habits, quitting smoking, exercising and reducing stress.
Related Articles:
Nattokinase the Natural Alternative to Harmful Prescription Blood Thinners
Reduce Your Stroke Risk With These Little-Known Tips
Studies Show Meditation Can Benefit Your Heart
Sources:
‘AstraZeneca's Brilique gets OK in Europe for ACS’ by Kevin Grogan, published online 07,12,10, pharmatimes.com
Plavix Side Effects published online, stroke.emedtv.com
‘Crestor : The Super Strong Statin Drug’ published online 14.11.08, thehealthierlife.co.uk
‘Crestor Statin Controversy: Results of Major Statin Trial are Biased and Flawed’ published online 23.07.10, thehealthierlife.co.uk
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