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![Boxed Warning for All Prescription NSAIDs
Cardiovascular Risk
NSAIDs may cause an increased risk of serious cardiovascular thrombotic
events, myocardial infarction, and stroke, which can be fatal. This risk may
increase with duration of use. Patients with cardiovascular disease or risk
factors for cardiovascular disease may be at greater risk.
[Product] is contraindicated for the treatment of perioperative pain in the
setting of coronary artery bypass graft (CABG) surgery.
Gastrointestinal Risk
NSAIDs, including [product], cause an increased risk of serious
gastrointestinal adverse events including bleeding, ulceration, and
perforation of the stomach or intestines, which can be fatal. These events
can occur at any time during use and without warning symptoms. Elderly
patients are at greater risk for serious gastrointestinal (GI) events.
Cardiovascular Risk
NSAIDs may cause an increased risk of serious cardiovascular thrombotic
events, myocardial infarction, and stroke, which can be fatal. This risk may
increase with duration of use. Patients with cardiovascular disease or risk
factors for cardiovascular disease may be at greater risk.
[Product] is contraindicated for the treatment of perioperative pain in the
setting of coronary artery bypass graft (CABG) surgery.
Gastrointestinal Risk
NSAIDs, including [product], cause an increased risk of serious
gastrointestinal adverse events including bleeding, ulceration, and
perforation of the stomach or intestines, which can be fatal. These events
can occur at any time during use and without warning symptoms. Elderly
patients are at greater risk for serious gastrointestinal (GI) events.](https://image.slidesharecdn.com/tenprinciplesoa-151106074653-lva1-app6892/85/Ten-Principles-in-Osteoarthritis-Management-32-320.jpg)
Uploaded byRachmat Gunadi Wachjudi
Ten Principles in Osteoarthritis Management
Osteoarthritis (OA) is a significant health concern affecting millions, with notable prevalence and burden in both the US and UK, leading to considerable disability. Effective management of OA must be patient-tailored and include both non-pharmacological (e.g., education, exercise) and pharmacological (e.g., NSAIDs, corticosteroids) strategies, while fostering an active doctor-patient relationship. Guidelines emphasize the importance of a comprehensive approach to reduce pain, improve quality of life, and limit disease progression.
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Ten Principles in Osteoarthritis Management
- 1. The management ofosteoarthritis For Primary Care Physician
- 2. Prevalence of Arthritisin US Adults* ■ 49.9 million (22.2%) with self-reported, physician-diagnosed arthritis†1 ■ 21.1 million (9.4%) with arthritis and arthritis-attributable activity limitation1 ■ Affects more women than men in every age group2 0 20 40 60 80 100 18–24 25–34 35–44 45–54 55–64 65–74 75–84 85+ Women Men Age Group, years * Data sources: 2007-2009 data from the National Health Interview Survey (NHIS). † Includes multiple forms of arthritis. HCP=health care professional. 1. CDC. MMWR Morb Mortal Wkly Rep. 2010;59(39):1261-1265. 2. Graphic adapted from CDC. NHIS Arthritis Surveillance: Arthritis Prevalence in Women and Men. www.cdc.gov/arthritis/data_statistics/national_nhis.htm. Accessed January 12, 2011. 3. CDC. MMWR Morb Mortal Wkly Rep. 2009;58(16):421-426. 4. Hootman JM, Helmick CG. Arthritis Rheum. 2006;54(1):226-229. ■ Arthritis and rheumatism → leading causes of disability in US3 ■ By 2030, a projected 67 million in US will have HCP-diagnosed arthritis4 USAdults(%) WithArthritis
- 3. Osteoarthritis: burden ofdisease ■ One in five people in the UK have arthritis1 ■ Arthritis is the largest single cause of physical disability in the UK2 ■ Osteoarthritis (OA) is the most common form of arthritis3 ■ OA is associated with considerable burden of disease – second only to cardiovascular disease in causing severe disability3
- 4. OA in PrimaryCare ■ Most patients with OA are managed in Primary Care4 ■ Overall, muscloskeletal problems account for one in ten (20%) of General Practice consultations4 ■ GPs have an opportunity to optimise patient care in OA
- 5. Factors Implicated inthe Development of OA Cartilage breakdown ObesityObesity Anatomic abnormalities Anatomic abnormalities Microfractures and bony remodeling Microfractures and bony remodeling Loss of joint stability Loss of joint stability TraumaTrauma AgingAging Genetic and metabolic diseases Genetic and metabolic diseases InflammationInflammation Immune system activity Immune system activity Compromised cartilage Biophysical changes • Collagen network fracture • Proteoglycan unraveling Biochemical changes • Inhibitors reduced • Proteolytic enzymes increased Abnormal stresses Abnormal cartilage Mandelbaum B et al. Orthopedics. 2005;28(2 suppl):s207-s214. Adapted with permission from 2002 Medtronic Sofamor Danek, Basic Bone Biology.
- 6. EULAR Diagnostic Criteriafor Knee OA (2010) ■ Based on review of studies from 1950-2008 and expert consensus ■ Focuses on clinical diagnosis: presence of three symptoms and three signs correctly diagnoses 99% of cases SymptomsSymptoms 1 Persistent knee pain √ 2 Limited morning stiffness √ 3 Reduced function √ SignsSigns 4 Joint crepitus √ 5 Restricted movement √ 6 Bony enlargement √ EULAR=European League Against Rheumatism. Zhang W et al. Ann Rheum Dis. 2010;69(3):483-489.
- 7. ACR Diagnostic Criteriafor Knee OA (1986) ■ Clarified and standardized definition of osteoarthritis Joint symptoms and signs associated with defective integrity of articular cartilage and changes in underlying joints at bone margin ■ Focuses on clinical examination of knee pain plus: ■ Sensitivity, 95%; specificity, 69% Presence of 3 of the followingPresence of 3 of the following 1 Age >50 years √ 2 Morning stiffness <30 minutes √ 3 Joint crepitus on active motion √ 4 Bony tenderness √ 5 Bony enlargement √ 6 No palpable warmth of synovium √ ACR=American College of Rheumatology. Altman RD et al. Arthritis Rheum. 1986;29(8):1039-1049.
- 8. Key principles5 : EULARguidelines 1. Treatment should be tailored to the patient 2. The relationship between the healthcare team and the patient should be a two-way process 3. Using tools can help to assess the patient’s pain and disability 4. Patient education has a significant impact on pain management 5. Treatment should be a combination of non-pharmacological and pharmacological measures
- 9. Management options5: EULAR guidelines 6.Non-pharmacological management strategies should be incorporated 7. Paracetamol and NSAIDs should be used as first-line pharmacotherapy 8. There is evidence to support the use of some symptomatic slow-acting drugs for OA (SYSADOA) 9. Corticosteroid intra-articular injections can be useful in acute exacerbations 10. Consider surgery in patients unresponsive to medical management
- 10. Key principle 1 Patient-tailoredtreatment ■ OA is a long-term, chronic condition and has a considerable impact on quality of life5 ■ Treatment should: be tailored to the patient5 consider the individual patient’s needs in terms of both functionality and of pain relief5 ■ It is likely that each individual patient will have to try a number of management options before finding the combination which works best for them5
- 11. Key principle 2 Doctor/patientrelationship5 ■ The relationship between the healthcare team and the patient is key ■ The patient should be an active partner in disease management ■ Involve the patient in treatment decisions and listen to their concerns ■ The patient is an expert in their disease: they know their pain better than anyone else and will have developed strategies to deal with it
- 12. Key principle 3Using tools ■ Tools can help to assess the patient’s pain and disability ■ Tools include: rating scales questionnaires6 pain diagrams ■ Using tools before and after treatment is also useful to determine whether treatment is working
- 13. Pain drawings Mark thearea on your body where you feel the described sensations Use the appropriate symbol Mark the areas of radiation Include all affected areas Numbness = = = = Pins and needles ° ° ° ° ° ° Burning xxxxxxxx Stabbing / / / / / / /
- 14. Rating scales ■ Visualanalogue scale No pain Worst possible pain • Pain intensity 0 No pain 1 Mild 2 Discomforting 3 Distressing 4 Horrible 5 Excruciating
- 15. Key principle 4Patient education ■ Studies suggest that education is around 20% as effective as NSAIDs, and can have a synergistic effect with other treatments8 ■ Patient information and self-management strategies can empower patients to take control of their arthritis ■ Effective education techniques include: individual education packs regular telephone calls group education patient coping skills spouse assisted coping skills training5
- 16. Key principle 5Management options ■ Treatment should be a combination of non-pharmacological and pharmacological measures5 ■ Indirect evidence suggests non- pharmacological treatments offer additional benefits over and above treatment with NSAIDs and analgesics5
- 17. Goals of OAManagement: OARSI Recommendations Reduce joint pain and stiffness Reduce physical disability Improve HRQoL Educate patients Limit progression of joint damage Knee and Hip OA: Goals of Treatment HRQoL=health-related quality of life; OARSI=Osteoarthritis Research Society International. Zhang W et al. Osteoarthritis Cartilage. 2008;16(2):137-162. Maintain and improve joint mobility
- 18. Integrated Approach toTreating Patients With OA NonpharmacologicNonpharmacologic PharmacologicPharmacologic ■ Patient education ■ Phone contact (promote self-care) ■ Referral to physical therapist ■ Aerobic, strengthening, and/or water- based exercise ■ Weight reduction ■ Walking aids, knee braces ■ Proper footwear, insoles ■ Thermal modalities ■ TENS ■ Acupuncture ■ APAP ■ Oral NSAIDs ■ Topical NSAIDs and capsaicin ■ Corticosteroid injections ■ Hyaluronate injections ■ Glucosamine, chondroitin sulphate, and/or diacerein ■ Weak opioids and narcotic analgesics for refractory pain* SurgicalSurgical ■ Total joint replacement ■ Unicompartmental knee replacement ■ Osteotomy and other joint preserving surgical procedures ■ Lavage/debridement in knee OA† ■ Joint fusion after failure of joint replacement * Pain resistant to ordinary treatment. † Controversial. TENS=transcutaneous electrical nerve stimulation. Zhang W et al. Osteoarthritis Cartilage. 2008;16(2):137-162.
- 19. Management option 6 Non-pharmacologicalmanagement ■ Life-style modification has an important role in management5,9 ■ For example5 : weight loss exercise – quadriceps strengthening – range of movement – general fitness – hydrotherapy assistive devices (canes and frames) appropriate footwear, insoles
- 20. Management option 6 Non-pharmacologicalmanagement ■ Little formal evidence to support complementary therapies, but some patients derive considerable benefit ■ Examples of complementary therapies include: Acupuncture Alexander technique Aromatherapy Chiropractice Hydrotherapy Massage Osteopathy Reflexology Tai chi
- 21. Management option 6 Non-pharmacologicalmanagement ■ Self-management strategies can improve patients’ ability to manage their pain and disability of OA5 ■ Access to patient organisations and support groups which provide help and advice
- 22. Management option 7 Analgesiaand NSAIDs ■ Use paracetamol as first-line therapy5 ■ It is likely that the majority of patients will have already tried over-the-counter paracetamol5 ■ In those patients with a poor response to paracetamol, NSAIDs should be considered5 ■ NICE guidance recommends that COX-2 selective inhibitors should be considered only in patients who may be at high risk of developing serious gastro-intestinal (GI) adverse events10 ■ The European Medicines Agency advised doctors that Cox-2 selective inhibitors should only be prescribed to people with arthritis at ‘the lowest effective dose for the shortest possible duration’. (EMEA 27 June 2005)
- 23. Management option 7(1) COX-2 selective inhibitors ■Consider in patients who may be at high risk of developing serious GI adverse events, and in whom an NSAID is clearly indicated10 See over for updated Cox-2 prescribing guidelines
- 24. Management option 7(1a) COX-2 selective inhibitors ■High-risk patients include, those: aged 65 years and over, with a previous clinical history of gastroduodenal ulcer, GI bleeding or gastroduodenal perforation. The use of even a COX-2 selective agent should be considered especially carefully in this situation, taking concomitant medication(s) that are known to increase the likelihood of upper GI adverse events (eg corticosteroids, anti-coagulants) 24 Please see Full Prescribing Information available at this presentation.
- 25. Management option 7(2) COX-2 selective inhibitors June 2005 – The European Medicines Agency reviewed Cox-2 selective inhibitors, they concluded that: – the risks of potential fatal skin reactions with Valdecoxib (Bextra) outweighed the benefits and suspended Valdecoxib for a year, pending a review. Pfizer voluntarily withdrew Valdecoxib – other Cox-2 selective inhibitors (Celecoxib, Etoricoxib, Lumiracoxib, Parecoxib) will have stronger guidelines for prescription: – Cox-2s should not be prescribed to people with ischaemic heart disease, cerebrovascular disease or peripheral arterial disease – caution when prescribing Cox-2s to people with heart disease, hypertension, hyperlipidaemia (cholesterol), diabetes and smokers – doctors are advised to prescribe the lowest effective Cox-2 dose for the shortest possible duration
- 26.
- 27. McKenna F etal. Scand J Rheumatol 2001;30:11–18. VAS=visual analogue scale. LessPain Patient’s Assessment of Pain (VAS): Mean change at week 6 MeanChange(mm) *p=0.001 vs. placebo placebo (n=200) celecoxib 100 mg BID (n=199) diclofenac 50 mg TID (n=199) CELECOXIBvs. diclofenac: 6-week Knee OA Trial McKenna et al. 2001: Patient’s Assessment of Pain
- 28. McKenna F etal. Scand J Rheumatol. 2001;30:11-18. American Pain Society (APS) Pain Measure: Worst Pain in the Past 24 Hours MeanChangeinScore p=0.05, active treatment vs. placebo (days 1-7). -4.0 -3.5 -3.0 -2.5 -2.0 -1.5 -1.0 -0.5 0.0 Baseline Day 1 Day 2 Day 3 Day 4 Day 5 Day 6 Day 7 placebo (n=200) celecoxib 100 mg BID (n=199) diclofenac 50 mg TID (n=199) LessPain CELECOXIBvs. diclofenac: 6-week Knee OA Trial McKenna et al. 2001: American Pain Society – Pain Measure
- 29.
- 30. Guidelines for Preventionof NSAID-Related Ulcer Complications (ACG Practice Guidelines 2009) za FL et al. Am J Gastroenterol 2009;104:728-738
- 31.
- 32. Boxed Warning forAll Prescription NSAIDs Cardiovascular Risk NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk. [Product] is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery. Gastrointestinal Risk NSAIDs, including [product], cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal (GI) events. Cardiovascular Risk NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk. [Product] is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery. Gastrointestinal Risk NSAIDs, including [product], cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal (GI) events.
- 33. 09/25/09 APTC Composite EndPoint (Adjudicated): Celecoxib vs ns-NSAIDs Meta-analysis of 25 RCTs White et al. Am J Cardiol. 2007. RelativeRisk(CI)ofSerious CVAdverseEvents ns-NSAIDs (n=13,990) Celecoxib 200-800 mg daily (n=19,773) 0.90 (95% CI: 0.60-1.33) 2.0 1.5 0.5 0 1.0 1.0 49 events 54 events P=.59 (NS)
- 34. CELECOXIB vs. naproxen& etoricoxib: CV Safety Profile Schwartz et al. 2007: Blood pressure change Compared to naproxen and etoricoxib, celecoxib only shows significant change compared to placebo. Meanwhile etoricoxib shows significant increase compared to placebo, baseline, and celecoxib and naproxen. + Significantly different from placebo (P ≤ .05) * Significantly different from baseline (P ≤ .05), placebo (P ≤ .05), and naproxen and celecoxib (P < .03) Schwartz JI et al. J Clin Pharmacol 2007;47:1521-31. + + * + + * Average blood pressure over a 24-hour period between days 1-14 2.4 3.6 7.7 0 1 2 3 4 5 6 7 8 9 Systolicbloodpressure,mmHg celecoxib 200 mg BID (n=21) naproxen 500 mg BID (n=21) etoricoxib 90 mg OD (n=21)
- 35. Moore RA etal. BMC Musculoskelet Disord 2007;8:73. celecoxib – Annually, per 1,000 patients, there were: •12 fewer upper GI complications •2 fewer fatal/non-fatal heart attacks or strokes celecoxib etoricoxib lumiracoxib all coxibs Event rate difference (coxib-NSAID per 1000 per year) Favours coxib Favours ns-NSAID GI bleed difference CV event dfifference Coxibs vs. ns-NSAIDs: GI and CV Benefit/Risk Profile Moore et al. 2007: GI and CV Event Rates
- 36. Celecoxib Renal & HeparSafety Profile
- 37. Incidence of patientswith treatment-related CV, renal, and hepatic AEs 1.7 1.1 4.1 5.2 0 1 2 3 4 5 6 CV / renal AE Hepatic AE %Patients celecoxib 200 mg OD diclofenac 50 mg BID CELECOXIB vs. diclofenac Dahlberg et al. 2009: CV / renal & hepatic AEs One-year, randomized, multicentre, double-blind, parallel-group study to assess the AE-related discontinuation rate with celecoxib and diclofenac in elderly patients with OA. No p-values reported for related/not-related-to-treatment incidence. Significantly fewer patients in the celecoxib group than the diclofenac group experienced cardiovascular/renal AEs (70/458 vs. 95/458, p=0.039) or hepatic AEs (10/458 vs. 39/458, p<0.0001). Dahlberg LE et al. Scand J Rheumatol 2009;38:133-143.
- 38. Prevalence of hepaticevents 0.24 0.97 0.59 0.5 0.37 0.31 0.21 0 0.2 0.4 0.6 0.8 1 1.2 %hepaticevents celecoxib diclofenac ketoprofen meloxicam etodolac piroxicam ibuprofen CELECOXIB vs ns-NSAIDs:Hepatic Safety Profile Sanchez-Matienzo et al. 2006: Prevalence of hepatic events A case/noncase analysis of spontaneous reports was conducted to compare the hepatic safety profile of COXIBs and ns- NSAIDs. Sanchez-Matienzo D et al. Clin Ther 2006;28:1123-1132.
- 40. Management option 8 Symptomaticslow-acting drugs of OA ■ Symptomatic slow-acting drugs of OA (SYSADOA) glucosamine chondroitin hyaluronic acid diacerein ■ Supported by increasing evidence, although further research is still required5,8,11,12 ■ Given that these agents appear to be well tolerated and do show some benefit their use should be considered13
- 41. Management option 9 Corticosteroidinjections ■ Corticosteroid intra-articular injections may be used in the management of patients with OA of the knee5 ■ Provide superior short-term efficacy (2-4 weeks) versus placebo8 ■ Recommended for acute exacerbations5
- 42. Management option 10 Surgery ■Refer for orthopaedic evaluation if patient is disabled by OA or in pain unrelieved by medical management5,9 ■ Joint replacement can be very effective5 ■ Newer techniques such as metal-on-metal resurfacing are less invasive15 ■ Patients should be made aware of the risks and benefits of surgery
- 43. Other useful resources ArthritisResearch Campaign http://www.arc.org.uk Primary Care Rheumatology Society http://www.pcrsociety.com British Society for Rheumatology http://www.rheumatology.org.uk The European League Against Rheumatism http://www.eular.org National Library for Health – Musculoskeletal Library http://libraries.nelh.nhs.uk/musculoskeletal Primary Care Question & Answer Service http://www.clinicalanswers.nhs.uk/index.cfm
- 44. References 1-9 1. ArthritisCare. 1 in 5 – The prevalence and impact of arthritis in the UK (Research report). February 2002. 2. Disability Care and Mobility Quarterly Statistical Enquiry - Disability Living Allowance, Attendance Allowance and Invalid Care Allowance. Dept of Work and Pensions 2002. 3. Watson M. Management of patients with osteoarthritis. Pharm J 1997;259:296-297. 4. Royal College of General Practitioners OPCS Department of Health and Social Security. Morbidity statistics from General Practice. Fourth National Survey 1991-1992. HMSO, 1996. 5. Jordan KM, Arden NK, Doherty M et al. EULAR recommendations 2003: an evidence based approach to the management of knee osteoarthritis: Report of a task force of the Standing Committee for International Clinical Studies Including Therapeutic Trials (ESCISIT). Ann Rheum Dis 2003;62:1145-1155. 6. Dawson J, Fitzpatrick R, Murray D et al. Questionnaire on the perceptions of patients about total knee replacement. J Bone Joint Surg (Br) 1998;80:63-69. 7. Creamer P, Lethbridge-Cejku M, Hochberg MC. Factors associated with functional impairment in symptomatic knee osteoarthritis. Rheumatology 2000;39:490-496. 8. Walker-Bone K, Javaid K, Arden N et al. Regular review: Medical management of osteoarthritis. BMJ 2000;321:936-940. 9. Recommendations for the medical management of osteoarthritis of the hip and knee: 2000 update. American College of Rheumatology Subcommittee on Osteoarthritis Guidelines. Arthritis Rheum 2000;43(9):1905-1915.
- 45. References 10-15 10. Guidanceon the use of cyclo-oxygenase (COX) II selective inhibitors, celecoxib, rofecoxib, meloxicam and etodolac for osteoarthritis and rheumatoid arthritis. NICE Technology Appraisal Guidance 27, July 2001. 11. Deal CL, Moskowitz RW. Nutraceuticals as therapeutic agents in osteoarthritis. The role of glucosamine, chondroitin sulfate and collagen hydrolysate. Rheum Clin N Am 1999;25:379-395 12. Is glucosamine worth taking for osteoarthritis. Drug & Ther Bull 2002;40:81-83. 13. Chard J, Dieppe P. Glucosamine for osteoarthritis: Magic, hype, or confusion? It's probably safe-but there's no good evidence that it works. BMJ 2001;322(7300):1439- 1440. 14. Guidance on the selection of prostheses for primary total hip replacement. NICE Technology Appraisal Guidance 2, April 2000. 15. Guidance on the use of metal on metal hip resurfacing arthroplasty. NICE Technology Appraisal Guidance 44, June 2002.
- 46. 46 Please see FullPrescribing Information available at this presentation. THANK YOU
Editor's Notes
- #3 Data from the 2007-2009 National Health Interview Survey reveal high rates of self-reported, doctor-diagnosed arthritis and limitations due to arthritis.1 In addition, in every adult age group, women are more likely to be affected by arthritis than men.2 Arthritis and rheumatism are the leading causes of disability in the United States,3 and it is estimated that by 2030, 67 million Americans will have health care practitioner-diagnosed arthritis.4 References: Centers for Disease Control and Prevention. Prevalence of doctor-diagnosed arthritis and arthritis-attributable activity limitation — United States, 2007–2009. MMWR Morb Mortal Wkly Rep. 2010;59(39):1261-1265. Centers for Disease Control and Prevention. NHIS Arthritis Surveillance: Arthritis Prevalence in Women and Men. www.cdc.gov/arthritis/data_statistics/national_nhis.htm. Accessed January 12, 2011. Centers for Disease Control and Prevention. Prevalence and most common causes of disability among adults—United States, 2005. MMWR Morb Mortal Wkly Rep. 2009;58(16):421-426. Hootman JM, Helmick CG. Projections of US prevalence of arthritis and associated activity limitations. Arthritis Rheum. 2006;54(1):226-229.
- #4 It has been estimated that one in five of the population - over nine million people - in the UK have arthritis1. Osteoarthritis (OA) is the most common form3 and is associated with considerable morbidity. It is second only to cardiovascular disease in causing severe morbidity3, in fact, arthritis is the largest single cause of physical disability in the UK2.
- #5 By far the majority of patients with OA are managed in Primary Care – with musclo-skeletal problems accounting for one in ten (10%) of General Practice consultations4. However, management of OA in Primary Care is limited by resources, especially the GP’s available time – the average GP consultation time is 7-8 minutes. Bearing in mind that patients are likely to present more than one problem per consultation – time spent specifically dealing with OA becomes even more limited. Despite the high prevalence and the burden of disease, musculoskeletal medicine is not a priority area to most practices. This is further compounded by a lack of formal training in musculoskeletal medicine and the absence of national targets (National Service Framework and so forth). Research from Arthritis Care suggests that around one-quarter of patients with arthritis are dissatisfied with the treatment that they receive from their GP, 82% feel that their GP does not have a good understanding of their condition and 85% feel that arthritis is not given a high enough priority1. It is hoped that this educational support programme will aid in building GP-patient relationships and improve overall quality of care. Early diagnosis of OA and appropriate management can reduce disability through treatment, education, and alterations in lifestyle and activities.
- #6 This slide provides an overview of the factors that can contribute to the development of OA. These factors can be divided into two groups: those placing abnormal stress on the cartilage, such as obesity and anatomic abnormalities, and those contributing to abnormalities of the cartilage, such as aging and genetic diseases. All of these factors can contribute to compromised cartilage and ultimately result in cartilage breakdown. Reference: Mandelbaum B, Waddell D. Etiology and pathophysiology of osteoarthritis. Orthopedics. 2005;28(2 suppl):s207-s214.
- #7 In 2010, the European League Against Rheumatism (EULAR) provided six criteria—three symptoms and three signs—that could be used to correctly diagnose OA of the knee in 99% of cases, when all six criteria are present. The three symptoms are: Persistent knee pain Limited morning stiffness Reduced function The three signs are: Joint crepitus Restricted movement Bony enlargement Reference: Zhang W, Doherty M, Peat G, et al. EULAR evidence-based recommendations for the diagnosis of knee osteoarthritis. Ann Rheum Dis. 2010;69(3):483-489.
- #8 In 1986 the American Rheumatism Association—now the American College of Rheumatology (ACR)—developed criteria to diagnose OA on the basis of knee pain and three of the following six criteria: Age older than 50 years Less than 30 minutes of morning stiffness Joint crepitus Bony tenderness Bony enlargement Absence of palpable warmth The sensitivity and specificity of these criteria were 95% and 69%, respectively. Reference: Altman R, Asch E, Bloch D, et al. Development of criteria for the classification and reporting of osteoarthritis: classification of osteoarthritis of the knee. Arthritis Rheum. 1986;29(8):1039-1049.
- #9 These five key principles are based around the EULAR guidelines5 and practical GP experience: Treatment should be tailored to the patient The relationship between the healthcare team and the patient should be a two-way process Using tools can help to assess the patient’s pain and disability Patient education has a significant impact on pain management Treatment should be a combination of non-pharmacological and pharmacological measures.
- #10 As we have already discussed, treatment should be a combination of non-pharmacological and pharmacological measures5: Non-pharmacological management strategies – life-style modification, education, self-management – should be included in management options Paracetamol and NSAIDs should be used as first-line pharmacotherapy. COX-2 selective inhibitors should be considered only in patients at high risk of gastro-intestinal events There is evidence to support the use of some symptomatic slow-acting drugs for OA (SYSADOA) e.g. glucosamine, chondroitin and hyaluronic acid Corticosteroid intra-articular injections can be useful in acute exacerbations Consider surgery in patients unresponsive to medical management.
- #11 OA is a long-term, chronic condition and has a considerable impact on quality of life – influencing many aspects of the patient’s health – both emotional and physical. Treatment should be tailored to the patient – and should consider the individual patient’s needs in terms of both functionality and of pain relief5. It is likely that each individual patient will sample a number of management options before finding the combination which works best for them. This is clarified in the 2003 EULAR guidelines which state that ‘There is no single right or wrong approach, and each health professional must decide with each patient the most appropriate management plan at a particular time and for that location’ 5.
- #12 Patients should be actively involved with treatment decisions and their concerns heard. Listen to the patient: remember that they know their pain better than anyone else and will have developed strategies to deal with it. It is essential that the patient is an active partner in their disease management and is kept fully informed of the diagnosis and treatment options. Giving patients the confidence and information to take responsibility for their health, can help patients to manage their OA more effectively and improve quality of life5.
- #13 Tools such as rating scales/questionnaires/pain diagrams can help to assess the patient’s pain and disability6. Using such tools before and after treatment is also useful to determine whether treatment is working, as radiological changes do not always correlate with disability or function7.
- #16 Studies suggest that education is around 20% as effective as NSAIDs, and can have a synergistic effect with other treatments8. Patient information and self-management strategies can empower patients to take control of their arthritis. Arthritis Care run a range of self-management courses including Challenging Arthritis and the Positive Future workshops aimed at younger people.
- #17 The optimal management of OA requires a combination of non-pharmacological and pharmacological treatment5. Non-pharmacological management strategies include lifestyle modifications, complementary therapies and self-management strategies and are covered in the next three slides.
- #18 Consensus guidelines from the Osteoarthritis Research Society International (OARSI) indicate six key goals for the treatment of knee and hip OA. Four of these goals relate to the patient’s physical state: Reduce joint pain and stiffness Maintain and improve joint mobility Reduce physical disability Limit progression of joint damage The other two key goals are to educate the patient about OA and its management, and to improve patient’s health-related quality of life. Reference: Zhang W, Moskowitz RW, Nuki G, et al. OARSI recommendations for the management of hip and knee osteoarthritis, Part II: OARSI evidence-based, expert consensus guidelines. Osteoarthritis Cartilage. 2008;16(2):137-62.
- #19 The Osteoarthritis Research Society International (OARSI) consensus guidelines describe an integrated approach to treating patients with OA, including nonpharmacologic, pharmacologic, and surgical interventions. Nonpharmacologic aspects of treatment include such interventions as patient education, exercise, weight reduction, and the nondrug therapies transcutaneous electrical nerve stimulation (TENS) and acupuncture. Listed among the pharmacologic treatments are acetaminophen, selective and nonselective NSAIDs, steroid injections, glucosamine and chondroitin, and for some patients, weak opioids and narcotic analgesics. Surgical interventions listed in the guidelines include total joint replacement, joint fusion in cases of replacement failure, unicompartmental knee replacement, osteotomy, and lavage and debridement in knee OA, although this last approach is controversial. Reference: Zhang W, Moskowitz RW, Nuki G, et al. OARSI recommendations for the management of hip and knee osteoarthritis, Part II: OARSI evidence-based, expert consensus guidelines. Osteoarthritis Cartilage. 2008;16(2):137-62.
- #20 Lifestyle modifications which include weight loss, exercise (quadriceps strengthening, range of movement and general fitness, hydrotherapy), appliances (canes, frames and knee bracing) and appropriate footwear5,9 all have an important role in management.
- #21 Complementary therapies include acupuncture, Alexander technique, aromatherapy, chiropractic, hydrotherapy, massage, osteopathy, reflexology and Tai Chi. Although, there is little formal evidence to support their use some patients derive considerable benefit from these treatments.
- #22 Self-management strategies can substantially improve patients’ ability to manage the pain and disability associated with OA5. Access to patient organisations and support groups for help and advice can be extremely helpful (e.g. Arthritis Care helplines: Freephone helpline: 0808 800 4050 Monday-Friday, 12 noon-4 pm National rate helpline: 020 7380 6555 Monday-Friday, 10 am-4 pm)
- #23 Although EULAR guidelines recommend paracetamol or NSAIDs, paracetamol is generally recommended as first-line pharmacotherapy in the majority of patients with OA. It is likely that most patients will have already tried over-the-counter medicines including paracetamol5. Therefore when considering treatment options ask the patient about any over-the-counter medications (including oral or topical analgesia) and any alternative medicines which they are taking. Only in those patients with a poor response to paracetamol, should NSAIDs be considered5. The National Institute of Clinical Excellence (NICE) recommends that COX-2 selective inhibitors should be considered only in patients who may be at ‘high risk’ of developing serious gastro-intestinal (GI) adverse events and when clearly indicators10.
- #24 NICE recommends that COX-2 selective inhibitors should be considered only in patients who may be at ‘high risk’ of developing serious GI adverse events, and in whom an NSAID is clearly indicated10. High risk patients include, those: aged 65 years and over, with a previous clinical history of gastroduodenal ulcer, GI bleeding or gastroduodenal perforation. The use of even a COX-2 selective agent should be considered especially carefully in this situation, taking concomitant medication(s) that are known to increase the likelihood of upper GI adverse events (e.g. corticosteroids, anti-coagulants), with serious co-morbidity, such as cardiovascular disease, renal or hepatic impairment, diabetes and hypertension who have a requirement for the prolonged use of maximum recommended doses of standard NSAIDs.
- #26 NICE recommends that COX-2 selective inhibitors should be considered only in patients who may be at ‘high risk’ of developing serious GI adverse events, and in whom an NSAID is clearly indicated10. High risk patients include, those: aged 65 years and over, with a previous clinical history of gastroduodenal ulcer, GI bleeding or gastroduodenal perforation. The use of even a COX-2 selective agent should be considered especially carefully in this situation, taking concomitant medication(s) that are known to increase the likelihood of upper GI adverse events (e.g. corticosteroids, anti-coagulants), with serious co-morbidity, such as cardiovascular disease, renal or hepatic impairment, diabetes and hypertension who have a requirement for the prolonged use of maximum recommended doses of standard NSAIDs.
- #28 Key point: Celecoxib relieves OA pain of the knee as effectively as diclofenac. Background: All efficacy outcomes were significantly superior with celecoxib compared with placebo at both week 2 and week 6. In the primary efficacy analysis of patient’s assessment of pain by VAS, there was no statistically significant difference between celecoxib and diclofenac. Reference: McKenna F et al. Celecoxib versus diclofenac in the management of osteoarthritis of the knee: a placebo-controlled, randomised, double-blind comparison. Scand J Rheumatol 2001;30:11-18.
- #29 Key point: Celecoxib decreased APS pain measure of worst pain in the past 24 hours as effectively as diclofenac. Background: Celecoxib reduced the amount of acute pain experienced by patients with knee OA compared with placebo within the first 24 hours of therapy. The American Pain Society (APS) pain measures were significantly improved with celecoxib compared with placebo on day 1, and this response was maintained throughout the 7-day evaluation period (p&lt;0.01). By day 7, 7% of patients taking placebo, 17% of those treated with celecoxib, and 15% of those treated with diclofenac reported no pain (p&lt;0.01, active treatment vs. placebo). Pain response was similar between celecoxib and diclofenac groups. Reference: McKenna F et al. Celecoxib versus diclofenac in the management of osteoarthritis of the knee: a placebo-controlled, randomised, double-blind comparison. Scand J Rheumatol 2001;30:11-18.
- #31 Patients with risk factors for cardiovascular disease (i.e., prior history of a cardiovascular event, diabetes, hypertension, hyperlipidemia, and obesity) oI en receive prophylactic aspirin. - ey may bene5 t from the substitution of a less cardiotoxic NSAID instead of a COX-2 inhibitor. Naproxen may be the agent of choice as it may have some cardioprotective properties (76,98,108,109,112) . In addition, these patients should receive a PPI or misoprostol because the combination of naproxen and low-dose aspirin markedly increases the risk of GI bleeding. Patients at very high GI risk who also have increased CV risk should not be treated with NSAIDs or coxibs and another form of treatment should be considered. Reference: Lanza FL et al. Am J Gastroenterol 2009;104:728-738
- #33 In April 2005, the FDA issued request letters to manufacturers of all NSAIDs, asking that they make labeling changes to their products.1 These letters included recommended labeling for both prescription and over-the-counter NSAIDs and a medication guide for the entire class of prescription products. All manufacturers of marketed prescription NSAIDs, including Celebrex (celecoxib), were asked to revise the labeling (package insert) for their products to include a boxed warning (shown), which highlights the potential for an increased risk of cardiovascular (CV) events.2-4 Manufacturers of over-the-counter NSAIDs were also asked to revise their labeling to provide more specific information about the potential CV risks of their individual products. References: FDA. COX-2 selective (includes Bextra, Celebrex, and Vioxx) and non-selective non-steroidal anti-inflammatory drugs (NSAIDs). April 7, 2005. www.fda.gov/drugs/drugsafety/postmarketdrugsafetyinformationforpatientsandproviders/ucm103420.htm. Accessed January 12, 2011. Celebrex [package insert]. New York, NY: Pfizer Inc.; June 2009. EC-Naprosyn/Naprosyn/Anaprox/Anaprox DS [package insert]. Nutley, NJ: Roche Pharmaceuticals; July 2008. Voltaren-XR [package insert]. East Hanover, NJ: Novartis; March 2009.
- #34 This slide represents results of the analysis of 25 completed clinical trials that compared celecoxib with nonselective NSAIDs. A total of 19,773 patients treated with a total daily celecoxib dose of 200-800 mg were compared with 13,990 patients treated with nonselective NSAIDs (all nonselective NSAIDs combined, any dose).1 There were no significant differences in adjudicated APTC event rates for celecoxib compared with nonselective NSAIDs (RR 0.90; 95% CI: 0.60-1.33), as shown in the slide, nor for unadjudicated event rates (RR 0.86; 95% CI: 0.59-1.26) (not shown).1,2 The basis of evaluating relative risk was event rate per 100 patient years.1 References 1. White WB, West CR, Borer JS, et al. Risk of cardiovascular events in patients receiving celecoxib: a meta-analysis of randomized clinical trials. Am J Cardiol. 2007;99:91-98. 2. FDA February 16-18, 2005 Joint Meeting with the Drug Safety and Risk Management Advisory Committee. Available at: http://www.fda.gov/ohrms/dockets/ac/cder05.html#ArthritisDrugs. Accessed January 11, 2007.
- #36 Key point: Celecoxib offers a favourable benefit/risk profile vs. ns-NSAIDs and other coxibs with 12 fewer upper GI complications and 2 fewer fatal/non-fatal heart attacks or strokes per 1,000 patients. Background: This study calculated the absolute risk GI and CV events. Studies with large amounts of information were included in the calculation of annualized rates for clearly defined gastrointestinal (complicated upper gastrointestinal perforations, ulcers, or bleeds, but not symptomatic or endoscopic ulcers) and serious cardiovascular outcomes (antiplatelet trial collaborators - APTC - outcome of fatal or nonfatal myocardial infarction or stroke, or vascular death). Meta-analyses and large randomized trials specifically analyzing serious gastrointestinal bleeding or cardiovascular events occurring with 5 different coxibs had appropriate data. In total there were 439 complicated upper gastrointestinal events in 49,006 patient-years of exposure and 948 serious cardiovascular events in 99,400 patient-years of exposure. Complicated GI events occurred less frequently with coxibs than ns-NSAIDs; serious CV events occurred at approximately equal rates. For each coxib (celecoxib, lumiracoxib, rofecoxib, valdecoxib and etoricoxib), the reduction in complicated upper GI events was numerically greater than any increase in APTC events. In the overall comparison, for every 1,000 patients treated for a year with a coxib rather than ns-NSAID, there would be 8 fewer complicated upper GI events, but one more fatal or nonfatal heart attack or stroke. However, varying results were obtained for different coxib-ns-NSAID comparisons. For example, for every 1,000 patients treated for a year with celecoxib rather than a ns-NSAID, there would be 12 fewer upper GI complications, and 2 fewer fatal or nonfatal heart attacks or strokes. For rofecoxib (no longer on the market), there would be 6 fewer upper GI complications, but 3 more fatal or nonfatal heart attacks or strokes. For lumiracoxib, there would be 8 fewer upper GI complications, but 1 more fatal or nonfatal heart attack or stroke. Reference: Moore RA et al. Cyclo-oxygenase-2 selective inhibitors and nonsteroidal anti-inflammatory drugs: balancing gastrointestinal and cardiovascular risk. BMC Musculoskelet Disord 2007;8:73.
- #41 There is growing evidence to support SYSADOA and recent data suggest that glucosamine sulphate could be used as a structure modifying agent in knee OA5, although further research is still required5,8,11,12. However, given that these agents appear to be well tolerated and do show some benefit their use should be considered13.
- #42 Corticosteroid intra-articular injections may be used in the management of patients with OA of the knee5. They provide superior short-term efficacy (2-4 weeks) versus placebo8. They are recommended for acute exacerbations, but have minimal medium to long-term effects5.
- #43 Patients with radiographic evidence of OA and severe symptomatic pain which is not relieved by medical management should be referred to an orthopaedic surgeon for evaluation5,9. Joint replacement can transform lives of patients with severe OA5. NICE guidance recommends that replacement hip joints should last for 10 years or more (10% revision rate at 10 years)14. A newer technique - metal on metal resurfacing - replaces damaged surfaces in the joint with metal surfaces. Less bone is removed than when fitting a conventional joint replacement. Resurfacing is indicated in younger patients, aged under 65 years, who are likely to outlive the life of a total hip replacement or those who take part in activities which are likely to shorten the life of a total hip replacement15. It is important that patients are made aware of the risks and benefits of any surgery – and in particular that less is known about resurfacing than conventional joint replacement.
- #44 The Arthritis Research Campaign aims to advance the understanding, prevention and treatment of arthritis and related conditions. The website provides information to people affected by arthritis and to the general public. The Primary Care Rheumatology Society aims to improve education in rheumatology in general practice, to set up relevant research topics, to increase communication between hospital rheumatologists and other relevant health professionals, with the ultimate aim of improving care for patients with rheumatic disease. The British Society for Rheumatology (BSR) is the UK professional organisation for people working in rheumatology and related fields. The principal objective of the BSR is to advance the science and practice of rheumatology and to promote study and research through scientific meetings and educational courses. They have an extensive links page on their website. European League Against Rheumatism (EULAR) aims to promote, stimulate and support the research, prevention, treatment and rehabilitation of rheumatic diseases. The EULAR web site provides up to date information in the field of rheumatology to Allied Health Professionals, Social Leagues and Patient Organisations Patient UK provides over 500 leaflets on health and disease together with details of over 2,000 self-help/patient support groups and similar organisations. It also provides a directory of useful health-focused UK websites.