Download - Osteoarthritis Management R Gunadi
Rachmat Gunadi Wachjudi
Lahir di Garut, 16-1-1955Pendidikan 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 SadikinOrganisasi Profesi IDI, IRA, PAPDI, PEROSI,
PERALMUNI
The Management of Osteoarthritis
Without Compromising the Patient's Safety
Rachmat Gunadi Wachjudi
Perhimpunan Reumatologi IndonesiaBandung
OA in Primary Care
■ Most patients with OA are managed in Primary Care
■ Overall, musculoskeletal problems account for 10-30 % of General Practice consultations4
■ GPs have an opportunity to optimise patient care in OA
Factors Implicated in the 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.
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 andthree 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.
Goals of OA Management:OARSI Recommendations
Reducejoint pain and
stiffness
Reduce physical disability
ImproveHRQoL
Educate patients
Limitprogression 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
ACR 2000 Guidelines— Pharmacologic/Surgical Therapy
American College of Rheumatology Subcommittee on Osteoarthritis Guidelines. Arthritis Rheum. 2000;43:1905-1915.
Mild to Moderate Pain
• Simple analgesics (eg, acetaminophen)
• OTC NSAIDs
• Topical creams
Moderate to Severe Pain
• Rx NSAIDs plus gastroprotective agent,or COX-2–selective inhibitors
AdditionalTherapies
• IA hyaluronans
• IA steroidsSurgical
Intervention
• Total knee replacement
EULAR guidelines
The 10 Keys
8Please see Full Prescribing Information available at this presentation.
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
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
Key principle 1Patient-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
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
Key principle 3Using 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
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 / / / / / / /
Rating scales ■ Visual analogue scale
No pain
Worst possible pain
• Pain intensity
0 No pain
1 Mild
2 Discomforting
3 Distressing
4 Horrible
5 Excruciating
Key principle 4Patient 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
Key principle 5Management 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
Management option 6Non-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
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 techniqueAromatherapy ChiropracticHydrotherapy MassageOsteopathy ReflexologyTai chi
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 PERMARIKelompok Senam Ranca Badak
Management option 7Analgesia 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)
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)
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
Celecoxib Efficacy in Osteoarthritis
McKenna F et al. Scand J Rheumatol 2001;30:11–18.VAS=visual analogue scale.
Less P
ain
Patient’s Assessment of Pain (VAS): Mean change at week 6
Mea
n C
ha
ng
e (m
m)
*p=0.001 vs. placebo
placebo(n=200)
celecoxib100 mg BID(n=199)
diclofenac50 mg TID(n=199)
CELECOXIB vs. diclofenac:6-week Knee OA TrialMcKenna et al. 2001: Patient’s Assessment of Pain
McKenna F et al. Scand J Rheumatol. 2001;30:11-18.
American Pain Society (APS) Pain Measure:Worst Pain in the Past 24 Hours
Mean
Ch
an
ge in
Score 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
0.0Baseline 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)
Less P
ain
CELECOXIB vs. diclofenac:6-week Knee OA TrialMcKenna et al. 2001: American Pain Society – Pain Measure
CelecoxibGastrointestinal Safety Profile
Silverstein FE et al. JAMA. 2000;284:1247-1255.
An
nu
aliz
ed in
cid
ence
(%
)(p
er N
o. o
f p
atie
nt-
year
s)
0
1
2
3
4
Upper GI ulcercomplications
Complications andsymptomatic ulcers
P=.09
P=.02
0.76%
1.45%
2.08%
3.54%
CLASS: UGI Ulcer Complications and Symptomatic Ulcers at 6 Months—All Patients
Nonspecific NSAIDs* (n=3981)
Celecoxib 400 mg BID(n=3987)
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.
SUCCESS-1: UGI Ulcer Complications and Symptomatic Ulcers
0.1
0.8 1.0
2.1
0
1
2
3
4
Ulcer complications Complications andsymptomatic ulcers
RRR=87.5%P<.05
RRR=51.5%P<.05
An
nu
aliz
ed r
ate
(eve
nts
per
100
pat
ien
t-ye
ars)
Nonspecific NSAIDs† (n=4394)
Celecoxib*(n=8800)
Utilization of Gastroprotective Strategies by Presence of GI Risk Factors Among New NSAID Users
Sturkenboom et al. Rheumatology. 2003;42(suppl 3):iii23-iii31.
≥≥2 Risk Factors2 Risk Factors1 Risk Factor1 Risk Factor
86.6% 81.2%
0.1%0.1% 2.5%2.5% 10.8%10.8% 0.2%0.2% 4.0%4.0% 14.7%14.7%
Coxib aloneCoxib alone NSAID+GPANSAID+GPA Coxib+GPACoxib+GPA No gastroprotectionNo gastroprotection
CONDOR 2010
0.9
3.8
0
0.5
1
1.5
2
2.5
3
3.5
4
Pro
po
rtio
n o
f p
ati
en
ts %
celecoxib 200 mg BID (n=2238)
diclofenac SR 75 mg BID + omeprazole 20 mg OD (n=2246)P<0.0001
Chan FKL et al. Lancet 2010; DOI:10.1016/S0140-6736(10)60673-3
Patient with celecoxib has lower risk on gastrointestinal events than those with diclofenac SR + omeprazole
(20 events, 95% CI, (20 events, 95% CI, 0.5-1.3)0.5-1.3)
(81 events, 95% CI, 2.9-4.3)
CelecoxibCardiovascular Safety
CLASS: Thromboembolic CV AEsASA NonusersASA NonusersASA Users*ASA Users*
PP=.899=.899PP=.947=.947
00
0.50.5
1.01.0
1.51.5
2.02.0
2.52.5
3.03.0
3.53.5
4.54.5
5.05.0
4.04.0
00 4040 8080 120120 160160 200200 240240 280280 320320 360360
DaysDays
Celecoxib 400 mg bid (n=3105)Celecoxib 400 mg bid (n=3105)
NS-NSAIDs (n=3124)NS-NSAIDs (n=3124)
Celecoxib 400 mg bid (n=882)Celecoxib 400 mg bid (n=882)
NS-NSAIDs (n=857)NS-NSAIDs (n=857)
Pat
ien
ts (
%)
Pat
ien
ts (
%)
00 4040 8080 120120 160160 200200 240240 280280 320320 360360
DaysDays
00
0.50.5
1.01.0
1.51.5
2.02.0
2.52.5
3.03.0
3.53.5
4.54.5
5.05.0
4.04.0
White et al. White et al. Am J CardiolAm J Cardiol. 2002;89:425-430. . 2002;89:425-430. Data on file. Pfizer Inc., New York, NY; FDA Advisory Committee Briefing Document. Data on file. Pfizer Inc., New York, NY; FDA Advisory Committee Briefing Document. Available at: http://www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4090B1_03_Pfizer-Celebrex-Bextra.pdf. Accessed January 12, 2005. Available at: http://www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4090B1_03_Pfizer-Celebrex-Bextra.pdf. Accessed January 12, 2005.
Medi-Cal: NSAIDs and Risk for AMI
0 0.2 0.4 0.6 0.8 1 1.2 1.4 1.6 1.8
2,356,885 person-years of follow-up; 15,343 cases of AMI2,356,885 person-years of follow-up; 15,343 cases of AMI
OR for AMI (95% CI)OR for AMI (95% CI)
Singh et al. EULAR. 2005. Singh et al. EULAR. 2005.
0.83 (0.60-1.14); 0.83 (0.60-1.14); PP=.26=.26
0.99 (0.72-1.37); 0.99 (0.72-1.37); PP=.97=.97
1.08 (0.95-1.22); 1.08 (0.95-1.22); PP=.22=.22
1.09 (1.02-1.15); 1.09 (1.02-1.15); PP<.008<.008
1.11 (1.01-1.22); 1.11 (1.01-1.22); PP<.02<.02
1.32 (1.22-1.42); 1.32 (1.22-1.42); PP<.0001<.0001
1.37 (1.05-1.78); 1.37 (1.05-1.78); PP<.02<.02
1.41 (1.01-1.96); 1.41 (1.01-1.96); PP<.04<.04
1.71 (1.35-2.17); 1.71 (1.35-2.17); PP<.0001<.0001
1.00 (reference)1.00 (reference)
NabumetoneNabumetone
ValdecoxibValdecoxib
NaproxenNaproxen
CelecoxibCelecoxib
IbuprofenIbuprofen
RofecoxibRofecoxib
MeloxicamMeloxicam
SulindacSulindac
IndomethacinIndomethacin
Remote useRemote use
CelecoxibRenal & Hepar Safety Profile
Incidence of patients with treatment-related CV, renal, and hepatic AEs
1.71.1
4.1
5.2
0
1
2
3
4
5
6
CV / renal AE Hepatic AE
% P
atie
nts
celecoxib 200 mg OD diclofenac 50 mg BID
CELECOXIB vs. diclofenacDahlberg 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.
Management option 8Symptomatic 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
Management option 9Corticosteroid 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
Management option 10Surgery
■ 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
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
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
Treatment Overview
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