A comparative study of the efficacy of NAXOZOL compared to celecoxib in patients with osteoarthritis.

OBJECTIVE: Selective cyclooxygenase-2 inhibitors (celecoxib) can minimize the gastrointestinal complications related to non-steroidal anti-inflammatory drug (NSAID) use. NAXOZOL is a new combination formulation designed to provide sequential delivery of a non-enteric-coated, immediate-release esomeprazole strontium tetrahydrate 20 mg mantle followed by an enteric-coated naproxen 500 mg core. However, there have been no studies comparing NAXOZOL to celecoxib with respect to gastrointestinal tract protection and pain relief in patients with osteoarthritis. This study was undertaken to compare the effects of NAXOZOL and celecoxib with respect to gastrointestinal tract protection and pain relief in patients with osteoarthritis. METHODS: The randomized enrolled patients were divided into two treatment groups: a NAXOZOL group and a celecoxib group. All participants received treatments (NAXOZOL, 500/20 mg (naproxen 500 mg, esomeprazole strontium tetrahydrate 20 mg) twice per day versus celecoxib, 200 mg daily) on a 1:1 allocation basis for 12 weeks. The primary outcome was the Leeds Dyspepsia Questionnaire (LDQ) score used for non-inferiority testing. Secondary outcome measures included the Gastrointestinal Symptom Rating Scale (GSRS) score, Visual Analogue Scale (VAS) score, European Quality of Life-5 dimensions (EQ-5D) scale and the EQ-5D Visual Analogue Scale (EQ VAS). Other outcome measures included the use of supplementary or rescue drugs, and the incidence of adverse events. RESULTS: The baseline-adjusted LDQ scores immediately after 12 weeks of treatment in NAXOZOL group were not inferior to those in celecoxib group. The overall change in the baseline-adjusted GSRS score, VAS score, EQ-5D, and EQ VAS was not different between the two groups. The usage of supplementary drugs and the drug-related incidence of adverse events were not different. However, the days to use rescue drug were longer in celecoxib group than in NAXOZOL group. CONCLUSION: NAXOZOL was not inferior to celecoxib in protecting the gastrointestinal tract and providing pain relief in patients with osteoarthritis.

Venous Thromboembolism Following Hip and Knee Replacement Arthroplasty in Korea: A Nationwide Study Based on Claims Registry.

The aim of this study was to examine the incidence and trends of clinically relevant venous thromboembolism (VTE) including deep vein thrombosis (DVT) and pulmonary embolism (PE) after hip and knee replacement arthroplasty (HKRA) in Korea. Between January 1 and December 31, 2010, 22,127 hip replacement arthroplasty (HRA) patients and 52,882 knee replacement arthroplasty (KRA) patients were enrolled in the analysis using the administrative claims database of the Health Insurance Review and Assessment Service (HIRA). All available parameters including procedure history and clinically relevant VTE during the 90 days after HKRA were identified based on diagnostic and electronic data interchange (EDI) codes. The overall incidence of VTE, DVT, and PE during the 90 days was 3.9% (n=853), 2.7% (n=597), and 1.5% (n=327) after HRA, while the incidence was 3.8% (n=1,990), 3.2% (n=1,699), and 0.7% (n=355) after KRA. The incidence of VTE after HKRA was significantly higher in patients who had previous VTE history (odds ratio [OR], 10.8 after HRA, OR, 8.5 after KRA), chronic heart failure (2.1, 1.3), arrhythmia (1.8, 1.7), and atrial fibrillation (3.4, 2.1) than in patients who did not. The VTE incidence in patients with chemoprophylaxis was higher than that in patients without chemoprophylaxis. The incidence of VTEs revealed in this retrospective review was not low compared with the results of the studies targeting other Asian or Caucasian populations. It may warrant routine prevention including employment of chemoprophylaxis. However, the limitation of the reviewed data mandates large scale prospective investigation to affirm this observation.

Effect of chondroitinase ABC on adhesion and behavior of synovial membrane-derived mesenchymal stem cells in rabbit partial-thickness chondral defects.

Transplanted cells may have difficulty attaching to the surface of partial-thickness chondral lesions because of the anti-adhesive properties of the proteoglycan rich matrix. Therefore, the current study attempts to evaluate the effect of chondroitinase ABC (chABC) on the adhesion and behavior of transplanted synovial membrane-derived mesenchymal stem cells (SDSCs) in rabbit partial-thickness chondral defects. In ex vivo adhesion experiments, chABC treatment (0.1 U/ml) was increased in SDSC attachment to the cartilage explants, and significantly diminished by pretreatment with neutralizing antibody against fibronectin. In the in vivo experiments, 1 day and 4 weeks after the chABC treatment (0.1 and 1 U/ml), the immunoreactivity (IR) against CS-56 (intact chondroitin sulfate antibody) was markedly decreased; however, the IR of 2B6 (stub of the chondroitin 4-sulfate chain), 3B3 (stub of the chondroitin 6-sulfate chain), and fibronectin was increased. At 12 weeks, this IR returned to normal except in the high-dose chABC-treated group (1 U/ml). Furthermore, the attachment of SDSCs to the chondral defects after chABC treatment was increased at 7 days compared with that in the chondral defects pretreated with saline. However, the tissue repaired by SDSCs was negatively stained for type II collagen at 12 weeks. In conclusion, these results showed that the exposure to fibronectin by chABC treatment enhances the attachment of SDSCs to partial-thickness chondral defects. However, the tissue regenerated by SDSCs showed lack of hyaline cartilage regeneration. Thus, to understand the fate of transplanted MSCs in cartilage defect is very important for successful cell therapies.