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資料３－６ コルヒチンの安全対策のための製造販売承認事項一部変更承認について［1.7MB］ (19 ページ)
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COLCHICINE FOR EARLY ACUTE GOUT FLARE
1067
of the data in the study and takes responsibility for the integrity of the
data and the accuracy of the data analysis.
Study conception and design. Terkeltaub, Furst, Bennett, Kook,
Crockett, Davis.
Acquisition of data. Kook, Davis.
Analysis and interpretation of data. Terkeltaub, Bennett, Kook,
Crockett, Davis.
14. Caraco Y, Putterman C, Rahamimov R, Ben-Chetrit E. Acute
colchicine intoxication—possible role of erythromycin administration. J Rheumatol 1992;19:494–6.
15. Cheng VC, Ho PL, Yuen KY. Two probable cases of serious drug
interaction between clarithromycin and colchicine. South Med J
2005;98:811–3.
16. Dogukan A, Oymak FS, Taskapan H, Guven M, Tokgoz B, Utas C.
Acute fatal colchicine intoxication in a patient on continuous
ambulatory peritoneal dialysis (CAPD): possible role of clarithromycin administration. Clin Nephrol 2001;55:181–2.
17. Hung IF, Wu AK, Cheng VC, Tang BS, To KW, Yeung CK, et al.
Fatal interaction between clarithromycin and colchicine in patients
with renal insufficiency: a retrospective study. Clin Infect Dis
2005;41:291–300.
18. Yussim A, Bar-Nathan N, Lustig S, Shaharabani E, Geier E,
Shmuely D, et al. Gastrointestinal, hepatorenal, and neuromuscular toxicity caused by cyclosporine-colchicine interaction in renal
transplantation. Transplant Proc 1994;26:2825–6.
19. Colcrys prescribing information. Philadelphia: URL Pharma;
2009. URL: http://www.accessdata.fda.gov/drugsatfda_docs/label/
2009/022351lbl.pdf.
20. Campbell WI, Patterson CC. Quantifying meaningful changes in
pain. Anaesthesia 1998;53:121–5.
21. Harden N, Cohen M. Unmet needs in the management of
neuropathic pain. J Pain Symptom Manage 2003;25 Suppl:S12–7.
22. Forouzanfar T, Weber WE, Kemler M, van Kleef M. What is a
meaningful pain reduction in patients with complex regional pain
syndrome type 1? Clin J Pain 2003;19:281–5.
23. Celebrex In Acute Gouty Arthritis Study (NCT00549549). URL:
http://clinicaltrials.gov/ct2/show/NCT00549549?term⫽NCT00549
549&rank⫽1.
24. Schumacher HR Jr, Boice JA, Daikh DI, Mukhopadhyay S,
Malmstrom K, Ng J, et al. Randomised double blind trial of
etoricoxib and indometacin in treatment of acute gouty arthritis.
BMJ 2002;324:1488–92.
25. Rubin BR, Burton R, Navarra S, Antigua J, Londono J, Pryhuber
KG, et al. Efficacy and safety profile of treatment with etoricoxib
120 mg once daily compared with indomethacin 50 mg three times
daily in acute gout: a randomized controlled trial. Arthritis Rheum
2004;50:598–606.
26. Janssens HJ, Janssen M, van de Lisdonk EH, van Riel PL, van
Weel C. Use of oral prednisolone or naproxen for the treatment of
gout arthritis: a double-blind, randomised equivalence trial. Lancet 2008;371:1854–60.
27. Becker MA, Schumacher HR Jr, Wortmann RL, MacDonald PA,
Eustace D, Palo WA, et al. Febuxostat compared with allopurinol
in patients with hyperuricemia and gout. N Engl J Med 2005;353:
2450–61.
28. Becker MA, Schumacher HR Jr, Wortmann RL, MacDonald PA,
Palo WA, Eustace D, et al. Febuxostat, a novel nonpurine selective
inhibitor of xanthine oxidase: a twenty-eight–day, multicenter,
phase II, randomized, double-blind, placebo-controlled, doseresponse clinical trial examining safety and efficacy in patients
with gout. Arthritis Rheum 2005;52:916–23.
ROLE OF THE STUDY SPONSOR
URL Pharma funded the study and choose United BioSource
Corporation to be the Contract Research Organization to run the
study. Dr. Davis is the Chief Medical Officer for URL Pharma and had
key roles in the study design, data collection, data analysis, and writing
of the manuscript. Prior to the start of the study, URL Pharma agreed
that the authors had full rights to submit the manuscript for publication, URL Pharma approval of the content of the submitted manuscript was not required, and publication of the manuscript was not
contingent upon the approval of URL Pharma. The authors had full
access to all data, and Dr. Terkeltaub made the final editorial
decisions.
REFERENCES
1. Ahern MJ, Reid C, Gordon TP, McCredie M, Brooks PM, Jones
M. Does colchicine work? The results of the first controlled study
in acute gout. Aust N Z J Med 1987;17:301–4.
2. Hellmann D. Medications. In: Imboden J, Hellmann D, Stone J,
editors. Current rheumatology and treatment. 2nd ed. New York:
McGraw-Hill; 2007. p. 545.
3. Schlesinger N, Schumacher R, Catton M, Maxwell L. Colchicine
for acute gout. Cochrane Database Syst Rev 2006;(4):CD006190.
4. Perez-Ruiz F, Mielgo FJ Gonzalez, Herrero Beites AM. Optimisation of the treatment of acute gout. BioDrugs 2000;13:415–23.
5. Terkeltaub RA. Clinical practice: gout. N Engl J Med 2003;349:
1647–55.
6. Emmerson BT. The management of gout. N Engl J Med 1996;334:
445–51.
7. Morris I, Varughese G, Mattingly P. Colchicine in acute gout.
BMJ 2003;327:1275–6.
8. Zhang W, Doherty M, Bardin T, Pascual E, Barskova V, Conaghan P, et al, EULAR Standing Committee For International
Clinical Studies Including Therapeutics. EULAR evidence based
recommendations for gout. Part II: Management. Report of a task
force of the EULAR Standing Committee for International Clinical Studies Including Therapeutics (ESCISIT). Ann Rheum Dis
2006;65:1312–24.
9. Wallace SL, Robinson H, Masi AT, Decker JL, McCarty DJ, Yu
TF. Preliminary criteria for the classification of the acute arthritis
of primary gout. Arthritis Rheum 1977;20:895–900.
10. IND (Investigational New Drug) safety reports. In: CFR – Code of
Federal Regulations Title 21, Section 312.32. Washington: US
Food & Drug Administration; 2009. URL: http://www.accessdata.
fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart⫽312&
showFR⫽1.
11. Terkeltaub RA. Colchicine update: 2008. Semin Arthritis Rheum
2009;38:411–9.
12. Rollot F, Pajot O, Chauvelot-Moachon L, Nazal EM, Kelaidi C,
Blanche P. Acute colchicine intoxication during clarithromycin
administration. Ann Pharmacother 2004;38:2074–7.
13. Terkeltaub R, Furst D, DiGiacinto J, Kook K, Davis M. The
Clinical Relevance of P-gp and CYP 3A4 on Colchicine Metabolism and Elimination: Dosing Recommendations for Macrolide
Antibiotics, Cyclosporine, Ketoconazole, Ritonavir and Diltiazem.
In: ACR/ARHP Annual Scientific Meeting, 2008. URL: http://
acr.confex,com/acr/2008/webprogram/Paper2463.html.
APPENDIX A: AGREE TRIAL CLINICAL
INVESTIGATORS
The clinical investigators in the AGREE trial are O. P.
Alvarado (Fort Worth, TX), K. Ayesu (Orange City, FL), H. S. Baraf
(Wheaton, MD), S. H. Barag (Rancho Cucamonga, CA), S. Bather
(Cedar Rapids, IA), C. A. Birbara (Worcester, MA), A. G. Captain
(Calhoun, GA), J. Christensen (Las Vegas, NV), C. F. Colopinto
(Voorhees, NJ), R. F. Cox (Irving, TX), A. Dahdul (Springfield, MA),
C. H. DeBusk (New Tazewell, TN), I. A. Diab (Middleburg Heights,
OH), R. DiMonte (West Chester, PA), J. F. Doris (Phoenix, AZ),
19
1067
of the data in the study and takes responsibility for the integrity of the
data and the accuracy of the data analysis.
Study conception and design. Terkeltaub, Furst, Bennett, Kook,
Crockett, Davis.
Acquisition of data. Kook, Davis.
Analysis and interpretation of data. Terkeltaub, Bennett, Kook,
Crockett, Davis.
14. Caraco Y, Putterman C, Rahamimov R, Ben-Chetrit E. Acute
colchicine intoxication—possible role of erythromycin administration. J Rheumatol 1992;19:494–6.
15. Cheng VC, Ho PL, Yuen KY. Two probable cases of serious drug
interaction between clarithromycin and colchicine. South Med J
2005;98:811–3.
16. Dogukan A, Oymak FS, Taskapan H, Guven M, Tokgoz B, Utas C.
Acute fatal colchicine intoxication in a patient on continuous
ambulatory peritoneal dialysis (CAPD): possible role of clarithromycin administration. Clin Nephrol 2001;55:181–2.
17. Hung IF, Wu AK, Cheng VC, Tang BS, To KW, Yeung CK, et al.
Fatal interaction between clarithromycin and colchicine in patients
with renal insufficiency: a retrospective study. Clin Infect Dis
2005;41:291–300.
18. Yussim A, Bar-Nathan N, Lustig S, Shaharabani E, Geier E,
Shmuely D, et al. Gastrointestinal, hepatorenal, and neuromuscular toxicity caused by cyclosporine-colchicine interaction in renal
transplantation. Transplant Proc 1994;26:2825–6.
19. Colcrys prescribing information. Philadelphia: URL Pharma;
2009. URL: http://www.accessdata.fda.gov/drugsatfda_docs/label/
2009/022351lbl.pdf.
20. Campbell WI, Patterson CC. Quantifying meaningful changes in
pain. Anaesthesia 1998;53:121–5.
21. Harden N, Cohen M. Unmet needs in the management of
neuropathic pain. J Pain Symptom Manage 2003;25 Suppl:S12–7.
22. Forouzanfar T, Weber WE, Kemler M, van Kleef M. What is a
meaningful pain reduction in patients with complex regional pain
syndrome type 1? Clin J Pain 2003;19:281–5.
23. Celebrex In Acute Gouty Arthritis Study (NCT00549549). URL:
http://clinicaltrials.gov/ct2/show/NCT00549549?term⫽NCT00549
549&rank⫽1.
24. Schumacher HR Jr, Boice JA, Daikh DI, Mukhopadhyay S,
Malmstrom K, Ng J, et al. Randomised double blind trial of
etoricoxib and indometacin in treatment of acute gouty arthritis.
BMJ 2002;324:1488–92.
25. Rubin BR, Burton R, Navarra S, Antigua J, Londono J, Pryhuber
KG, et al. Efficacy and safety profile of treatment with etoricoxib
120 mg once daily compared with indomethacin 50 mg three times
daily in acute gout: a randomized controlled trial. Arthritis Rheum
2004;50:598–606.
26. Janssens HJ, Janssen M, van de Lisdonk EH, van Riel PL, van
Weel C. Use of oral prednisolone or naproxen for the treatment of
gout arthritis: a double-blind, randomised equivalence trial. Lancet 2008;371:1854–60.
27. Becker MA, Schumacher HR Jr, Wortmann RL, MacDonald PA,
Eustace D, Palo WA, et al. Febuxostat compared with allopurinol
in patients with hyperuricemia and gout. N Engl J Med 2005;353:
2450–61.
28. Becker MA, Schumacher HR Jr, Wortmann RL, MacDonald PA,
Palo WA, Eustace D, et al. Febuxostat, a novel nonpurine selective
inhibitor of xanthine oxidase: a twenty-eight–day, multicenter,
phase II, randomized, double-blind, placebo-controlled, doseresponse clinical trial examining safety and efficacy in patients
with gout. Arthritis Rheum 2005;52:916–23.
ROLE OF THE STUDY SPONSOR
URL Pharma funded the study and choose United BioSource
Corporation to be the Contract Research Organization to run the
study. Dr. Davis is the Chief Medical Officer for URL Pharma and had
key roles in the study design, data collection, data analysis, and writing
of the manuscript. Prior to the start of the study, URL Pharma agreed
that the authors had full rights to submit the manuscript for publication, URL Pharma approval of the content of the submitted manuscript was not required, and publication of the manuscript was not
contingent upon the approval of URL Pharma. The authors had full
access to all data, and Dr. Terkeltaub made the final editorial
decisions.
REFERENCES
1. Ahern MJ, Reid C, Gordon TP, McCredie M, Brooks PM, Jones
M. Does colchicine work? The results of the first controlled study
in acute gout. Aust N Z J Med 1987;17:301–4.
2. Hellmann D. Medications. In: Imboden J, Hellmann D, Stone J,
editors. Current rheumatology and treatment. 2nd ed. New York:
McGraw-Hill; 2007. p. 545.
3. Schlesinger N, Schumacher R, Catton M, Maxwell L. Colchicine
for acute gout. Cochrane Database Syst Rev 2006;(4):CD006190.
4. Perez-Ruiz F, Mielgo FJ Gonzalez, Herrero Beites AM. Optimisation of the treatment of acute gout. BioDrugs 2000;13:415–23.
5. Terkeltaub RA. Clinical practice: gout. N Engl J Med 2003;349:
1647–55.
6. Emmerson BT. The management of gout. N Engl J Med 1996;334:
445–51.
7. Morris I, Varughese G, Mattingly P. Colchicine in acute gout.
BMJ 2003;327:1275–6.
8. Zhang W, Doherty M, Bardin T, Pascual E, Barskova V, Conaghan P, et al, EULAR Standing Committee For International
Clinical Studies Including Therapeutics. EULAR evidence based
recommendations for gout. Part II: Management. Report of a task
force of the EULAR Standing Committee for International Clinical Studies Including Therapeutics (ESCISIT). Ann Rheum Dis
2006;65:1312–24.
9. Wallace SL, Robinson H, Masi AT, Decker JL, McCarty DJ, Yu
TF. Preliminary criteria for the classification of the acute arthritis
of primary gout. Arthritis Rheum 1977;20:895–900.
10. IND (Investigational New Drug) safety reports. In: CFR – Code of
Federal Regulations Title 21, Section 312.32. Washington: US
Food & Drug Administration; 2009. URL: http://www.accessdata.
fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart⫽312&
showFR⫽1.
11. Terkeltaub RA. Colchicine update: 2008. Semin Arthritis Rheum
2009;38:411–9.
12. Rollot F, Pajot O, Chauvelot-Moachon L, Nazal EM, Kelaidi C,
Blanche P. Acute colchicine intoxication during clarithromycin
administration. Ann Pharmacother 2004;38:2074–7.
13. Terkeltaub R, Furst D, DiGiacinto J, Kook K, Davis M. The
Clinical Relevance of P-gp and CYP 3A4 on Colchicine Metabolism and Elimination: Dosing Recommendations for Macrolide
Antibiotics, Cyclosporine, Ketoconazole, Ritonavir and Diltiazem.
In: ACR/ARHP Annual Scientific Meeting, 2008. URL: http://
acr.confex,com/acr/2008/webprogram/Paper2463.html.
APPENDIX A: AGREE TRIAL CLINICAL
INVESTIGATORS
The clinical investigators in the AGREE trial are O. P.
Alvarado (Fort Worth, TX), K. Ayesu (Orange City, FL), H. S. Baraf
(Wheaton, MD), S. H. Barag (Rancho Cucamonga, CA), S. Bather
(Cedar Rapids, IA), C. A. Birbara (Worcester, MA), A. G. Captain
(Calhoun, GA), J. Christensen (Las Vegas, NV), C. F. Colopinto
(Voorhees, NJ), R. F. Cox (Irving, TX), A. Dahdul (Springfield, MA),
C. H. DeBusk (New Tazewell, TN), I. A. Diab (Middleburg Heights,
OH), R. DiMonte (West Chester, PA), J. F. Doris (Phoenix, AZ),
19