Source: https://www.guideline.gov/summaries/summary/38625?
Timestamp: 2016-09-27 12:05:04
Document Index: 521793351

Matched Legal Cases: ['art 2', 'art 2', 'art 2', 'art 1', 'art 1', 'art 1', 'art 1', 'art 1', 'art 2']

2012 American College of Rheumatology guidelines for management of gout. Part 2: therapy and antiinflammatory prophylaxis of acute gouty arthritis. | National Guideline Clearinghouse
Khanna D, Khanna PP, Fitzgerald JD, Singh MK, Bae S, Neogi T, Pillinger MH, Merill J, Lee S, Prakash S, Kaldas M, Gogia M, Perez-Ruiz F, Taylor W, Liote F, Choi H, Singh JA, Dalbeth N, Kaplan S, Niyyar V, Jones D, Yarows SA, Roessler B, Kerr G, King C, Levy G, Furst DE, Edwards NL, Mandell B, Schumacher HR, Robbins M, Wenger N, Terkeltaub R. 2012 American College of Rheumatology guidelines for management of gout. Part 2: therapy and antiinflammatory prophylaxis of acute gouty arthritis. Arthritis Care Res (Hoboken). 2012 Oct;64(10):1447-61. [68 references] PubMed View the original guideline documentation This is the current release of the guideline.
(274.9), Gouty arthropathy, unspecified
(274.00), Injection of steroid
(99.23) MSH
, Arthritis, Gouty
, Injections, Intramuscular
(387413002), Colchicine
(73133000), Corticoid preparation
(79440004), Corticotropin preparation
(111153005), Corticotropin preparation
(40789008), Cox-2 inhibitor
(387050005), Drug prophylaxis
(182929008), Drugs for the treatment of gout
(330060000), Gout
(90560007), Ice
(896008), Ice bag
(59102007), Injection of steroid
(296778005), Intra-articular injection
(27813003), Intramuscular injection
(76601001), Joints gout affected
(170733007), Joints gout affected
(190828008), Joints gout affected
(48440001), Ketorolac
(372501008), Methylprednisolone
(27242001), Non-steroidal anti-inflammatory agent
(372665008), Patient education
(311401005), Prednisolone
(116602009), Self-care interventions
(116566001), Triamcinolone acetonide
(395913005) SPN
(12-082) Sections
.PDF 126.7 kb
.XML 67.8 kb
Citation: National Guideline Clearinghouse (NGC). Guideline summary: 2012 American College of Rheumatology guidelines for management of gout. Part 2: therapy and antiinflammatory prophylaxis of acute gouty arthritis. In: National Guideline Clearinghouse (NGC) [Web site]. Rockville (MD): Agency for Healthcare Research and Quality (AHRQ); 2012 Oct 01. [cited 2016 Sep 27]. Available: https://www.guideline.gov Download citation file: RIS (Zotero)
Note from the National Guideline Clearinghouse (NGC): This article concentrates on two of the four gout domains that the American College of Rheumatology (ACR) requested for evaluation of pharmacologic and nonpharmacologic management approaches: analgesic and antiinflammatory management of acute attacks of gouty arthritis and pharmacologic antiinflammatory prophylaxis of acute attacks of gouty arthritis. Part 1 of the guidelines focused on systematic nonpharmacologic measures (patient education, diet and lifestyle choices, identification and management of comorbidities) that impact hyperuricemia, and made recommendations on pharmacologic urate-lowering therapy (ULT) in a range of case scenarios of patients with disease activity manifested by acute and chronic forms of gouty arthritis, including chronic tophaceous gouty arthropathy (see the NGC summary of the ACR guideline 2012 American College of Rheumatology guidelines for management of gout. Part 1: systematic nonpharmacologic and pharmacologic therapeutic approaches to hyperuricemia).
The original guideline document provides clinical algorithms for:
Overview of management of an acute gout attack Recommendations for the individual pharmacologic monotherapy options for an acute gouty arthritis attack Acute gouty arthritis attack management in the nothing by mouth (NPO) patient Pharmacologic antiinflammatory prophylaxis of gout attacks and its relationship to pharmacologic urate-lowering therapy (ULT) Scope
To develop nonpharmacologic and pharmacologic guidelines for treatments in gout that are safe and effective, i.e., with an acceptable risk/benefit ratio To provide guidelines useful for both rheumatologists and other health care providers on an international level To reflect best practice, supported either by level of evidence or consensus-based decision making Target Population
Treatment within 24 hours of an episode of acute gouty arthritis Continuation of urate-lowering therapy during treatment for acute gouty arthritis Patient education for self-management Monotherapy
Intraarticular corticosteroid injections Intravenous or intramuscular methylprednisolone Subcutaneous synthetic adrenocorticotropic hormone (ACTH) Topical ice Prophylactic therapy Duration of antiinflammatory prophylaxis Note: The Task Force Panel (TFP) considered the following but made no recommendation: intramuscular ketorolac, topical NSAIDs, intramuscular triamcinolone acetonide monotherapy. The TFP also considered complementary therapy with cherry juice or extract, salicylate-rich willow bark extract, ginger, flaxseed, charcoal, strawberries, black currant, burdock, sour cream, olive oil, horsetail, pears, or celery root and did not recommend them.
Effectiveness of treatment Improvement in pain scores Effectiveness of prevention strategies Frequency and severity of acute relapse Time to pain relief Methodology
PubMed and the Cochrane Central Register of Controlled Trials (CENTRAL) were searched to find all articles on gout with the help of an experienced librarian. PubMed is a database of medical literature from the 1950s to present. CENTRAL includes references from PubMed, EMBASE, and the Cochrane Review Groups' specialized registers of controlled trials and hand search results. Search terminology (hedge) based on the Cochrane Highly Sensitive Search Strategy was used for identifying randomized trials. The hedge was expanded to include articles discussing research design, cohort, case–control, and cross-sectional studies. Limits added to the hedge include English language and the exclusion of "animal only" studies. The searches for all four domains were conducted simultaneously and therefore included terms for hyperuricemia and other gout-related issues.
Subsequently, the systematic review was updated by repeating the search with the same criteria to include any articles that were published between September 25, 2010 and March 31, 2011, and the guideline authors hand searched recent meeting abstracts from the American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) for any randomized controlled trials that were yet to be published. The supplemental search resulted in four additional manuscripts and five meeting abstracts on pharmacologic agents, some of which were subsequently published and then reevaluated for evidence grade. Finally, there were 41 manuscripts on nonpharmacologic modalities (such as diet, alcohol, exercise, etc.) that included both retrospective and prospective studies, but all were excluded, since none were randomized controlled studies on interventions in gout patients. There were 87 manuscripts on pharmacologic agents for the treatment of patients with gout. Of these, 47 were randomized controlled trials and included in the evidence report, whereas the remaining 40 uncontrolled trials were excluded. A total of 21 manuscripts on urate-lowering therapy (ULT) were separately addressed (see the NGC summary of the ACR guideline 2012 American College of Rheumatology guidelines for management of gout. Part 1: systematic nonpharmacologic and pharmacologic therapeutic approaches to hyperuricemia).
A total of 30 manuscripts and 5 meeting abstracts were assessed, with 26 manuscripts and 2 meeting abstracts on acute gout and 4 manuscripts and 3 meeting abstracts on prophylaxis included in the evidence report and evaluated by the Task Force Panel.
The RAND/University of California-Los Angeles (UCLA) method requires 2 groups of experts: a core expert panel (CEP) that provides input into case scenario development, and a task force panel (TFP) that votes on the case scenarios. A systematic review of pertinent literature was performed concurrently, and a scientific evidence report was generated. This evidence report was then given to the TFP, in conjunction with a variety of clinical scenarios and clinical decision-making questions of interest for each scenario.
The level of evidence supporting each recommendation was ranked based on previous methods used by the American College of Cardiology and applied to other recent American College of Rheumatology (ACR) recommendations.
Design: RAND/University of California at Los Angeles (UCLA) Appropriateness Method Overview
So that the voting panel could focus on gout treatment decisions, a number of key assumptions were made, as described in part 1 of the guidelines (see the National Guideline Clearinghouse [NGC] summary of the ACR guideline 2012 American College of Rheumatology guidelines for management of gout. Part 1: systematic nonpharmacologic and pharmacologic therapeutic approaches to hyperuricemia). Importantly, each proposed recommendation assumed that correct diagnoses of gout and acute gouty arthritis attacks had been made for the voting scenario in question. For treatment purposes, it was also assumed that treating clinicians were competent, and considered underlying medical comorbidities (including diabetes mellitus, gastrointestinal disease, hypertension, and hepatic, cardiac, and renal disease) and potential drug toxicities and drug–drug interactions when making both treatment choices and dosing decisions on chosen pharmacologic interventions. The RAND/UCLA methodology used here emphasizes the level of evidence, safety, and quality of therapy, and excludes analyses of societal cost of health care.
Appropriate therapy and antiinflammatory prophylaxis of acute gouty arthritis
Adverse effects of drugs used for gout treatment and prevention Drug-drug interactions for patients being treated for comorbidities Drug-disease interactions Qualifying Statements
Guidelines and recommendations developed and/or endorsed by the American College of Rheumatology (ACR) are intended to provide guidance for particular patterns of practice and not to dictate the care of a particular patient. The ACR considers adherence to these guidelines and recommendations to be voluntary, with the ultimate determination regarding their application to be made by the physician in light of each patient's individual circumstances. Guidelines and recommendations are intended to promote beneficial or desirable outcomes but cannot guarantee any specific outcome. Guidelines and recommendations developed or endorsed by the ACR are subject to periodic revision as warranted by the evolution of medical knowledge, technology, and practice. Therapies that were approved after the original literature review, or diet and lifestyle measures studied after the original literature review, are not included in these recommendations. The ACR gout guidelines are designed to reflect best practice, supported either by level of evidence or consensus-based decision making. These guidelines cannot substitute for individualized direct assessment of the patient, coupled with clinical decision making by a competent health care practitioner. The motivation, financial circumstances, and preferences of the gout patient also need to be considered in clinical practice, and it is incumbent on the treating clinician to weigh the issues not addressed by this methodology, such as treatment costs, when making management decisions. Last, the guidelines for gout management presented herein were not designed to determine eligibility for health care cost coverage by third party payors. Limitations of the Recommendations
Limitations of the recommendations include that only approximately 30% were based on level A evidence, with approximately half based on level C evidence; this indicates the need for more studies in the aspects of gout management considered. The process used was limited by the current trial designs for assessment of acute gout therapies and prophylaxis of antiinflammatory pharmacologic agents in gout. For acute gout studies, most studies were on nonsteroidal antiinflammatory drugs (NSAIDs) and involved an active comparator and noninferiority trial design. However, the majority of these studies failed to provide a noninferiority margin, which needs to be defined a priori to assess the validity of these trials. Although the majority of studies assessed pain as the primary outcome for the acute gout trials, there is a lack of a single uniform measure that precludes meta-analysis. There is a lack of consensus on what time period after initiation of therapy constitutes a primary response, since trials ranged from a few hours to 10 days. With the exception of recent analyses of biologic interleukin-1 (IL-1) inhibitors, there was a lack of robust clinical trials of gout attack prophylaxis using antiinflammatory pharmacologic agents. Also, the primary measure in these trials is the recurrence of self-reported acute gout attacks, an outcome that has not been validated using Outcome Measures in Rheumatology criteria. Efforts are underway to precisely define acute gout attack in gout clinical trials. Implementation of the Guideline
Khanna D, Khanna PP, Fitzgerald JD, Singh MK, Bae S, Neogi T, Pillinger MH, Merill J, Lee S, Prakash S, Kaldas M, Gogia M, Perez-Ruiz F, Taylor W, Liote F, Choi H, Singh JA, Dalbeth N, Kaplan S, Niyyar V, Jones D, Yarows SA, Roessler B, Kerr G, King C, Levy G, Furst DE, Edwards NL, Mandell B, Schumacher HR, Robbins M, Wenger N, Terkeltaub R. 2012 American College of Rheumatology guidelines for management of gout. Part 2: therapy and antiinflammatory prophylaxis of acute gouty arthritis. Arthritis Care Res (Hoboken). 2012 Oct;64(10):1447-61. [68 references] PubMed Adaptation
Managing Perceived Potential Conflict of Interest (COI)
Dr. Dinesh Khanna has received consultant fees, speaking fees, and/or honoraria (less than $10,000 each) from Novartis and Ardea and (more than $10,000 each) from Takeda and Savient, and has served as a paid investment consultant for Guidepoint. Dr. Puja P. Khanna has received speaking fees (less than $10,000) from Novartis and (more than $10,000) from Takeda, and has served on the advisory board for Novartis. Dr. Pillinger has received speaking fees and/or honoraria (less than $10,000 each) from the RA Investigator Network, NY Downtown Hospital, Winthrop Hospital, and Einstein College of Medicine. Dr. Perez-Ruiz has received consultant fees, speaking fees, and/or honoraria (less than $10,000 each) from Novartis, Menarini, and Savient, and (more than $10,000) from Ardea. Dr. Lioté has received consultant fees, speaking fees, and/or honoraria (less than $10,000 each) from Novartis Global, Novartis France, and Ipsen, and has served as a paid investment consultant for Gerson Lehrman Group. Dr. Choi has served on the advisory boards (less than $10,000 each) for Takeda, URL, and Savient. Dr. Singh has received consultant fees, speaking fees, and/or honoraria (less than $10,000 each) from Ardea, Savient, Allergan, and Novartis, and (more than $10,000) from Takeda, and has received investigator-initiated grants from Takeda and Savient. Dr. Dalbeth has received consultant fees, speaking fees, and/or honoraria (less than $10,000 each) from Novartis, Takeda, and Ardea, has received research funding from Fonterra, and holds a patent from Fonterra for milk products for gout. Dr. Niyyar has received honoraria (less than $10,000) from the American Society of Nephrology. Dr. Kerr has served as a study investigator (more than $10,000 each) for Savient and Nuon. Dr. Edwards has received consultant fees, speaking fees, and/or honoraria (less than $10,000 each) from Savient, Takeda, Ardea, and Regeneron, and (more than $10,000) from Novartis, and has given expert testimony for Novartis. Dr. Mandell has received consultant fees, speaking fees, and/or honoraria (less than $10,000 each) from Savient, Novartis, and Pfizer. Dr. Schumacher has received consultant fees (less than $10,000 each) from Pfizer, Regeneron, West-Ward, and Ardea, and (more than $10,000) from Novartis. Dr. Terkeltaub has received consultant fees (less than $10,000 each) from Takeda, Savient, Ardea, BioCryst, URL, Regeneron, Pfizer, Metabolex, Nuon, Chugai, EnzymeRx, Ajanta, Anadys, Celgene, Isis, and Prescription Solutions, and (more than $10,000) from Novartis, has received grant support from the VA San Diego Healthcare System and the National Institutes of Health (NIH), and has served as a paid investment consultant for Leerink Swann, Medacorp, and Guidepoint.
A supplemental figure and Appendix A are available from the Arthritis Care and Research Web site .
Gout. 2012 Sep. 5 p. Available in PDF in English and Spanish from the American College of Rheumatology (ACR) Web site. NSAIDs: nonsteroidal anti-inflammatory drugs. 2012 Aug. 5 p. Available in PDF from the ACR Web site . Please note: This patient information is intended to provide health professionals with information to share with their patients to help them better understand their health and their diagnosed disorders. By providing access to this patient information, it is not the intention of NGC to provide specific medical advice for particular patients. Rather we urge patients and their representatives to review this material and then to consult with a licensed health professional for evaluation of treatment options suitable for them as well as for diagnosis and answers to their personal medical questions. This patient information has been derived and prepared from a guideline for health care professionals included on NGC by the authors or publishers of that original guideline. The patient information is not reviewed by NGC to establish whether or not it accurately reflects the original guideline's content.
This NGC summary was completed by ECRI Institute on December 27, 2012. The information was verified by the guideline developer on January 17, 2013. This summary was updated by ECRI Institute on September 18, 2015 following the U.S. Food and Drug Administration advisory on non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs).