SAFETY OFANALGESICS, NON-STEROIDAL ANTI-INFLAMMATORY DRUGS AND OPIOIDS

Fuggle, N.R.; Curtis, E.M.; Shaw, S.; Spooner, L.; Bruyère, O.; Ntanil, G.; Parsons, C.; Conaghan, P.G.; Corp, N.; Honvo, G.; Maggi, S.; Uebelhart, D.; Baird, J.; Dennison, E.M.; Reginster, J.-Y.; Cooper, C.

Abstract

Objectives: To assess the safety of opioids and COX-2 inhibitors in the management of osteoarthritis (OA) in a systematic review and meta-analysis of randomized, placebo-controlled trials.

Materials and methods: A comprehensive literature search was undertaken in the databases MEDLINE, Cochrane Central Register of Controlled Trials (Ovid CENTRAL), and Scopus. Randomized, double-blind, placebo-controlled, parallel-group trials that assessed adverse events (AEs) with opioids or COX-2 inhibitors in patients with OA were eligible for inclusion. The primary outcomes were severe and serious AEs, as well as MedDRA System Organ Class (SOC)-related Es:gastrointestinal (GI) disorders, cardiac disorders, vascular disorders, nervous system disorders, and dermatologic disorders. Results: For opioids, database searches identified 2189 records from which, after exclusions, 17 papers were included in the meta-analysis. More disorders of the lower gastrointestinal (GI) tract (constipation, fecaloma) were reported with both immediate-release (IR) and extended release (ER) formulations of opioids versus placebo: IR opioids (relative risk [RR] = 5.20, 95% confidence interval [CI] 3.42, 7.89); ER opioids (RR = 4.22, 95% CI 3.44, 5.17). The risk of risk of nausea, vomiting or loss of appetite increased 4 to 5-fold with both IR (RR = 3.39, 95% CI 2.22, 5.18) and ER opioids (RR = 4.03, 95% CI 3.37, 4.83). An increased risk of dermatologic AEs (rash and pruritis) (IR opioids: RR = 3.60, 95% CI 1.74, 7.43; ER opioids: RR = 7.87, 95% CI, 5.20, 11.89). For COX-2 inhibitors, database searches identified 2149 records from which, after exclusions, 40 trials were included in the meta-analysis. The use of COX-2 inhibitors in OA was associated with a significantly increased risk of drugrelated AEs compared with placebo (relative risk [RR] = 1.26, 95% CI 1.09, 1.46; I2 = 24%). The risk of upper gastrointestinal complications (including dyspepsia, gastritis, and heartburn) was significantly increased with COX-2 inhibitors versus placebo (RR = 1.19, 95% CI 1.03, 1.38; I2 = 0%). The risk of heart failure and edema was increased by nearly 70% with COX-2 inhibitors versus placebo (RR = 1.68, 95% CI 1.22, 2.31; 0%).

Conclusions: Our results confirm the concerns regarding safety and tolerability surrounding the use of opioids and COX-2 inhibitors in OA

Citation

Fuggle, N., Curtis, E., Shaw, S., Spooner, L., Bruyère, O., Ntanil, G., …Cooper, C. (2019, April). SAFETY OFANALGESICS, NON-STEROIDAL ANTI-INFLAMMATORY DRUGS AND OPIOIDS. Poster presented at World Congress on Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (WCO-IOF-ESCEO 2019), Paris, France

• Presentation Conference Type: Poster
• Conference Name: World Congress on Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (WCO-IOF-ESCEO 2019)
• Conference Location: Paris, France
• Start Date: Apr 4, 2019
• End Date: Apr 7, 2019
• Deposit Date: Jun 27, 2023