PURPOSE: Salbutamol is the most common β2-agonist being currently used in the treatment of asthma. It was only available as a racemate, a 50:50 mixture of the dextro [(S)-salbutamol] and levo [(R)-salbutamol] rotatory forms. Regular and excessive use of racemate can induce paradoxical reactions in some subjects with asthma. The present study, compared MDI Salbutamol with levo [(R)-salbutamol] isomer over 8 weeks in terms of clinical efficacy and safety.
METHODS: A prospective, parallel design, comparative, intention to treat study lasting eight weeks, involving 80 patient of either sex after taking their informed consent. Patients were randomly divided into 2 groups, A and B of 40 patients each. Patients in Group A and Group B were administered Salbutamol MDI two puffs 100 mcg per puff four times daily and Levosalbutamol MDI two puffs each containing 50 mcg four times daily respectively. Rescue dose two or more puffs was allowed as required and the number of additional doses were counted by patients. Observations were made and analyzed at 0, 4 and 8 weeks for FEV1, FVC, and PEFR and side effects.
RESULTS: Highly significant (p < 0.001) mean percent change in FEV1, FVC and PEFR at 4 and 8 weeks of Group B (Levosalbutamol) patients as compared to mean percent change in FEV1 of Group A (Salbutamol) patients at 4 weeks and 8 weeks.
CONCLUSION: High therapeutic efficacy was observed with the use of the Levosalbutamol MDI with lesser side effects.
CLINICAL IMPLICATIONS: Levosalbutamol can be preferred over salbutamol for better control of asthma symptoms.
DISCLOSURE: Hitender Kumar, No Financial Disclosure Information; No Product/Research Disclosure Information