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Author Interview: Dr. Anne-Marie Schjerning Olsen
Duration of Treatment With NSAIDS and Impact on Risk of Death and Recurrent Myocardial Infarction in Patients With Prior MI
Author Interview: Dr. Anne-Marie Schjerning Olsen
Duration of Treatment With Nonsteroidal Anti-Inflammatory Drugs and Impact on Risk of Death and Recurrent Myocardial Infarction in Patients With Prior Myocardial Infarction
Circulation. 2011
doi: 10.1161/CIRCULATIONAHA.110.004671
What are the main findings of the study?
Our present results indicate that there is no apparent safe therapeutic window for NSAIDs in patients with prior MI. We demonstrated that short-term treatment with most NSAIDs is associated with increased cardiovascular risk. Notably, commonly used NSAIDs, such as diclofenac, which in some countries is available over the counter without any expert advice on potential side effects, were associated with increased risk treatment onset, and the risk continued to persist during the course of treatment. Particularly worrying is the fact that diclofenac was associated with higher cardiovascular risk than the selective COX-2 inhibitor rofecoxib, which was withdrawn from the market in 2004 owing to its unfavorable cardiovascular risk profile.
Were any of the findings unexpected?
Yes and no. Recent studies have associated NSAID use with increased cardiovascular risk in healthy individuals and in patients with established cardiovascular disease, so we expected that patients with prior MI were at increased risk when taking NSAIDs.
Only a few studies have conducted time-to-event analyses for NSAID treatment, and these studies have suggested that an increased risk exists at the initiation of therapy and persists afterward. However, we were surprised that commonly used NSAIDs, such as diclofenac, which in some countries is available over the counter without any expert advice on potential side effects, were associated with increased risk treatment onset, and the risk continued to persist during the course of treatment. Particularly worrying is the fact that diclofenac was associated with higher cardiovascular risk than the selective COX-2 inhibitor rofecoxib, which was withdrawn from the market in 2004 owing to its unfavorable cardiovascular risk profile.
What should clinicians and patients take away from this study?
It would seem prudent to limit NSAID use in patients with cardiovascular disease and to get the message out to clinicians taking care of these patients that NSAIDs are potentially harmful, even for short-term treatment. The accumulating evidence suggests that we must limit NSAID use to the absolute minimum in patients with established cardiovascular disease.
Cox-2 inhibitors are generally not recommended in patients with known cardiovascular disease and in patients with increased risk of developing cardiovascular disease. The doctors should consider alternatives to NSAID therapy based on the individual patient. It may contain analgesic alternative such as paracetamol and/or non-pharmacological measures such as weight loss, physical therapy and exercise. Required use of NSAIDs in the treatment of comorbid conditions in patients with known cardiovascular disease must be considered as an expert task and the doctors should refer these patients to an expert for further assessment and treatment. If NSAID therapy is necessary for patients with known cardiovascular disease the doctors should choose a more selective COX-1 inhibitor in minimum dose (e.g. naproxen≤ 500mg daily or ibuprofen ≤1200mg daily) for shortest period of time.
What recommendations do you have for cardiology health care providers as a result of your study?
Although our study is based on observational data, it provides strong evidence for early increased risk associated with NSAID treatment in post-MI patients. Therefore, our results emphasize caution in any use of NSAIDs in patients with previous MI and that NSAIDs should only be considered as the last alternative after careful consideration of the balance between risk and benefit.
ABSTRACT
Duration of Treatment With Nonsteroidal Anti-Inflammatory Drugs and Impact on Risk of Death and Recurrent Myocardial Infarction in Patients With Prior Myocardial Infarction
A Nationwide Cohort Study
Anne-Marie Schjerning Olsen, MB; Emil L. Fosbøl, MD, PhD; Jesper Lindhardsen, MD; Fredrik Folke, MD, PhD; Mette Charlot, MD; Christian Selmer, MD; Morten Lamberts, MD; Jonas Bjerring Olesen, MD; Lars Køber, MD, DMSc; Peter R. Hansen, MD, PhD, DMSc; Christian Torp-Pedersen, MD, DMSc Gunnar H. Gislason, MD, PhD
From the Department of Cardiology, Copenhagen University Hospital, Gentofte (A.-M.S.O., E.L.F., J.L., F.F., M.C., C.S., M.L., J.B.O., P.R.H., C.T.P., G.H.G.); and Department of Cardiology, the Heart Centre, Copenhagen University Hospital, Rigshospitalet (L.K.), Denmark.
Background— Despite the fact that nonsteroidal anti-inflammatory drugs (NSAIDs) are contraindicated among patients with established cardiovascular disease, many receive NSAID treatment for a short period of time. However, little is known about the association between NSAID treatment duration and risk of cardiovascular disease. We therefore studied the duration of NSAID treatment and cardiovascular risk in a nationwide cohort of patients with prior myocardial infarction (MI).
Methods and Results— Patients  30 years of age who were admitted with first-time MI during 1997 to 2006 and their subsequent NSAID use were identified by individual-level linkage of nationwide registries of hospitalization and drug dispensing from pharmacies in Denmark. Risk of death and recurrent MI according to duration of NSAID treatment was analyzed by multivariable time-stratified Cox proportional-hazard models and by incidence rates per 1000 person-years. Of the 83 677 patients included, 42.3% received NSAIDs during follow-up. There were 35 257 deaths/recurrent MIs. Overall, NSAID treatment was significantly associated with an increased risk of death/recurrent MI (hazard ratio, 1.45; 95% confidence interval, 1.29 to 1.62) at the beginning of the treatment, and the risk persisted throughout the treatment course (hazard ratio, 1.55; 95% confidence interval, 1.46 to 1.64 after 90 days). Analyses of individual NSAIDs showed that the traditional NSAID diclofenac was associated with the highest risk (hazard ratio, 3.26; 95% confidence interval, 2.57 to 3.86 for death/MI at day 1 to 7 of treatment).
Conclusions— Even short-term treatment with most NSAIDs was associated with increased risk of death and recurrent MI in patients with prior MI. Neither short- nor long-term treatment with NSAIDs is advised in this population, and any NSAID use should be limited from a cardiovascular safety point of view.More Heart Attack Studies from Angina.com
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Highlights of Article by Dr. Erik Hess et of Mayo Clinic ;CIRCOUTCOMES 2012
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Chest pain is the 2nd most common reason patients come to EDs across the United States
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Initial testing – including information obtained from the history, physical exam, electrocardiogram, and cardiac troponin – identifies > 98% of heart attacks
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To avoid missing a diagnosis of heart attack or pre-heart attack symptoms, emergency physicians often admit patients to observation units or to the hospital for extensive diagnostic testing, including stress testing
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This results in false positive test results, unnecessary exposure to radiation, and unnecessary downstream procedures such as stent placement in arteries of the heart
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Decision aids are evidence-based tools designed to educate and engage patients in decisions regarding their care
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We hypothesized that patients who were educated regarding their future risk for a heart attack and engaged in the decision of whether to be admitted to the observation unit for stress testing or to follow-up with a Mayo Clinic heart doctor in the next 72 hours would have greater knowledge about their short-term risk for heart attack, be more aware of the management options, and choose less intensive approaches to evaluation
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We randomly assigned 204 patients who came to the ED with chest pain and were being considered for observation unit admission to the decision aid or to usual care
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Decision aid patients:
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Had greater knowledge regarding their short-term risk for a heart attack
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Less frequently decided to be admitted to the observation unit for stress testing
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Had 4 times greater engagement in the decision making process
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Had no adverse events within 30 days of the ED visit
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Take home points
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Patients want to be educated and engaged in decisions regarding their care
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Once properly informed and engaged in treatment decisions, patients often choose less intensive treatment options
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Integrated health systems like the Mayo Clinic in which physicians collaboratively work together to provide ER patients ready access to outpatient follow-up have potential to improve the value of Emergency care
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Glucose, Insulin and Potassium (“GIK”) TO MINIMIZE IMPACT OF HEART ATTACKS BEFORE PATIENTS GET TO THE HOSPITAL
Study puts life-saving drugs in the hands of paramedics, decreasing rate of cardiac arrest and death from heart attacks
CHICAGO (March 27, 2012) — Paramedics can potentially reduce someone’s chances of having a cardiac arrest or dying by 50 percent by immediately administering a mixture of glucose, insulin and potassium (“GIK”) to people having a heart attack, according to research presented today at the American College of Cardiology’s 61st Annual Scientific Session. The Scientific Session, the premier cardiovascular medical meeting, brings cardiovascular professionals together to further advances in the field.
The study showed that patients who received GIK immediately after being diagnosed with acute coronary syndrome — which indicates a possible heart attack is either in progress or on the way — were 50 percent less likely to have cardiac arrest (a condition in which the heart suddenly stops beating) or die than those who received a placebo, although the treatment did not prevent the heart attack from occurring. The reduction in in-hospital cardiac arrest or death was a “secondary endpoint”, so statistically was not definitive, but was consistent with how GIK seems to work in experimental models of heart attack.
The effect was also present for patients with ST-elevation heart attacks, which require immediate treatment. For those patients, immediate GIK was associated with a 60 percent reduction in in-hospital cardiac arrest or death.
“When started immediately in the home or on the way to the hospital — even before the diagnosis is completely established — GIK appears not completely prevent any heart attack from occurring, but appeared in this trial to reduce the size of heart attacks and to reduce by half the risk of having a cardiac arrest or dying,” said Harry P. Selker, MD, MSPH, executive director of the Institute for Clinical Research and Health Policy Studies at Tufts Medical Center, who led the study with Joni Beshansky, RN, MPH, co-principal investigator and project director. “Acute coronary syndromes represent the largest cause of death in this country. GIK is a very inexpensive treatment that appears to have promise in reducing those deaths and morbidity.”
The cost of the treatment is about $50.
“Because the trial is the first to show GIK could be effective when used by paramedics in real-world community settings, it could have important implications for the treatment of heart attacks,” Dr. Selker said. Previous clinical trials have shown no consistent effect, likely because the GIK was given too late to help. This study, the “IMMEDIATE Trial,” was the first to test the effectiveness of administering GIK at the very first signs of a threatening heart attack, in the community, rather than waiting hours until the diagnosis was well-established at a hospital, as done in previous clinical trials.
“We wanted to do something that is effective and can be used anywhere,” said Dr. Selker. “We’ve done a lot of studies of acute cardiac care in emergency departments and hospitals, but more people die of heart attacks outside the hospital than inside the hospital. Hundreds of thousands of people per year are dying out in the community; we wanted to direct our attention to those patients.”
The researchers trained paramedics in 36 Emergency Medical Services systems in 13 cities across the country to administer GIK after determining that a patient was likely having a threatened or already established heart attack using electrocardiograph-based ACI-TIPI (acute cardiac ischemia time-insensitive predictive instrument) and thrombolytic predictive instrument decision support that prints patient-specific predictions on the top of an electrocardiogram. The paramedics used these predictions to decide if a patient would likely benefit from treatment. There were 911 patients randomized to receive either the GIK treatment or a placebo.
Administering GIK immediately also reduced the severity of the damage to the heart tissue from the heart attack. On average, 2 percent of the heart tissue was destroyed by the heart attack in people receiving GIK, compared with 10 percent in those who received the placebo. Although a significant proportion of suspected heart attacks are later determined to be false alarms (23 percent in this study), administering GIK does not appear to cause any harmful effects in such patients.
The research team will follow up with study participants at six and 12 months to evaluate the longer-term benefit of the GIK treatment.
This study was funded by the NIH’s National Heart, Lung and Blood Institute.
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Amazon.com 's Editorial Reviews
Angina: New Ways to Treat
Chronic Chest Pain
Part of the award winning public television series Healthy head
/Healthy Mind. It's one of the scariest medical symptoms for people who are generally healthy: a tightening, painful feeling in the chest known as Angina. In some cases this chest pain can be a serious warning that requires immediate treatment. But for the millions of people with chronic, stable angina the discomfort is something that can be readily managed with a variety of treatments. In this program we take a look at what generally causes angina, what can be done to prevent it and how it can be effectively treated with lifestyle changes, innovative drug therapies and medical procedures.
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Amazon.com Editorial Review:
Philips HeartStart Home Defibrillator (AED)
Be prepared for the unexpected.
When sudden cardiac arrest (SCA) strikes, the electrical system of the heart short circuits, causing the heart to quiver rather than pump in a normal rhythm. It typically results in the abnormal heart rhythm know as ventricular fibrillation (VF). It usually happens without warning and the majority of people have no previously recognized symptoms of heart disease. And it most often happens at home. For the best chance of survival from SCA caused by VF, a defibrillator should be used within 5 minutes. Yet, less than 1 in 20 people survive largely because a defibrillator does not arrive in time.
Just as seat belts or airbags do not save every life in a traffic accident, a defibrillator will not save every person who suffers a sudden cardiac arrest. Yet many lives could be saved if more people could be reached more quickly.
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