Best Practice
Palliative Care
Quality Improvement
Medical Record Documentation Review for 2006
Current News
Chlamydia Screening in Women
Technology
New and Emerging Technology
Disease Prevention and Disease Management
Disease Management
Disease Prevention
Palliative Care
By Robert MacDonald Thomas, MD, Medical Director for Clinical Affairs
| The following is presented to highlight medical "best practice" in the CareFirst and CareFirst BlueChoice service
areas and to share with medical professionals throughout the region the innovative approaches being adopted in
Maryland, Washington, D.C. and Northern Virginia. The "best practice" approach to patient care not only improves
the quality of care, it also helps limit rising costs. |
Palliative care is meant to relieve suffering and improve the
quality of life for patients with advanced illnesses and their
families. This is achieved through careful communication
with the patient and family members regarding the goal of
therapy (cure or comfort) and the treatment of symptoms
such as pain, anorexia, constipation, dyspnea and nausea.
Spiritual and bereavement support are also addressed by
effective palliative care.
Robert L., a 40-year-old actor living
in New York City, was admitted to the
hospital with end-stage AIDS characterized
by extreme weight loss, bedsores, CMV
retinitis, untreatable protozoal diarrhea and
severe oral phargyeal candidiasis. After
several weeks, he died in the hospital --
- alone, anxious, depressed and blind. His
death held little dignity. I remember Robert
vividly. He was one of my first patients that
I admitted during an internship at a busy,
over-crowded hospital in Manhattan. |
|
One person or physician can rarely perform all of these
tasks; coordination of an array of medical and social
services is necessary to achieve a dignified end to life.
By 2030, an estimated 20 percent of the country’s
population will be age 65 or older. As health care has
advanced in its ability to treat disease, the population of
people with chronic diseases has expanded. With the ability
to extend the lives of patients with chronic disease, medical
science has blurred the line between curable illness and
illness that results in death. For many, death is regarded as
failure of medical science. Palliative medicine evolved to
minimize the unrealistic and potentially harmful mind-set
that death can be prevented or prolonged at any cost.
Palliative medicine was first recognized as a medical
specialty in Britain in 1987. This approach grew out of the
hospice movement which was defined as a specific care
plan for dying patients and their families. Palliative care
has expanded to include patients not only nearing death,
but those with chronic although not fatal illnesses which
result in a significant decrease in function, independence
and the ability to enjoy life. Examples of these chronic
illnesses include heart disease, stroke and emphysema.
Palliative care can be delivered in numerous settings:
hospital, home, nursing home or hospice. Common
causes of death among Americans include heart disease,
malignant neoplasm and stroke. Palliative care has
traditionally been defined as an alternative to curative
care, the treatment of disease so it does not return.
Timing of the initiation of palliative care is important. A
patient dying of ovarian cancer usually has a period
of functional stability following initial therapy, then
several progressive weeks or months of functional decline.
This decline often follows a linear pathway to eventual,
expected death. Chronic disease with its unpredictable
course of exacerbations followed by periods of stability with
a slow decline becomes a challenge in regards to timing
of initiation of palliation. Common chronic diseases such
as severe heart failure or Chronic Obstructive Pulmonary
Disease (COPD) usually follow a course showing years
of slow decline punctuated by periods of exacerbations,
changes in therapy and a resetting of the curve. Death
usually is unpredictable, e.g. arrhythmia or pulmonary
embolus. Because it is not possible to accurately predict the
timing of death in chronic disease, palliative care should be
woven into the course of chronic disease. Often, the timing
by the physician of a simple, open-ended question -- “What
do you see as the goal of this therapy?” -- clears the way
towards palliative care.
In the Case Management department at CareFirst and
CareFirst BlueChoice, Case Managers often assist the
patient, caregivers and physician in providing appropriate
interventions to meet the patient's physical, emotional
and spiritual needs. Case Managers may coordinate care
from local community resources, non-profit organizations,
pharmaceutical assistance programs, as well as alternative complementary medicine to assist the patient in the
transition from active to palliative treatment of their illness.
The Case Manager works with other members of the team
to coordinate care and to help the patient and family make
decisions regarding palliative care, and transitioning to
hospice care when appropriate.
Symptom management serves as the foundation of
palliative care. A clear discussion with the patient and
family about symptom management will do much to allay
the patient's fear of a painful, uncertain death. Physical
symptoms such as, pain, immobility, dyspnea, constipation,
nausea, vomiting, delirium, fatigue and anorexia should
be included in this discussion. Emotional symptoms of
depression, anxiety, delirium, fear, agitation and spiritual
anguish can be addressed and treated effectively.
Culture can change the framing of the Question
The U.S. is a heterogeneous nation. Our western philosophy
and mode of communication, combined with the culture of
medicine as practiced in America, requires the discussion
of palliative care to be done in a nuanced, culturally connected
fashion. Here are samples of how some members
of various cultures practice palliative care:
- Hindus respect the doctor's opinion and will often
request that the physician be the patient's proxy
- Chinese/Asians often wish that the patient not be
informed of the terminal nature of the disease.
Cancer is especially feared. The health care proxy
is often the eldest son. Traditional therapy, herbs
and acupuncture are often used in conjunction
with Western treatment
- African Americans have a history of receiving
inappropriate, under-treatment (the legacy of
the Tuskegee Syphilis Experiment has not been
forgotten). African Americans may therefore
request aggressive care up to the end-point of a
terminal diagnosis
When in doubt as to a culturally-specific situation, frame
the question, “I don’t know much about medical beliefs in
your culture, can you tell me about this?”
The overlap of curative treatment with palliative medicine
and end of life care can be confusing. Consultation with a
palliative care team can provide a high quality assessment
of the patient's symptoms and recommend specific
treatments for the patient and family. The team will be able to address the use of opioids as the standard of care
for patients with terminal pain. Dosing of narcotics in
patients with a history of chronic pain can be challenging.
Adding non-steroidal anti-inflammatory drugs may lessen
side effects (confusion or constipation); use of implantable
drug delivery systems can provide better pain management
with less side effects (fatigue, suppression of consciousness);
nerve blocks like a celiac plexus block for pancreatic cancer
are often helpful.
Dyspnea is a frightening symptom for many people. Often,
the etiology is uncertain (CHF vs. pneumonia) and further
testing would be burdensome. In this situation, opioids can
relieve dyspnea and are considered the drugs of choice. In
addition, nasal oxygen and anti-anxiety drugs can calm
patients when dyspnea is associated with fear and anxiety.
Cough can be mild or severe to the point of suffering,
especially with lung cancer patients. When in
doubt, centrally acting opioids, anti-histamines and
anticholinergics to dry secretions are useful.
In conclusion, palliative care improves the quality of life
for patients and their families facing life-threatening illness
through the prevention, assessment and treatment of pain
and other physical, psychosocial and spiritual problems.
Palliative Care:
- Provides relief from pain and other distressing
symptoms
- Affirms life and regards dying as a normal process;
intends neither to hasten nor postpone death
- Offers a support system to help patients live as
actively as possible until death
- Offers a support system to help the family cope
during the patient’s illness and in their own
bereavement
- Uses a team approach to address the needs of
patients and their families (including bereavement
counseling)
- Will enhance the quality of life, and may also
positively influence the course of a patient’s illness
Thanks to Loren Friedman, MD, of the Arlington Palliative
Care for assistance with this article.
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Medical Record Documentation Review for 2006
In the fall of 2006, CareFirst BlueChoice assessed a random sample of primary care practitioners’ medical records.
To determine the percentage of adult CareFirst BlueChoice members who receive preventive services according to
established guidelines, Quality Improvement (QI) nurses evaluated a sample of records. During this review, they
looked for documentation of blood pressure, cholesterol, substance use, depression and weight screening (using Body
Mass Index [BMI]). Although performance improved from the 2003 medical record review, there are still opportunities
for improvement.
The following table shows the improvements made, and the opportunities that exist to improve preventive services in
several elements.
| |
Percent of sample with appropriate screening |
| Preventive Service |
Year 2003 |
Year 2006 |
| Blood pressure screening |
70.9% |
97.87% |
| Cholesterol screening |
49.7% |
76.31% |
| Colon cancer screening |
45.99%* |
44.69%** |
| Substance use screening |
54.6% |
64.15% |
Depression screening
(symptoms assessed) |
10.4% |
29.04% |
| Weight screening (BMI) |
N/A |
3.62% (Baseline measure) |
*Based on administrative data
**Based on HEDIS colorectal cancer screening administrative data
CareFirst BlueChoice applauds the improvements our practitioners made in blood pressure and cholesterol screening.
To assist in your documentation of BMI and depression screening, CareFirst BlueChoice makes available body mass
index tables and depression screening forms. To have these materials sent to your office, please call the Quality
Improvement Department at 800-323-4472 and request copies. In addition, CareFirst BlueChoice offers a free webbased
Continuing Medical Education offering for colorectal cancer screening practice guidelines. This link can be
accessed at http://www.carefirst.com/providers/CenterForProviderEducation/CME/index.html.
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Chlamydia Screening in Women
 The Centers for Disease Control
and Prevention (CDC) and
the Maryland Healthcare
Commission (MHCC) report
that chlamydia is the country’s
most commonly reported
sexually transmitted disease,
with approximately three million
new cases each year (CDC, 2006).
About 70 percent of infected
women have no discernable
chlamydia symptoms, so
screening is extremely important.
If left undetected and untreated,
chlamydia can lead to pelvic
inflammatory disease, infertility,
ectopic pregnancy and chronic
pelvic pain. A woman with
chlamydia is up to five times more
likely to acquire HIV if exposed
(CDC, 2006).
Last year’s MHCC statistics for
CareFirst BlueChoice members
show that only 35 percent of
female members aged 16 to 25 years were screened for
chlamydia. While this is an increase from the 2004 rate of
31 percent, there remains much room for improvement.
The CDC and the U.S. Preventive Services Task Force
(USPSTF) strongly recommend annual chlamydia
screening for all sexually active women 25 years of age
and younger. Annual screening is also recommended for
older women with risk factors for chlamydia, such as new
or multiple sex partners. Also, pregnant women should
have a screening test for chlamydia.
CDC guidelines (MMWR 2002; 51[No. RR-15]:1-39) state
that a C. trachomatis nucleic acid amplification test
(NAAT) performed on an endocervical swab specimen
provides the highest sensitivity and may be preferred if a
pelvic examination is acceptable. Otherwise, a NAAT can
be performed on a urine specimen. Unamplified nucleic
acid hybridization tests, enzyme immunoassays (EIAs)
and direct fluorescent antibody (DFA) tests performed
on an endocervical swab specimen are acceptable for
screening, although these tests are less sensitive than
the NAAT. C. trachomatis culture performed on an
endocervical swab specimen is also a suitable test for
screening.
Because the damage caused by chlamydia may be “silent,”
it is extremely important for practitioners to screen for,
and treat, chlamydial infections before they can cause
serious reproductive and other health problems.
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New and Emerging Technology
CareFirst and CareFirst BlueChoice’s Technology Assessment Committee – which includes CareFirst and CareFirst BlueChoice physicians, nurses and external consulting physicians – reviews new and developing technologies. The committee relies on current medical literature, local expert consultants and physicians to determine whether those technologies meet CareFirst and CareFirst BlueChoice’s criteria for coverage. Coverage policies applicable to national Blue Cross Blue Shield accounts and Federal Employees Benefits Programs may differ from those at the local account level. The review criteria can be found in the Providers & Physicians section of www.carefirst.com by clicking on Medical Policies. The Technology Assessment Committee recently made the following determinations:
| Lipoprotein-associated phospholipase (Lp-PLA2) in assessment of risk for cardiovascular disease and stroke: |
|
Lp-PLA2 is an enzyme associated with low density lipoproteins as a platelet activating factor. It is felt to have a proinflammatory role in the progression of atherosclerosis, which is now believed to involve an infl ammatory process. Lp-PLA2 has therefore been proposed as a biomarker in cardiovascular risk assessment. Diadexus, Inc. of San Francisco was granted a marketing clearance by the FDA under 510(k) statutes for its PLAC® Lp-PLA2 test as an aid in determining risk for heart disease and stroke caused by atherosclerosis.
CareFirst and CareFirst BlueChoice determination:
Although a number of studies have established Lp-PLA2 as a biomarker for cardiovascular disease, epidemiological studies such as the ARIC (Atherosclerosis Risk in Communities) study have not yet established the clinical utility of Lp-PLA2 in improving health outcomes. Th e authors of the ARIC study concluded that the use of Lp-PLA2 did not improve on existing risk stratifi cation models. Studies have also shown that statin drugs and fi brates tend to lower Lp-PLA2 levels, but it is not known whether management of medications based on Lp-PLA2 constitutes an improvement over existing treatment guidelines. Currently, Lp-PLA2 measurement is not included in the National Heart Lung and Blood Institute’s National Cholesterol Education Program Adult Treatment Panel III. CareFirst and CareFirst BlueChoice consider Lp-PLA2 measurement to be experimental and investigational.
|
| Pulmonary vein isolation / ablation for atrial fibrillation |
|
Atrial fibrillation, the most common cardiac arrhythmia, is often controlled with medication. In patients with unsatisfactory response to medical treatment, pulmonary vein isolation (PVI) is increasingly being proposed as a remedy, as it is believed the arrhythmogenic focus is most often in the base of the pulmonary veins where they enter the left atrium.
CareFirst and CareFirst BlueChoice determination:
Evidence for the use of PVI in selected patients is beginning to accumulate, but is still ambiguous as to effectiveness and durability. The most recent guidelines from the American College of Cardiology grade the evidence for PVI at grade IIa, level of evidence C. As the evidence for improvement in net health outcomes remains ambiguous, CareFirst and CareFirst BlueChoice consider the procedure experimental and investigational.
|
| Electrical bioimpedance scanning of the breast |
|
Cancerous tumors cause alterations in ionic permeability, molecular structures and cellular fluid compartments that can effect measurable changes in bioimpedance. Electrical impedance scanning (EIS) of the breast has been proposed as an adjunct to mammography; the developers of the technology report that impedance scanning can be used to increase the sensitivity of x-ray mammography, identify lesions that are benign, and assist the physician in determining if a biopsy is necessary.
Breast impedance scanning passes a continuous one-volt electrical current through the breast, where it is measured by sensory devices. An image is created on a monitor, which shows cancerous lesions as an area of brightness on a gray scale. Impedance scanning is not intended for use in cases where there is no mammographic fi nding of abnormality or in cases where the mammogram is highly suggestive of the presence of malignancy. It is intended for those cases where a lesion is “probably” benign on mammography, but which warrants follow-up, or where a lesion is determined to be “suspicious” in nature, and which may require biopsy. Th us impedance scanning is proposed to improve selection of patients for biopsy procedures and to avoid unnecessary biopsies.
CareFirst and CareFirst BlueChoice determination:
Net health outcomes would be improved if there were evidence that unnecessary biopsies could, in fact, be avoided. There have been few studies to date published in the peer reviewed literature, and the reported results from those studies indicate that positive and negative predictive values and thus diagnostic accuracy of EIS may not be sufficient to achieve this goal, owing to reported instances of both false positive and false negative results. Furthermore, there is no expert consensus published to indicate the technology has enabled physicians to make better patient care decisions. There is insufficient evidence that EIS improves net health outcomes, and thus CareFirst and CareFirst BlueChoice consider bioimpedance scanning of the breast to be experimental and investigational.
|
| Correlated audioelectric cardiography: |
|
Computer-assisted auscultory devices have been developed to assist the physician in diagnosing cardiac diseases by evaluating heart sounds. Heart sound recording with computer analysis is intended to identify heart murmurs and normal S1-S2 heart sounds, as well as any additional heart sounds (S3 and S4) that may be present. Th e detection of murmurs and third and fourth heart sounds is difficult for the human ear, because of the low frequency and low amplitude. Auscultation thus involves a high degree of subjectivity on the part of the examiner. The purpose behind the development of these devices is to improve rates of detection of heart sounds, and reduce variability between examiners, which it is hoped will improve diagnostic capability. Conditions for which correlated audioelectric cardiography are being investigated include myocardial infarction, left ventricular hypertrophy, hypertrophic cardiomyopathy, and heart failure.
CareFirst and CareFirst BlueChoice determination:
There is insufficient evidence published in the peer-reviewed literature to permit conclusions with respect to health outcomes. One study attempted to measure diagnostic capability of such a device in an emergency room setting by comparing sensitivity, specificity, and positive and negative predictive values of the device against conventional auscultation by a physician. In this study, the specificity reported was slightly higher for the physician and positive and negative predictive values did not appear to be significantly different. Because there is insuffi cient evidence to determine that correlated audioelectric cardiology can improve health outcomes, it is considered experimental and investigational by CareFirst and CareFirst BlueChoice.
|
| Lumbar intervertebral discreplacement |
|
xReplacing a degenerated lumbar disc with a prosthetic has been proposed as an alternative to spinal fusion surgery. The primary purpose for the use of the prosthetic device is that they are designed to maintain fl exibility in the lower spine that is lost when adjacent segments are fused. By so doing, it is thought degeneration of segments adjacent to the index segment can be reduced over time. Two such devices, designed in Europe, have been approved by the FDA for U.S. distribution. Th e Charite® (DePuy Spine, Inc.) has been approved since October 2004, and in August of 2006 the ProDisc-L™ from Synthes USA received its approval for marketing. Both devices were granted approval based on the short term results of randomized, non-inferiority studies comparing the prosthetics to spinal fusion.
CareFirst and CareFirst BlueChoice determination:
The use of these prosthetic disc devices has become controversial. The outcomes reported from the U.S. clinical trials so far are limited to short-term results, and with prosthetic orthopedic devices, long-term data is essential for documentation of durability of the devices. Although both of the designs have been available in Europe for a much longer time than in the U.S., documentation of their performance over time is limited, and generally do not adequately address whether the devices reduce or prevent adjacent level degeneration. There is evidence that the plastic core assemblies of both the Charite® and the ProDisc-L™ are subject to wear and device failure that has resulted in the need for reoperation, which can be very delicate due to the anterior surgical approach. The clinical trials upon which FDA based its approval decisions have been criticized for their study designs, which essentially compared the prosthetic devices to suboptimal or outmoded techniques of spinal fusion. The questions of whether the use of these artificial lumbar disc assemblies can improve the net health outcomes, and whether they are at least as effective as the most modern techniques of spinal fusion have not been adequately addressed by the published evidence, and therefore CareFirst and CareFirst BlueChoice consider them experimental and investigational.
|
| Expired nitric oxide (NO) measurement in the diagnosis and treatment of asthma |
|
Exhaled gaseous nitric oxide (NO), which is normally produced in the airway mucosa, is known to be elevated in asthmatic patients, and is even higher during acute exacerbations than during remissions. The measurement of exhaled NO has therefore been proposed as a surrogate marker of airway inflammation for purposes of evaluating a patient’s response to medications and perhaps reduction of dosages of inhaled corticosteroids.
CareFirst and CareFirst BlueChoice determination:
The published evidence at the present time does not permit conclusions regarding the effect of the technology on health outcomes. Although initial studies show promise, the overall clinical utility of the test in disease management of asthma patients has not been defined, and has not shown clear superiority over conventional methods. CareFirst and CareFirst BlueChoice therefore consider the procedure to be experimental and investigational.
|
| Magnetic resonance spectroscopy |
|
Magnetic resonance spectroscopy (MRS) is often seen as an adjunct to the widely-used magnetic resonance imaging, as the same apparatus is used. MRS, however, focuses on spectrographic analysis of functional chemical processes within the area of interest rather than the image.
CareFirst and CareFirst BlueChoice determination:
MRS has been used in the research setting as a tool to study pathological processes, primarily in the central nervous system such as brain tumors, dementia, and Alzheimer’s disease. There is no definitive published data, however, to establish how this information can be used in the treatment decision process. There is insufficient data to establish standards of sensitivity and specificity, or positive and negative predictive values. There is insufficient data to establish what may be considered “abnormal” values with regard to MRS. As the clinical utility of a diagnostic test is related to how the results of that test may be used in treatment planning and patient management decisions, there is insufficient information available to document how MRS can be applied in the clinical setting. Published systematic literature reviews by authors within the specialty generally conclude that the use of MRS for characterizing brain tumors is promising, but that additional highquality studies are needed. CareFirst and CareFirst BlueChoice consider MRS to be experimental and investigational.
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Disease Management
Recent Literature Related to: CareFirst and CareFirst BlueChoice Disease Prevention and Management Initiatives
By Richard S. Safeer, MD, Medical Director, Preventive Medicine
 CareEssentials: As part of the Disease Management component of CareEssentials, the CareFirst and CareFirst BlueChoice multi-faceted care management program that provides you with essential tools for patient care, this article is intended to call your attention to recent literature that may be of interest to you. For more information on how to enroll your patients in one of our disease management programs, please call 800-783-4582.
Disease Management
| ASTHMA |
|
Few clinicians doubt the important role inhaled steroids play in controlling asthma. Equally well known are the potential side effects of long term inhaled steroid use. One of the principal tenants of the asthma guidelines is to step down therapy when a patient has their asthma under control. A recent study printed in the New England Journal of Medicine, “Randomized Comparison of Strategies for Reducing Treatment in Mild Persistent Asthma”, demonstrated an effective approach.
The authors looked at a group of mild persistent asthmatics who were well controlled on fluticasone twice daily. They separated this population in to three arms; those that stayed on fluticasone twice a day, fluticasone plus salmeterol (once a day) and montelukast at night. There were many different events which qualified as treatment failure, including, but not limited to: hospitalization or an urgent care visit for asthma, use of oral steroids and a decrease in FEV1 by more than 20 percent below baseline value. The treatment failure rate for the three groups were fluticasone alone 20.2%, fluticasone – salmeterol together 20.4 percent and montelukast 30.3 percent. The authors concluded “we found that patients whose asthma is well controlled with the use of twice-daily fluticasone can be safely swiched to step down treatment with once-daily fluticasone plus salmeterol.”
Your asthmatic patients can benefit from our disease management program by learning how to take their medications properly and how to identify an asthma exacerbation early, so that an appropriate intervention can be delivered to thwart an emergency room visit. Call 1-800-783-4582 to refer your patient.
Where to Find it: New Engl J Med 2007;356(20):2027-2039
|
| DIABETES |
|
There’s no perfect, quick and easy way to treat a diabetic and prevent its unsavory complications. The “Effect of Rosiglitazone on the Risk of Myocardial Infarction and Death from Cardiovascular Causes” proves this point. Medications have long been in our toolbox for treating chronic disease. Along with the potential to help, medications are known to have side effects. The adverse cardiovascular effects of thiazolidinediones have been postulated, but not studied in a meaningful way.
Nissen and Wolski performed a meta-analysis of 42 trails (which included 28,000 patients) comparing the use of Rosiglitazone to any drug regimen other than Rosiglitazone to treat diabetics. The authors concluded that “compared with placebo or with other antidiabetic regimens, treatment with rosiglitazone was associated with a significant increase in the risk of myocardial infarction.” The authors admit there are some weaknesses in their study (i.e. a prospective trial would be more emphatic), but nonetheless are concerned by the implications of their findings. The studies included in the meta-analysis were relatively short term (6-24 months), drawing the authors to write “rosiglitazone therapy may be capable of provoking myocardial infarction or death from cardiovascular causes aft er relatively short-term exposure. In contrast, long-term therapies that improve cardiovascular outcomes, such as statins and antihypertensive drugs, often take several years to provide benefits.”
“The FDA considers demonstration of a sustained reduction in blood glucose levels with an acceptable safety profile adequate for approval of antidiabetic agents. However, the ultimate value of antidiabetic therapy is the reduction of the complications of diabetes, not improvement in a laboratory measure of glycemic control.” We know from other studies that controlling cholesterol and blood pressure levels in diabetics has a greater impact on decreasing adverse clinical outcomes than lowering serum glucose levels. Our diabetic disease management nurses can help your patients track and address all of the key parameters that help measure the health of your diabetic patients.
Where to Find it: N Engl J Med 2007;356:2457-2471
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Disease Prevention
| ASPIRIN – DISEASE PREVENTION AND DISEASE MANAGEMENT ROLLED UP IN ONE |
|
Aspirin has stood the test of time in its popularity. No doubt this popularity has been buoyed by the accumulation of data resulting in the following recommendation from the United States Preventive Services Task Force advising clinicians to “discuss aspirin chemoprevention with adults who are at increased risk for coronary heart disease (CHD).” Aspirin’s relative importance is made clear by a systematic review and analysis of the data. The National Commission on Prevention Priorities ranks aspirin chemoprophylaxis at the top of the list, alongside childhood immunizations and tobacco-use screening and brief intervention, for clinically preventable burden and cost effectiveness.
Despite the widespread conviction of aspirin’s cardiovascular benefits, the optimal dose for this indication remains elusive. Campbell et. al. conducted a systematic review to discover the dose of aspirin which optimizes its benefits and minimizes its risks. “Clinical outcomes trials directly comparing different dosages of aspirin have included patients with virtually every clinical manifestation of atherosclerotic disease: stroke, transient ischemic attack (TIA), percutaneous coronary and peripheral interventions, carotid endarterectomy, and myocardial infarction (MI).” These trials included “nearly 10,000 patients at dosages ranging from 30 mg/d to 1300 mg/d. A significant benefit of higher dosages of aspirin was not demonstrated in any trial, and in most trials the lowest event rates were realized among patients randomized to the low-dosage groups.”
Although hemorrhagic stroke is a devastating risk from aspirin use, gastrointestinal bleeding is far more common. “Unfortunately, enteric-coated or buff ered aspirin preparations do not appear to infl uence the risk of major bleeding in the upper GI tract.” Th e authors conclude that “the clinical data are most supportive of a 75- or 81-mg daily dose.” Of course, there is a segment of the population that doesn’t tolerate aspirin, where other antiplatelet medications might be considered. Clopidogrel is one option. Eshagian and colleagues reviewed the “Role of Clopidogrel in Managing Atherothrombotic Cardiovascular Disease.” Compared with aspirin, the authors state “Clopidogrel has improved gastrointestinal tolerance but causes an excess of rash, diarrhea, and adverse hematologic outcomes.” The article goes on to summarize the findings of combining aspirin and clopidogrel therapy versus aspirin alone:
-
Combination therapy is associated with a favorable benefit-risk profile in patients at high risk (especially in acute coronary syndromes and after stenting).
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In patients at low risk (stable cardiovascular disease), however, the bleeding risk of dual therapy exceeds its potential benefit.
When comparing clopidogrel with ticlopidine:
Th e large impact of aspirin on preventing heart disease has led researchers to question the benefits of aspirin in other areas, such as cancer prevention. Th e United States Preventive Services Task Force reviewed the literature to weigh the merits of aspirin use in colon cancer prevention, against the risks associated with long term use of aspirin. While the literature reveals discrepancies (observational studies supporting and randomized controlled trials detracting), the authors of “The Use of Aspirin for Primary Prevention of Colorectal Cancer: A Systematic Review for the U.S. Preventive Services Task Force”, state the overall trend shows some colon cancer prevention benefits with aspirin use. The dose of aspirin needed to achieve a meaningful reduction in colon cancer incidence is higher than that needed for primary prevention of heart disease, thus increasing the probability of gastrointestinal bleeding and other side effects. Of course, we already have effective screening strategies for colon cancer, making the additional risk of high dose aspirin less attractive. Th e authors conclude that “Further evaluation of the cost-effectiveness of chemoprevention compared with a screening strategy is required”.
Like many preventive medicine recommendations, the uptake of aspirin to prevent heart disease has been challenging. Pignone et. al. measured “Aspirin Use Among Adults Aged 40 and Older in the United States”. Th e investigators surveyed a nationally representative population to also understand why or why not Americans are using aspirin to prevent heart disease. Regular use of aspirin to prevent cardiovascular disease was reported by 41% of the participants. “The factor most strongly associated with aspirin use was reporting a previous conversation with a healthcare provider about aspirin (88 percent aspirin use among respondents reporting such discussion versus 17% who did not report discussion)”.
Our disease management nurses talk to our members about over the counter medications, including aspirin. Th ey won’t tell your patients what to take, rather suggest they have that discussion with you, their provider. If appropriate, your recommendation for daily aspirin prophylaxis can be a powerful message. To refer your patients with coronary artery disease, diabetes and heart failure in to our disease management programs, please call 800-783-4582.
Where to Find it:
-
Priorities Among Effective Clinical Preventive Services. Am J Prev Med 2006; 31(1):52-61.
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Aspirin Dose for the Prevention of Cardiovascular Disease. JAMA, May 9, 2007 – Vol 297, No. 18
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Role of Clopidogrel in Managing Atherothrombotic Cardiovascular Disease. Ann Intern Med. 2007;146:434-441.
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The Use of Aspirin for Primary Prevention of Colorectal Cancer: A Systematic Review for the U.S. Preventive ServicesTask Force. Ann Intern Med 2007;146:365-375.
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Aspirin Use Among Adults Aged 40 and Older in the United States. Am J Prev Med 2007;32(5):403-407.
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