Asthma Treatment
Asthma Drug Albuterol May Help Treat MS
Sept. 13, 2010 — Adding the asthma drug albuterol to a treatment for multiple sclerosis (MS) improved walking ability and delayed the time to first relapse among patients in a newly published study.
Patients starting daily injections of the MS drug glatiramer acetate — known by the brand name Copaxone — showed improvement over the course of a year when oral albuterol was added to the treatment regimen.
Those treated with Copaxone and placebo showed slight declines in function after a year of treatment, study researcher Samia J. Khoury, MD, of Harvard Medical School tells WebMD.
The study was small, but Khoury says the findings indicate the inexpensive drug may be a useful addition to early MS treatment.
“I do give albuterol to my patients early in treatment if they don’t have contraindications,” she says. “It is cheap and generally well tolerated and patients take just one pill a day.”
Albuterol for MS
The inhaled form of albuterol is widely prescribed to patients with asthma, COPD, and other pulmonary diseases to open constricted airways.
Khoury and colleagues at Harvard’s Brigham and Women’s Hospital first considered using albuterol as an additional early treatment for multiple sclerosis almost a decade ago.
That was when the researchers first reported that the asthma drug inhibited production of specific inflammation-causing messenger proteins linked to MS, known as interleukin-12 (IL-12).
High levels of IL-12 have been reported in patients with secondary progressive MS, which is an advanced form of the disease characterized by progressive symptoms and few or no relapses.
Disease-modifying drugs like Copaxone, interferon-beta 1a and 1b, and Tysabri appear to slow the progression from early disease to secondary progressive MS. It is now recommended that patients consider starting these treatments as early as possible following diagnosis.
In the newly reported study, Khoury and colleagues randomly assigned 44 patients with relapsing-remitting MS who had not previously received treatment affecting the immune system to receive daily injections of Copaxone with oral albuterol or a placebo pill for up to two years.
Neurological testing was performed at the beginning of the study and again at three, six, 12, 18, and 24 months. Blood samples were collected four times over the first year. Brain imaging to look for the lesions associated with MS was also performed at enrollment and at 12 and 24 months.
Thirty-nine patients were included in the final analysis. Improvement in functional status was seen in the combined treatment group at six months and a year, but not at two years. Most of the improvement was related to walking and was measured by timing how long it took a patient to walk 25 feet.
Published online today, the study appears in the September issue of the Archives of Neurology.
Treatment with albuterol is generally not recommended for some patients taking beta-blockers or for those with heart palpitations or anxiety, Khoury says.
She adds that MS patients without these contraindications may benefit from taking the drug with disease-modifying therapy during the first year of treatment.
Second Opinion
National MS Society spokesman Nicholas LaRocca, PhD, says larger studies are needed to confirm the findings.
“This is a promising study, but it was small,” he tells WebMD. “I think it would be premature to recommend adding this to treatment based on one study.”
But Khoury says since albuterol is now generic, its manufacturers have little financial incentive to conduct additional research.
As researchers search for new and better MS treatments, LaRocca says taking a closer look at drugs that are already available makes sense.
“The cost of developing new drugs is astronomical,” he says. “If there are drugs already out there that are not overly expensive and can be used with the currently available treatments, that is certainly worth exploring.”
For the Treatment of Asthma, Surveyed Safety-Minded Physicians May Be the Most Rapid Adopters of Emerging Brands With a Novel Mechanism of Action
BURLINGTON, Mass., Sept 13, 2010 /PRNewswire via COMTEX/ — Decision Resources, one of the world’s leading research and advisory firms for pharmaceutical and healthcare issues, identifies a segment of safety-minded physicians who are the most likely to rapidly adopt emerging brands with a novel mechanism of action when compared with other physician segments in the analysis. Thirty percent of physicians surveyed fall into the safety-minded physician segment and report their top drivers of brand choice when prescribing a drug for asthma include the drug’s risk of life-threatening side effects, risk of severe side effects and a long-term safety record.
According to the new report, Brand Perception Series: Physician Segmentation in Asthma, physicians report the greatest need in asthma treatment is for a drug with a novel mechanism of action. The safety-minded physician segment contains the greatest percentage of surveyed physicians who say they are familiar with such agents, including Aerovance’s Aerovant, GlaxoSmithKline’s Bostria and Ception Therapeutics/Cephalon’s Cinquil.
More than half of surveyed physicians in the safety-minded segment say they currently prescribe Sepracor/Nycomed’s Alvesco, the newest of inhaled corticosteroids (ICS). The safety-minded physician segment is also a high-volume segment, treating more asthma patients per month and writing more prescriptions for asthma medications per week than other segments in the analysis.
“Surveyed safety-minded physicians’ use of Alvesco and their familiarity with emerging brands with a novel mechanism of action indicate they may more readily use these novel emerging brands despite their concern with long-term safety, especially if the mechanism of action is considered safe,” said Decision Resources Analyst Amanda Puffer, M.Sc. “Considering safety-minded physicians’ use of current brands and the patient populations they treat, these physicians may be a good target for emerging brands with a novel mechanism of action.”
About Brand Perception Series: Physician Segmentation
Brand Perception Series: Physician Segmentation identifies key physician segments to uncover targeted opportunities for current and emerging drug brands. This series offers a fresh look at a competitive drug market by analyzing physician perception of current and emerging drugs using unique physician profiles that will help biopharmaceutical companies understand and size market opportunities.
About Decision Resources
Decision Resources (www.decisionresources.com) is a world leader in market research publications, advisory services and consulting designed to help clients shape strategy, allocate resources and master their chosen markets. Decision Resources is a Decision Resources, Inc. company.
About Decision Resources, Inc.
Decision Resources, Inc. is a cohesive portfolio of companies that offers best-in-class, high-value information and insights on important sectors of the healthcare industry. Clients rely on this analysis and data to make informed decisions. Please visit Decision Resources, Inc. at www.DecisionResourcesInc.com.
All company, brand, or product names contained in this document may be trademarks or registered trademarks of their respective holders.
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Lisa Osgood Christopher Comfort
781-993-2606 781-993-2597
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Half of Children With Treatment-Resistant Asthma Not Treated According to Guidelines
September 14, 2010 — Many children with treatment-resistant asthma under specialist care are misdiagnosed. More than half would be successfully managed with a re-evaluation and better use of standard therapies, British researchers report.
In a review published in the September 4 issue of the Lancet, Andrew Bush, MD, consultant pediatric chest physician, and his colleague Sejal Saglani, MD, both from Royal Brompton Hospital in London, United Kingdom, examined evidence drawn from children with mild to moderate asthma and data extrapolated from adults with severe asthma. They will present the full results next week at the European Respiratory Society 2010 Annual Meeting in Barcelona, Spain.
“Despite the interest in innovative approaches, getting the basics right in children with apparently severe asthma will remain the foundation of management for the foreseeable future,” Drs. Bush and Saglani write.
“The current best approach is thorough multidisciplinary assessment of children with problematic severe asthma, which should result in at least half of these children being successfully managed with conventional treatments,” they continue.
According to the authors, management strategies — incorporating improved asthma education related to adherence to treatment, inhaler technique, dose, and frequency — and minimization of environmental triggers need to be reviewed in these apparently treatment-resistant patients.
The review examines studies that have been published in the past 15 years. The authors make recommendations on the basis of findings from a literature review and from their own clinical practice. Drawing data from their own series of home visits to investigate therapy use, the authors report that “treatment-related issues contributed to poor control in about half the patients.”
Among areas discussed during home visits with patients, the investigators addressed psychosocial issues as a trigger for asthma exacerbations. They found anxiety and depression were common among children with severe asthma and their parents.
“Any major illness will have spin-offs on the child’s life. A child is more than a pair of lungs, so anxiety and depression are common in children and parents, very naturally, and need to be addressed,” Dr. Bush told Medscape Medical News.
Comorbidities such as reflux, rhinosinusitus, dysfunctional breathing, food allergy, and obesity were reviewed for their role in the potential exacerbation of asthma.
Once these potentially reversible factors have been identified in treatment-resistant patients, the authors recommend that the next step be a discussion with a multidisciplinary team.
“The aim is to decide whether further invasive investigations are justified and, if not, to develop a plan to address the reversible factors identified,” they write.
Dr. Bush added that good respiratory nurses find out far more than professors in clinics, “so we need a full multidisciplinary team to try to sort out an individualized treatment plan on the basis of what is causing the pathology. Let’s work together to get more information.”
However, if satisfied that the basic patient management needs are met, the review showed that there was less evidence available to help decide on the next steps.
Dr. Bush recommends open discussion of the options available. “The best trials are in omalizumab, which would be my first choice if the child met the criteria; otherwise we develop an individualized treatment plan based on the type of inflammation of the airway,” he said.
Commenting on the review, Jonathan Grigg, MD, professor of paediatric respiratory and environmental medicine at Barts and the London School of Medicine, Queen Mary University, United Kingdom, said difficult-to-treat asthma is a major problem but receives little attention.
“Bush and Saglani’s comprehensive review in the Lancet is welcome. What is now needed is a concerted effort by funders to support comprehensive trials of new therapies. Governments should also recognize the importance of innovation when evaluating the cost-effectiveness of therapies that may be used in children with difficult asthma,” he said.
Warren Lenney, MD, consultant respiratory paediatrician from the University Hospital of North Staffordshire in the United Kingdom, who also commented on the review, agrees that home visits are essential to understand if and how therapies are being used.
“Once these basic failings have been rectified there remain a small number of children with asthma who are problematic to manage and need the expertise of specialized children’s asthma centers. This paper gives an excellent plan to address the need at the very severe end of the spectrum,” he pointed out.
He added that often labeling a child’s asthma as “very severe disease” is unfounded. “Despite huge increases in our knowledge of childhood asthma over the past 30 years, the striking feature for all to consider is that basic diagnosis and decision making is weak.”
Dr. Bush emphasized a need for further research and collation of patient data, adding that an adult registry already exists and a pediatric one is being set up. His team is also part of European initiatives.
Dr. Bush’s emphasis “on reconsidering the diagnosis and carefully assessing whether there has been good adherence with treatment is crucial,” said Raezelle Zinman, MD, from the Division of Pulmonary Medicine at the Children’s Hospital of Philadelphia in Pennsylvania, in an interview with Medscape Medical News.
“I am not sure that this necessitates an admission to hospital or home visit as a first step,” Dr. Zinman added. “There needs to be documentation of what medication has been prescribed and with what frequency the prescription is actually being filled. This can be clarified with a call to the pharmacy. Simply checking the technique of medication delivery can be done in the office and can be very informative. For example, I have seen patients with vocal cord dysfunction and asthma who have been instructed to take their medication by performing an inspiratory capacity and breath-hold maneuver. In this condition, the vocal cords come together rather than separate when trying to take a breath in and the medication is not able to penetrate to the lungs.”
“A better technique is to have the patient breathe in and out of a valved holding chamber 5 times after actuating the metered dose inhaler into the chamber,” Dr. Zinman suggested.
“Another frequent comorbidity in difficult-to-treat asthmatics is sinusitis. I frequently am able to gain control [of asthma] after initiating therapy for rhinitis and sinusitis,” she pointed out. “In children who have not responded to therapy, I have used a clinical trial of oral steroids for 2 weeks on an outpatient basis, with reassessment of lung function at the end of that period to look for improvement. These results are interpreted as evidence of reversibility but should not be presumed to be the ultimate improvement achievable.”
“It is rare that invasive investigations are required beyond [computed tomography] imaging of the chest and sinus to rule out other diagnoses if the patient fails to respond to the above,” Dr. Zinman asserted. “The difficult-to-control pediatric asthmatic patient warrants referral to a pediatric pulmonologist who has the expertise to work through these issues and determine appropriate therapy. We have all seen patients who have been misdiagnosed and overtreated with chronic steroid therapy to the point of becoming Cushingoid. Earlier referral should prevent this and decrease morbidity.”
Dr. Bush, Dr. Grigg, Dr. Lenney, and Dr. Zinman have disclosed no relevant financial relationships.