EFFICACY AND SAFETY OF LEVODROPROPIZINE AND DIHYDROCODEINE ON NONPRODUCTIVE COUGH IN PRIMARY AND METASTATIC LUNG-CANCER

Nonproductive cough is a frequent and distressing symptom in patients with lung cancer, and it is not even relieved by palliative chemothera py, A double-blind, randomized clinical trial regarding the treatment of nonproductive cough was performed in 140 adults with primary lung c ancer or metastatic cancer of the lungs. The therapeutic efficacy and the tolerability of a 7-day treatment with levodropropizine drops (75 mg t,i,d,) were evaluated in comparison with dihydrocodeine drops (10 mg t.i.d.; 7 days). Efficacy was assessed on the basis of cough severi ty scores, number of night awakenings due to cough, and overall estima te of antitussive efficacy. Tolerability was evaluated bg laboratory r esults, vital signs and any adverse event occurring during the clinica l trial, including presence or absence of somnolence, Subjective cough severity was significantly reduced during treatment with either levod ropropizine and dihydrocodeine, the antitussive effect and its time-pr ofile being similar for both drugs. Also, according to the investigato r's evaluation, both levodropropizine and dihydrocodeine produced a si gnificant decrease in cough severity. Concurrently with the relief of cough, the number of night awakenings was decreased significantly by b oth drugs, with no difference between the two treatments. No change in laboratory test values was considered clinically relevant, and vital signs were not clinically affected. The number of patients reporting a dverse events was similar in the levodropropizine (n=6) and dihydrocod eine (n=4) group. However, the percentage of patients experiencing som nolence in the group receiving levodropropizine (8%) was significantly lower as compared with that of the dihydrocodeine group (22%). These results confirm the antitussive effectiveness of levodropropizine and suggest a more favourable benefit/risk profile when compared to dihydr ocodeine.