In the News
for the Week of 12-15-09
- Benefits of intensive glycemic control may depend on comorbidities
- Analyses of statin trials support intensive lipid lowering in high-risk patients
- MKSAP Quiz: mucosa-associated lymphoid tissue lymphoma
- Seasonal flu vaccination rates steady but earlier compared to last year
- Osteoporosis, osteopenia common in COPD patients, study finds
- Oxygen treats cluster headaches successfully
- ACP Advocate covers CPT coding changes
Cartoon caption contest
- Vote for your favorite entry
Physician editor: Darren Taichman, FACP
Benefits of intensive glycemic control may depend on comorbidities
Diabetic patients with greater comorbidity didn’t benefit from intensive glycemic control in a recent observational study.
The Italian study included 2,613 patients with type 2 diabetes who were categorized into high and low-to-moderate comorbidity subgroups for the five-year study. In the lower morbidity group, an A1c of 6.5% or less was associated with a lower incidence of cardiovascular events (hazard ratio, 0.60; P=0.005). That was not the case for the patients with more comorbidities; they showed no reduction in cardiovascular problems at the lower A1c level. Also, for patients with A1cs below 7.0%, better glycemic control was associated with fewer cardiovascular events in the low comorbidity group but not in the patients with more comorbidities. The research was published in the Dec. 15 Annals of Internal Medicine.
The findings might explain discrepancies between recent controlled and observational trials that have tried to assess the effects of intensive glycemic control, the study authors concluded. If patients with high comorbidity don’t benefit from tight control but other patients do benefit, the averaging effect could lead to a null result. Acknowledging that this study was limited by its short length and observational nature, the authors called for a randomized, controlled trial that subgroups patients based on levels of comorbidity in order to verify their conclusions.
However, a randomized trial would have to be enormous and costly in order to detect an effect on cardiovascular disease in this relatively young, healthy population, noted an accompanying editorial. The editorialist concluded that such a trial, and the intensive treatment that would ensue if it were successful, would be unlikely to be cost-effective. Clinicians should instead rely on the existing evidence that supports aiming for an A1c of just below 7%, the editorial recommended..
Analyses of statin trials support intensive lipid lowering in high-risk patients
Reanalyses of two major lipid-lowering trials support the lower-is-better approach to managing LDL cholesterol in high-risk patients.
The analyses looked at the Pravastatin or Atorvastatin Evaluation and Injection Therapy-Thrombolysis in Myocardial Infarction 22 (PROVE IT-TIMI 22) and the Incremental Decrease in End Point Through Aggressive Lipid Lowering (IDEAL) trials. The reanalyses used alternative approaches to comparing survival by including previously censored events with the goal of discovering the effects of intensive lipid-lowering therapy on total cardiovascular events. The results appear in the Dec. 15 Journal of the American College of Cardiology.
In the PROVE-IT reanalysis, researchers reported that the first primary end point events (death, myocardial infarction, unstable angina requiring rehospitalization, stroke or revascularization for 30 days or more) were reduced by 16% with atorvastatin, 80 mg, versus pravastatin, 40 mg. The IDEAL reanalysis found that, compared with patients who received 20 to 40 mg daily, patients who received atorvastatin, 80 mg daily, had significantly lower relative risk of subsequent cardiovascular events (17% lower for a first event, 24% for a second, 19% for a third, 24% for a fourth and 28% for a fifth).
The reanalyses raise the question of whether a broader composite of morbid events should be used in major cardiovascular trials, said an accompanying editorial. However, there are legitimate concerns about doing so, the editorial pointed out. For example, “hard” outcomes such as death, MI and stroke are irrevocable whereas hospitalization or revascularization may not have long-term consequences or might prove to be false alarms. In addition, many “soft” events are hard to adjudicate due to the subjective nature of decisions about causes of hospitalization or diagnoses.
While the authors of both analyses argue in favor of including all adverse cardiovascular outcomes in trials, the editorialist pointed to compelling arguments against such an approach. Specifically, because patients who have an initial event are at higher risk of suffering a subsequent event, the effects of therapy are magnified by counting those events. Such an approach, as opposed to using the conventional time to first event, would give too much weight to patients with recurrent events.
The current findings are useful in understanding intensive lipid-lowering therapy, the editorial concluded, but are not reason to change methods used in prospectively designed trials. Time-to-event analysis remains the best standard for cardiovascular death, MI and stroke.
MKSAP Quiz: mucosa-associated lymphoid tissue lymphoma
A 58-year-old man is evaluated for a 1-month history of heartburn that has persisted despite proton-pump inhibitor (PPI) therapy. His family history is unremarkable, and his medical history is otherwise noncontributory.
Physical examination, vital signs and complete blood count are normal. Biopsy results of a 3-cm submucosal mass identified during upper endoscopy confirm the presence of mucosa-associated lymphoid tissue lymphoma.
Which of the following is the most appropriate initial therapy for this patient?
A) Antibiotics and PPI therapy
C) Radiation therapy
D) Rituximab, chemotherapy, and radiotherapy
Click here or scroll to the bottom of the page for the answer and critique
Seasonal flu vaccination rates steady but earlier compared to last year
Seasonal flu vaccination rates among American adults slightly improved over the previous year. As of the middle of November, about 32% of all U.S. adults and 37% of adults recommended to receive a flu vaccination had been vaccinated (those 50 years of age and older, with at-risk medical conditions, health care workers and those who are in close contact with people in high-risk categories).
One difference from last year is that more adults began getting the flu vaccine earlier this year. Vaccination during September increased from 3% in 2008 to 9% in 2009. Yet, overall vaccination through mid-November of this year was comparable to the same period last year.
In addition, about half of health care workers had been vaccinated by the middle of November this year, roughly the same proportion that was vaccinated during the entire influenza season last year. Nonetheless, 39% of health care workers reported they had no intention of being vaccinated despite the risk of transmitting influenza to patients.
Other findings from the study include:
- Of those who'd sought vaccination, about 38% said there was none available when they tried;
- There was little evidence that people were forgoing seasonal influenza vaccine in order to be vaccinated against H1N1;
- About 44% of vaccinated adults said their health care provider was the most influential source of information;
- Unvaccinated adults relied less on health care providers and more on news reports than vaccinated adults;
- Whites were more likely to have been vaccinated; Hispanics adults were the least likely.
The findings are from a national survey of 5,679 adults conducted online between Nov. 4-16, 2009.
"Health care workers are at the front lines of patient care, so it is critical for them to be vaccinated, not only for their own protection, but for their patients," said William Schaffner, MACP, president-elect, National Foundation for Infectious Diseases and chairman of the department of preventive medicine and professor of infectious diseases in the department of medicine at Vanderbilt University. "These data also draw important attention to the fact that, despite overwhelming expert advice, they are not taking precautions against influenza."
The survey was done by RAND and supported by GlaxoSmithKline, a manufacturer of flu vaccine.
Osteoporosis, osteopenia common in COPD patients, study finds
Osteoporosis and osteopenia are common and often undertreated in patients with chronic obstructive pulmonary disease (COPD), but inhaled corticosteroid (ICS) use does not increase risk for these disorders, according to a new study.
Researchers examined bone mineral density (BMD) and fracture rates in patients who had moderate to severe COPD and were taking salmeterol/fluticasone propionate or fluticasone propionate or salmeterol alone. The randomized, double-blind, placebo-controlled, parallel-group study, a subset of the Toward a Revolution in COPD Health Study (TORCH), involved 658 patients at 88 U.S. centers. Patients received placebo, 50 µg of salmeterol, 500 µg of fluticasone propionate, or 50 µg of salmeterol and 500 µg of fluticasone propionate twice daily for three years. BMD of the hip and lumbar spine was measured at baseline and yearly thereafter, and occurrence of traumatic and nontraumatic bone fractures was noted. The results appear in the December issue of CHEST.
Eighteen percent of men and 30% of women had osteoporosis and 42% of men and 41% of women had osteopenia at baseline. Treatments for BMD loss were uncommon, with only 7% of patients receiving a bisphosphonate and 23% receiving other medications for BMD at baseline. An additional 11% and 9% of patients began taking bisphosphonate or another BMD medication, respectively, during the study. Both at baseline and during the study, women were more likely to receive BMD treatment than men.
At three years, all data were available for 43% of patients. BMD changed little during the study, and BMD change did not differ significantly by COPD treatment (adjusted mean percentage change from baseline at hip and lumbar spine, 3.1% and 0% for placebo, 1.7% and 1.5% for salmeterol, 2.9% and 0.3% for fluticasone propionate, and 3.2% and 0.3% for salmeterol/fluticasone/propionate). Incidence of nontraumatic and traumatic fractures (range, 5.1% to 6.3%) also did not differ by COPD treatment.
The authors noted that their results could have been affected by the study's high dropout rate and by possible underreporting of vertebral fractures, among other factors. Nevertheless, they concluded that osteopenia and osteoporosis are both very common in patients with COPD and often go untreated, but that inhaled corticosteroids do not appear to increase the risk for these disorders. An accompanying editorial reiterated the study's limitations and said that it did not definitively determine the causal effect of inhaled corticosteroids on osteoporosis in COPD, but did highlight the low rates of osteoporosis treatment in this population. "When osteopenia or osteoporosis is confirmed, we should seriously consider the use of BMD-sparing medication, regardless of whether or not the subject is receiving therapy with an ICS," the editorialists wrote.
Oxygen treats cluster headaches successfully
Inhaled oxygen effectively relieves the pain of cluster headaches compared with placebo, according to a new randomized trial.
The study included 57 patients with episodic cluster headaches and 19 with chronic cluster headaches. Under the double-blind, crossover trial set-up, the participants each treated four headache episodes, alternately with high-flow inhaled oxygen or the placebo (normal air from a high-flow container). Patients were instructed to administer the treatment at 12 L/min for 15 minutes at the onset of symptoms. If they did not experience relief after 15 minutes, they could take medication. The primary end point of the study was being pain-free at 15 minutes. The research was published in the Dec. 9 Journal of the American Medical Association.
According to the patient reports, oxygen was 78% effective at making patients pain-free at 15 minutes, compared to 20% for air, a statistically significant difference (P<0.001). Oxygen was also found superior according to the study’s secondary end points, which included freedom from pain at 30 minutes, reductions in pain, need for medication, associated symptoms and overall response.
According to the study authors, this is the first adequately powered trial comparing oxygen to placebo for cluster headaches and the results confirm both clinical experience and current guidelines. No adverse events have been found to be associated with such use of oxygen, and thus it represents a treatment strategy for patients in whom triptans are contraindicated. Oxygen can also be taken more frequently than triptans, although it should be used cautiously in patients who smoke, because of the fire risk. The researchers recommended that a head-to-head comparison of oxygen and triptans be conducted.
ACP Advocate covers CPT coding changes
Medicare plans to eliminate the Current Procedural Terminology consultation codes as of Jan. 1, 2010. ACP is seeking a delay in the implementation of the new procedures to allow adequate time for preparation, but physicians should begin familiarizing themselves with the upcoming changes. The latest issue of ACP Advocate details ACP's advocacy efforts in this area and offers advice on the new regulations. Further information on these coding changes will also be available in the January ACP Internist.
Cartoon caption contest.
Vote for your favorite entry
ACP InternistWeekly's cartoon caption contest continues. Readers can vote for their favorite caption to determine the winner.
"Let's celebrate. I have been converted from observation to inpatient status."
"Way to go on the champagne tap! This round's on me."
"I have one of those 'Cadillac' health care plans."
Go online to pick the winner, who receives a $50 gift certificate good toward any ACP program, product or service. Voting continues through Dec. 21, with the winner announced in the Dec. 22 issue..
MKSAP answer and critique
The correct answer is A) Antibiotics and PPI therapy. This item is available online to MKSAP 14 subscribers in the Hematology and Oncology section, Item 80.
ACP's Medical Knowledge Self-Assessment Program (MKSAP) allows you to:
- Update your knowledge in all areas of internal medicine
- Prepare for ABIM certification or recertification
- Support your clinical decisions in practice
- Assess your medical knowledge with 1,200 multiple-choice questions
To order the latest edition of MKSAP, go online.
Gastric mucosa-associated lymphoid tissue (MALT) lymphoma is almost always associated with Helicobacter pylori infection, and disease in most patients regresses after treatment with antibiotics and a proton-pump inhibitor alone within several months. Eradication of H. pylori is necessary to achieve remission of the MALT lymphoma. Monitoring with repeated endoscopies every 3 to 4 months is required. Rituximab, radiation therapy, or a combination of both therapies with chemotherapy might be used if the lymphoma has progressed despite the administration of antibiotics, or if there is no disease regression by 18 months after treatment with antibiotics and the proton-pump inhibitor. MALT is considered an indolent, low-grade lymphoma. Evidence of monoclonal B lymphocytes as indicated by immunoglobulin heavy-chain rearrangement may still be found in the gastric biopsy specimens of some patients with MALT as long as 2 to 4 years after an antibiotic-induced complete remission. The clinical implication of this finding is unknown but may warrant indefinite surveillance of these patients until further research is conducted in this area.
- Gastric mucosa-associated lymphoid tissue (MALT) lymphoma is almost always associated with Helicobacter pylori infection.
- Disease in most patients with MALT lymphoma regresses after treatment with antibiotics alone within several months.
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A 72-year-old woman is evaluated during a routine examination. She has very severe COPD with multiple exacerbations. She has dyspnea at all times with decreased exercise capacity. She does not have cough or any change in baseline sputum production. She is adherent to her medication regimen, and she completed pulmonary rehabilitation 1 year ago. She quit smoking 1 year ago. Her medications are a budesonide/formoterol inhaler, tiotropium, and an albuterol inhaler as needed. Following a physical and pulmonary exam, what is the most appropriate next step in management?
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