Zileuton vs. Theophylline in Moderate Asthma
May 15, 1998 2 minutes read
Zileuton vs. Theophylline in Moderate Asthma
ABSTRACT & COMMENTARY
Synopsis: Zileuton is as effective and as safe as theophylline in the treatment of moderate asthma.
Source: Schwartz HJ, et al. Arch Intern Med 1998;158: 141-148.
Zileuton, a leukotriene synthesis inhibitor, was compared with blood level adjusted theophylline for its efficacy in moderate asthma in a double-blind, multi-center study of 13 weeks' duration. Among 313 patients from 38 centers who completed the study, the first-dose administration from all groups showed 11-13% improvement of FEV1 within 30 minutes. The theophylline group initially showed greater improvement in symptom scores, beta agonist usage, and peak expiratory flow rate compared to the two zileuton groups given 400 or 600 mg qid. However, when the minimal effect was assessed, there were no differences in the active groups or between groups, and zileuton produced significantly greater improvement in FEV1 compared to theophylline at several time intervals. All groups showed comparable quality of life scores and adverse events. Thus, zileuton is as effective and as safe as theophylline.
COMMENT BY SHELDON L. SPECTOR, MD
The antileukotrienes are a new class of medications with both anti-inflammatory and mild bronchodilatory effects, thereby suggesting their usefulness in the treatment of asthma.1
Of the two agents commercially available, zileuton is a synthesis inhibitor and zafirlukast is a receptor antagonist. Theophylline has similar clinical characteristics, but its narrow therapeutic range and potential side effects necessitate careful monitoring in the patient receiving it. Schwartz and coworkers confirmed the ant-inflammatory role of antileukotrienes in this sudy by noting significant eosinopenia in the zileuton group.2 However, no one is certain if the anti-inflammatory effect will provide long-term benefits over months or years. Although none of the patients studied over the 13 weeks had abnormal liver function tests (LFTs), the package insert for zileuton mentions LFT monitoring monthly for three months and quarterly thereafter.
Zafirlukast is a clinically useful receptor-blocking antileukotriene with its twice daily dosing (rather than qid dosing, as with zileuton) and does not require the extra expense of LFT monitoring.3
The antileukotrienes are presently being compared to not only theophylline, but also to other agents used in the treatment of asthma, such as salmeterol, cromolyn, nedocromil, and steroid aerosols. After the results of these studies are published, I would predict an expanded role in the treatment of asthma beyond their suggested role in "mild, persistent asthma" as mentioned in the 1997 NHLBI guidelines.4
References
1. Spector SL. Leukotriene activity modulation in asthma. Drugs 1997;54:369-384.
2. Schwartz HJ, et al. A randomized control trial comparing zileuton with theophylline in moderate asthma. Arch Intern Med 1998;158:141-148.
3. Spector SL, Fish JE. A new approach: Clinical review of zafirlukast (Accolate, lCl-204,219). Eur Respir Rev 1997;7:46,269-273.
4. The Expert Panel Highlights of the Expert Panel Report ll: Guidelines for the Diagnosis and Management of Asthma (draft). National Institutes of Health, National Heart, Lung and Blood Insititute, February 1997;1-50.
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