Efficacy and Tolerability of Levodropropizine in Adult Patients with Non-productive Cough. Comparison with Dextromethorphan

doi:10.1006/pupt.1997.0083

Pulmonary Pharmacology & Therapeutics

Volume 10, Issue 2, April 1997, Pages 89-96

https://doi.org/10.1006/pupt.1997.0083 Get rights and content

Abstract

The results of a double-blind, randomized clinical trial involving 209 adult patients of either sex with moderate non-productive cough are reported. The therapeutic efficacy and the tolerability of levodropropizine syrup (60 mg t.i.d. for 5 days) was evaluated in comparison with dextromethorphan syrup (15 mg t.i.d. for 5 days). Efficacy was assessed by the number of coughing spells in a 6 h period, the cough frequency classes, the cough intensity and the night awakenings due to cough. Tolerability was evaluated by laboratory results, vital signs and any adverse event occurred during the clinical trial, including presence or absence of somnolence. Independently from the underlying pathology and from the degree of baseline cough severity, the number of coughing spells was significantly (P<0.05) reduced by both levodropropizine and dextromethorphan already after the 2nd day of treatment, the effect and its time of onset being similar for both drugs. Cough intensity was significantly (P<0.01) reduced by both drugs throughout the treatment, at an earlier time with levodropropizine than with dextromethorphan. Concurrently with the relief of cough, the number of night awakenings was decreased remarkably and significantly (P<0.05), with levodropropizine displaying an improvement significantly higher (P<0.05) than dextromethorphan. No change in laboratory tests values was considered clinically relevant and vital signs were not clinically affected by the study drugs. The number of patients reporting adverse events was significantly higher (P<0.05) in the dextromethorphan (12.1%) than in the levodropropizine (3.6%) group. Overall, somnolence was reported for a low percentage of patients with both drugs, with the percentage of patients experiencing this side effect being one half in the group treated with levodropropizine (4.6%) as compared with dextromethorphan (10.4%). These results confirm the antitussive effectiveness of levodropropizine and point out a more favourable benefit/risk profile when compared to dextromethorphan.

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However, levodropropizine, a peripherally acting antitussive drug, has a good tolerability and safety profile. Levodropropizine has been demonstrated to show equivalent efficacy and less sedative effects compared to other antitussive agents such as the centrally acting cough suppressants dextromethorphan or dihydrocodeine [6,7]. Levodropropizine-containing products, for adults and children older than 2 years for the symptomatic therapy of cough, are approved for use in many countries in syrup, oral drop or tablet form.
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Given its demonstrated antitussive efficacy and safety in adults [22–26], and the encouraging data supporting its efficacy and safety in children [27–31], levodropropizine appears to be an appropriate candidate for further evaluation as a potential antitussive for the pediatric population.
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^☆: This clinical study was supported by Dompé farmaceutici s.p.a.

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Regular ArticleEfficacy and Tolerability of Levodropropizine in Adult Patients with Non-productive Cough. Comparison with Dextromethorphan☆

Abstract

Regular Article
Efficacy and Tolerability of Levodropropizine in Adult Patients with Non-productive Cough. Comparison with Dextromethorphan☆