Comparison of the Efficacy and Safety of Pregabalin and Duloxetine in Taxane-Induced Sensory Neuropathy: A Randomized Controlled Trial
Background and objective
Taxane-induced peripheral neuropathy (TIPN) is a main toxicity of taxanes with no effective treatment. This study aimed to compare the efficacy and safety of pregabalin (150 mg daily) and duloxetine (60 mg daily) for managing TIPN in breast cancer patients.
This randomized, double-blind, Phase II clinical trial was carried out at a chemotherapy center affiliated to Mazandaran University of Medical Sciences. Patients with breast cancer who received paclitaxel or docetaxel and had a grade 1 or more neuropathy (based on the National Cancer Institute Common Terminology Criteria for Adverse Events version (NCI-CTCAE v4.03), and who had score 4 or higher neuropathic pain severity [based on the visual analog scale (VAS)] were enrolled. Response to treatment was assessed based on improvements in the VAS, NCI-CTCAE, and Patient Neurotoxicity Questionnaire (PNQ) scores during a 6-week trial.
Both interventions were effective in decreasing TIPN compared to baseline. At Week 6, the VAS scores were improved in 37/40 (92.5%) and 16/42 (38.1%) of the patients in the pregabalin and duloxetine groups, respectively (p < 0.001). Improvement in NCI-CTCAE sensory neuropathy was also more significant with pregabalin (37/40; 92.5%) in comparison to duloxetine (13/42; 31%) (p < 0.001). Pregabalin was also more beneficial than duloxetine in improving the PNQ scores by 36/40 (90%) and 13/42 (31%), respectively (p < 0.001). Both interventions were tolerated well with mild adverse events.
Both pregabalin and duloxetine were well tolerated and efficacious in relieving neuropathic pain, however a 60 mg dose of duloxetine is inferior to a 150 mg dose of pregabalin.
The authors would like to acknowledge the kind assistance and financial support provided by Mazandaran University of Medical Sciences (Proposal ID: 1897–20/05/94).
All authors contributed to the study design. ES was responsible for the study conception, definition of intellectual content, literature search, and manuscript preparation. GJ was responsible for the study conception, and clinical studies. NH conducted to definition of intellectual content. AA contributed to the data analysis and statistical analysis. NT contributed to data acquisition, and clinical studies. RA contributed to study conception, literature search, data acquisition, manuscript preparation and is guarantor for the study. All authors reviewed and edited the manuscript and approved the final manuscript.
Compliance with Ethical Standards
The authors acknowledge the kind assistance and financial support provided by Mazandaran University of Medical Sciences (Proposal ID: 1897–20/05/94).
Conflict of interest
Authors declare that they have no conflicts of interest.
The study was approved by ethics committee of Mazandaran University of Medical Sciences (IR.MAZUMS.REC.94-1897). The study was submitted, evaluated and approved by the Iranian Registry of Clinical Trials (IRCT201602112027N5). All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
Written informed consent was obtained from each patient prior to study enrolment.
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