Rachmat Gunadi Wachjudi: The Management of Osteoarthritis Without Compromising Patient Safety
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This document provides biographical and career information about Rachmat Gunadi Wachjudi, including his place and date of birth, education history, specializations, current position, and professional organizations. It then discusses osteoarthritis (OA) management in primary care settings and lists common symptoms and signs used in the EULAR diagnostic criteria for knee OA. Finally, it outlines factors implicated in OA development and goals for OA treatment according to OARSI recommendations.
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Rachmat Gunadi Wachjudi: The Management of Osteoarthritis Without Compromising Patient Safety
- 1. Rachmat Gunadi Wachjudi Lahir di Garut, 16-1-1955 Pendidikan SD-SMA : Garut Dokter umum: FK UNSRI Palembang Spesialis1: FK UNPAD Bandung Spesialis2: FK UI Jakarta Clinical Rheumatology & Osteoporosis training Arthritis foundation of WA Pekerjaan: Ka Div Reumatologi Dep I Peny Dalam RS Dr Hasan Sadikin Organisasi Profesi IDI, IRA, PAPDI, PEROSI, PERALMUNI
- 2. The Management of Osteoarthritis Without Compromising the Patient's Safety Rachmat Gunadi Wachjudi Perhimpunan Reumatologi Indonesia Bandung
- 3. OA in Primary Care ■ Most patients with OA are managed in Primary Care ■ Overall, musculoskeletal problems account for 10- 30 % of General Practice consultations 4 ■ GPs have an opportunity to optimise patient care in OA
- 4. Factors Implicated in the Development of OA Obesity Aging Anatomic abnormalities Genetic and metabolic Microfractures diseases and bony Abnormal stresses Abnormal cartilage remodeling Inflammation Loss of joint stability Immune Compromised cartilage system Trauma activity Biophysical changes Biochemical changes • Collagen network fracture • Inhibitors reduced • Proteoglycan unraveling • Proteolytic enzymes increased Cartilage breakdown Mandelbaum B et al. Orthopedics. 2005;28(2 suppl):s207-s214. Adapted with permission from 2002 Medtronic Sofamor Danek, Basic Bone Biology.
- 5. EULAR Diagnostic Criteria for 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 Symptoms 1 Persistent knee pain √ 2 Limited morning stiffness √ 3 Reduced function √ Signs 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.
- 6. Goals of OA Management: OARSI Recommendations Maintain and improve joint mobility Reduce Reduce joint pain and physical stiffness disability Knee and Hip OA: Goals of Treatment Improve Educate HRQoL patients Limit progression of joint damage HRQoL=health-related quality of life; OARSI=Osteoarthritis Research Society International. Zhang W et al. Osteoarthritis Cartilage. 2008;16(2):137-162.
- 7. ACR 2000 Guidelines— Pharmacologic/Surgical Therapy Mild to Moderate Pain Moderate to Severe Pain • Simple analgesics • Rx NSAIDs plus (eg, acetaminophen) gastroprotective agent, • OTC NSAIDs or COX-2–selective inhibitors • Topical creams Additional Therapies • IA hyaluronans Surgical • IA steroids Intervention • Total knee replacement American College of Rheumatology Subcommittee on Osteoarthritis Guidelines. Arthritis Rheum. 2000;43:1905-1915.
- 8. The 10 Keys EULAR guidelines Please see Full Prescribing Information available at this presentation. 8
- 9. Key principles5: EULAR guidelines 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
- 10. 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
- 11. Key principle 1 Patient-tailored treatment ■ OA is a long-term, chronic condition and has a considerable impact on quality of life ■ Treatment should: be tailored to the patient 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 them
- 12. Key principle 2 Doctor/patient relationship5 ■ 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
- 13. Key principle 3 Using tools ■ Tools can help to assess the patient’s pain and disability ■ Tools include: rating scales questionnaires pain diagrams ■ Using tools before and after treatment is also useful to determine whether treatment is working
- 14. Pain drawings Mark the area 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 ///////
- 15. Rating scales ■ Visual analogue scale No Worst pain possible pain • Pain intensity 0 No pain 1 Mild 2 Discomforting 3 Distressing 4 Horrible 5 Excruciating
- 16. Key principle 4 Patient education ■ Studies suggest that education is around 20% as effective as NSAIDs, and can have a synergistic effect with other treatments ■ 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 training
- 17. Key principle 5 Management options ■ Treatment should be a combination of non- pharmacological and pharmacological measures ■ Indirect evidence suggests non-pharmacological treatments offer additional benefits over and above treatment with NSAIDs and analgesics
- 18. Management option 6 Non-pharmacological management ■ Life-style modification has an important role in management5,9 ■ For example: weight loss exercise – quadriceps strengthening – range of movement – general fitness – hydrotherapy assistive devices (canes and frames) appropriate footwear, insoles
- 19. Management option 6 Non-pharmacological management ■ Little formal evidence to support complementary therapies, but some patients derive considerable benefit ■ Examples of complementary therapies include: Acupuncture Alexander technique Aromatherapy Chiropractic Hydrotherapy Massage Osteopathy Reflexology Tai chi
- 20. Management option 6 Non-pharmacological management ■ Self-management strategies can improve patients’ ability to manage their pain and disability of OA ■ Access to patient organisations and support groups which provide help and advice PERMARI Kelompok Senam Ranca Badak
- 21. Management option 7 Analgesia and 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 ■ At ‘the lowest effective dose for the shortest possible duration’. (EMEA 27 June 2005)
- 22. 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 ■ 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)
- 23. Management option 7 (2) COX-2 selective inhibitors June 2005 – The European Medicines Agency reviewed Cox-2 selective inhibitors, they concluded that: – 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
- 25. CELECOXIB vs. diclofenac: 6-week Knee OA Trial McKenna et al. 2001: Patient’s Assessment of Pain Patient’s Assessment of Pain (VAS): Mean change at week 6 *p=0.001 vs. placebo Mean Change (mm) Less Pain placebo celecoxib diclofenac (n=200) 100 mg BID 50 mg TID (n=199) (n=199) VAS=visual analogue scale. McKenna F et al. Scand J Rheumatol 2001;30:11–18.
- 26. CELECOXIB vs. diclofenac: 6-week Knee OA Trial McKenna et al. 2001: American Pain Society – Pain Measure American Pain Society (APS) Pain Measure: Worst Pain in the Past 24 Hours Baseline Day 1 Day 2 Day 3 Day 4 Day 5 Day 6 Day 7 0.0 -0.5 p=0.05, active treatment vs. Mean Change in Score placebo (days 1-7). -1.0 Less Pain -1.5 -2.0 -2.5 -3.0 placebo (n=200) -3.5 celecoxib 100 mg BID (n=199) -4.0 diclofenac 50 mg TID (n=199) McKenna F et al. Scand J Rheumatol. 2001;30:11-18.
- 28. CLASS: UGI Ulcer Complications and Symptomatic Ulcers at 6 Months—All Patients P=.02 4 3.54% Annualized incidence (%) (per No. of patient-years) 3 Celecoxib 400 mg BID P=.09 (n=3987) 2.08% Nonspecific NSAIDs* 2 (n=3981) 1.45% 1 0.76% 0 Upper GI ulcer Complications and complications symptomatic ulcers Silverstein FE et al. JAMA. 2000;284:1247-1255.
- 29. SUCCESS-1: UGI Ulcer Complications and Symptomatic Ulcers RRR=51.5% 4 P<.05 (events per 100 patient-years) RRR=87.5% P<.05 3 Celecoxib* 2.1 (n=8800) Annualized rate 2 Nonspecific NSAIDs† (n=4394) 1.0 1 0.8 0.1 0 Ulcer complications Complications and symptomatic ulcers SUCCESS=Successive Celecoxib Efficacy and Safety Study in OA. *Celecoxib 200 mg/day or 400 mg/day; †Diclofenac 50 mg BID or naproxen 500 mg BID. Singh G et al. Presented at: EULAR; June 13-16, 2001; Prague, Czech Republic.
- 30. Utilization of Gastroprotective Strategies by Presence of GI Risk Factors Among New NSAID Users 1 Risk Factor ≥2 Risk Factors 0.1% 2.5% 10.8% 0.2% 4.0% 14.7% 86.6% 81.2% Coxib alone NSAID+GPA Coxib+GPA No gastroprotection Sturkenboom et al. Rheumatology. 2003;42(suppl 3):iii23-iii31.
- 31. CONDOR 2010 Patient with celecoxib has lower risk on gastrointestinal events than those with diclofenac SR + omeprazole 3.8 Proportion of patients % 4 3.5 (81 events, 3 95% CI, 2.9- 2.5 4.3) 2 1.5 0.9 1 0.5 (20 events, 95% CI, 0.5-1.3) 0 celecoxib 200 mg BID (n=2238) diclofenac SR 75 mg BID + omeprazole 20 mg OD (n=2246) 0001 n FKL et al. Lancet 2010; DOI:10.1016/S0140-6736(10)60673-3
- 33. CLASS: Thromboembolic CV AEs ASA Users* ASA Nonusers 5.0 5.0 Celecoxib 400 mg bid (n=882) Celecoxib 400 mg bid (n=3105) 4.5 4.5 NS-NSAIDs (n=857) NS-NSAIDs (n=3124) 4.0 4.0 3.5 3.5 3.0 3.0 2.5 2.5 Patients (%) 2.0 2.0 P=.947 P=.899 1.5 1.5 1.0 1.0 0.5 0.5 0 0 0 40 80 120 160 200 240 280 320 360 0 40 80 120 160 200 240 280 320 360 Days Days White et al. Am J Cardiol. 2002;89:425-430. Data on file. Pfizer Inc., New York, NY; FDA Advisory Committee Briefing Document. Cardiol. Available at: http://www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4090B1_03_Pfizer-Celebrex-Bextra.pdf. Accessed January 12, 2005.
- 34. Medi-Cal: NSAIDs and Risk for AMI 2,356,885 person-years of follow-up; 15,343 cases of AMI OR for AMI (95% CI) Remote use 1.00 (reference) Indomethacin 1.71 (1.35-2.17); P<.0001 Sulindac 1.41 (1.01-1.96); P<.04 Meloxicam 1.37 (1.05-1.78); P<.02 Rofecoxib 1.32 (1.22-1.42); P<.0001 Ibuprofen 1.11 (1.01-1.22); P<.02 Celecoxib 1.09 (1.02-1.15); P<.008 Naproxen 1.08 (0.95-1.22); P=.22 Valdecoxib 0.99 (0.72-1.37); P=.97 Nabumetone 0.83 (0.60-1.14); P=.26 0 0.2 0.4 0.6 0.8 1 1.2 1.4 1.6 1.8 Singh et al. EULAR. 2005.
- 35. Celecoxib Renal & Hepar Safety Profile
- 36. CELECOXIB vs. diclofenac Dahlberg et al. 2009: CV / renal & hepatic AEs Incidence of patients with treatment-related CV, renal, and hepatic AEs 6 5.2 5 4.1 % Patients 4 3 1.7 2 1.1 1 0 CV / renal AE Hepatic AE celecoxib 200 mg OD diclofenac 50 mg BID 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.
- 37. Management option 8 Symptomatic slow-acting drugs of OA ■ Symptomatic slow-acting drugs of OA (SYSADOA) glucosamine chondroitin hyaluronic acid ■ Supported by increasing evidence, although further research is still required ■ Given that these agents appear to be well tolerated and do show some benefit their use should be considered
- 38. Management option 9 Corticosteroid injections ■ Corticosteroid intra-articular injections may be used in the management of patients with OA of the knee ■ Provide superior short-term efficacy (2-4 weeks) versus placebo ■ Recommended for acute exacerbations
- 39. Management option 10 Surgery ■ Refer for orthopaedic evaluation if patient is disabled by OA or in pain unrelieved by medical management ■ Joint replacement can be very effective ■ Newer techniques such as metal-on-metal resurfacing are less invasive ■ Patients should be made aware of the risks and benefits of surgery
- 40. OA: Management Summary • First: Be sure the pain is joint related (not a tendonitis or bursitis adjacent to joint) • Initial treatment • Muscle strengthening exercises and reconditioning walking program • Weight loss • Acetaminophen for pain relieve • Local heat/cold and topical agents • SYSADOA
- 41. OA: Management Summary (cont’d) • Second-line approach • NSAIDs or COX-2 inhibs if acetaminophen fails • Intra-articular agents or lavage • Opioids • Third-line • Arthroscopy • Osteotomy • Total joint replacement
- 44. Thank You
Notas del editor
- 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 consultations 4 . 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 priority 1 . 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.
- 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.
- 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.
- 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.
- Shown here are current ACR recommendations for pharmacologic treatment of OA. 1 The ACR recommends that when necessary, pharmacologic therapy should be added to continuing nonpharmacologic approaches. Recommendations vary for patients with mild, moderate, or severe disease. Simple analgesics, such as acetaminophen, are considered appropriate and are commonly used as first-line pharmacologic therapy for mild-to-moderate OA based on cost, efficacy, and toxicity profile. Although NSAIDs are widely used and can be effective, and for many patients with OA, relief of mild-to-moderate pain afforded by the simple analgesic, acetaminophen, is comparable to that achievable using over-the-counter (OTC) NSAIDs. Topical creams may also be used for pain relief in patients with mild disease. Prescription (Rx) NSAIDs are recommended for treatment of moderate to severe OA, but are associated with increased risk of serious GI bleeding events and should be given with gastrointestinal protective agents in patients at increased risk for GI events. COX-2-specific inhibitors are associated with a somewhat better toxicity profile, but are still categorized as NSAIDs with the same risks and warnings. 2,3 Patients with moderate-to-severe OA may be placed directly on prescription NSAIDs with gastroprotective agents, or COX-2 inhibitors. Knee replacement therapy is considered a last resort in the management of OA. For the first time, intra-articular hyaluronan therapy is now recommended by the ACR as an alternative to oral agents in the palliation of joint pain. This therapeutic approach may be especially advantageous in patients in whom nonselective NSAIDs or COX-2-specific inhibitors are contraindicated, or in whom they have been associated with lack of efficacy. As evidence regarding the effects of various therapeutic modalities on disease progression becomes available, it is likely that these recommendations will be modified. 1. ACR Subcommittee on Osteoarthritis Guidelines. Arthritis Rheum. 2000;43:1905-1915. 2. Celebrex™ [US prescribing information]. 2000. 3. Vioxx ® [US prescribing information]. 2000.
- These five key principles are based around the EULAR guidelines 5 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.
- As we have already discussed, treatment should be a combination of non-pharmacological and pharmacological measures 5 : 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.
- 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 relief 5 . 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 .
- 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 life 5 .
- Tools such as rating scales/questionnaires/pain diagrams can help to assess the patient’s pain and disability 6 . 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 function 7 .
- Studies suggest that education is around 20% as effective as NSAIDs, and can have a synergistic effect with other treatments 8 . 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.
- The optimal management of OA requires a combination of non-pharmacological and pharmacological treatment 5 . Non-pharmacological management strategies include lifestyle modifications, complementary therapies and self-management strategies and are covered in the next three slides.
- Lifestyle modifications which include weight loss, exercise (quadriceps strengthening, range of movement and general fitness, hydrotherapy), appliances (canes, frames and knee bracing) and appropriate footwear 5,9 all have an important role in management.
- 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.
- Self-management strategies can substantially improve patients’ ability to manage the pain and disability associated with OA 5 . 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)
- 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 paracetamol 5 . 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 considered 5 . 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 indicators 10 .
- 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 indicated 10 . 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.
- 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 indicated 10 . 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.
- 09/25/09 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.
- 09/25/09 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 <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 <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.
- CLASS prospectively evaluated the effects of celecoxib at 2 to 4 times’ the maximum therapeutic dose versus therapeutic doses of nonspecific NSAIDs on measures of GI toxicity. In this double-blind RCT, patients were randomly assigned to receive celecoxib 400 mg BID, ibuprofen 800 mg TID, or diclofenac 75 mg BID for a minimum of 6 months. Aspirin use ( 325 mg/day) for cardiovascular prophylaxis was allowed. The primary outcome was ulcer complications, defined as perforation, gastric outlet obstruction, and bleeding. 1 For all patients, celecoxib was associated with fewer upper GI ulcer complications, both alone (0.76% versus 1.45%, P =.09) and combined with symptomatic GDU (2.08% versus 3.54%, P =.02). Rates are expressed as annualized incidence (number of events/number of patient-years). Similarity between celecoxib and nonspecific NSAIDs in upper GI complication rate is likely due to the higher-than-expected rate seen in the celecoxib group. The annualized incidence of ulcer complications in patients taking celecoxib previously derived from pooled analyses of 14 RCTs was 0.2%. The higher-than-anticipated rate of patients on concurrent ASA therapy in the current study (nearly double the rate observed in earlier trials) may explain the higher-than-anticipated incidence of GI complications. The decrease in upper GI toxicity was strongest among patients not taking ASA concomitantly. Reference: 1. Silverstein FE, Faich G, Goldstein JL, et al. Gastrointestinal toxicity with celecoxib versus nonsteroidal anti-inflammatory drugs for osteoarthritis and rheumatoid arthritis: the CLASS study—a randomized controlled trial. JAMA. 2000;284:1247-1255.
- In a large, double-blind, controlled study (SUCCESS-1), 13,274 patients with OA were enrolled from 1142 centers in 39 countries and were randomly assigned to receive celecoxib 200 mg/day, celecoxib 400 mg/day, or a nonselective NSAID (naproxen 1000 mg/day in USA/Canada and diclofenac 100 mg/day in the other 37 countries). Upper GI events were received in a blinded fashion by an independent GI events committee and were categorized as ulcer complications (perforations, gastric outlet obstruction, bleeding) or symptomatic ulcerations. 1 Upper GI symptoms, including dyspepsia, abdominal pain, and nausea, were significantly lower in the celecoxib-treated patients compared with those receiving nonselective NSAIDs (data not shown). Celecoxib was associated with fewer upper GI ulcer complications alone (0.1% versus 0.8%, P =.008) and combined with symptomatic ulcers (1.0% versus 2.1%, P =.049) compared with nonselective NSAIDs (rates are expressed as annualized incidence [events per 100 patient-years]). Thus, celecoxib reduced the risk of ulcer complications by 88% and the risk of symptoms plus ulcer complications by 52%. Reference: Singh G, Goldstein J, Bensen W, et al. SUCCESS-1 in osteoarthritis trial: celecoxib significantly reduces risk of serious upper GI complications compared to NSAIDs while providing similar efficacy in 13,274 randomized patients. Presented at: European League Against Rheumatism; June 13-16, 2001; Prague, Czech Republic.
- A retrospective, observational cohort study was completed using information from the Integrated Primary Care Information (IPCI) database in The Netherlands. The study population included all patients 18 and older with at least 12 months of valid database history. The study population was then divided into 4 groups based on the drugs they were using: COX-2-specific inhibitors (celecoxib and rofecoxib); COX-2 preferential agents (nimesulide, nabumetone, and meloxicam); diclofenac plus misoprostol; and NS-NSAIDs. Of patients with 1 risk factor for a GI event, 86.6% were not treated with a gastroprotective agent (GPA) while taking a nonselective NSAID. When evaluating patients with 2 or more risk factors, the statistics did not improve much; 81.2% of these patients were not treated with a GPA when initiated on NS-NSAID therapy. Reference Sturkenboom MC, Burke TA, Dieleman JP, Tangelder MJ, Lee F, Goldstein JL. Underutilization of preventive strategies in patients receiving NSAIDs. Rheumatology . 2003;42(suppl 3):iii23-iii31.
- 09/25/09 Site investigators reported 253 potential endpoint cases to the gastrointestinal adjudication committee for assessment (71 in the celecoxib group and 182 in the diclofenac plus omeprazole group). The committee identified 20 primary endpoints in patients receiving celecoxib and 81 in patients taking diclofenac plus omeprazole. With a Cox proportional hazard model, the proportion of patients reaching the primary endpoint during the 6month study period was 0·9% (95% CI, 0·5–1·3) in the celecoxib group and 3·8% (2·9–4·3) in the diclofenac plus omeprazole group (difference 2·9%, 2·0–3·8%; p<0·0001)
- CLASS did not show an increased CV risk for celecoxib, unlike VIGOR for rofecoxib. Rates of CV AEs were similar for patients taking celecoxib or NSAIDs overall, and among both ASA users or nonusers of ASA. ASA users had a higher incidence of CV AEs, and the CLASS population, overall, had a stronger history of CV disease. Twenty-one percent of the CLASS trial participants were taking low-dose ASA. Approximately 40% of patients in CLASS had a history of CV disease including hypertension, hypercholesterolemia, prior MI, and some manifestation of coronary artery disease. From a theoretical standpoint, the CLASS population had a fairly high proportion of patients with vascular disease who were at risk for events during this 1-year trial. For the non-ASA cohort, the incidence of serious thromboembolic AEs for celecoxib (800 mg qd) and the comparator NSAID groups was 0.9% and 1.0%, respectively. In each of the subsets of this study, ASA users and with ASA nonusers, the incidence of serious thromboembolic AEs with celecoxib was similar to the comparator NSAID groups. References Silverstein FE, Faich G, Goldstein JL, et al. Gastrointestinal toxicity with celecoxib vs nonsteroidal anti-inflammatory drugs for osteoarthritis and rheumatoid arthritis: the CLASS study: a randomized controlled trial. Celecoxib Long-term Arthritis Safety Study. JAMA . 2000;284:1247-1255. Data on file. Pfizer Inc, New York, NY. White WB, Faich G, Whelton A, et al. Comparison of thromboembolic events in patients treated with celecoxib, a cyclooxygenase-2 specific inhibitor, versus ibuprofen or diclofenac. Am J Cardiol . 2002;89:425-430.
- This study examined the risk of AMI with celecoxib, valdecoxib, rofecoxib, meloxicam, and NS-NSAIDs in a large population of patients with arthritis. Data were obtained from the Medicaid program in California for a nested case-control study of patients with physician-diagnosed arthritis who were using NSAIDs as a treatment. The study concluded that several COX-2 selective inhibitors and NS-NSAIDs increase the risk of AMI in patients with arthritis, especially at high doses. The researchers go on to say that since the drugs are comparably effective, they should be used on the basis of their GI and CV safety in each particular patient. The graph shows the odds ratios for each study drug. Indomethacin had the highest, while nabumetone had the lowest. Reference Singh et al. EULAR. 2005.
- There is growing evidence to support SYSADOA and recent data suggest that glucosamine sulphate could be used as a structure modifying agent in knee OA 5 , although further research is still required 5,8,11,12 . However, given that these agents appear to be well tolerated and do show some benefit their use should be considered 13 .
- Corticosteroid intra-articular injections may be used in the management of patients with OA of the knee 5 . They provide superior short-term efficacy (2-4 weeks) versus placebo 8 . They are recommended for acute exacerbations, but have minimal medium to long-term effects 5 .
- 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 evaluation 5,9 . Joint replacement can transform lives of patients with severe OA 5 . 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 replacement 15 . 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.
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