Brad53
04-16-2006, 10:16 PM
I received 2 Taxus stents in August of 2005, and 2 Cypher stents 7 weeks ago. As far as I know, these are the only 2 brands of stents approved by the FDA, for use in the US. Both manufacturers, Boston Scientific (Taxus) and Johnson & Johnson (Cypher) recommend taking Plavix and aspirin for 1 full year, after receiving a stent. My doctor and other cardiologists, that I have seen in 2 different hospitals, have prescribed this for my follow up medicinal regime. This is a standard within the US, and probably around the world, and is more than likely due to the findings of the CURE trial and the CAPRIE trial.
I cannot tolerate aspirin or any NSAID, because I abused the drugs for many years. They produced ulcers in my small intestine, and erosions in my stomach and esophagus. They are cured, but 1 aspirin can cause me lots of pain 2-3 days. My cardiologist says not to take aspirin, due to possible intestinal bleeding, in people like myself. I have taken Plavix since a stroke and heart attack 3 years ago. I haven't noticed any side effects.
So people like myself have to have protection. Plavix is better than it's competitor, so I lovingly take it without fail for stroke and post stent thrombosis prevention.
Here are some excerpts taken from the respective trials and published by the National Institutes of Health (NIH) :
CAPRIE
A randomised, blinded, trial of clopidogrel versus aspirin in patients at risk of ischaemic events.
BACKGROUND: Many clinical trials have evaluated the benefit of long-term use of antiplatelet drugs in reducing the risk of clinical thrombotic events. Aspirin and ticlopidine have been shown to be effective, but both have potentially serious adverse effects. Clopidogrel (Plavix), a new thienopyridine derivative similar to ticlopidine, is an inhibitor of platelet aggregation induced by adenosine diphosphate.
METHODS: CAPRIE was a randomised, blinded, international trial designed to assess the relative efficacy of clopidogrel (75 mg once daily) and aspirin (325 mg once daily) in reducing the risk of a composite outcome cluster of ischaemic stroke, myocardial infarction, or vascular death; their relative safety was also assessed. The population studied comprised subgroups of patients with atherosclerotic vascular disease manifested as either recent ischaemic stroke, recent myocardial infarction, or symptomatic peripheral arterial disease. Patients were followed for 1 to 3 years. FINDINGS: 19,185 patients, with more than 6300 in each of the clinical subgroups, were recruited over 3 years, with a mean follow-up of 1.91 years. There were 1960 first events included in the outcome cluster on which an intention-to-treat analysis showed that patients treated with clopidogrel had an annual 5.32% risk of ischaemic stroke, myocardial infarction, or vascular death compared with 5.83% with aspirin. These rates reflect a statistically significant (p = 0.043) relative-risk reduction of 8.7% in favour of clopidogrel (95% Cl 0.3-16.5). Corresponding on-treatment analysis yielded a relative-risk reduction of 9.4%. There were no major differences in terms of safety. Reported adverse experiences in the clopidogrel and aspirin groups judged to be severe included rash (0.26% vs 0.10%), diarrhoea (0.23% vs 0.11%), upper gastrointestinal discomfort (0.97% vs 1.22%), intracranial haemorrhage (0.33% vs 0.47%), and gastrointestinal haemorrhage (0.52% vs 0.72%), respectively. There were ten (0.10%) patients in the clopidogrel group with significant reductions in neutrophils (< 1.2 x 10(9)/L) and 16 (0.17%) in the aspirin group.
INTERPRETATION: Long-term administration of clopidogrel to patients with atherosclerotic vascular disease is more effective than aspirin in reducing the combined risk of ischaemic stroke, myocardial infarction, or vascular death. The overall safety profile of clopidogrel is at least as good as that of medium-dose aspirin.
*Note that aspirin caused intracranial haemorrhage in .47% vs Plavix .33% of patients, and gastrointestinal haemorrhage .72% vs Plavix.52%
*Neutrophils squeeze through the capillary walls and into infected tissue where they kill the invaders (e.g., bacteria). Aspirin decreased these white blood cell components in .17%, compared to .10% of the patients who took Plavix.
CURE Trial
Effects of pretreatment with clopidogrel and aspirin followed by long-term therapy in patients undergoing percutaneous coronary intervention: the PCI-CURE study.
BACKGROUND: Despite the use of aspirin, there is still a risk of ischaemic events after percutaneous coronary intervention (PCI). We aimed to find out whether, in addition to aspirin, pretreatment with clopidogrel followed by long-term therapy after PCI is superior to a strategy of no pretreatment and short-term therapy for only 4 weeks after PCI.
Long-term administration of clopidogrel after PCI was associated with a lower rate of cardiovascular death, myocardial infarction, or any revascularisation, and of cardiovascular death or myocardial infarction.
At follow-up, there was no significant difference in major bleeding between the groups.
INTERPRETATION: In patients with acute coronary syndrome receiving aspirin, a strategy of clopidogrel pretreatment followed by long-term therapy is beneficial in reducing major cardiovascular events, compared with placebo.
*Acute coronary syndrome is an umbrella term used to cover any group of clinical symptoms compatible with acute myocardial ischemia.
I cannot tolerate aspirin or any NSAID, because I abused the drugs for many years. They produced ulcers in my small intestine, and erosions in my stomach and esophagus. They are cured, but 1 aspirin can cause me lots of pain 2-3 days. My cardiologist says not to take aspirin, due to possible intestinal bleeding, in people like myself. I have taken Plavix since a stroke and heart attack 3 years ago. I haven't noticed any side effects.
So people like myself have to have protection. Plavix is better than it's competitor, so I lovingly take it without fail for stroke and post stent thrombosis prevention.
Here are some excerpts taken from the respective trials and published by the National Institutes of Health (NIH) :
CAPRIE
A randomised, blinded, trial of clopidogrel versus aspirin in patients at risk of ischaemic events.
BACKGROUND: Many clinical trials have evaluated the benefit of long-term use of antiplatelet drugs in reducing the risk of clinical thrombotic events. Aspirin and ticlopidine have been shown to be effective, but both have potentially serious adverse effects. Clopidogrel (Plavix), a new thienopyridine derivative similar to ticlopidine, is an inhibitor of platelet aggregation induced by adenosine diphosphate.
METHODS: CAPRIE was a randomised, blinded, international trial designed to assess the relative efficacy of clopidogrel (75 mg once daily) and aspirin (325 mg once daily) in reducing the risk of a composite outcome cluster of ischaemic stroke, myocardial infarction, or vascular death; their relative safety was also assessed. The population studied comprised subgroups of patients with atherosclerotic vascular disease manifested as either recent ischaemic stroke, recent myocardial infarction, or symptomatic peripheral arterial disease. Patients were followed for 1 to 3 years. FINDINGS: 19,185 patients, with more than 6300 in each of the clinical subgroups, were recruited over 3 years, with a mean follow-up of 1.91 years. There were 1960 first events included in the outcome cluster on which an intention-to-treat analysis showed that patients treated with clopidogrel had an annual 5.32% risk of ischaemic stroke, myocardial infarction, or vascular death compared with 5.83% with aspirin. These rates reflect a statistically significant (p = 0.043) relative-risk reduction of 8.7% in favour of clopidogrel (95% Cl 0.3-16.5). Corresponding on-treatment analysis yielded a relative-risk reduction of 9.4%. There were no major differences in terms of safety. Reported adverse experiences in the clopidogrel and aspirin groups judged to be severe included rash (0.26% vs 0.10%), diarrhoea (0.23% vs 0.11%), upper gastrointestinal discomfort (0.97% vs 1.22%), intracranial haemorrhage (0.33% vs 0.47%), and gastrointestinal haemorrhage (0.52% vs 0.72%), respectively. There were ten (0.10%) patients in the clopidogrel group with significant reductions in neutrophils (< 1.2 x 10(9)/L) and 16 (0.17%) in the aspirin group.
INTERPRETATION: Long-term administration of clopidogrel to patients with atherosclerotic vascular disease is more effective than aspirin in reducing the combined risk of ischaemic stroke, myocardial infarction, or vascular death. The overall safety profile of clopidogrel is at least as good as that of medium-dose aspirin.
*Note that aspirin caused intracranial haemorrhage in .47% vs Plavix .33% of patients, and gastrointestinal haemorrhage .72% vs Plavix.52%
*Neutrophils squeeze through the capillary walls and into infected tissue where they kill the invaders (e.g., bacteria). Aspirin decreased these white blood cell components in .17%, compared to .10% of the patients who took Plavix.
CURE Trial
Effects of pretreatment with clopidogrel and aspirin followed by long-term therapy in patients undergoing percutaneous coronary intervention: the PCI-CURE study.
BACKGROUND: Despite the use of aspirin, there is still a risk of ischaemic events after percutaneous coronary intervention (PCI). We aimed to find out whether, in addition to aspirin, pretreatment with clopidogrel followed by long-term therapy after PCI is superior to a strategy of no pretreatment and short-term therapy for only 4 weeks after PCI.
Long-term administration of clopidogrel after PCI was associated with a lower rate of cardiovascular death, myocardial infarction, or any revascularisation, and of cardiovascular death or myocardial infarction.
At follow-up, there was no significant difference in major bleeding between the groups.
INTERPRETATION: In patients with acute coronary syndrome receiving aspirin, a strategy of clopidogrel pretreatment followed by long-term therapy is beneficial in reducing major cardiovascular events, compared with placebo.
*Acute coronary syndrome is an umbrella term used to cover any group of clinical symptoms compatible with acute myocardial ischemia.
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Brad53
04-19-2006, 02:13 AM
Any comment?
redbaron
04-19-2006, 08:24 AM
From the New England Journal of Medicine-
Quote "The cumulative incidence of recurrent bleeding during the 12-month period was 8.6 percent (95 percent confidence interval, 4.1 to 13.1 percent) among patients who received clopidogrel and 0.7 percent (95 percent confidence interval, 0 to 2.0 percent) among those who received aspirin plus esomeprazole (difference, 7.9 percentage points; 95 percent confidence interval for the difference, 3.4 to 12.4; P=0.001).
Conclusions Among patients with a history of aspirin-induced ulcer bleeding whose ulcers had healed before they received the study treatment, aspirin plus esomeprazole was superior to clopidogrel in the prevention of recurrent ulcer bleeding. Our finding does not support the current recommendation that patients with major gastrointestinal intolerance of aspirin be given clopidogrel." Unquote.
I had a bleeding Ulcer caused by Aspirin, and I found that Clopidogrel caused diarrhoea, but by combining Aspirin with Losec everything is fine again.
I'm not saying that Clopidogrel is a bad drug, I just thought that this may be of interest to anyone experiencing side-effects from taking Clopidogrel.
Quote "The cumulative incidence of recurrent bleeding during the 12-month period was 8.6 percent (95 percent confidence interval, 4.1 to 13.1 percent) among patients who received clopidogrel and 0.7 percent (95 percent confidence interval, 0 to 2.0 percent) among those who received aspirin plus esomeprazole (difference, 7.9 percentage points; 95 percent confidence interval for the difference, 3.4 to 12.4; P=0.001).
Conclusions Among patients with a history of aspirin-induced ulcer bleeding whose ulcers had healed before they received the study treatment, aspirin plus esomeprazole was superior to clopidogrel in the prevention of recurrent ulcer bleeding. Our finding does not support the current recommendation that patients with major gastrointestinal intolerance of aspirin be given clopidogrel." Unquote.
I had a bleeding Ulcer caused by Aspirin, and I found that Clopidogrel caused diarrhoea, but by combining Aspirin with Losec everything is fine again.
I'm not saying that Clopidogrel is a bad drug, I just thought that this may be of interest to anyone experiencing side-effects from taking Clopidogrel.
Lenin
04-20-2006, 09:30 AM
I question most of the conclusions (presumably in red)...but none more than:
Long-term administration of clopidogrel after PCI was associated with a lower rate of cardiovascular death, myocardial infarction, or any revascularisation, and of cardiovascular death or myocardial infarction.
An inspection of the CURE data commonly given as a graph fairly clearly shows that not one additional death FROM CLOT is achieved after the 60 th day.
The studies both give short shrift (or deliberate lies) to the severe unstaunchable bleeding that others have found. I guess only SANOFI/SQUIBB have these answers.
PLAVIX is not long for this world...wait for it. The background noise is already being heard in this or that article.
As for a claim that CAPRIE shows clopidogrel to be better than aspirin: within any reasonable meaning of the word, the clot protection shown by CAPRIE is the same for both.
My sample of one (ME) discontinued PLAVIX early because of daily nose bleeds for 45 days. A nose bleed is something I haven't suffered since I was a kid in spite of taking 650 mg. aspirin or more per day. If my nose is bleeding from a drug, odds are very good that something else inside is bleeding also.
However, IF one cannnot take aspirin, one is left with no choice for a stent placement. However IF one cannot take aspirin, I would think there is a VERY good chance of not being able to take clopigorel for exactly the same reason.
But for me, if I ever need another percutaneous procedure, my clot prevention will be aspirin alone...or if truly desperate, anticoagulant therapy with warfarin or heparin.
There was an interesting page on nursing that discussed methodology for pharmaceutically staunching bleeds caused by anticoagulants but how difficult it was to staunch bleeds caused by anti-platelet therapy.
Long-term administration of clopidogrel after PCI was associated with a lower rate of cardiovascular death, myocardial infarction, or any revascularisation, and of cardiovascular death or myocardial infarction.
An inspection of the CURE data commonly given as a graph fairly clearly shows that not one additional death FROM CLOT is achieved after the 60 th day.
The studies both give short shrift (or deliberate lies) to the severe unstaunchable bleeding that others have found. I guess only SANOFI/SQUIBB have these answers.
PLAVIX is not long for this world...wait for it. The background noise is already being heard in this or that article.
As for a claim that CAPRIE shows clopidogrel to be better than aspirin: within any reasonable meaning of the word, the clot protection shown by CAPRIE is the same for both.
My sample of one (ME) discontinued PLAVIX early because of daily nose bleeds for 45 days. A nose bleed is something I haven't suffered since I was a kid in spite of taking 650 mg. aspirin or more per day. If my nose is bleeding from a drug, odds are very good that something else inside is bleeding also.
However, IF one cannnot take aspirin, one is left with no choice for a stent placement. However IF one cannot take aspirin, I would think there is a VERY good chance of not being able to take clopigorel for exactly the same reason.
But for me, if I ever need another percutaneous procedure, my clot prevention will be aspirin alone...or if truly desperate, anticoagulant therapy with warfarin or heparin.
There was an interesting page on nursing that discussed methodology for pharmaceutically staunching bleeds caused by anticoagulants but how difficult it was to staunch bleeds caused by anti-platelet therapy.
Beefsteak
04-20-2006, 01:57 PM
The current NEJM has a paper on this.
Don't know if this is the article Redbaron is referring to as I can't access the full article.
Volume 354:1706-1717 April 20, 2006 Number 16
Anyway the Conclusions in this trial were:
There was a suggestion of benefit with clopidogrel treatment in patients with symptomatic atherothrombosis and a suggestion of harm in patients with multiple risk factors.
Overall, clopidogrel plus aspirin was not significantly more effective than aspirin alone in reducing the rate of myocardial infarction, stroke, or death from cardiovascular causes.
Don't know if this is the article Redbaron is referring to as I can't access the full article.
Volume 354:1706-1717 April 20, 2006 Number 16
Anyway the Conclusions in this trial were:
There was a suggestion of benefit with clopidogrel treatment in patients with symptomatic atherothrombosis and a suggestion of harm in patients with multiple risk factors.
Overall, clopidogrel plus aspirin was not significantly more effective than aspirin alone in reducing the rate of myocardial infarction, stroke, or death from cardiovascular causes.
Brad53
04-20-2006, 04:38 PM
I only looked at the 2 trials that Lenin quoted. What I found amazed me, in contrast to his observations, which were not what the actual government trials concluded. I could have searched for other trials, but I focused on these two, because of what Lenin posted.
I know many, many people who take plavix and have never had nose bleeds. I know of maybe two that got nosebleeds from Plavix. One for sure. Nosebleeds from Plavix are not common.
There are many drugs that I cannot tolerate, but the general population can. I do not post outrageous information on these drugs, because I recognize my personal weakness in tolerating some drugs.
Whether or not you like Plavix is because of your reaction to it. People from all over the world come here to learn how to survive heart disease. They should not be discouraged from taking a life saving drug. You seem to have integrity and credit at this site. Therefore the magnitude of your influence, from your incorrect information about Plavix, is exponential.
What you say about Plavix is outrageous when you consider that both, and the only manufacturers of stents approved by the FDA for US, insist you take aspirin and Plavix for one year after, after PCI. These competitors want the very best outcome when their stents are used. I think that it would take a real leap of faith to believe they would give false instructions to the recipients of their stents.
Many elderly people cannot take aspirin, but can tolerate Plavix for the prevention of stroke. I have had two strokes and I will be taking Plavix for the rest of my life. Plavix is the most common medicine used to treat people who have had prior strokes, or who are at a high risk for a stroke.
I was loaded with Plavix and aspirin before my last two stents which required rotoblational arthectomy in my left main and ostial Lad. I had a left and right cath simultaneously. Pacer leads hooked up inside my right ventricle, while rotoblation and stenting was done in my Lad. A 1.3 inch by 3 mm stent. That's a whopper. Ok, I had to give myself 15 shots of Lovenox in the stomach, one for practice before I left the hospital and two/day for 7 days. These injections hurt a whole lot. The medicine feels like venom as it spreads across the abdomen. Then, you seep blood for awhile at the injection site. I ruined some shirts and bed linen for sure. I wouldn't dare speak bad about Lovenox, because I know that it is a life saver.
These procedures cause injury to your arteries and heart, to some degree. Therefore blood clots are likely to form. The doctors do all within their power to stop these killers. Thrombosis is a number one concern with the doctors.
Earlier I said the two stent manufacturers were competitors, that is Boston Scientific and Cordis, a subsidiary of J&J, but the FTC is in the process of approving the buy out of Cordis by Boston Scientific. The FTC's counterpart in Europe have already said yes to the buy out. I wonder what implications this will have for we the people with CAD?
I know many, many people who take plavix and have never had nose bleeds. I know of maybe two that got nosebleeds from Plavix. One for sure. Nosebleeds from Plavix are not common.
There are many drugs that I cannot tolerate, but the general population can. I do not post outrageous information on these drugs, because I recognize my personal weakness in tolerating some drugs.
Whether or not you like Plavix is because of your reaction to it. People from all over the world come here to learn how to survive heart disease. They should not be discouraged from taking a life saving drug. You seem to have integrity and credit at this site. Therefore the magnitude of your influence, from your incorrect information about Plavix, is exponential.
What you say about Plavix is outrageous when you consider that both, and the only manufacturers of stents approved by the FDA for US, insist you take aspirin and Plavix for one year after, after PCI. These competitors want the very best outcome when their stents are used. I think that it would take a real leap of faith to believe they would give false instructions to the recipients of their stents.
Many elderly people cannot take aspirin, but can tolerate Plavix for the prevention of stroke. I have had two strokes and I will be taking Plavix for the rest of my life. Plavix is the most common medicine used to treat people who have had prior strokes, or who are at a high risk for a stroke.
I was loaded with Plavix and aspirin before my last two stents which required rotoblational arthectomy in my left main and ostial Lad. I had a left and right cath simultaneously. Pacer leads hooked up inside my right ventricle, while rotoblation and stenting was done in my Lad. A 1.3 inch by 3 mm stent. That's a whopper. Ok, I had to give myself 15 shots of Lovenox in the stomach, one for practice before I left the hospital and two/day for 7 days. These injections hurt a whole lot. The medicine feels like venom as it spreads across the abdomen. Then, you seep blood for awhile at the injection site. I ruined some shirts and bed linen for sure. I wouldn't dare speak bad about Lovenox, because I know that it is a life saver.
These procedures cause injury to your arteries and heart, to some degree. Therefore blood clots are likely to form. The doctors do all within their power to stop these killers. Thrombosis is a number one concern with the doctors.
Earlier I said the two stent manufacturers were competitors, that is Boston Scientific and Cordis, a subsidiary of J&J, but the FTC is in the process of approving the buy out of Cordis by Boston Scientific. The FTC's counterpart in Europe have already said yes to the buy out. I wonder what implications this will have for we the people with CAD?