Abstract ID: A36
Abstract Title: Ziconotide Impact on Quality of Life (QoL) and Functional Ability in Severe Chronic Pain Patients Utilizing A Fast Titration Schedule
Authors: Narayana A1, Marmon T2, McLennan G3, Gee L4
Elan Pharmaceuticals, Inc. San Diego CA USA1, Elan Pharmaceuticals, Inc. San Diego CA USA2, Elan Pharmaceuticals, Inc. San Diego CA USA3, Elan Pharmaceuticals, Inc. San Diego CA USA4
Poster Type: Poster
ABSTRACT BODY
Introduction: Ziconotide is a non-opioid analgesic administered intrathecally to treat severe chronic pain. Quality of Life (QoL) and functional ability are crucial components in the assessment of any chronic pain condition. We reviewed the impact of ziconotide on pain-related disability and QoL using the Pain Disability Index (PDI) and Sickness Impact Profile short form (SIP-20).
Methods: Baseline assessments of the PDI and SIP-20 were collected in Study 96-002 (a fast titration trial enrolling patients with non-malignant pain). Follow up assessments were collected at Week 4, and periodically, in Study 95-002 (an open-label long-term extension study) for any patient who transitioned from Study 96-002. Only patients who demonstrated an analgesic response to ziconotide in Study 96-002 could transition into Study 95-002. Changes from baseline to Week 4 and to last available observation were analyzed. Baseline scores were calculated by averaging patients’ screening and pre-dosing scores. The PDI measures pain-related interference with role functioning in 7 areas (occupational, home/family, recreational, social, sexual, self care, life support), all rated on an 11-point scale, where a score of 0 meant “no disability at all” and a score of 10 signified “total disability.” The three scores of the PDI - Overall Disability, Discretionary Activity Disability, and Obligatory Function Disability, were calculated. The SIP-20 asks 20 questions about a patient’s ability to perform normal tasks. Each affirmative response indicated a negative disease impact on the patient’s life and was assigned a score of one. All affirmative responses were tallied for a total score, with minimum score of 0 representing no impact on function and a maximum score of 20 signifying maximum impact on function.
Results: The mean baseline PDI Overall Disability Score was 48.6 (N=92, SD=11.70). The mean improvement in the PDI Overall Disability Score from baseline to Week 4 for the 61 patients with values at both time points was 4.7 (SD=15.0; p=0.0492). The mean improvement in the PDI Overall Disability Score from baseline to the last available observation was 3.6 (N=70; SD=12.9; p=0.0232). The mean baseline PDI Discretionary Activity Score was 39.3 (N=92; SD=8.9). The mean improvement from baseline to Week 4 was 4.3 (N=61; SD=11.6; p=0.0135) and the mean improvement from baseline to last available observation was 3.0 (N=70; SD=9.8; p=0.0132). The mean baseline PDI Obligatory Function Disability Score was 9.3 (N=92, SD=4.5). The mean improvement in the PDI Obligatory Function Disability Score from baseline to Week 4 was 0.4 (N=61; SD=5.6; p=0.5766). The mean improvement in the PDI Obligatory Function Disability Score from baseline to last available observation was 0.6 (N=70, SD=5.6, p=0.3635). The mean baseline SIP-20 score was 14.0 (N=92; SD=4.4). The mean change from baseline to Week 4 in the SIP-20 for the 61 patients with values at both time points was 1.9 (SD=4.9; p=0.0027). The mean change in the SIP-20 from baseline to the last available observation was 1.1 (N=71; SD 4.8; p=0.0650).
Conclusion: Pain-related functional improvements and QoL improvements are critical goals in pain management. Ziconotide demonstrated statistically significant improvements in patient functional ability (PDI Overall Disability, PDI Discretionary Activity Disability) and a positive trend for QoL improvement (SIP-20) in the treatment of severe chronic pain.
ATTACHED FILES
Reg Anesth Pain Med 2005; 30(3):A36