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Utah Medicaid Pharmacy and Therapeutics Committee Drug Class Review Non-Selective Oral Nonsteroidal Anti-Inflammatory Drugs AHFS Classification: 28:08.04.92 Other Nonsteroidal Anti-inflammatory Agents Diclofenac Etodolac Fenoprofen Flurbiprofen Ibuprofen Indomethacin Ketoprofen Ketorolac Mefenamic Acid Meloxicam Nabumetone Naproxen Oxaprozin Piroxicam Sulindac Tolmetin Final Report April 2018 Review prepared by: Elena Martinez Alonso, B.Pharm., Medical Writer Vicki Frydrych, B.Pharm., Pharm.D., Clinical Pharmacist Valerie Gonzales, Pharm.D., Clinical Pharmacist Joanita Lake, B.Pharm., MSc EBHC (Oxon), Research Assistant Professor, Clinical Pharmacist Michelle Fiander, MA, MLIS, Research Assistant Professor, Evidence Synthesis Librarian Joanne LaFleur, PharmD, MSPH, Associate Professor University of Utah College of Pharmacy University of Utah College of Pharmacy, Drug Regimen Review Center Copyright © 2018 by University of Utah College of Pharmacy Salt Lake City, Utah. All rights reserved 1 Contents Executive Summary ...................................................................................................................................... 3 Introduction ................................................................................................................................................... 6 Table 1. FDA-Approved Oral Non-selective NSAIDs......................................................................... 7 Table 2. FDA-Approved Indication for Oral Non-selective NSAIDs ................................................ 13 Disease Overview and Guideline Recommendations ............................................................................. 14 A) Disease Overview ....................................................................................................................... 14 B) Guideline Recommendations ...................................................................................................... 17 Table 3. Guideline Recommendations for Oral NSAIDs ................................................................... 18 Table 4. Clinical Practice Guidance with Less Methodological Rigor than Guidelines Included in Table 3 ................................................................................................................................................ 24 Pharmacology & Special Populations ......................................................................................................... 25 Table 5. In Vitro Selectivity Ratio for NSAIDs ................................................................................. 25 Table 6. Pharmacokinetics for Oral Non-selective NSAIDs .............................................................. 26 Table 7. Special Population Considerations for Oral Non-selective NSAIDs ................................... 29 Methods ...................................................................................................................................................... 33 Clinical Efficacy ......................................................................................................................................... 35 Figure 1. PRISMA flow diagram of the selection process ................................................................. 35 Figure 2. Head-to-Head Efficacy Evidence among Non-selective NSAIDs ...................................... 36 Safety .......................................................................................................................................................... 46 Table 8. Gastrointestinal Toxicity Risk: NSAID Evidence................................................................ 47 Table 9. Selection of NSAID agent based on patient´s cardiovascular and gastrointestinal risk ....... 49 Table 10: Cardiovascular Toxicity Risk: NSAID Evidence............................................................... 52 Table 11: Hepatic Toxicity Risk: NSAID Evidence .......................................................................... 55 Summary ..................................................................................................................................................... 57 Table 12. Evidence-Based Findings on the Comparative Effectiveness among Oral nsNSAIDs ...... 57 References ................................................................................................................................................... 60 Appendix A. FDA-Approved Nonopioid Analgesics ................................................................................. 73 Appendix B. NSAID Interactions ............................................................................................................... 74 Appendix C. Literature Search Strategies ................................................................................................... 76 Appendix D. Key Findings Reported in Systematic Reviews/Meta-Analyses ........................................... 91 Appendix E. Excluded References............................................................................................................ 100 2 Executive Summary Introduction: Non-steroidal anti-inflammatory drugs (NSAIDs) are the most commonly used agents worldwide for the treatment of pain and inflammation associated with several inflammatory conditions such as osteoarthritis and low back pain. NSAIDs exhibit analgesic, anti-inflammatory, and antipyretic effects by inhibiting the action of cyclooxygenase (COX). Several safety concerns associated with the use of NSAIDs include gastrointestinal, cardiovascular, and renal adverse events. Most of the clinical guidelines for specific pain conditions (e.g., osteoarthritis, ankylosing spondylitis, gout, and low back pain) recommend the use of the NSAID class as efficacious, without specifying preference for any particular NSAID. NSAIDs differ in safety profiles and drug interaction. Guidelines emphasize that the selection of an NSAID should be based on the patient’s comorbidities (gastrointestinal and/or cardiovascular diseases) and use of concomitant drugs. The NSAID class includes the traditional agents (nonselective NSAIDs) such as ibuprofen and naproxen and the selective COX-2 inhibitors (coxibs) such as celecoxib. Among the nonselective NSAIDs, meloxicam, etodolac, and nabumetone are sometimes further classified as partially selective based on their partial selectivity to COX-2 over COX-1. This report reviews the comparative efficacy and safety of 16 oral non-selective NSAIDs (nsNSAIDs) for the treatment of mild to moderate pain, osteoarthritis, rheumatoid arthritis, juvenile rheumatoid arthritis, bursitis, tendinitis, ankylosing spondylitis, dysmenorrhea, and gout: diclofenac, etodolac, fenoprofen, flurbiprofen, ibuprofen, indomethacin, ketoprofen, ketorolac, mefenamic acid, meloxicam, nabumetone, naproxen, oxaprozin, piroxicam, sulindac, tolmetin. Diclofenac is available in 3 salt formulations (diclofenac acid, potassium, or sodium), and naproxen is available as naproxen and naproxen sodium. Each oral nsNSAID is available by prescription. Naproxen and ibuprofen are additionally available without prescription. Efficacy: Following a systematic literature search for direct head-to-head comparisons among nsNSAIDs, 29 publications representing 20 systematic reviews/meta-analyses (SR/MAs), 8 randomized controlled trials (RCTs), and 1 substudy of an RCT were identified. Meta-analyses were generally not performed because RCTs used different nsNSAID comparators, as well as different pain outcome parameters and/or assessment tools. Evidence from the majority of studies showed no significant efficacy differences among the various nsNSAIDs. Listed below is a summary of the available evidence by indication: Osteoarthritis: There was high-quality evidence (2 SR/MAs including many RCTs with consistent results) showing no significant differences in relieving osteoarthritis symptoms between partially selective NSAIDs (etodolac or meloxicam) compared to nsNSAIDs, or between various nsNSAIDs. One SR/MA showed less pain reduction with more withdrawals due to a lack of efficacy for meloxicam compared to nsNSAIDs (e.g., naproxen, diclofenac, nabumetone, or piroxicam). There was low-quality evidence from 2 short-term trials reporting no significant differences between nabumetome (partially selective NSAID) and nsNSAIDs. Rheumatoid arthritis: There was low- to moderate-quality evidence from 2 SRs and 1 RCT reporting no significant efficacy differences among nsNSAIDs. However, some differences in 3 specific outcomes were found among nsNSAIDs in the 2 SRs. One SR reported higher withdrawal rates due to a lack of efficacy with meloxicam compared to other nsNSAIDs (e.g., naproxen, diclofenac, nabumetone). Another SR showed flurbiprofen is statistically superior to ibuprofen in terms of articular pain relief, to indomethacin in terms of articular swelling reduction, and to naproxen, indomethacin, and ibuprofen regarding articular stiffness reduction. Juvenile arthritis (including juvenile idiopathic arthritis): There is insufficient evidence from 2 RCTs to confirm any difference among nsNSAID. Ankylosing spondylitis: There was low- to moderate-quality evidence (2 SRs including small studies with imprecise estimate of effect) showing no significant differences in pain and stiffness reduction among the nsNSAIDs. Acute gout: Moderate-quality evidence from 3 SRs showed similar efficacy in reducing acute gout pain among nsNSAIDs. Indomethacin, naproxen and sulindac are currently approved
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