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(836)
S60
D20 - Spinal Analgesia (836) Pancreatic cancer survivorship: Intrathecal drug delivery system for pain management
Abstracts (838) Application of a topical medication containing highdose capsaicin (0.25%) in a lidocaine-containing vehicle for treatment of painful diabetic neuropathy and postherpetic neuralgia
L Stearns, W Poling, J Kiser, J Nasternak, E Berryman; Valley Cancer Pain Treatment Center, Phoenix, AZ Pancreatic adenocarcinoma is predominantly unresectable at diagnosis and is most frequently a fatal disease. Nationally the average survivorship is 10 months. Among pancreatic cancer patients, pain is associated with decreased survival rates. Quality of life and survivorship are the principal outcome measures for patients suffering from unresectable pancreatic cancer. Successful pain management may be a significant predictor of prolonged survivorship among pancreatic cancer patients. No study has demonstrated an impact on survivorship secondary to the treatment of pancreatic cancer pain and the use of the Intrathecal Drug Delivery System (IDDS). A retrospective chart review was conducted to identify all pancreatic cancer patients treated with IDDS at a cancer pain treatment center between January 2002 and June 2005. Forty three patients had known dates of diagnosis and known dates of death. The Arizona Department of Health Services (AZDHS) Cancer Registry provided similar information for pancreatic cancer patients residing in Maricopa County for that time period. 713 Maricopa county residents had known dates of diagnosis and known dates of death. Among the Maricopa County pancreatic cancer patients, the mean survivorship was 5 months. Among the VCPTC pancreatic cancer patients who did not receive the IDDS for pain, 10 (23.3%), the mean survivorship was 10.8 months. Among the VCPTC pancreatic cancer patients receiving the implantable IDDS for pain management, 33 (76.7%), the mean survivorship was 14.2 months. Mean survivorship among the VCPTC pancreatic cancer patients receiving the implantable IDDS for pain management is nearly 3 times greater than the general survivorship of pancreatic cancer patients in Maricopa County. Among the VCPTC patients the mean survivorship is nearly 50% greater for patients receiving the implantable IDDS for pain management versus those patients that did not. The implantable IDDS for pain management among pancreatic cancer patients may be a significant predictor of increased survivorship.
J Bernstein, S Phillips; Winston Laboratories, Inc., Vernon Hills, IL A cream containing high-dose capsaicin (0.25%) with lidocaine to reduce local burning/stinging sensations recently became available for relief of painful diabetic neuropathy (PDN) and postherpetic neuralgia (PHN). Current treatments of choice for these conditions, tricyclic antidepressants and antiepileptic drugs, often provide incomplete relief and may have significant side effects. A 6 week open-label trial was conducted in 355 patients (66% female; 34% male; mean age 59 years) with PDN (31%), PHN (7%) or other pain syndromes (61%). 77% of these patients experienced pain for ⬎1 year, with 91% experiencing the pain half or more of the time each day. 83% had used one or more medications, most commonly gabapentin and narcotics, and most continued them throughout the study. After 2weeks of treatment with study medication, patients reported decreased pain severity of 26%, from 7.57 to 5.60 (0-10), with 50% of subjects responding within 1 week. Pain-induced interference with work, decreased from 84% to 70% and paininduced interference with social activities decreased from 78% to 60%. 51% of patients had a Global Assessment of Improvement ⬎5 (0-10). After 6weeks of treatment, pain severity decreased 34%, from 7.55 to 5.00 and pain-induced interference with work decreased to 67%. 58% of patients had a Global Assessment of Improvement ⬎5. While 88% of patients experienced transient burning sensations at application sites, 52% of patients indicated these sensations decreased within 5 days. Patients were more satisfied with the study medication than with their prior medication, 6.22 vs. 4.84 (0-10). Only 14% of the patients indicated that they would not continue the medication after the study. The results demonstrate that high-dose capsaicin in a lidocaine-containing vehicle is a safe and effective treatment for PDN and PHN, providing significant pain relief, while avoiding drug interactions or systemic adverse events that may accompany the use of oral medications.
D22 - Topical Analgesics
D30 - Other
(837) Comparison of the efficacy and safety of lidocaine patch 5% versus celecoxib in musculoskeletal conditions: An analysis of a pooled elderly subset
(839) Effect of amitriptyline and gabapentin on chronic central neuropathic pain in persons with spinal cord injury
A Gammaitoni, N Oleka, E Gould; Endo Pharmaceuticals, Chadds Ford, PA Uncertainty regarding the long-term use of COX-2 selective inhibitors in treating musculoskeletal pain conditions, particularly for elderly patients, has prompted many physicians and patients to seek alternative therapies that are as effective, but safer than the drugs currently being prescribed for these conditions. The purpose of this analysis was to assess the efficacy and safety of the lidocaine patch 5% compared to celecoxib 200 mg/d when treating elderly patients (ⱖ 65 years of age) with moderate-to-severe osteoarthritis (OA) of the knee or chronic axial low back pain (LBP) with and without radiation. Elderly patients from two multicenter open-label parallel-group studies (OA: 38 of 119 total and LBP: 16 of 79 total) were identified. Patients were randomized to treatment with the lidocaine patch 5% (n⫽27) or celecoxib 200 mg/d (n⫽27) after a washout period (7—14 d). Early termination of both the 12-week studies occurred due to increasing safety concerns surrounding the COX-2 inhibitor class. Results from a 4-week analysis using an elderly subset of patients are presented. At Week 4, comparable improvements in the Brief Pain Inventory (BPI) average pain intensity score were observed following lidocaine patch 5% and celecoxib 200 mg/d treatments (–2.08 and –2.59, respectively; P⫽.5). Similar improvements were also seen in other BPI subscales, as well as other descriptive pain quality parameters. Only 2 patients in each group experienced treatment-related adverse events, which included application site rash (n⫽1, 3.7%), skin laceration (n⫽1, 3.7%), and irritability (n⫽1, 3.7%) with lidocaine patch 5%, and lower abdominal pain (n⫽1, 3.7%) and dyspnoea exertional (n⫽1, 3.7%) with celecoxib 200 mg/d. Lidocaine patch 5% may offer clinicians a safe, viable alternative treatment option for the management of musculoskeletal pain in elderly patients; further study is warranted. This study was funded by Endo Pharmaceuticals.
D Rintala, S Holmes, D Courtade, R Fiess, L Tastard, G Loubser; CVPH Medical Center, Plattsburgh, NY Chronic central neuropathic pain in individuals with spinal cord injury (SCI) is difficult to treat adequately. A randomized (order of medications), triple-cross-over, double-blind, controlled study was undertaken to evaluate the effectiveness of two medications—amitriptyline (maximum daily dose ⫽ 150 mg.) and gabapentin (3600 mg.)—that are commonly prescribed for central neuropathic pain in persons with SCI. The effectiveness of these drugs was compared to that of an active control medication— diphenhydramine (75 mg.), which was selected as the control because it has some side-effects that are similar to those of the other two medications such as drowsiness and dry mouth, thus helping to maintain the double-blind design. Thirty-eight individuals with SCI and central neuropathic pain were enrolled; 22 completed all three arms of the study. The hypothesis was that both amitriptyline and gabapentin would result in significantly lower pain intensity compared with diphenhydramine at the end of week 8 on each medication. However, in Bonferroni-adjusted paired t-tests following a significant repeated measures analysis of variance (F ⫽ 4.02, p ⫽ .034), pain intensity was significantly lower when on amitriptyline (mean of 3.46 on a 0 – 10 scale) than when on either gabapentin (4.85, t ⫽ 2.3, p ⫽ .030) or diphenhydramine (5.11, t ⫽ 2.8, p ⫽ .012). Gabapentin and diphenhydramine were not significantly different from each other (t ⫽ 0.48, p ⫽ .639). However, some persons had greater reductions in pain while on gabapentin. Pain intensity at week 8 did not vary by the order in which any of the three medications were received. Amount of oxycodone used for breakthrough pain did not differ by medication. Amitriptyline was associated with more side-effects, however the dropout rate was slightly lower when taking amitriptyline, perhaps indicating that benefits outweighed side-effects. The most frequent side-effects were dry mouth, drowsiness, and fatigue.
D20 - Spinal Analgesia (836) Pancreatic cancer survivorship: Intrathecal drug delivery system for pain management
Abstracts (838) Application of a topical medication containing highdose capsaicin (0.25%) in a lidocaine-containing vehicle for treatment of painful diabetic neuropathy and postherpetic neuralgia
L Stearns, W Poling, J Kiser, J Nasternak, E Berryman; Valley Cancer Pain Treatment Center, Phoenix, AZ Pancreatic adenocarcinoma is predominantly unresectable at diagnosis and is most frequently a fatal disease. Nationally the average survivorship is 10 months. Among pancreatic cancer patients, pain is associated with decreased survival rates. Quality of life and survivorship are the principal outcome measures for patients suffering from unresectable pancreatic cancer. Successful pain management may be a significant predictor of prolonged survivorship among pancreatic cancer patients. No study has demonstrated an impact on survivorship secondary to the treatment of pancreatic cancer pain and the use of the Intrathecal Drug Delivery System (IDDS). A retrospective chart review was conducted to identify all pancreatic cancer patients treated with IDDS at a cancer pain treatment center between January 2002 and June 2005. Forty three patients had known dates of diagnosis and known dates of death. The Arizona Department of Health Services (AZDHS) Cancer Registry provided similar information for pancreatic cancer patients residing in Maricopa County for that time period. 713 Maricopa county residents had known dates of diagnosis and known dates of death. Among the Maricopa County pancreatic cancer patients, the mean survivorship was 5 months. Among the VCPTC pancreatic cancer patients who did not receive the IDDS for pain, 10 (23.3%), the mean survivorship was 10.8 months. Among the VCPTC pancreatic cancer patients receiving the implantable IDDS for pain management, 33 (76.7%), the mean survivorship was 14.2 months. Mean survivorship among the VCPTC pancreatic cancer patients receiving the implantable IDDS for pain management is nearly 3 times greater than the general survivorship of pancreatic cancer patients in Maricopa County. Among the VCPTC patients the mean survivorship is nearly 50% greater for patients receiving the implantable IDDS for pain management versus those patients that did not. The implantable IDDS for pain management among pancreatic cancer patients may be a significant predictor of increased survivorship.
J Bernstein, S Phillips; Winston Laboratories, Inc., Vernon Hills, IL A cream containing high-dose capsaicin (0.25%) with lidocaine to reduce local burning/stinging sensations recently became available for relief of painful diabetic neuropathy (PDN) and postherpetic neuralgia (PHN). Current treatments of choice for these conditions, tricyclic antidepressants and antiepileptic drugs, often provide incomplete relief and may have significant side effects. A 6 week open-label trial was conducted in 355 patients (66% female; 34% male; mean age 59 years) with PDN (31%), PHN (7%) or other pain syndromes (61%). 77% of these patients experienced pain for ⬎1 year, with 91% experiencing the pain half or more of the time each day. 83% had used one or more medications, most commonly gabapentin and narcotics, and most continued them throughout the study. After 2weeks of treatment with study medication, patients reported decreased pain severity of 26%, from 7.57 to 5.60 (0-10), with 50% of subjects responding within 1 week. Pain-induced interference with work, decreased from 84% to 70% and paininduced interference with social activities decreased from 78% to 60%. 51% of patients had a Global Assessment of Improvement ⬎5 (0-10). After 6weeks of treatment, pain severity decreased 34%, from 7.55 to 5.00 and pain-induced interference with work decreased to 67%. 58% of patients had a Global Assessment of Improvement ⬎5. While 88% of patients experienced transient burning sensations at application sites, 52% of patients indicated these sensations decreased within 5 days. Patients were more satisfied with the study medication than with their prior medication, 6.22 vs. 4.84 (0-10). Only 14% of the patients indicated that they would not continue the medication after the study. The results demonstrate that high-dose capsaicin in a lidocaine-containing vehicle is a safe and effective treatment for PDN and PHN, providing significant pain relief, while avoiding drug interactions or systemic adverse events that may accompany the use of oral medications.
D22 - Topical Analgesics
D30 - Other
(837) Comparison of the efficacy and safety of lidocaine patch 5% versus celecoxib in musculoskeletal conditions: An analysis of a pooled elderly subset
(839) Effect of amitriptyline and gabapentin on chronic central neuropathic pain in persons with spinal cord injury
A Gammaitoni, N Oleka, E Gould; Endo Pharmaceuticals, Chadds Ford, PA Uncertainty regarding the long-term use of COX-2 selective inhibitors in treating musculoskeletal pain conditions, particularly for elderly patients, has prompted many physicians and patients to seek alternative therapies that are as effective, but safer than the drugs currently being prescribed for these conditions. The purpose of this analysis was to assess the efficacy and safety of the lidocaine patch 5% compared to celecoxib 200 mg/d when treating elderly patients (ⱖ 65 years of age) with moderate-to-severe osteoarthritis (OA) of the knee or chronic axial low back pain (LBP) with and without radiation. Elderly patients from two multicenter open-label parallel-group studies (OA: 38 of 119 total and LBP: 16 of 79 total) were identified. Patients were randomized to treatment with the lidocaine patch 5% (n⫽27) or celecoxib 200 mg/d (n⫽27) after a washout period (7—14 d). Early termination of both the 12-week studies occurred due to increasing safety concerns surrounding the COX-2 inhibitor class. Results from a 4-week analysis using an elderly subset of patients are presented. At Week 4, comparable improvements in the Brief Pain Inventory (BPI) average pain intensity score were observed following lidocaine patch 5% and celecoxib 200 mg/d treatments (–2.08 and –2.59, respectively; P⫽.5). Similar improvements were also seen in other BPI subscales, as well as other descriptive pain quality parameters. Only 2 patients in each group experienced treatment-related adverse events, which included application site rash (n⫽1, 3.7%), skin laceration (n⫽1, 3.7%), and irritability (n⫽1, 3.7%) with lidocaine patch 5%, and lower abdominal pain (n⫽1, 3.7%) and dyspnoea exertional (n⫽1, 3.7%) with celecoxib 200 mg/d. Lidocaine patch 5% may offer clinicians a safe, viable alternative treatment option for the management of musculoskeletal pain in elderly patients; further study is warranted. This study was funded by Endo Pharmaceuticals.
D Rintala, S Holmes, D Courtade, R Fiess, L Tastard, G Loubser; CVPH Medical Center, Plattsburgh, NY Chronic central neuropathic pain in individuals with spinal cord injury (SCI) is difficult to treat adequately. A randomized (order of medications), triple-cross-over, double-blind, controlled study was undertaken to evaluate the effectiveness of two medications—amitriptyline (maximum daily dose ⫽ 150 mg.) and gabapentin (3600 mg.)—that are commonly prescribed for central neuropathic pain in persons with SCI. The effectiveness of these drugs was compared to that of an active control medication— diphenhydramine (75 mg.), which was selected as the control because it has some side-effects that are similar to those of the other two medications such as drowsiness and dry mouth, thus helping to maintain the double-blind design. Thirty-eight individuals with SCI and central neuropathic pain were enrolled; 22 completed all three arms of the study. The hypothesis was that both amitriptyline and gabapentin would result in significantly lower pain intensity compared with diphenhydramine at the end of week 8 on each medication. However, in Bonferroni-adjusted paired t-tests following a significant repeated measures analysis of variance (F ⫽ 4.02, p ⫽ .034), pain intensity was significantly lower when on amitriptyline (mean of 3.46 on a 0 – 10 scale) than when on either gabapentin (4.85, t ⫽ 2.3, p ⫽ .030) or diphenhydramine (5.11, t ⫽ 2.8, p ⫽ .012). Gabapentin and diphenhydramine were not significantly different from each other (t ⫽ 0.48, p ⫽ .639). However, some persons had greater reductions in pain while on gabapentin. Pain intensity at week 8 did not vary by the order in which any of the three medications were received. Amount of oxycodone used for breakthrough pain did not differ by medication. Amitriptyline was associated with more side-effects, however the dropout rate was slightly lower when taking amitriptyline, perhaps indicating that benefits outweighed side-effects. The most frequent side-effects were dry mouth, drowsiness, and fatigue.