Journal ArticleDOI
Lower-dose diclofenac submicron particle capsules provide early and sustained acute patient pain relief in a phase 3 study.
Allan Gibofsky,Stephen D. Silberstein,Charles Argoff,Stephen E. Daniels,Steve Jensen,Clarence L. Young +5 more
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TLDR
Lower-dose diclofenac submicron particle capsules provided effective analgesia in this phase 3 clinical study in patients with acute pain and are a potentially promising option for the treatment of patients with severe acute pain.Abstract:
Background: Non-steroidal anti-inflammatory drugs are prescribed for the treatment of patients with acute pain but use of such analgesics is associated with dose-dependent adverse events (AEs). Diclofenac submicron particle capsules have been developed using SoluMatrix technology to provide analgesia at lower doses than available solid oral dosing forms. Our study evaluated the analgesic efficacy and safety of lower-dose diclofenac submicron particle capsules in patients with acute pain following elective surgery. Methods: A phase 3, multicenter, double-blind study enrolled 428 patients, aged 18 to 65 years, with moderate-to-severe pain following bunionectomy under regional anesthesia. Patients experiencing a pain intensity rating of > 40 mm on a 100-mm Visual Analog Scale were randomized to receive lower-dose diclofenac submicron particle capsules (35 or 18 mg, 3 times daily [TID]), celecoxib (200 mg, twice daily [BID], 400-mg loading dose), or placebo. The primary efficacy parameter was the overall (sum...read more
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Journal ArticleDOI
New insights into the use of currently available non-steroidal anti-inflammatory drugs
Kay Brune,Paola Patrignani +1 more
TL;DR: A better understanding of the inhibitory activity and COX-1/COX-2 selectivity of an NSAID at therapeutic doses, based on pharmacokinetic and pharmacodynamic properties can guide the selection of appropriate NSAIDs for pain management.
Journal ArticleDOI
Advances in NSAID development: evolution of diclofenac products using pharmaceutical technology.
TL;DR: How pharmaceutical technology has been used to modify the pharmacokinetic properties of diclofenac, leading to the creation of novel drug products with improved clinical utility is illustrated.
Journal ArticleDOI
Nanodrugs: pharmacokinetics and safety
TL;DR: A better understanding of the pharmacokinetic and safety characteristics of nanodrugs and the limitations of each delivery option is necessary for the further development of efficacious nanodrogs with high therapeutic potential and a wide safety margin.
Journal ArticleDOI
Gastrointestinal injury associated with NSAID use: a case study and review of risk factors and preventative strategies
Jay L. Goldstein,Byron L Cryer +1 more
TL;DR: A case report of a patient experiencing a gastric ulcer following NSAIDs use is presented and some of the risk factors and potential strategies for prevention of upper GI mucosal injuries and associated bleeding following NSAID use are examined.
Journal ArticleDOI
Nonopioid analgesics for postoperative pain management.
TL;DR: Nonopioid analgesics are important components of multimodal postoperative analgesia and the selection of the most appropriate compound for an individual patient can be based more and more on ever increasing data on these important analgesics.
References
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Journal ArticleDOI
Comparison of Upper Gastrointestinal Toxicity of Rofecoxib and Naproxen in Patients with Rheumatoid Arthritis
Claire Bombardier,Loren Laine,Alise S. Reicin,Deborah R. Shapiro,Ruben Burgos-Vargas,Barry R. Davis,Richard O. Day,Marcos Bosi Ferraz,Christopher J. Hawkey,Marc C. Hochberg,Tore K Kvien,Thomas J. Schnitzer +11 more
TL;DR: In patients with rheumatoid arthritis, treatment with rofecoxib, a selective inhibitor of cyclooxygenase-2, is associated with significantly fewer clinically important upper gastrointestinal events than treatment with naproxen, a nonselective inhibitor.
Journal ArticleDOI
Gastrointestinal Toxicity With Celecoxib vs Nonsteroidal Anti-inflammatory Drugs for Osteoarthritis and Rheumatoid Arthritis: The CLASS Study: A Randomized Controlled Trial
Fred E. Silverstein,Gerald A. Faich,Jay L. Goldstein,Lee S. Simon,Theodore Pincus,Andrew Whelton,Robert W. Makuch,Glenn M. Eisen,Naurang M. Agrawal,William F. Stenson,Aimee M. Burr,William W. Zhao,Jeffrey D. Kent,James B. Lefkowith,Kenneth M. Verburg,G. Steven Geis +15 more
TL;DR: In this study, celecoxib, at dosages greater than those indicated clinically, was associated with a lower incidence of symptomatic ulcers and ulcer complications combined, as well as other clinically important toxic effects, compared with NSAIDs at standard dosages.
Journal ArticleDOI
Do selective cyclo-oxygenase-2 inhibitors and traditional non-steroidal anti-inflammatory drugs increase the risk of atherothrombosis? Meta-analysis of randomised trials
TL;DR: Selective COX 2 inhibitors are associated with a moderate increase in the risk of vascular events, as are high dose regimens of ibuprofen and diclofenac, but high dose naproxen is not associated with such an excess.
Journal ArticleDOI
Risk of acute myocardial infarction and sudden cardiac death in patients treated with cyclo-oxygenase 2 selective and non-selective non-steroidal anti-inflammatory drugs: nested case-control study
David J. Graham,David Campen,Rita Hui,Michele M. Spence,Craig Cheetham,Gerald Levy,Stanford Shoor,Wayne A. Ray,Wayne A. Ray +8 more
TL;DR: Rofecoxib use increases the risk of serious coronary heart disease compared with celecoxib use, and naproxen use does not protect against serious coronaryHeart disease.
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