Posts Tagged ‘aspirin’
Everything You Wanted to Know About Sex But Were Afraid to Ask
My apologies to Dr. David Reuben, who wrote the book by this title in 1971, for stealing his title. Yes it seems a long time ago that people thought this was so controversial. I guess that’s what the Internet has done. People are definitely more informed. Or are they?
It turns out that we cardiologists are not doing a very good job giving advice on resuming sexual activity after sustaining a myocardial infarction, and it seems we must do better. I must plead guilty as charged. I spend considerable time telling people to take Plavix and aspirin, and to increase their statin dose, but honestly, it never really occurred to me to tell people about sex.
A study known as TRIUMPH or Translational Research Investigating Underlying Disparities in Recovery from Acute Myocardial Infarction: Patients’ Health Status was presented at the recent American Heart Association meeting in Washington D.C. It is quite an eye opener. Only 46% of the men and 34% of the women received post discharge instruction when to resume sexual activity. Less than 40% of men and less than 20% of women had any discussion at all about sex with any of their physicians in the year after a heart attack.
The study found that 67% of men resumed sexual activity, but only 40% of women in that year. These data were controlled for variables such as age and partner status, so the reasons for the disparity is not that women were single or uninvolved more than men. It seems that there is significant room for improvement.
This lack of information clearly needs to be improved, and to become a greater focus of our discussion with patients. It may help to start a program with a trained health care professional who would take the lead in providing information and guidance with a doctor’s order. This is similar to other outreach programs that have been successful. Cardiac rehab may also serve as a place to provide this kind of information. Offices visits post hospitalization also seem like a place to start the conversation, as these areas are generally more private than a patient room or other hospital settings.
It’s time to help “Stella get her groove back.” It’s just one more example that we must care for the whole patient not just the lipid levels. Thanks to these researcher’s for pointing out an area of much needed improvement.
One Pill Cures All
It has long been a goal of doctors, not drug companies, to make a pill that combines multiple medications that can be taken once a day. When I was in school, we named it “Wonderall.” This concept vastly increases compliance and it is hoped would prevent “events.”
The drugs in these pills are generic drugs that we have been used for years and are proven to do the jobs they are supposed to. The drawback is the doses chosen may not be enough for a particular patient. In medicine, one size generally does not fit all.
It is very easy for a patient to have to take more than 10 different medications several times a day. If you have heart disease, diabetes, lung problems, the list gets long indeed. Besides, the cost is just not practical and leads to many problems.
These pills contain 75 mg of aspirin, 40 mg simvastatin, 50 mg of atenolol and 10 mg of lisinopril. There has been some discussion about removing the aspirin because of the recent difficulties that I have blogged about. If you survived a stroke, you get a pill with 12.5 mg hydrochlorothiazide instead of the atenolol.
The study to take place in Great Britain, Ireland and the Netherlands and is known as UMPIRE or Use of a Multidrug Pill in Reducing Cardiovascular Events and will enroll 2000 subjects. To be enrolled they have had to have sustained a stroke, myocardial infarction or be at high risk. The primary end point is compliance but events will be monitored.
Another study which is starting is known as TIPS 2, which uses a pill containing 25 mg hydrochlorothiazide, 100 mg atenolol, 10mg ramipril, 40mg simvastatin and 200mg aspirin. This study will enroll 500 subjects and will be presented at the American College of Cardiology meeting in 2011.
Sadly none of these studies will take place in the United States. What’s up with that? Are we afraid of making it too easy for our patients? It’s really a disgrace, if you ask me. We should be at the forefront of this work to give possibly better, certainly easier care to our patients. Are we as physicians so enamored with 20 medications on a patient’s list? Do we get a prize for the most medications prescribed? Can we get with the program?
Aspirin: Risk vs. Benefit
Medicine is an enterprise that evolves over time. This is because new information comes to light and the synthesis of data takes time. Also, not surprisingly, much of what we do comes with the baggage of “that’s how we have always done it.” Change is incremental and often controversial.I have blogged in the past about the use of aspirin. This topic needs to be divided into those patients who have had a vascular event such as a stroke or myocardial infarction and those who are at risk and have not had an event. It is otherwise called primary and secondary prevention. Further, the groups need to be divided into male and female because the difference between them seems to be quite real but poorly understood.
If you have suffered stroke caused by a blood clot or a myocardial infarction, or have undergone coronary artery bypass grafting or angioplasty, then taking aspirin for life is generally recommended. It’s in the primary prevention group that the discussion is about.
This discussion dates back to 2002 when the US Preventive Services Task Force published its original study. This was updated in March of this year and states that aspirin is beneficial to men 45 to 79 in preventing myocardial infarction and preventing stroke in women aged 55-79. In 2003, the FDA advisory panel voted 11-3 to reject a petition by Bayer to expand aspirin’s indications to be used for primary prevention in moderate risk patients.
Since that time, papers have been published showing that in key patient populations such as those with asymptomatic atherosclerosis, type 2 diabetes and peripheral artery disease, no benefit over risk can be found. This was further propelled by the publication of an article by the group that started the whole debate the Antithrombotic Treatment Trialist group from Oxford, England. It was this group, in 2002, which published the original article. This group published again this March reversing their original opinion. I quote from their article, “We should be careful not to give the impression that aspirin doesn’t work. It works. But the balance of benefit / hazard is not good enough for a primary-prevention situation.”1
If you are taking low dose aspirin to “prevent” something and have never had an event then you should talk with your doctor. This is especially true of women who seem to be at the greatest risk and receive the least benefit. The risk of bleeding is real; the benefit seems more ephemeral.
1. Lancet 2009; 373:1849-1860.
Is Your Medicine Making You Sick to your Stomach?
Gastrointestinal side effects such as reflux and bleeding are common in patients who take aspirin and Plavix. As I have written in other blogs, the effect of aspirin is local and systemic so that enteric coated aspirin does not lessen this risk. The importance of the drugs in preventing sudden coronary stent thrombosis led to the guideline recommendation that proton pump inhibitors be given along with aspirin and Plavix to lessen the risk.
Proton pump inhibitors such as Nexium and Protonix are drugs used to decrease the amount of acid in the stomach leading to a significant reduction in ulcers and reflux. They are used along with another class of drugs called H2 antagonists which are Zantac, Pepcid and Tagamet.
On May 6, 2009, a study was released at the Society for Cardiovascular Angiography and Interventions from researchers at Medco, a large pharmaceutical distributor. The study looked at the data from 16,690 patients and their conclusions were that instead of lowering the risk of major adverse cardiovascular events, this combination of drugs increased the risk from 17.9% to 25.1 %. Their data showed that all PPI’s were the same as far as risk of events.
As I have written before, this is the wonder and frustration of medicine. How can something which appears so logical be so wrong? Is it wrong? Why is it wrong? Researchers went to work to discover the problem. It seems that these drugs share a metabolic enzyme pathway and much like cars on a busy street, not all the traffic can travel at the same time. As Plavix needs to be metabolized, this interferes with the levels of the active drug, which in turn lessens the drug’s effectiveness.
But is it true? The Principle-TIMI 44 trial examined this problem and the study was released on line before publication. They found that no association was found between PPI use and increased risk for major cardiovascular events. This study used twice the normal dose of Plavix. In a similar study using twice the dose of Plavix (150mg a day), the PACA trial (Proton Pump Inhibitors and Clopidogrel Association) found that Protonix was better than Prilosec in preserving the necessary effect of Plavix.
What to do? I am recommending to my patients that if they must take these drugs they should increase the dose of Plavix. A better choice is probably to use the H2 blockers instead of these drugs for prophylaxis of GI bleeding. If PPI’s must be used, Protonix may be the best choice in the class. More information will be presented at the American Heart Association meeting in November. Individuals who are on these combinations should discuss this with their cardiologists.
At low risk for cardiovascular events? Aspirin still recommended
Aspirin has long held a place in the secondary prevention of heart attack and death. In other words, there is no controversy about aspirin’s use if you have the diagnosis of atherosclerotic disease. In fact, this is a Class 1A (the highest level) indication in Cardiovascular Guidelines for practice.The controversy is: can we prevent heart attacks and death in patients who have no knowledge of their atherosclerotic burden. This is not a small group of people. It is estimated that 50 million Americans use low dose aspirin regularly for cardioprophylaxis.
Multiple trials have been done with the seminal trial being the Physicians Health Study that started in the mid 1980’s. Basically 22,071 male physicians who were age 40-84 were enrolled. The first problem was they were all men so no knowledge of women’s benefit was gained. They were randomized to take 325mg of aspirin every other day or placebo. Since even physicians are limited, they took the pills from a blister pack and in the aspirin group every other pill was a placebo.
The trial was stopped early because if you were over 50 years of age and a male you had a 44% reduction in heart attacks. A small group had chronic stable angina (i.e. secondary prevention). Although they were “enrolled improperly” the risk reduction of heart attack was 87%. Reduction of stroke and cardiovascular death were found to be inconclusive because of very low rates of occurrence.
Women got their chance in the Women’s Health Study a 40,000 patient trial that showed low dose aspirin did not lower the risk of MI but did lower the risk of stroke.
In 1994 the Antiplatelet Trialist Group published their overview of 174 randomized trials of antiplatet agents. This study included 70,000 high risk patients and 30,000 low risk patients. Again the number of females was unknown. The findings were that long-term antiplatet therapy in patients at high risk of vascular disease offers significant protection against MI, stroke and death. Cardiovascular Guidelines state that among patients with a 10-year cardiovascular risk greater than or equal to 10% this therapy is warranted. See 09/04/09 blog regarding calculating your risk.
Low dose aspirin is used. This is defined as 75-325mg a day. The use of enteric coated does not appear to reduce the risk of GI bleeding complications contrary to common belief. The lower the dose of aspirin used the lower the risk of GI bleeding.
Confused yet? Most doctors are. The best summary is that if patients who are at low risk for cardiovascular events take aspirin for an average of 6.4 years three cardiovascular events are prevented per 1000 women and four cardiovascular events are prevented for men. 2.5 major bleeding events per 1000 occurred among woman and 3.0 per 1000 men.
All About Aspirin
In previous blog posts (08/10/09, 08/16/09) I have reviewed the concept of antiplatelet drugs and their primary role in the protection of patients with coronary atherosclerotic heart disease from heart attack and death. They also serve to help prevent stent closure by clotting. In my next several blogs I will show how, although these concepts seem simple, they continue to engender controversy.
The first controversy again concerns aspirin. I find aspirin’s history compelling. This compound has been in use since ancient times. The active compound acetylsalicylic acid was first prepared by the French chemist Charles Gerhardt in 1853. The name was patented in 1899 after scientists at Bayer decided it was less irritating than salicylate alone. Aspirin soon became quite a hit and now an estimated 40,000 metric tons are used a year.
Two fun facts about aspirin: why is the dose of aspirin 325 mg? It’s because that was the amount of medicine in the tablet that withstood the manufacturing process including the stamping of the Bayer “cross” on the pill. Second, Germany was forced to give up the patent on aspirin in France, Russia, England and the United States after WW I as part of the war reparations.
You would think that since this substance has been around since Hippocrates that we would know how it worked. That piece of science waited until1971 when John Robert Vane showed that aspirin suppressed prostaglandin and thromboxane production. In 1982, he won the Nobel Prize in Medicine for this discovery and was knighted.
Aspirin has been further characterized as a COX-1 (cyclooxygenase enzyme) inhibitor which irreversibly blocks the formation of thromboxane A2 in platelets leading them to lose their ability to form clots. It is this action that we as cardiologists depend upon. The amount of aspirin to accomplish this is small — roughly 40mg a day, which is where the use of 81mg of aspirin gets its recommendation. This is a source of controversy among physicians and in many cases, more aspirin is needed to accomplish the clinical goal of preventing heart attacks, death from cardiovascular causes or stent closure. The more aspirin you take, the higher the likelihood of GI bleed; so that balance is what comes into play.
Next…the beginning of the trials.
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