Opioids in non-cancer pain: Improved quality of life with Kadian® (morphine sulfate sustained-release capsules) in patients with chronic, non-malignant, moderate/severe pain: The KRONUS-MSP trial

Abstract

Alleviating pain and sleep disturbances while minimizing adverse events are all important treatment goals in patients with chronic non-malignant pain; such “whole patient” management can improve quality of life (QoL). The KRONUS-MSP trial is the largest study to date to examine the use of a sustained-release opioid for chronic non-malignant pain, and includes measures of QoL. The aim was to assess the improvement in QoL in patients with chronic, non-malignant, moderate to severe pain with Kadian treatment. A community-based, prospective, randomized, open-label, blinded endpoint design was employed. Investigators randomized 1418 patients with chronic, non-malignant, moderate/severe pain and a baseline visual numeric scale (VNS) pain score ≥4 to a 4-week AM or PM QD regimen with Kadian. All patients had previous unsuccessful pain management. Dose adjustments were permitted; however, Q12h dosing was withheld until Week 2. Final evaluations occurred at Week 4. QoL was assessed using the SF36v2 Health Survey. Pain relief and sleep improvement were measured using a VNS (0-10 scale). Adverse events were collected and evaluated. A broad range of patients with diverse chronic non-malignant pain conditions displayed statistically significant improvements at Week 4 in the physical (12%) and mental (15.6%) composite scores of the SF36v2 (p<0.0001) as well as the VNS scores for pain relief (32%; p<0.0001) and sleep (29%; p<0.0001) compared to baseline. Kadian was well tolerated, with 70% (988/1418) of patients completing the study. Adverse events were reported by 40% (563/1418) of patients, with constipation (12%) and nausea (10%) being most frequent. Only 10% of patients discontinued due to adverse events. No differences in responses were seen between patients in the AM or PM dosing groups. Kadian therapy was efficacious, safe, well tolerated, and demonstrated improved QoL in a broad range of patients with chronic non-malignant pain.