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NEW CLINICAL STUDY SHOWS CHILDREN PREFER ACCOLATE TABLET THERAPY TO COMMONLY USED INHALED CORTICOSTEROID FOR DAILY TREATMENT OF ASTHMA
GENEVA, SWITZERLAND September 21, 1998
Data released today at the European Respiratory Society (ERS) annual meeting show that 70 percent of children with asthma (ages 12-17) prefer the tablet therapy ACCOLATE(r) (zafirlukast) from Zeneca Pharmaceuticals over treatment with the inhaled corticosteroid beclomethasone dipropionate (BDP).
ACCOLATE was the first medication from the first new class of asthma controller therapies--called leukotriene receptor antagonists (LTRAs)--to be introduced in nearly 25 years. In the United States, ACCOLATE is indicated for the preventive and chronic treatment of asthma in patients 12 years of age and older. The drug has been prescribed more than 3.5 million times to more than one million patients since receiving approval from the Food and Drug Administration in September 1996, making ACCOLATE the most prescribed asthma drug in its class. (endnote 1)
Data on patient preference were presented by Professor E.G. Weinberg (Red Cross Memorial Children's Hospital, Rondebosch, South Africa) to doctors attending ERS.(endnote 2) In an eight-week, open-label, cross-over trial, patient preference for ACCOLATE (20 mg twice daily [bid]) or inhaled BDP (100-200 microg bid) was compared in 132 adolescent asthma patients (ages 12-17 years, with mean percent predicted FEV1 97 percent). At entry, patients were well-controlled on inhaled corticosteroid (ICS) therapy and their inhaler technique was assessed against a checklist of five essential steps prior to randomization. After completion of two four-week treatment periods (patients taking ACCOLATE throughout one period and BPD throughout the other), patient reported overall preference was 2.6 fold in favor of ACCOLATE (70 percent ACCOLATE vs. 27 percent BDP; p plus/minus 0.001, Mainland-Gart and Prescott tests). Inhaler technique assessed prior to entry into the trial was correct in only 29 percent of patients, despite regular use of inhaler therapy. Both treatments were well-tolerated.
Professor Weinberg concluded, "These data show that preference for tablet therapy and the simplicity of dosing with tablets versus inhaled corticosteroids may result in improved compliance with regular asthma therapy, particularly in the adolescent population where compliance is a common problem."
Results of Study Adding ACCOLATE To An ICS
Results of another study for ACCOLATE, presented at the same meeting by Dr. Anjuli Nayak (Asthma & Allergy Research Associates, Normal, Ill.), show that the addition of ACCOLATE to a standard dose of BDP may offer similar results to doubling the dose of BDP in some asthma patients who remain symptomatic.(endnote 3)
In the 13-week, double-blind, double dummy, parallel-group trial, 394 patients (ages 12-79) with symptomatic asthma despite treatment on ICS were randomized to one of three treatments: 40 mg bid ACCOLATE plus a standard dose of ICS (SDICS--BDP 336 microg/d); 80 mg bid ACCOLATE plus SDICS (BDP 336 microg/d); or doubled dosage of ICS (DDICS--BDP 672 microg/d). (endnote 4) Mean improvements in baseline daytime asthma symptoms scores were 16 percent for patients administered ACCOLATE 40 mg bid plus SDICS, 16 percent for treatment group taking DDICS, and 23 percent for those dosed ACCOLATE 80 mg bid plus SDICS. Morning peak expiratory flow (PEF) increased 21 L/min in patients taking ACCOLATE 40 mg bid plus SDICS, 25 L/min in patients taking ACCOLATE 80 mg bid plus SDICS, and 13 L/min in the DDICS group. The corresponding reductions in daytime PEF variability were 16 percent, 24 percent, and 5 percent. All treatments in this trial were well tolerated. Pharyngitis, headache and sinusitis were the most commonly reported adverse events. Seven patients taking ACCOLATE 80 mg bid plus BDP 336 microg/d, four taking ACCOLATE 40 mg bid plus BDP 336 microg/d, and one taking BDP 672 microg/d experienced increased liver enzymes two-times or greater than the upper limit of normal.
Dr. Nayak concluded, "Adding ACCOLATE to inhaled corticosteroids may provide the same degree of control as increasing the dose of steroids in patients who experience asthma symptoms while on low-dose inhaled corticosteroids. This may provide an option to physicians and patients who may not want to increase the level of steroid treatment above labeled doses."
ACCOLATE is an oral controller agent taken twice daily, even during symptom-free periods, either one hour before or two hours after meals. It should not be used to reverse a sudden asthma attack. ACCOLATE Tablets are generally well tolerated by most patients. Patients should consult with their doctors before changing their current asthma medications, if they are prescribed a blood thinner, if they are nursing, or if their medical condition worsens. Side effects include headache, infection, and nausea.(endnote 5) A rare side effect of ACCOLATE, mostly seen at doses up to four times higher than the U.S. approved dose, is elevation of liver enzymes. Patients experiencing signs and/or symptoms of liver dysfunction (e.g., right upper quadrant abdominal pain, nausea, fatigue, lethargy, pruritus, jaundice, and flu-like symptoms) should contact their physician immediately. The role of ACCOLATE in the management of patients receiving antiasthma therapy other than as-needed inhaled B2-agonists, or as an inhaled corticosteroid-sparing agent, remains to be fully characterized.
Additional Background
Zeneca was the first pharmaceutical company to synthesize an antileukotriene molecule that was successfully developed and approved in the United States for use in humans. In the United States, ACCOLATE is available as a convenient, easy-to-take, twice-daily tablet therapy. It was the first LTRA compound included in the revised asthma treatment guidelines from the National Institutes of Health (NIH). More than 8,000 patients have participated in clinical trials for ACCOLATE, making it the most widely studied LTRA.
Zeneca Pharmaceuticals is a business unit of Zeneca Inc., a $3.4 billion bioscience business with approximately 7,200 employees in the United States. Zeneca Inc. is a wholly-owned subsidiary of the U.K.-based Zeneca Group PLC (NYSE:ZEN), a major $8.6 billion international bioscience business engaged in the research, development, manufacturing, and marketing of ethical (prescription) pharmaceuticals, agricultural and specialty chemical products, and the supply of health care services.
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NOTE: For full prescribing information for ACCOLATE, please call 1-800-456-3669, ext. 2231, or access the World Wide Web at http://www.usa.zeneca.com/pharm/pibs/pib_accolate.htm.
ENDNOTES: (1) Physician Drug & Diagnosis Audit (PDDA) and Source Prescription Audit (SPA), Weekly Retail Prescriptions, November 1996 - September 1998, Scott-Levin, a division of PMSI, Scott-Levin, Inc.
(2) Weinberg EG, Summerton L, Harris A. Assessment of preference for oral zafirlukast vs. inhaled beclomethasone in adolescent asthmatics. ERS Annual Meeting, Geneva, Switzerland, September 1998.
(3) Nayak AS, Anderson PJ, Charous BL, Williams KL, Miller CJ, Bonuccelli CM, Simonson SG. Addition of zafirlukast compared with a doubled dosage of inhaled corticosteroids in asthmatic patients with symptoms on inhaled corticosteroids. ERS Annual Meeting, Geneva, Switzerland, September 1998.
(4) The U.S. approved dose of ACCOLATE is 20 mg bid. The safety and efficacy of doses > 20 mg bid remain to be determined.
(5) In clinical trials, an increased proportion of patients on ACCOLATE who are over the age of 55 reported infection compared to those treated with placebo.
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