Efficacy and tolerability of levodropropizine in adult patients with non-productive cough. Comparison with dextromethorphan.
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 6h 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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Istituto di Clinica Tisiologica e Malattie Respiratorie, Seconda Università degli Studi, Napoli, Italy.
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D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000996:Antitussive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D003371:Cough / Q000188:drug therapy*; D003915:Dextromethorphan / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011409:Propylene Glycols / Q000009:adverse effects / Q000627:therapeutic use*; D012894:Sleep Stages
D000996:Antitussive Agents; D011409:Propylene Glycols; D003915:Dextromethorphan; C035916:dipropizine