Dabigatran for stroke prevention in atrial fibrillation: is it worth it?

For most patients with paroxysmal or persistent atrial fibrillation, anticoagulation with warfarin is recommended to reduce the risk of thromboembolic stroke. This recommendation generally requires that a patient come in for frequent International Normalized Ratio (INR) measurements, adjusting the dose of warfarin as needed to keep him or her in a narrow therapeutic range, and avoiding a long list of medications that alter warfarin metabolism. However, a review of diagnosis and treatment of atrial fibrillation in the January 1st issue of AFP describes an alternative:

The anticoagulation agent dabigatran, a direct thrombin inhibitor, was recently approved by the U.S. Food and Drug Administration for the prevention of stroke and systemic embolism with atrial fibrillation. In a randomized trial, 150 mg of dabigatran twice per day was shown to be superior to warfarin in decreasing the incidence of ischemic and hemorrhagic strokes. Patients assigned to dabigatran had a higher incidence of myocardial infarction than those assigned to warfarin, but the difference was not statistically significant.

As we will describe in a future STEPS article, clinical trials have shown dabigatran to be at least as effective at preventing strokes in patients with atrial fibrillation compared to warfarin, with a similar side effect profile. Its advantages over warfarin are that laboratory monitoring and dose adjustment are not required, and that dabigatran appears to have far fewer drug-drug interactions. That being said, a month's supply of dabigatran costs about $200, compared to $10 for warfarin. So is the increased cost worth it?

There are at least three approaches to answering this question:

1) Can the patient afford the drug? Does his or her health insurance cover it? If so, prescribe. If not, don't.

2) A cost-effectiveness analysis recently published in the Annals of Internal Medicine suggested that "dabigatran may be a cost-effective alternative to warfarin depending on pricing," although this analysis was based on a number of assumptions and data from a single industry-sponsored randomized trial with only two years of follow-up.

3) As is the case for many evidence-based interventions, many patients with atrial fibrillation who should be taking warfarin are not. In a study that AFP previously summarized in Tips From Other Journals, researchers described a "break-even point" at which "as many lives are saved by creating a new drug as by maximizing the delivery of established drugs." Would increasing the proportion of eligible patients taking any anticoagulant drug lead to a greater population-level benefit than switching every patient who is already using warfarin to dabigatran?

Primary care physicians may not be used to examining individual medical problems from a population health perspective, and in deciding whether to prescribe dabigatran or warfarin in day-to-day practice, option #1 is likely to be the most practical and widely used. But in an era in which the annual rise in U.S. prescription drug costs consistently outpaces inflation, ignoring the broader view is no longer an option.

Consequences of judicious antibiotic use

A physician reader of AFP submitted the following post.

**

I appreciated the article in the December 1, 2010 issue, "Diagnosis and Treatment of Acute Bronchitis," especially its discussion of the preponderance of viral versus bacterial infections and the need to be more judicious in our use of antibiotics for bronchitis. I strive to practice evidence-based medicine and spend a lot of time explaining my decision to not prescribe antibiotics for viral conditions. However, this practice comes at a cost.

My colleagues and I have a busy group family practice in Des Moines, Iowa, and we take turns staffing the walk-in clinic. Recently, a father brought in his teenage son with an obvious viral condition that had lasted for three weeks. After a thorough history and physical exam, I told them that it appeared to be a viral syndrome, but I would go ahead and do a complete blood count with differential and rapid Strep screen just to be certain.

When the laboratory technician entered the room, the father told her that they didn’t need the lab work and she should tell the doctor to just give them some antibiotics. The lab tech appropriately told the patient that the doctor had ordered the tests to see if he needed them or not, and they allowed the specimens to be taken. The results showed a negative Strep screen and a low white blood cell count with a right shift in the differential. I spent some time going over the lab results and explaining why it was unnecessary to prescribe an antibiotic for a viral illness, and wrote a prescription for Robitussin with codeine for symptomatic relief. The patient and his father then stormed out of the exam room and through a crowded waiting room, with the father yelling, “This (expletive) clinic sucks!”

A little while later, I received the following message from the patient's mother on my office voice mail: “My son was just seen in the walk-in clinic. He has been sick for three weeks and we waited for three hours to get in, but the 'care' he got from you was ridiculous. Just take some Robitussin? This is exactly why we have stopped going to your clinic regularly, because the doctors there are no help whatsoever. I can tell you I am going to give you every bad review I can on the Internet and everybody I know, I will tell.”

We receive similar complaints fairly commonly. Although they will not dissuade me from "doing the right thing" regarding antibiotic prescriptions, I wonder how many other clinicians will continue to suffer the slings and arrows of a demanding public when it is a lot easier, less time consuming, and certainly less stressful to just give patients what they want. I would, however, encourage all of my primary care colleagues to stick to our guns in educating the public about the appropriate use of antibiotics, despite the occasional assaults on our professional integrity.

Steve R. Eckstat, DO
Medical Director
Mercy West Medical Clinic
Des Moines, Iowa

Geriatric assessment tools

The editors of AFP recognize the importance of providing family physicians with clinical information and tools relevant to the care of older patients. Our AFP By Topic collection on Geriatric Care contains links to content on general screening and prevention, as well as up-to-date guidance on managing specific issues such as elder abuse, falls, home care, and adverse drug events. Also, the inaugural print issue of 2011 features a review of the geriatric assessment by Drs. Bassem Elsawy and Kim Higgins. The authors explain why this type of structured evaluation is specific to older patients:

The geriatric assessment differs from a typical medical evaluation by including nonmedical domains; by emphasizing functional capacity and quality of life; and, often, by incorporating a multidisciplinary team including a physician, nutritionist, social worker, and physical and occupational therapists. This type of assessment often yields a more complete and relevant list of medical problems, functional problems, and psychosocial issues.

In addition to describing the essential components of the geriatric assessment, the article contains tools for assessing independence in activities of daily living, a nutritional health checklist, and brief instruments to detect hearing and cognitive impairment.

As more primary care practices transition to electronic medical record systems, we recognize that print may not necessarily be the most useful format for many readers. What do you think we could do to make point-of-care tools, tables, and figures more accessible in your practice setting? We invite you to submit comments or suggestions on this blog, our Facebook page, or by e-mail at afpedit@aafp.org.

Folic acid for the prevention of neural tube defects

In 1992, the U.S. Public Health Service recommended that women of childbearing age take folate supplements to reduce the incidence of neural tube defects, which occur in about 1 in 1000 pregnancies. Subsequently, the Food and Drug Administration began requiring that enriched grain products be fortified with folic acid. Ten years later, the incidence of neural tube defects had declined, though there was little change in the percentage of women of childbearing age (25-30%) who reported taking folate supplements on a regular basis, as AFP reported in a Clinical Brief. A more recent study conducted in Canada found that 22% of women of childbearing age have red blood cell folate concentrations that are considered suboptimal for neural tube defect prevention.

The December 15th issue of AFP features the U.S. Preventive Service Task Force's updated recommendation statement on folic acid for the prevention of neural tube defects, along with a Putting Prevention Into Practice case study. Recognizing that a substantial proportion of pregnancies are unplanned, the USPSTF gives an "A" grade to the recommendation that "all women planning or capable of pregnancy take a daily supplement containing 0.4 to 0.8 mg (400 to 800 mcg) of folic acid." (You can find more information about preconception and prenatal issues in AFP's Prenatal Care collection.)

USPSTF recommendations are written for primary care clinicians, but it is relatively rare for patients to present specifically for preconception care visits, where they can receive education about the need to take folic acid supplements. What alternative strategies does your practice use to inform patients about these and other important preventive health needs, such as healthy eating and exercise, that wouldn't necessarily bring them into the office?

Avoiding the perils of plagiarism

About a year ago, a primary care supplement sponsored by a prominent physician specialty organization arrived at my home address. The topic of the supplement was a professional interest of mine; in fact, I had published an original paper on the subject in a leading research journal the year before. Skimming the introduction to the first article, I felt a deja-vu sensation. Not only had I read these words before, I was pretty sure that I had actually written them. Indeed, comparing the text to my paper, the first three paragraphs were virtually identical, with only a few words changed here and there, and no citation.

The December 15th Inside AFP column reviews how to avoid the perils of plagiarism in medical and other publications. Plagiarism is a term that means different things to different people, but AFP's policies are that 1) wording should be paraphrased in such a way as to make it your own; 2) verbatim wording should be enclosed in quotation marks; 3) original sources should be cited for any wording or concepts taken from them.

As the Inside AFP column notes (direct quotation, crediting the source): "You can expose yourself to accusations of plagiarism by using another's words, even with proper attribution, if they are too close in form or content to the original source. This is a matter of degree, and sometimes is a judgment call, but it's best to err on the side of caution and make the phrasing your own." But if I were to rewrite this quoted passage along the lines of the following, I would be guilty of what is sometimes called the "too-perfect paraphrase":

You can open yourself up to accusations of plagiarism by using someone else's words, even with proper citation, if they are too close in form or content to the original. This is a matter of degree, and subject to interpretation, but it's best to err on the side of caution and make the words your own.

Even if the proper citation was included, this passage would still be considered plagiarism.

AFP's editors use the internationally recognized Committee on Publication Ethics guidelines for addressing claims of possible plagiarism in our pages. We carefully consider concerns raised by editors and readers and contact the authors for full explanations before taking any actions. Since plagiarism is a serious matter that can have professional and personal consequences, we strongly encourage prospective authors to contact us with questions or clarifications prior to submitting manuscripts for consideration.

Antibiotics for acute bronchitis: just don't do it

In 1998, AFP published an article on acute bronchitis that pointed out the discrepancy between usual practice and evidence demonstrating the lack of effectiveness of prescribing antibiotics for this condition:

Although many authorities have argued that antibiotics have no role in the treatment of acute bronchitis, these agents remain the predominant therapy offered to patients. Primary care physicians in the United States have treated acute bronchitis with a wide range of antibiotics even though scant evidence exists that antibiotics offer any significant advantage over placebo.

Twelve years later, it appears that little has changed. According to an updated review of the diagnosis and treatment of acute bronchitis by Ross Albert, MD, PhD in AFP's December 1st issue,

Because of the risk of antibiotic resistance and of Clostridium difficile infection in the community, antibiotics should not be routinely used in the treatment of acute bronchitis, especially in younger patients in whom pertussis is not suspected. Although 90 percent of bronchitis infections are caused by viruses, approximately two thirds of patients in the United States diagnosed with the disease are treated with antibiotics. ... Clinical data support that antibiotics do not significantly change the course of acute bronchitis, and may provide only minimal benefit compared with the risk of antibiotic use itself.

If the evidence has been this clear for so long, why do family physicians continue to prescribe antibiotics for patients with acute bronchitis? The usual explanations are that 1) patients expect to receive antibiotics; and 2) prescribing an antibiotic takes less time than talking the patient out of the prescription. However, Dr. Albert's article also observes that "studies have shown that the duration of office visits for acute respiratory infection is unchanged or only one minute longer when antibiotics are not prescribed." To help AFP's readers better manage patients' expectations, the article contains a handy table of communication strategies that clinicians can use to avoid unnecessary and potentially harmful antibiotic prescriptions.

Close-ups: bringing the patient perspective to AFP

In 2007, AFP introduced a new regular feature called "Close-ups: A Patient's Perspective." In an editorial explaining the rationale for Close-ups, which includes a patient's story in his or her own words, a photo of the patient, and a brief clinician commentary, Associate Deputy Editor Caroline Wellbery, MD wrote:

Physicians live in a health care environment that continually raises difficult issues, many of them of a magnitude that transcends our personal practices: uninsured patients, a fragmented health care system, epidemics of obesity and lung disease, the threat of bioterrorism, contentious issues such as abortion, and rising health care costs. For anyone overwhelmed by contemporary health care developments, going back to our roots—meaningful, healing relationships with the people and communities we care for—might put our daily practice into perspective. Close-ups offers an intimate, personal reminder of this most important task.

"The Blood Sugar Diaries" in the December 1st issue of AFP relates the fears of a man with type 2 diabetes when he is told by his physician that he will need to use insulin. Explaining that several close relatives suffered serious complications or death shortly after starting insulin, the man says: "These are the reasons why I told my doctor 'no way' when she told me that I needed insulin. I didn't want to end up like my family members. I didn't want to go on dialysis, lose my leg, go blind, or die." These sentences speak volumes about the need for family physicians not only to provide patient education to patients with chronic conditions, but to explore existing beliefs regarding health and to meet patients where they are.

You can find a collection of previously published Close-Ups at http://www.aafp.org/afp/closeups. We welcome new submissions from patients and clinicians. Guidelines for contributing to this feature can be found in our Authors' Guide.