LONG-TERM SAFETY AND EFFICACY OF REPEATED APPLICATIONS OF CAPSAICIN 8% PATCH (QUTENZATM) IN PAINFUL DIABETIC PERIPHERAL NEUROPATHY: PACE STUDY
AACE ePoster Library. Vinik A. 05/13/15; 97789; 235
Aaron Vinik
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LONG-TERM SAFETY AND EFFICACY OF REPEATED APPLICATIONS OF CAPSAICIN 8% PATCH (QUTENZATM) IN PAINFUL DIABETIC PERIPHERAL NEUROPATHY: PACE STUDY
Aaron I Vinik1, Serge Perrot2, Etta J Vinik1, Ladislav Pazdera3, Hélène Jacobs4, Malcolm Stoker4, Stephen Long4, Robert Snijder4, Marjolijne van der Stoep4, Enrique Ortega5, Nathaniel Katz6
1. Eastern Virginia Medical School, The Strelitz Diabetes Center, 855 W Brambleton Avenue, Room 2018, Norfolk, VA 23510, USA
2. Hôpital Hôtel Dieu, Paris Descartes University, Paris, France
3. Bohumila Hrabala 1589, 516 01 Rychnov nad Kneznou, Czech Republic
4. Astellas Pharma Global Development, Sylviusweg 62, PO Box 344, 2300 AH Leiden, The Netherlands
5. Hospital Rio Hortega, C/ Dulzaina nº 2, 47012 Valladolid, Spain
6. Analgesic Solutions, Natick, MA, USA; Tufts University School of Medicine, Boston, MA, USA
Objective
PACE assessed the safety and efficacy of repeated capsaicin 8% patch applications plus standard of care (SOC) versus SOC alone over 52 weeks in painful diabetic peripheral neuropathy (PDPN). The Norfolk QOL-DN scale was utilised to assess any adverse functional consequences of repeat capsaicin 8% patch applications reflected in reduced quality of life and sensory testing, including the Utah Early Neuropathy Scale (UENS), was performed to identify changes in sensory function or symptoms of early neuropathy that may be associated with such treatment.
Methods
This open-label, 52-week study randomised patients with painful, distal, symmetrical, sensorimotor polyneuropathy due to diabetes, glycosylated haemoglobin ≤9%, and numeric pain rating scale ≥4, to capsaicin 8% patch 30 min plus SOC, capsaicin 60 min plus SOC or SOC alone. Patients received up to seven applications. The primary endpoint was change from baseline to end of study (EoS) in Norfolk QOL DN total score. Secondary endpoints were UENS score, sensory perception testing, Brief Pain Inventory-Diabetic Neuropathy (BPI-DN) 24 hr average pain, ≥30% reduction in BPI-DN average pain, BPI-DN pain severity and interference indices.
Results
In total, 468 patients with mean pain 5.6 and mean Norfolk QOL-DN score 41.4 were randomised to capsaicin patch 30 min plus SOC (n=156), capsaicin 60 min plus SOC (n=157) or SOC alone (n=155).
Safety
A greater improvement from baseline to EoS in mean Norfolk QOL DN score was observed with capsaicin patch 30 min versus SOC (mean difference -20.9 [90% CI -31.7, -10.1]) and capsaicin 60 min versus SOC (-26.1 [-36.8, -15.4]). Subscale scores for symptoms, physical functioning/large fibre, small fibre, autonomic and activities of daily living improved with capsaicin over SOC. Mean (SD) changes in UENS total score from baseline to EoS also showed improvement in all arms and were -2.1 (5.03), -3.0 (5.05), -1.2 (4.22) in capsaicin 30 min, capsaicin 60 min and SOC arms, respectively.
Efficacy
The 30% responder rate for BPI-DN average pain was 67.3% for capsaicin 30 min, 67.5% for capsaicin 60 min and 40.6% for SOC alone arms. Furthermore, improved BPI-DN pain severity and interference indices were observed with capsaicin versus SOC by EoS.
Discussion
Repeated application of the capsaicin 8% patch over 52 weeks was well tolerated with no loss of sensation, no functional deterioration in quality of life and improved pain relief versus SOC in PDPN.
Conclusion
PACE showed that long-term treatment with the capsaicin 8% patch in PDPN relieved pain without any substantial safety issues.
Abstract category: Diabetes mellitus/prediabetes
Body text size: 2601 characters with spaces [2700 maximum]
Relevant financial disclosures
Aaron Vinik: Received research funding from Astellas Pharma, Pfizer and Daiichi Sankyo; Astellas Pharma has licensed the Norfolk QOL-DN from Eastern Virginia Medical School; Aaron Vinik has received royalties from the licensing
Etta Vinik: Astellas Pharma has licensed the Norfolk QOL-DN from Eastern Virginia Medical School; Etta Vinik has received royalties from the licensing
Nathaniel Katz: None
Serge Perrot: None
Enrique Ortega: None
Ladislav Pazdera: None
Helene Jacobs: employee of Astellas Pharma Global Development
Malcolm Stoker: employee of Astellas Pharma Global Development
Robert Snijder: employee of Astellas Pharma Global Development
Marjolijne van der Stoep: employee of Astellas Pharma Global Development
Stephen Long: employee of Astellas Pharma Global Development at time of study
Aaron I Vinik1, Serge Perrot2, Etta J Vinik1, Ladislav Pazdera3, Hélène Jacobs4, Malcolm Stoker4, Stephen Long4, Robert Snijder4, Marjolijne van der Stoep4, Enrique Ortega5, Nathaniel Katz6
1. Eastern Virginia Medical School, The Strelitz Diabetes Center, 855 W Brambleton Avenue, Room 2018, Norfolk, VA 23510, USA
2. Hôpital Hôtel Dieu, Paris Descartes University, Paris, France
3. Bohumila Hrabala 1589, 516 01 Rychnov nad Kneznou, Czech Republic
4. Astellas Pharma Global Development, Sylviusweg 62, PO Box 344, 2300 AH Leiden, The Netherlands
5. Hospital Rio Hortega, C/ Dulzaina nº 2, 47012 Valladolid, Spain
6. Analgesic Solutions, Natick, MA, USA; Tufts University School of Medicine, Boston, MA, USA
Objective
PACE assessed the safety and efficacy of repeated capsaicin 8% patch applications plus standard of care (SOC) versus SOC alone over 52 weeks in painful diabetic peripheral neuropathy (PDPN). The Norfolk QOL-DN scale was utilised to assess any adverse functional consequences of repeat capsaicin 8% patch applications reflected in reduced quality of life and sensory testing, including the Utah Early Neuropathy Scale (UENS), was performed to identify changes in sensory function or symptoms of early neuropathy that may be associated with such treatment.
Methods
This open-label, 52-week study randomised patients with painful, distal, symmetrical, sensorimotor polyneuropathy due to diabetes, glycosylated haemoglobin ≤9%, and numeric pain rating scale ≥4, to capsaicin 8% patch 30 min plus SOC, capsaicin 60 min plus SOC or SOC alone. Patients received up to seven applications. The primary endpoint was change from baseline to end of study (EoS) in Norfolk QOL DN total score. Secondary endpoints were UENS score, sensory perception testing, Brief Pain Inventory-Diabetic Neuropathy (BPI-DN) 24 hr average pain, ≥30% reduction in BPI-DN average pain, BPI-DN pain severity and interference indices.
Results
In total, 468 patients with mean pain 5.6 and mean Norfolk QOL-DN score 41.4 were randomised to capsaicin patch 30 min plus SOC (n=156), capsaicin 60 min plus SOC (n=157) or SOC alone (n=155).
Safety
A greater improvement from baseline to EoS in mean Norfolk QOL DN score was observed with capsaicin patch 30 min versus SOC (mean difference -20.9 [90% CI -31.7, -10.1]) and capsaicin 60 min versus SOC (-26.1 [-36.8, -15.4]). Subscale scores for symptoms, physical functioning/large fibre, small fibre, autonomic and activities of daily living improved with capsaicin over SOC. Mean (SD) changes in UENS total score from baseline to EoS also showed improvement in all arms and were -2.1 (5.03), -3.0 (5.05), -1.2 (4.22) in capsaicin 30 min, capsaicin 60 min and SOC arms, respectively.
Efficacy
The 30% responder rate for BPI-DN average pain was 67.3% for capsaicin 30 min, 67.5% for capsaicin 60 min and 40.6% for SOC alone arms. Furthermore, improved BPI-DN pain severity and interference indices were observed with capsaicin versus SOC by EoS.
Discussion
Repeated application of the capsaicin 8% patch over 52 weeks was well tolerated with no loss of sensation, no functional deterioration in quality of life and improved pain relief versus SOC in PDPN.
Conclusion
PACE showed that long-term treatment with the capsaicin 8% patch in PDPN relieved pain without any substantial safety issues.
Abstract category: Diabetes mellitus/prediabetes
Body text size: 2601 characters with spaces [2700 maximum]
Relevant financial disclosures
Aaron Vinik: Received research funding from Astellas Pharma, Pfizer and Daiichi Sankyo; Astellas Pharma has licensed the Norfolk QOL-DN from Eastern Virginia Medical School; Aaron Vinik has received royalties from the licensing
Etta Vinik: Astellas Pharma has licensed the Norfolk QOL-DN from Eastern Virginia Medical School; Etta Vinik has received royalties from the licensing
Nathaniel Katz: None
Serge Perrot: None
Enrique Ortega: None
Ladislav Pazdera: None
Helene Jacobs: employee of Astellas Pharma Global Development
Malcolm Stoker: employee of Astellas Pharma Global Development
Robert Snijder: employee of Astellas Pharma Global Development
Marjolijne van der Stoep: employee of Astellas Pharma Global Development
Stephen Long: employee of Astellas Pharma Global Development at time of study
LONG-TERM SAFETY AND EFFICACY OF REPEATED APPLICATIONS OF CAPSAICIN 8% PATCH (QUTENZATM) IN PAINFUL DIABETIC PERIPHERAL NEUROPATHY: PACE STUDY
Aaron I Vinik1, Serge Perrot2, Etta J Vinik1, Ladislav Pazdera3, Hélène Jacobs4, Malcolm Stoker4, Stephen Long4, Robert Snijder4, Marjolijne van der Stoep4, Enrique Ortega5, Nathaniel Katz6
1. Eastern Virginia Medical School, The Strelitz Diabetes Center, 855 W Brambleton Avenue, Room 2018, Norfolk, VA 23510, USA
2. Hôpital Hôtel Dieu, Paris Descartes University, Paris, France
3. Bohumila Hrabala 1589, 516 01 Rychnov nad Kneznou, Czech Republic
4. Astellas Pharma Global Development, Sylviusweg 62, PO Box 344, 2300 AH Leiden, The Netherlands
5. Hospital Rio Hortega, C/ Dulzaina nº 2, 47012 Valladolid, Spain
6. Analgesic Solutions, Natick, MA, USA; Tufts University School of Medicine, Boston, MA, USA
Objective
PACE assessed the safety and efficacy of repeated capsaicin 8% patch applications plus standard of care (SOC) versus SOC alone over 52 weeks in painful diabetic peripheral neuropathy (PDPN). The Norfolk QOL-DN scale was utilised to assess any adverse functional consequences of repeat capsaicin 8% patch applications reflected in reduced quality of life and sensory testing, including the Utah Early Neuropathy Scale (UENS), was performed to identify changes in sensory function or symptoms of early neuropathy that may be associated with such treatment.
Methods
This open-label, 52-week study randomised patients with painful, distal, symmetrical, sensorimotor polyneuropathy due to diabetes, glycosylated haemoglobin ≤9%, and numeric pain rating scale ≥4, to capsaicin 8% patch 30 min plus SOC, capsaicin 60 min plus SOC or SOC alone. Patients received up to seven applications. The primary endpoint was change from baseline to end of study (EoS) in Norfolk QOL DN total score. Secondary endpoints were UENS score, sensory perception testing, Brief Pain Inventory-Diabetic Neuropathy (BPI-DN) 24 hr average pain, ≥30% reduction in BPI-DN average pain, BPI-DN pain severity and interference indices.
Results
In total, 468 patients with mean pain 5.6 and mean Norfolk QOL-DN score 41.4 were randomised to capsaicin patch 30 min plus SOC (n=156), capsaicin 60 min plus SOC (n=157) or SOC alone (n=155).
Safety
A greater improvement from baseline to EoS in mean Norfolk QOL DN score was observed with capsaicin patch 30 min versus SOC (mean difference -20.9 [90% CI -31.7, -10.1]) and capsaicin 60 min versus SOC (-26.1 [-36.8, -15.4]). Subscale scores for symptoms, physical functioning/large fibre, small fibre, autonomic and activities of daily living improved with capsaicin over SOC. Mean (SD) changes in UENS total score from baseline to EoS also showed improvement in all arms and were -2.1 (5.03), -3.0 (5.05), -1.2 (4.22) in capsaicin 30 min, capsaicin 60 min and SOC arms, respectively.
Efficacy
The 30% responder rate for BPI-DN average pain was 67.3% for capsaicin 30 min, 67.5% for capsaicin 60 min and 40.6% for SOC alone arms. Furthermore, improved BPI-DN pain severity and interference indices were observed with capsaicin versus SOC by EoS.
Discussion
Repeated application of the capsaicin 8% patch over 52 weeks was well tolerated with no loss of sensation, no functional deterioration in quality of life and improved pain relief versus SOC in PDPN.
Conclusion
PACE showed that long-term treatment with the capsaicin 8% patch in PDPN relieved pain without any substantial safety issues.
Abstract category: Diabetes mellitus/prediabetes
Body text size: 2601 characters with spaces [2700 maximum]
Relevant financial disclosures
Aaron Vinik: Received research funding from Astellas Pharma, Pfizer and Daiichi Sankyo; Astellas Pharma has licensed the Norfolk QOL-DN from Eastern Virginia Medical School; Aaron Vinik has received royalties from the licensing
Etta Vinik: Astellas Pharma has licensed the Norfolk QOL-DN from Eastern Virginia Medical School; Etta Vinik has received royalties from the licensing
Nathaniel Katz: None
Serge Perrot: None
Enrique Ortega: None
Ladislav Pazdera: None
Helene Jacobs: employee of Astellas Pharma Global Development
Malcolm Stoker: employee of Astellas Pharma Global Development
Robert Snijder: employee of Astellas Pharma Global Development
Marjolijne van der Stoep: employee of Astellas Pharma Global Development
Stephen Long: employee of Astellas Pharma Global Development at time of study
Aaron I Vinik1, Serge Perrot2, Etta J Vinik1, Ladislav Pazdera3, Hélène Jacobs4, Malcolm Stoker4, Stephen Long4, Robert Snijder4, Marjolijne van der Stoep4, Enrique Ortega5, Nathaniel Katz6
1. Eastern Virginia Medical School, The Strelitz Diabetes Center, 855 W Brambleton Avenue, Room 2018, Norfolk, VA 23510, USA
2. Hôpital Hôtel Dieu, Paris Descartes University, Paris, France
3. Bohumila Hrabala 1589, 516 01 Rychnov nad Kneznou, Czech Republic
4. Astellas Pharma Global Development, Sylviusweg 62, PO Box 344, 2300 AH Leiden, The Netherlands
5. Hospital Rio Hortega, C/ Dulzaina nº 2, 47012 Valladolid, Spain
6. Analgesic Solutions, Natick, MA, USA; Tufts University School of Medicine, Boston, MA, USA
Objective
PACE assessed the safety and efficacy of repeated capsaicin 8% patch applications plus standard of care (SOC) versus SOC alone over 52 weeks in painful diabetic peripheral neuropathy (PDPN). The Norfolk QOL-DN scale was utilised to assess any adverse functional consequences of repeat capsaicin 8% patch applications reflected in reduced quality of life and sensory testing, including the Utah Early Neuropathy Scale (UENS), was performed to identify changes in sensory function or symptoms of early neuropathy that may be associated with such treatment.
Methods
This open-label, 52-week study randomised patients with painful, distal, symmetrical, sensorimotor polyneuropathy due to diabetes, glycosylated haemoglobin ≤9%, and numeric pain rating scale ≥4, to capsaicin 8% patch 30 min plus SOC, capsaicin 60 min plus SOC or SOC alone. Patients received up to seven applications. The primary endpoint was change from baseline to end of study (EoS) in Norfolk QOL DN total score. Secondary endpoints were UENS score, sensory perception testing, Brief Pain Inventory-Diabetic Neuropathy (BPI-DN) 24 hr average pain, ≥30% reduction in BPI-DN average pain, BPI-DN pain severity and interference indices.
Results
In total, 468 patients with mean pain 5.6 and mean Norfolk QOL-DN score 41.4 were randomised to capsaicin patch 30 min plus SOC (n=156), capsaicin 60 min plus SOC (n=157) or SOC alone (n=155).
Safety
A greater improvement from baseline to EoS in mean Norfolk QOL DN score was observed with capsaicin patch 30 min versus SOC (mean difference -20.9 [90% CI -31.7, -10.1]) and capsaicin 60 min versus SOC (-26.1 [-36.8, -15.4]). Subscale scores for symptoms, physical functioning/large fibre, small fibre, autonomic and activities of daily living improved with capsaicin over SOC. Mean (SD) changes in UENS total score from baseline to EoS also showed improvement in all arms and were -2.1 (5.03), -3.0 (5.05), -1.2 (4.22) in capsaicin 30 min, capsaicin 60 min and SOC arms, respectively.
Efficacy
The 30% responder rate for BPI-DN average pain was 67.3% for capsaicin 30 min, 67.5% for capsaicin 60 min and 40.6% for SOC alone arms. Furthermore, improved BPI-DN pain severity and interference indices were observed with capsaicin versus SOC by EoS.
Discussion
Repeated application of the capsaicin 8% patch over 52 weeks was well tolerated with no loss of sensation, no functional deterioration in quality of life and improved pain relief versus SOC in PDPN.
Conclusion
PACE showed that long-term treatment with the capsaicin 8% patch in PDPN relieved pain without any substantial safety issues.
Abstract category: Diabetes mellitus/prediabetes
Body text size: 2601 characters with spaces [2700 maximum]
Relevant financial disclosures
Aaron Vinik: Received research funding from Astellas Pharma, Pfizer and Daiichi Sankyo; Astellas Pharma has licensed the Norfolk QOL-DN from Eastern Virginia Medical School; Aaron Vinik has received royalties from the licensing
Etta Vinik: Astellas Pharma has licensed the Norfolk QOL-DN from Eastern Virginia Medical School; Etta Vinik has received royalties from the licensing
Nathaniel Katz: None
Serge Perrot: None
Enrique Ortega: None
Ladislav Pazdera: None
Helene Jacobs: employee of Astellas Pharma Global Development
Malcolm Stoker: employee of Astellas Pharma Global Development
Robert Snijder: employee of Astellas Pharma Global Development
Marjolijne van der Stoep: employee of Astellas Pharma Global Development
Stephen Long: employee of Astellas Pharma Global Development at time of study
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