Duloxetine relieves pain in patients with chronic low back pain
Treatment with duloxetine significantly reduces pain over 52 weeks in patients with chronic low back pain without new safety concerns, according to the results of a phase III trial.
The open-label phase III study included 150 patients (mean age 56.4 years; 53.3 percent female; mean weight, 62.6 kg) treated with 60-mg duloxetine once daily for 52 weeks.
Safety was evaluated based on adverse events (AEs), vital signs, laboratory test values, electrocardiogram, Columbia-Suicide Severity Rating Scale and occurrence of falls. Efficacy measures included the Brief Pain Inventory (BPI; average pain, worst pain, least pain and pain right now), BPI Interference, Patient’s Global Impression of Improvement (PGI-I), Clinical Global Impressions of Severity (CGI-S), Roland-Morris Disability Questionnaire–24 (RDQ-24), 36-Item Short-Form Health Survey (SF-36) and European Quality of Life-5 Dimensions Questionnaire (EQ-5D).
The incidence rate of AEs and adverse drug reactions (ADRs) were 86.1 percent and 50.3 percent, respectively. ADRs occurring in ≥5-percent of patients were somnolence, constipation, nausea and dry mouth. AEs led to treatment discontinuation in 16 patients.
In terms of efficacy, BPI average pain score significantly decreased from baseline at all time points: from week 2 (mean change, −1.02) to week 50 (mean change, −2.2). There were also improvements seen in BPI pain severity (worst pain, least pain and pain right now), BPI Interference, PGI-I, CGI-S, RDQ-24, SF-36 and EQ-5D.
The present data indicate that duloxetine is useful in the long-term treatment of patients with chronic low back pain, researchers said.