Abstract
Hydroxypropyl-β-cyclodextrin-diclofenac (HPβCD-diclofenac) is an NSAID used to treat acute moderate-to-severe postoperative pain. This post hoc analysis investigated the safety of HPβCD-diclofenac in patients aged ≥ 65 years. Data from three phase III trials of HPβCD-diclofenac in adult patients with acute moderate-to-severe postoperative pain were pooled (NCT00448110, NCT00507026, and NCT00726388). Patients who received one or more dose of HPβCD-diclofenac or placebo were included and stratified according to age: < 65, 65-74, or ≥ 75 years. Numerical and categorical variables were compared across the groups using ANOVA and Cochran-Mantel-Haenszel tests, respectively. Cochran-Mantel-Haenszel relative risks compared with placebo were calculated, adjusted by study. Overall, 1289 patients were included: 878, 282, and 129 in the < 65, 65-74, and ≥ 75-years groups, respectively. Overall incidence of treatment-emergent adverse events (TEAEs) was similar in the three groups (p = 0.4360). Incidences of postoperative anemia (p < 0.0001), constipation (p = 0.0017), and hypotension (p = 0.0003) increased significantly across the age groups, whereas headache (p = 0.0008) and flatulence (p = 0.0118) decreased significantly. Relative risks f...Continue Reading
References
Dec 1, 1994·Anesthesia and Analgesia·A J SouterP F White
Mar 9, 2002·British Journal of Anaesthesia·J B ForrestUNKNOWN POINT Investigators
Jun 1, 2004·Pharmacological Reviews·Allan J McLean, David G Le Couteur
Apr 9, 2005·Drugs & Aging·Ruth Savage
Aug 16, 2005·International Journal of Pharmaceutics·Thorsteinn LoftssonMár Másson
May 24, 2006·Anesthesia and Analgesia·Tong J Gan
May 11, 2007·Best Practice & Research. Clinical Anaesthesiology·Frédéric Aubrun, Frédéric Marmion
May 25, 2007·Fundamental & Clinical Pharmacology·Sarah N HilmerDavid G Le Couteur
Nov 29, 2007·Anesthesiology·Sachin KheterpalRichard D Swartz
Feb 13, 2009·Anesthesiology·Sachin KheterpalDarrell A Campbell
Oct 5, 2010·Drugs & Aging·Robert L BarkinDickson S Wu
Jan 7, 2011·Journal of the American Society of Nephrology : JASN·Sharon AndersonKevin P High
Apr 1, 2011·Journal of the American Medical Directors Association·Jennifer Gonik Chester, James L Rudolph
Jul 6, 2011·BMJ : British Medical Journal·Jerry H Gurwitz
Oct 13, 2011·The American Journal of Gastroenterology·Juan F Gallegos-OrozcoJean M Stoa
Aug 14, 2012·Anesthesia and Analgesia·Tong J GanDaniel B Carr
Jan 19, 2013·The Clinical Journal of Pain·Stephen DanielsDaniel B Carr
Feb 27, 2013·Age and Ageing·Aza AbdullaUNKNOWN British Geriatric Society
Apr 10, 2013·Pain Medicine : the Official Journal of the American Academy of Pain Medicine·Jacques E ChellyDaniel B Carr
Apr 16, 2014·JAMA Internal Medicine·Bruce L DavidsonMartin H Prins
May 13, 2015·Drugs·Roy AltmanClarence Young
Sep 1, 2015·Anesthesiology Clinics·Bret D Alvis, Christopher G Hughes
Sep 1, 2015·Anesthesiology Clinics·Jason L McKeown
May 18, 2016·Journal of Clinical Anesthesia·Tong J GanDaniel B Carr
Jul 23, 2016·Drugs·Sheridan M Hoy
Dec 28, 2016·Pain Medicine : the Official Journal of the American Academy of Pain Medicine·Stephen E DanielsDaniel B Carr