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A single-blind crossover study of two different slow release theophylline preparations
1Pulmonary Department, Medical School, University of Athens, Sotiria Hospital, Greece.
The Journal of International Medical Research
|November 1, 1988
Summary
Choline theophyllinate demonstrated superior plasma concentration stability and reduced bronchodilator use compared to anhydrous theophylline in patients with chronic respiratory conditions. This suggests a potentially safer and more effective slow-release theophylline option.
Area of Science:
- Pharmacology
- Respiratory Medicine
- Clinical Therapeutics
Background:
- Theophylline is a bronchodilator used for managing chronic respiratory diseases like asthma and chronic bronchitis.
- Slow-release formulations aim to provide stable plasma concentrations and reduce dosing frequency.
- Variability in theophylline absorption and metabolism necessitates careful formulation selection.
Purpose of the Study:
- To compare the pharmacokinetic stability and clinical efficacy of two slow-release theophylline preparations: choline theophyllinate and anhydrous theophylline.
- To evaluate the impact of these formulations on the need for rescue bronchodilator medication.
- To assess the incidence of adverse drug reactions associated with each formulation.
Main Methods:
- A single-blind, randomized crossover study involving 18 adult patients with chronic bronchitis or asthma.
- Patients received either 600 mg choline theophyllinate or 300 mg anhydrous theophylline orally every 12 hours for 7 days, with a 2-day washout period.
- Plasma theophylline concentrations were measured at multiple time points daily during the final 5 days of each treatment period.
Main Results:
- Choline theophyllinate maintained plasma theophylline concentrations within a fluctuation of <= 40% in all patients, compared to 83% of patients on anhydrous theophylline.
- Patients required significantly fewer salbutamol inhaler puffs for bronchospasm relief when taking choline theophyllinate (25 puffs) versus anhydrous theophylline (41 puffs).
- Adverse drug reactions were reported in one patient on choline theophyllinate and four patients on anhydrous theophylline.
Conclusions:
- Choline theophyllinate offers more consistent plasma theophylline levels and improved clinical control compared to anhydrous theophylline in slow-release formulations.
- The reduced need for rescue bronchodilators suggests enhanced efficacy and potentially better patient outcomes with choline theophyllinate.
- Choline theophyllinate appears to be a safer slow-release theophylline option with a lower incidence of adverse events.