TY - JOUR
T1 - Prospective evaluation of local sustained release of celecoxib in dogs with low back pain
AU - Wiersema, Tijn
AU - Tellegen, Anna R.
AU - Beukers, Martijn
AU - van Stralen, Marijn
AU - Wouters, Erik
AU - van de Vooren, Mandy
AU - Woike, Nina
AU - Mihov, George
AU - Thies, Jens C.
AU - Creemers, Laura B.
AU - Tryfonidou, Marianna A.
AU - Meij, Björn P.
N1 - Funding Information:
Funding: This research was funded by Health Holland, grant number 40-43100-98-022 and by the Dutch Arthritis Society, grant number LLP12 and LLP22.
Publisher Copyright:
© 2021 by the authors. Licensee MDPI, Basel, Switzerland.
PY - 2021/8
Y1 - 2021/8
N2 - Back pain affects millions globally and in 40% of the cases is attributed to intervertebral disc degeneration. Oral analgesics are associated with adverse systemic side-effects and insufficient pain relief. Local drug delivery mitigates systemic effects and accomplishes higher local dosing. Clinical efficacy of intradiscally injected celecoxib (CXB)-loaded polyesteramide microspheres (PEAMs) was studied in a randomized prospective double-blinded placebo controlled veterinary study. Client-owned dog patients suffering from back pain were treated with CXB-loaded (n = 20) or unloaded PEAMs (“placebo”) (n = 10) and evaluated by clinical examination, gait analysis, owners’ question-naires, and MRI at 6 and 12 weeks follow-up. At 6 and 12 weeks, CXB-treated dogs experienced significantly less pain interference with their daily life activities compared to placebo. The risk ratio for treatment success was 1.90 (95% C.I. 1.24–2.91, p = 0.023) at week 6 and 1.95 (95% C.I. 1.10–3.45, p = 0.036) at week 12. The beneficial effects of CXB-PEAMs were more pronounced for the subpopula-tion of male dogs and those with no Modic changes in MRI at inclusion in the study; disc protrusion did not affect the outcome. It remains to be determined whether intradiscal injection of CXB-PEAMs, in addition to analgesic properties, has the ability to halt the degenerative process in the long term or restore the disc.
AB - Back pain affects millions globally and in 40% of the cases is attributed to intervertebral disc degeneration. Oral analgesics are associated with adverse systemic side-effects and insufficient pain relief. Local drug delivery mitigates systemic effects and accomplishes higher local dosing. Clinical efficacy of intradiscally injected celecoxib (CXB)-loaded polyesteramide microspheres (PEAMs) was studied in a randomized prospective double-blinded placebo controlled veterinary study. Client-owned dog patients suffering from back pain were treated with CXB-loaded (n = 20) or unloaded PEAMs (“placebo”) (n = 10) and evaluated by clinical examination, gait analysis, owners’ question-naires, and MRI at 6 and 12 weeks follow-up. At 6 and 12 weeks, CXB-treated dogs experienced significantly less pain interference with their daily life activities compared to placebo. The risk ratio for treatment success was 1.90 (95% C.I. 1.24–2.91, p = 0.023) at week 6 and 1.95 (95% C.I. 1.10–3.45, p = 0.036) at week 12. The beneficial effects of CXB-PEAMs were more pronounced for the subpopula-tion of male dogs and those with no Modic changes in MRI at inclusion in the study; disc protrusion did not affect the outcome. It remains to be determined whether intradiscal injection of CXB-PEAMs, in addition to analgesic properties, has the ability to halt the degenerative process in the long term or restore the disc.
KW - Biomaterials
KW - Controlled release
KW - Degenerative lumbosacral stenosis
KW - Intervertebral disc degeneration
KW - Microspheres
KW - Non-steroidal anti-inflammatory drugs
KW - intervertebral disc degeneration
KW - controlled release
KW - microspheres
KW - non-steroidal anti-inflammatory drugs
KW - biomaterials
KW - degenerative lumbosacral stenosis
UR - http://www.scopus.com/inward/record.url?scp=85112035690&partnerID=8YFLogxK
U2 - 10.3390/pharmaceutics13081178
DO - 10.3390/pharmaceutics13081178
M3 - Article
C2 - 34452138
AN - SCOPUS:85112035690
SN - 1999-4923
VL - 13
SP - 1
EP - 17
JO - Pharmaceutics
JF - Pharmaceutics
IS - 8
M1 - 1178
ER -