- Email: [email protected]
Pregabalin safely and efficaciously treats chronic central neuropathic pain after spinal cord injury
Abstracts
S25
C03 - Central Pain
C05 - Joint and Muscle Pain
(665) Pregabalin safely and efficaciously treats chronic central neuropathic pain after spinal cord injury
(667) Ongoing pain & stress levels among Lupus patients
P. Siddall, M. Cousins, A. Otte, K. Phillips, T. Griesing; Anaesthesia, University of Sydney, E25 - Royal North Shore Hospital, Sydney, Australia Pregabalin (PGB) has demonstrated efficacy and safety in the treatment of neuropathic pain (NeP) associated with diabetic peripheral neuropathy and postherpetic neuralgia. Results from a randomized, placebocontrolled trial performed to evaluate the efficacy and safety of PGB for the treatment of central NeP due to spinal cord injury (SCI) are described. This 13-week trial (1-week baseline phase ⫹ 12-week doubleblind treatment) randomized 137 patients to either escalating doses of 150, 300, and 600 mg/day (BID) of PGB (n⫽70) or placebo (n⫽67). All patients had been diagnosed with central NeP pain due to non-progressive traumatic SCI. Stable doses of pain medication, including opioids and antidepressants, were allowed. The primary efficacy variable was endpoint mean pain score (11-point scale). Secondary efficacy measures included responder rates, pain related sleep interference and Patient Global Impression of Change (PGIC). Patients were well matched demographically. Mean age was 50.1 years (range, 21-80), and mean baseline pain scores were 6.7⫾1.4 (placebo group) and 6.5⫾1.2 (pregabalin group). Endpoint mean pain was significantly lower in pregabalin treated patients versus placebo: 4.66 vs. 6.20 (P⬍0.001). At endpoint, significantly more pregabalin-treated patients met 30% responder criteria (42% PGB vs. 16.4% PBO), had a reduction in sleep interference (p⬍0.0001 vs. PBO) and reported improvement in PGIC scores (p⬍0.001 vs. PBO). The most common adverse events (AEs) were somnolence, dizziness, asthenia, dry mouth, constipation, edema, and amnesia. Discontinuations due to AEs were 21.4% for patients on PGB and 13.4% for patients on placebo. Findings from this trial show that pregabalin is an efficacious and well-tolerated treatment for central NeP due to SCI. These data contribute to the growing body of evidence demonstrating that pregabalin has clinically meaningful utility across a broad range of NeP syndromes.
(666) Neuropathic pain following spinal cord injury: Defining a day of manageable pain J. Richards, N. Brandenburg, J. Endicott, D. Lammertse, S. Charlifue, Y. Chen, G. Whiteneck; University of Alabama at Birmingham, Birmingham, AL Three major sub-types of pain follow spinal cord injury: musculoskeletal, neuropathic and visceral. Neuropathic pain, chiefly radicular at or below the level of neurologic injury, is often the most problematic to treat and least understood. We identified SCI patients with documented neuropathic pain to determine its impact on quality of life measures and to discern whether there is a dose dependent relationship between neuropathic pain severity and QOL measures. 133 persons 17 years post injury (94% ASIA A, 6% ASIA B) were queried about their pain over the past week, and were asked to complete the Medical Outcomes Study Sleep Scale (MOS-S), the Hospital Anxiety and Depression Scale (HADS), the Satisfaction with Life Scale (SWLS), and the Brief Symptom Inventory (BSI). Participants were divided into three groups based on reported average pain levels over the last week as Mild (0-3), Moderate (4-6), and Severe (7-10) with 53, 39, and 41 in each group respectively. The Mild group scored within normal limits on all measures compared to the Moderate and Severe groups which combined, reported more sleep disturbance (MOS-S summary scale 9: mean ⫽ 30.7 vs 22.0; p⬍.01), greater global distress (BSI General Severity Index: mean⫽ 60.9 vs 55.3; p⬍.01), and lower satisfaction with life (SWLS: mean ⫽ 19.6 vs 23.3; p⬍.01). While means for measures of anxiety and depression (HADS) were within normal limits for all groups, a significantly greater percentage of the moderate/severe pain group scored above the normative cutoff score for both anxiety and depression compared to the mild pain group. Moderate and severe pain groups generally did not differ from each other across most measures. Results suggest that if clinicians can reduce average neuropathic pain to mild levels in this group, this pain type is manageable in terms of its impact on quality of life.
H. Logan, M. Graham, J. Shuster, D. Theriaque, H. Richards, W. Reeves; University of Florida, Gainesville, FL The purpose of this investigation was to compare daily lupus-related symptoms with markers of daily stress, disease severity, and coping among 42 patients (M age⫽40) who maintained daily diaries for 28 days followed by weekly diaries for 4 weeks. Patients were recruited at the time of their initial visit at UFL lupus clinic. Patients were contacted by telephone weekly to verify that symptoms, stress, and coping were being recorded in the diaries and to report the number and expected severity of hassles for the upcoming week. Fifteen Blacks and 27 nonBlacks completed relevant data. Results showed a significant correlation between baseline disease severity (SLEDAI) and average of the daily symptoms of chest and muscle pain (r⫽.34 p⬍.05; r⫽⫽.34 p⬍.05) and joint swelling (r⫽.36 p⬍.05); facial rash (r⫽.31 p⬍.05). The baseline disease severity was significantly correlated with the average of how stressful subjects assessed tomorrow to be (r⫽.31 p⬍.05). There was a significant positive correlation between baseline plasma levels of double stranded DNA(higher levels associated with greater disease severity) and average daily religious coping r⫽.31 p⬍.05. For those patients whose disease became less severe across the 2 month study period, reliance on religious coping was greatest (r⫽.31 p⬍.05). There were no significant differences between Blacks and non-Blacks on baseline disease severity or average daily symptoms (p⬎.2) Analysis of coping by race showed that non-Blacks had higher average daily religious coping scores than did Blacks (F1,35⫽5.03 p⬍.05). The average of the expected severity of the weekly hassles was significantly greater among Black patients than among non-Blacks (F1,35⫽5.78 p⬍.05). We conclude that more severe disease and stress are associated with daily painful symptoms and there are ethnoracial differences in expected severity of hassles and religious coping but not in disease severity.
C06 - Low Back Pain (668) Impact of low back pain on health-related quality of life before and after treatment with an analgesic medication D. Hewitt, J. Schein, M. Kosinski, W. Olson, N. Rosenthal; Ortho-McNeil Pharmaceutical, Inc., Raritan, NJ This post hoc analysis of two multicenter, randomized, double-blind, placebo-controlled trials assessed the burden of chronic low back pain (LBP) on health-related quality of life (HRQoL) before and after treatment with an analgesic. The pooled sample included 660 patients with chronic (⬎3 months), moderate-to-severe LBP (Pain Visual Analogue [PVA] scale score 40-100). Patients in both trials received an oral analgesic or placebo for 13 weeks. Baseline scores on the Short Form 36 Health Survey (SF-36) for trial participants were compared with: (1) U.S. normative scores for the general population; and (2) disease-specific benchmarks from the Medical Outcomes Study (MOS). Overall, patients with chronic LBP had significantly lower mean SF-36 scores than the U.S. norm for all scales (MANOVA F⫽289.2, p⬍0.001), including scores ⬎1.5 standard deviations (SD) lower than the U.S. norm for most physical health scales. Patients with moderate-to-severe LBP in the clinical trials had greater HRQoL burden on most SF-36 scales compared with diseasespecific benchmarks from patients in the MOS who had LBP (any severity), hypertension, congestive heart failure, type 2 diabetes, recent myocardial infarction, or depression. The burden of LBP was greater among trial patients who experienced more severe pain. SF-36 bodily pain scores were ⬎2 SD lower than U.S. norms among patients with PVA scale scores between 80-100 mm; and they were ⬎1 SD lower among those with PVA scale scores between 40-80 mm. Physical health domains had better discriminant validity than mental health domains. Statistically significant HRQoL benefits emerged in physical health domains when pain improved by 21-30 points on the PVA scale and clear improvement in all aspects of HRQoL occurred when pain improved by at least 31 points on the PVA scale. This analysis confirms the tremendous burden of chronic LBP on HRQoL and demonstrates that pain relief may reduce this major HRQoL burden.
S25
C03 - Central Pain
C05 - Joint and Muscle Pain
(665) Pregabalin safely and efficaciously treats chronic central neuropathic pain after spinal cord injury
(667) Ongoing pain & stress levels among Lupus patients
P. Siddall, M. Cousins, A. Otte, K. Phillips, T. Griesing; Anaesthesia, University of Sydney, E25 - Royal North Shore Hospital, Sydney, Australia Pregabalin (PGB) has demonstrated efficacy and safety in the treatment of neuropathic pain (NeP) associated with diabetic peripheral neuropathy and postherpetic neuralgia. Results from a randomized, placebocontrolled trial performed to evaluate the efficacy and safety of PGB for the treatment of central NeP due to spinal cord injury (SCI) are described. This 13-week trial (1-week baseline phase ⫹ 12-week doubleblind treatment) randomized 137 patients to either escalating doses of 150, 300, and 600 mg/day (BID) of PGB (n⫽70) or placebo (n⫽67). All patients had been diagnosed with central NeP pain due to non-progressive traumatic SCI. Stable doses of pain medication, including opioids and antidepressants, were allowed. The primary efficacy variable was endpoint mean pain score (11-point scale). Secondary efficacy measures included responder rates, pain related sleep interference and Patient Global Impression of Change (PGIC). Patients were well matched demographically. Mean age was 50.1 years (range, 21-80), and mean baseline pain scores were 6.7⫾1.4 (placebo group) and 6.5⫾1.2 (pregabalin group). Endpoint mean pain was significantly lower in pregabalin treated patients versus placebo: 4.66 vs. 6.20 (P⬍0.001). At endpoint, significantly more pregabalin-treated patients met 30% responder criteria (42% PGB vs. 16.4% PBO), had a reduction in sleep interference (p⬍0.0001 vs. PBO) and reported improvement in PGIC scores (p⬍0.001 vs. PBO). The most common adverse events (AEs) were somnolence, dizziness, asthenia, dry mouth, constipation, edema, and amnesia. Discontinuations due to AEs were 21.4% for patients on PGB and 13.4% for patients on placebo. Findings from this trial show that pregabalin is an efficacious and well-tolerated treatment for central NeP due to SCI. These data contribute to the growing body of evidence demonstrating that pregabalin has clinically meaningful utility across a broad range of NeP syndromes.
(666) Neuropathic pain following spinal cord injury: Defining a day of manageable pain J. Richards, N. Brandenburg, J. Endicott, D. Lammertse, S. Charlifue, Y. Chen, G. Whiteneck; University of Alabama at Birmingham, Birmingham, AL Three major sub-types of pain follow spinal cord injury: musculoskeletal, neuropathic and visceral. Neuropathic pain, chiefly radicular at or below the level of neurologic injury, is often the most problematic to treat and least understood. We identified SCI patients with documented neuropathic pain to determine its impact on quality of life measures and to discern whether there is a dose dependent relationship between neuropathic pain severity and QOL measures. 133 persons 17 years post injury (94% ASIA A, 6% ASIA B) were queried about their pain over the past week, and were asked to complete the Medical Outcomes Study Sleep Scale (MOS-S), the Hospital Anxiety and Depression Scale (HADS), the Satisfaction with Life Scale (SWLS), and the Brief Symptom Inventory (BSI). Participants were divided into three groups based on reported average pain levels over the last week as Mild (0-3), Moderate (4-6), and Severe (7-10) with 53, 39, and 41 in each group respectively. The Mild group scored within normal limits on all measures compared to the Moderate and Severe groups which combined, reported more sleep disturbance (MOS-S summary scale 9: mean ⫽ 30.7 vs 22.0; p⬍.01), greater global distress (BSI General Severity Index: mean⫽ 60.9 vs 55.3; p⬍.01), and lower satisfaction with life (SWLS: mean ⫽ 19.6 vs 23.3; p⬍.01). While means for measures of anxiety and depression (HADS) were within normal limits for all groups, a significantly greater percentage of the moderate/severe pain group scored above the normative cutoff score for both anxiety and depression compared to the mild pain group. Moderate and severe pain groups generally did not differ from each other across most measures. Results suggest that if clinicians can reduce average neuropathic pain to mild levels in this group, this pain type is manageable in terms of its impact on quality of life.
H. Logan, M. Graham, J. Shuster, D. Theriaque, H. Richards, W. Reeves; University of Florida, Gainesville, FL The purpose of this investigation was to compare daily lupus-related symptoms with markers of daily stress, disease severity, and coping among 42 patients (M age⫽40) who maintained daily diaries for 28 days followed by weekly diaries for 4 weeks. Patients were recruited at the time of their initial visit at UFL lupus clinic. Patients were contacted by telephone weekly to verify that symptoms, stress, and coping were being recorded in the diaries and to report the number and expected severity of hassles for the upcoming week. Fifteen Blacks and 27 nonBlacks completed relevant data. Results showed a significant correlation between baseline disease severity (SLEDAI) and average of the daily symptoms of chest and muscle pain (r⫽.34 p⬍.05; r⫽⫽.34 p⬍.05) and joint swelling (r⫽.36 p⬍.05); facial rash (r⫽.31 p⬍.05). The baseline disease severity was significantly correlated with the average of how stressful subjects assessed tomorrow to be (r⫽.31 p⬍.05). There was a significant positive correlation between baseline plasma levels of double stranded DNA(higher levels associated with greater disease severity) and average daily religious coping r⫽.31 p⬍.05. For those patients whose disease became less severe across the 2 month study period, reliance on religious coping was greatest (r⫽.31 p⬍.05). There were no significant differences between Blacks and non-Blacks on baseline disease severity or average daily symptoms (p⬎.2) Analysis of coping by race showed that non-Blacks had higher average daily religious coping scores than did Blacks (F1,35⫽5.03 p⬍.05). The average of the expected severity of the weekly hassles was significantly greater among Black patients than among non-Blacks (F1,35⫽5.78 p⬍.05). We conclude that more severe disease and stress are associated with daily painful symptoms and there are ethnoracial differences in expected severity of hassles and religious coping but not in disease severity.
C06 - Low Back Pain (668) Impact of low back pain on health-related quality of life before and after treatment with an analgesic medication D. Hewitt, J. Schein, M. Kosinski, W. Olson, N. Rosenthal; Ortho-McNeil Pharmaceutical, Inc., Raritan, NJ This post hoc analysis of two multicenter, randomized, double-blind, placebo-controlled trials assessed the burden of chronic low back pain (LBP) on health-related quality of life (HRQoL) before and after treatment with an analgesic. The pooled sample included 660 patients with chronic (⬎3 months), moderate-to-severe LBP (Pain Visual Analogue [PVA] scale score 40-100). Patients in both trials received an oral analgesic or placebo for 13 weeks. Baseline scores on the Short Form 36 Health Survey (SF-36) for trial participants were compared with: (1) U.S. normative scores for the general population; and (2) disease-specific benchmarks from the Medical Outcomes Study (MOS). Overall, patients with chronic LBP had significantly lower mean SF-36 scores than the U.S. norm for all scales (MANOVA F⫽289.2, p⬍0.001), including scores ⬎1.5 standard deviations (SD) lower than the U.S. norm for most physical health scales. Patients with moderate-to-severe LBP in the clinical trials had greater HRQoL burden on most SF-36 scales compared with diseasespecific benchmarks from patients in the MOS who had LBP (any severity), hypertension, congestive heart failure, type 2 diabetes, recent myocardial infarction, or depression. The burden of LBP was greater among trial patients who experienced more severe pain. SF-36 bodily pain scores were ⬎2 SD lower than U.S. norms among patients with PVA scale scores between 80-100 mm; and they were ⬎1 SD lower among those with PVA scale scores between 40-80 mm. Physical health domains had better discriminant validity than mental health domains. Statistically significant HRQoL benefits emerged in physical health domains when pain improved by 21-30 points on the PVA scale and clear improvement in all aspects of HRQoL occurred when pain improved by at least 31 points on the PVA scale. This analysis confirms the tremendous burden of chronic LBP on HRQoL and demonstrates that pain relief may reduce this major HRQoL burden.