(806): Long-term safety and efficacy of OROS hydromorphone in patients with chronic low back pain

Abstract

More than 60% of the population will experience significant low back pain (LBP), with over 10% having chronic pain lasting more than 6 months. Few studies have evaluated the long-term safety and efficacy of long-acting opioid analgesics for chronic LBP, a condition that interferes with work and other daily activities. This is a 6-month extension of a 7-week, multicenter, open-label, non-comparative study in patients with chronic LBP assessing the long-term safety, tolerability, and clinical efficacy of once-daily OROS® hydromorphone. All patients who completed the initial study were eligible to enter and were continued on their existing dose of OROS® hydromorphone. The safety and efficacy of OROS® hydromorphone were assessed monthly using the Brief Pain Inventory, Patient/Investigator Global Evaluations, and daily pain diaries. Of the 113 patients who entered the 6-month extension, 83 (73.5%) completed this trial. The severity of pain (worst, least, on average, right now, and last 24 hours) did not change during the 6 months (mean [SD], 0.3 [1.67]; P> .1), suggesting maintenance of the clinical benefits observed in the initial 7-week study. Treatment effectiveness with OROS® hydromorphone was reported as “good” or “better” by patients (mean [SD], 3.1 [1.05]) and investigators (mean [SD], 3.3 [0.93]). Pain relief obtained with OROS® hydromorphone at the final visit of the 7-week trial (mean [SD], 2.4 [0.75]) was maintained throughout the 6-month extension (mean [SD], 2.5 [0.67]; P> .1). Adverse events (AEs) were similar to those in the initial 7-week study; 17 (15.0%) patients reported a treatment-emergent AE and 12 (10.6%) discontinued due to any AE. Once-daily OROS® hydromorphone was generally safe and well tolerated throughout the 6-month extension trial. Initial clinical benefits were maintained for at least 6 months, suggesting that once-daily OROS® hydromorphone is an effective long-term treatment for chronic LBP. More than 60% of the population will experience significant low back pain (LBP), with over 10% having chronic pain lasting more than 6 months. Few studies have evaluated the long-term safety and efficacy of long-acting opioid analgesics for chronic LBP, a condition that interferes with work and other daily activities. This is a 6-month extension of a 7-week, multicenter, open-label, non-comparative study in patients with chronic LBP assessing the long-term safety, tolerability, and clinical efficacy of once-daily OROS® hydromorphone. All patients who completed the initial study were eligible to enter and were continued on their existing dose of OROS® hydromorphone. The safety and efficacy of OROS® hydromorphone were assessed monthly using the Brief Pain Inventory, Patient/Investigator Global Evaluations, and daily pain diaries. Of the 113 patients who entered the 6-month extension, 83 (73.5%) completed this trial. The severity of pain (worst, least, on average, right now, and last 24 hours) did not change during the 6 months (mean [SD], 0.3 [1.67]; P> .1), suggesting maintenance of the clinical benefits observed in the initial 7-week study. Treatment effectiveness with OROS® hydromorphone was reported as “good” or “better” by patients (mean [SD], 3.1 [1.05]) and investigators (mean [SD], 3.3 [0.93]). Pain relief obtained with OROS® hydromorphone at the final visit of the 7-week trial (mean [SD], 2.4 [0.75]) was maintained throughout the 6-month extension (mean [SD], 2.5 [0.67]; P> .1). Adverse events (AEs) were similar to those in the initial 7-week study; 17 (15.0%) patients reported a treatment-emergent AE and 12 (10.6%) discontinued due to any AE. Once-daily OROS® hydromorphone was generally safe and well tolerated throughout the 6-month extension trial. Initial clinical benefits were maintained for at least 6 months, suggesting that once-daily OROS® hydromorphone is an effective long-term treatment for chronic LBP.