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By Louis Kuritzky, MD, Clinical Assistant Professor, University of Florida, Gainesville. Dr. Kuritzky is a consultant for GlaxoSmithKline and is on the speaker's bureau of GlaxoSmithKline, 3M, Wyeth-Ayerst, Pfizer, Novartis, Bristol-Myers Squibb, AstraZeneca, Jones Pharma, and Boehringer Ingelheim.
Step-Down Therapy for Controlled Mild Persistent Asthma
For persistent asthma, clinical guidelines recommend low-dose inhaled corticosteroids (LDIC) as initial maintenance therapy. If asthma is well controlled with this treatment, it is suggested that clinicians pursue "step-down therapy," ie, try to reduce the intensity of pharmacotherapy without incurring an increase in asthma symptomatology.
To test the viability of two different step-down regimens, 500 patients with mild persistent asthma that was well controlled on fluticasone 100 mcg b.i.d. were randomized to try either montelukast 5-10 mg once daily or fluticasone 100 mcg + salmeterol 50 mcg once daily. The "control" population continued to receive 100 mcg fluticasone b.i.d. Treatment failure was defined as including any of: hospitalization or acute care asthma visit, need for systemic increased steroids (oral or inhaled), 20% decrease from baseline FEV1, 35% decrease from baseline peak expiratory flow, or frequent use of rescue beta-agonist.
During 4 months of follow-up, treatment failure occurred in the same number of individuals who stepped down to fluticasone + salmeterol (20%) as those who continued on "full dose" inhaled steroid. On the other hand, 30% of the subjects stepped down to montelukast experienced treatment failure.
Use of montelukast for step-down therapy is associated with greater risk of treatment failure than step-down to once daily fluticasone + salmeterol.
The American Lung Association Asthma Clinical Research Centers. N Engl J Med. 2007;356:2027-2039.
Risk-management for Persons at High Risk of GI Bleeding
Persons with a history of ulcer bleeding are at great risk of rebleeding if a traditional NSAID is administered: as much as 19% over 6 months. Current guidelines suggest that appropriate steps for risk reduction in such individuals include utilization of a COX-2 inhibitor instead of an NSAID or combining a proton pump inhibitor (PPI) with an NSAID. Trials of such interventions are encouraging, and have shown bleeding rates as low as 5% over 6 months.
Whether combining a PPI with a COX-2 inhibitor would reduce risk still further was the hypothesis question of this trial by Chan et al. Subjects admitted for GI bleeding (n = 273) due to an ulcer on NSAIDs (all of whom were helicobacter negative) were randomized to celecoxib 200 mg b.i.d. plus placebo or esomeprazole 20 mg b.i.d. and followed for 1 year. The primary endpoint was recurrent bleeding within 13 months of study enrollment.
None of the study subjects who received celecoxib + esomeprazole experienced a GI bleed, compared with 8.9% of subjects treated with celecoxib alone. The authors suggest that this data should provide evidence to support recommending celecoxib in combination with a PPI for optimum risk reduction in persons at high risk of GI bleeding.
Chan FKL, et al. Lancet 2007;369:1621-1626.
Group visits: Assessment of Patient Acceptance
Group visits (GVIS) have appeal from a variety of vantage points, both patient and provider related. In an era of pressing time constraints and often shrinking resources, GVIS offers some respite. High-profile disorders such a s hypertension, diabetes, obesity, and dyslipidemia (which occupy a compelling place due to both epidemiologic presence and significant consequences) lend themselves well to consideration of GVIS. Clinician advocacy is important in development and utilization of GVIS, but patient acceptance is at least as important.
Kawasaki, et al conducted a survey by a single trained interviewer using a scripted interview of 296 persons with hypertension. After describing GVIS, subjects were asked whether they would be willing to attend one. Subsequently, those who said no were queried as to whether incentives, such as a monetary compensation for parking/transportation, more time with their physician, or less visit waiting time, would induce them to change their mind about GVIS.
With no mention of incentives, 68% of respondents were willing to participate in GVIS. Willingness did not vary across ethnicity, age, or gender. After incentive offering, an additional 37% responded affirmatively to GVIS, with economic subsidy being the least common reason chosen.
These data suggest that patients are receptive, at least in principle, to GVIS, and that individuals with an initially tepid response might warm to the idea if incentives to greater address their personal needs are included.
Kawasaki Lm, et al. Am J Managed Care. 2007;13:257-262.