Efficacy and safety of levodropropizine and dihydrocodeine on nonproductive cough in primary and metastatic lung cancer

Abstract

Nonproductive cough is a frequent and distressing symptom in patients with lung cancer, and it is not even relieved by palliative chemotherapy. A double-blind, randomized clinical trial regarding the treatment of nonproductive cough was performed in 140 adults with primary lung cancer 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 severity scores, number of night awakenings due to cough, and overall estimate of antitussive efficacy. Tolerability was evaluated by laboratory results, vital signs and any adverse event occurring during the clinical trial, including presence or absence of somnolence. Subjective cough severity was significantly reduced during treatment with either levodropropizine and dihydrocodeine, the antitussive effect and its time-profile being similar for both drugs. Also, according to the investigator's evaluation, both levodropropizine and dihydrocodeine produced a significant decrease in cough severity. Concurrently with the relief of cough, the number of night awakenings was decreased significantly by both 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 adverse events was similar in the levodropropizine (n=6) and dihydrocodeine (n=4) group. However, the percentage of patients experiencing somnolence 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 dihydrocodeine.

Comparison of analgesic effects and patient tolerability of nabilone and dihydrocodeine for chronic neuropathic pain: randomised, crossover, double blind study

“…5 Its psychotropic and sedative side effects make it a good comparative agent for a study with nabilone. 6 Neuropathic pain is a common condition associated with various injuries to the central and peripheral nervous systems. It is often refractory to treatment with currently available drugs, and other classes of "adjuvant" drugs may be needed.…”

Antitussive Drugs—Past, Present, and Future

“…The effect of levodropropizine on cough associated with lung cancer was studied by Luporini et al (1998). In a comparative double-blind trial, 75 mg of levodropropizine three times a day and 10 mg of dihydrocodeine three times a day were administered for 7 days in 66 and 69 patients, respectively.…”

Levodropropizine for treating cough in adult and children: a meta-analysis of published studies

“…In a double blind, two parallel groups , randomized study [12], Luporini et al evaluated the efficacy of levodropropizine compared to dihydrocodeine (oral t.i.d. administration for 7 days) in the treatment of non-productive cough in 140 adults with primary lung cancer or metastatic cancer of the lungs.…”