Professional Documents
Culture Documents
SLIDE SET
Section I
INTRODUCTION AND DESCRIPTION OF PAIN Pain: introduction Pain: assessment Pain: a multifactorial syndrome Pain: aetiology Pain: prevalence
Introduction to pain
Pain is "an unpleasant sensory and emotional experience associated with actual or potential tissue damage1 Acute Pain
Pain that stops with simple measures such as resting or taking an analgesic is acute pain
Chronic Pain
When it is intractable and develops into a condition it is called chronic pain
Assessment of pain
Pain is a subjective experience, but it can be described and assessed using validated questionnaires and scales Categorical scales Numerical scales Visual analogue scales
Assessment of pain
Descriptions of the Categorical Pain Relief Scale, Visual Analogue Pain Scale, and Pain Relief Scale
Categorical Pain Relief Scale The patient is asked to rate pain relief experienced now with the following possible responses: 0 My pain is now worse compared with my usual pain 1 There is no change in my pain compared with my usual pain 2 There is slight improvement in my pain compared with my usual pain 3 There is moderate improvement in my pain compared with my usual pain 4 There is a lot of improvement in my pain compared with my usual pain 5 I have complete relief of my pain Visual Analogue Pain Scale The scale is a 100-mm-long horizontal line drawn on a piece of paper. It ranges from 0 on the left axis, which indicates no pain, to 100 mm on the right axis, which indicates worst pain possible. At each time point, patients are asked to mark across the line with a pen as to the degree of pain they are expecting at that time. 0.100 No pain Worst pain possible Pain Relief Scale The scale is a 100-mm-long horizontal line drawn on a piece of paper It ranges from 0 on the left axis, which indicates no pain relief, to 100 mm on the right axis, which indicates complete pain relief. At each time point, patients are asked to mark across the line with a pen as to the degree of pain relief they are experiencing at that time 0100 No pain relief Complete pain relief
Categorical scale
Commonly used one-dimensional pain intensity scales: the 11-point NRS, the VAS from no pain (=0) to worst pain imaginable [=10 (or 100)] and the four-point categorical verbal rating scale (VRS) NRS Numeric Rating Scale; VRS Verbal Rating Scale; VAS Visual Analogue Scale
Adapted from Breivik H et al. Br J Anaesthesia 2008;101(1):17-24.
Numerical scale
Basic requirement: measure amount of pain Have you experienced unusual or ongoing pain recently? Yes____ NO_____ Numeric rating scale (NRS) No pain 0 Worst possible pain 10 Location of pain____ (Provide body figure drawing if necessary)
What medication and other treatment do you use for pain relief No relief Level of pain relief (with current medication and other treatment)
Adapted from http://stahlonline.cambridge.org/content/ep/images/85702c15_tbl11.gif
Complete relief
NO HURT 0
HURTS WORST 10
Adapted from Hockenberry MJ, Wilson D: Wongs essentials of pediatric nursing, ed. 8, St. Louis, 2009, Mosby. Used with permission. Copyright Mosby.
Anxiety
Housing
Physical factors
Panic Low mood Psychological factors Financial status
TOTAL PAIN
Social factors
Depression
Irritation Philosophical factors
Why?
Judgement
Religion
Values
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Pain aetiology
Skeletal system,other,16%
Symptomatic pain, 9%
Neurological conditions, 4%
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Spine/Back Arthrosis Other Ischaemic heart disease Symptomatic pain Injuries Neurological conditions Medical interventions Tumours
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Prevalence of pain
Post-operative pain
Cancer pain
1. Breivik H et al. Eur J Pain 2006;10(4):287-333; 2 . Verhaak et al. Pain 1998;77(3):231-239; 3. Perkins FM & Kehlet H, Anesthesiology 2000;93(4):1123-1133; 4. Higginson 1 Prog Pain Res Manage 1997;8:707-716.
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Prevalence of pain
Chronic pain is a major healthcare problem worldwide1 Each year, acute pain affects 1520%, while chronic pain affects 25 30% of the US population2 Chronic pain is also a major healthcare problem in Asia Pacific where it has long been neglected due to a lack of understanding and awareness among the general public, health policy makers, and healthcare professionals1 With chronic pain currently affecting one in five adults worldwide, it is poised to become one of the most critical healthcare issues1 Chronic pain can drastically limit the quality of life and well-being of sufferers and places a considerable burden on healthcare systems1
1. Asia Pacific Declaration for Chronic Pain Relief. Backgrounder. 1st Congress of the Association of Southeast Asian Pain Societies 2006; (http://www.masp.org.my/index.cfm?menuid=19&parentid=12). 2. Bonica JJ, Loeser JD. Bonicas Management of Pain. 3rd ed. Philadelphia, PA: Lippincott Williams & Wilkins; 2001:316.
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Section II
PAIN: AN UNMET CLINICAL NEED Risk of under-treatment of pain Under-treatment of pain Barriers to pain management Pain an unmet clinical need in Europe Cancer pain an unmet need Pain an unmet need in Asia Pacific
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1. Donna VW. Non-Narcotic Options for Pain Relief with Chronic Neuropathic Conditions. J Nurse Practition 2008; http://www.medscape.com/viewarticle/576064
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Almost
50%
while
29%
Chronic pain in America: roadblocks to relief. Survey Conducted for: The American Pain Society, The American Academy of Pain Medicine and Janssen Pharmaceutica Conducted by: Roper Starch Worldwide Inc. January 1999; http://www.ampainsoc.org/links/roadblocks/ 17
Physician related
Patient related
Fear pain portends a serious illness or poor diagnosis Concerns about side effects of opioids Association of the appropriate clinical use of opioids with addiction Resigned to live with pain
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Pain
Employment
Clinical intervention
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Duration of pain
On average, sufferers lived with chronic pain for a mean of 5.9 years One-fifth had suffered pain for >20 years
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Pain perceptions
64% feel treatment is inadequate Most patients prescribed NSAIDS (44%)
28% believe healthcare professionals (HCPs) do not know how to treat pain Only 5% receive strong opioids
PAIN
43% believe HCPs focus on illness not pain
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Breivik H et al. Ann Oncol 2009; [online Feb 24, 2009; doi:10.1093/annonc/mdp001].
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PAIN
Most common side effect constipation 37% 22% never asked about their pain by HCPs
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Summary
Pain is widespread
More than half of patients reported pain within the previous month
Pain is undertreated
Almost one-tenth of those suffering moderateto-severe pain were not receiving prescription analgesia
Breakthrough pain is common but the majority of sufferers do not receive additional medication
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1. Asia Pacific Declaration for Chronic Pain Relief. Backgrounder. 1st Congress of the Association of Southeast Asian Pain Societies 2006; (http://www.masp.org.my/index.cfm?menuid=19&parentid=12).
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Section III
GOAL OF PAIN MANAGEMENT Principles of pain management WHO ladder of pain intervention Challenging the WHO 3 step ladder The need of the hour: a two step analgesic approach
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Psycho-social support
Coanalgesics
Non-Opioid analgesics
PAIN
1. Bond MR. Pain its nature and treatment. Churchill Livingstone , 2006; 2. White A, et al. Rheumatology 2007;46(3):384-390.;3. Krismer M, et al. Best Pract Res Clin Rheumatol 2007;21(1):77-91.
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World Health Organization. Cancer pain relief: with a guide to opioid availability. 2nd ed. Geneva:The Organization;1996.
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Barriers that hinder drug use Guidelines poorly implemented Chronic pain more difficult to treat than expected
1. Cleeland CS et al. NEJM 1994;330(9):592-596. 2. Maltoni M et al. Support Cancer Care 2005;13(11):888-894.
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28.6
* 22.8
11.2
** 8.6
Patients receiving Step 3 opioids early had superior pain relief patients had fewer days with pain intensity > 5 (NRS 0-10)
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85.7 86.2
Fewer patients receiving Step 3 opioids early were dissatisfied with therapy
Innovative treatment
*p<0.001, **p=0.023
Conventional treatment: treated according to WHO 3 step ladder Innovative treatment: direct move to Step 3 after Step 1
Maltoni M et al. Support Cancer Care 2005;13(11):888-894.
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Oxycodone
AN OVERVIEW
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* Capsules are not available in all countries. Korea has IR tablet & Japan has powder formulation.
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Characteristics of oxycodone
No ceiling dose2
Predictable PK profile2
1. Riley J et al. Curr Med Res Opin 2008;24(1):175-192; 2. Levy MH et al. Eur J Pain 2001;5(Suppl. A):113-116; 3. Biancofiore G. Ther Clin Risk Manage 2006;2(3):229-234. 4. Curtis GB et al. Eur J Clin Pharmacol 1999;55(6):425-429.
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1. Curtis GB et al. Eur J Clin Pharmacol 1999;55(6):425-429; 2. Sunshine A et al. J Clin Pharmacol 1996;36(7):595-603; 3. Citron ML et al. Cancer Invest 1998;16(8):562-571.
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Section IV
EFFICACY OF OXYCODONE TABLETS IN PAIN MANAGEMENT Neuropathic pain Somatic pain Visceral pain Cancer pain
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Oxycodone tablets
Proven efficacy in neuropathic pain
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1. Asia Pacific Declaration for Chronic Pain Relief. Backgrounder. 1st Congress of the Association of Southeast Asian Pain Societies 2006; (http://www.masp.org.my/index.cfm?menuid=19&parentid=12).
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1. Asia Pacific Declaration for Chronic Pain Relief. Backgrounder. 1st Congress of the Association of Southeast Asian Pain Societies 2006; (http://www.masp.org.my/index.cfm?menuid=19&parentid=12).
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Characterised by:
Burning, aching or shooting pain Allodynia Hyperalgesia
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Diabetic neuropathy*
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Baseline
Initiation of oxycodone
(CR)
VAS 1-2/10 (94%; n=33) VAS 4-8/10 (6%; n=2) VAS 2-4/10 (100%; n=100)
Oxycodone controlled-release tablets may be effective in neuropathic pain arising from diverse aetiologies
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Steady pain
Brief pain
Skin pain
Oxycodone controlled-release tablets are effective for the relief of overall, steady, brief and skin pain in patients with post-herpetic neuralgia, when compared with placebo
Watson C and Babul N. Neurology 1998;50(6):1837-1841.
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Steady pain
Brief pain
Skin pain
Oxycodone controlled-release tablets are effective in the relief of neuropathic pain in diabetic neuropathy, when compared with active placebo
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Baseline
Days 1-27
Days 28-42
When first-line therapies are inadequate, oxycodone controlled-release tablets are effective in low doses in controlling severe painful diabetic neuropathy
Gimbel JS et al. Neurology 2003;60(6):927-934.
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Gabapentin plus morphine provides pain control superior to either agent alone
Patients had neuropathic pain due to PHN (n=22) or DPN (n=35) Maximum doses; morphine alone, 120mg; combination morphine 60 mg, gabapentin (GBT) 2400 mg; GBT alone 3200 mg
P<0.001 GBT vs. GBT/morphine P=0.01 morphine vs. placebo P=0.04 morphine vs. GBT/morphine
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Oxycodone prolonged release tablets with gabapentin optimise pain relief in PDN
Co-administration of oxycodone prolonged release tablets and existing gabapentin (GBT) therapy has a clinically meaningful effect in painful diabetic neuropathy (PDN)
Mean BS-11 pain scores (boxes)
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Days of treatment
* FBSS, failed back surgery syndrome; ** MSC, medullary spinal canal
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Oxycodone controlled-release tablets and pregabalin combination therapy facilitates dose reduction
Study end
Monotherapy
Combined therapy
(Oxycodone tablets(CR) n=106; (Oxycodone tablets (CR)+ pregabalin n=134) pregabalin n=169)
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Tricyclic antidepressants
Combined opioids Gabapentin Tramadol Pregabalin
Tricyclic antidepressants, opioids, gabapentin, tramadol and pregabalin can be considered effective treatments for postherpetic neuralgia
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Hempenstall K et al. Analgesic therapy in postherpetic neuralgia: a quantitative systematic review. PLoS Med 2005;2:e164.
No. of patients with >50% pain relief if 100 patients are treated
For every 100 patients treated with the TCAs amitriptyline or desipramine, 43 would achieve greater than 50% pain relief.
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No. of patients with >50% pain relief if 100 patients are treated
For every 100 patients treated with gabapentin, 31 would achieve greater than 50% pain relief
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No. of patients with >50% pain relief if 100 patients are treated
For every 100 patients with moderate-to-severe intensity pain treated with oxycodone, 40 would achieve greater than 50% pain relief.
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Oxycodone tablets
Proven efficacy in somatic pain
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* *
* p< 0.001
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Interference Composite
P=0.012
Enjoyment of Life
P<0.001
Sleep
P=0.006
Normal Work
P=0.018
Mood
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Weeks
Roth SH et al. Arch Intern Med 2000;160(6):853-860.
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3-month efficacy and safety study of oxycodone prolonged release tablets in osteoarthritis
All the pain scores were significantly lower with oxycodone prolonged release tablets than with placebo (The figure below shows the patients BS-11 pain
scores recorded as part of the Brief Pain Inventory on Day 15 or at stable dosing.)
Pain score
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3-month efficacy and safety study of oxycodone prolonged release tablets in osteoarthritis
Oxycodone tablets significantly reduced pain and associated interference with daily function in osteoarthritis patients compared with placebo (The figure
shows the BS-11 scores for pain interference on Day 15 or at stable dosing.)
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Conclusion: Patients with non-cancer pain experienced prolonged relief with tolerable side effects and modest need for dose escalation during long-term therapy with oxycodone controlled-release tablets.
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Oxycodone controlled-release tablets may be beneficial to osteoarthritis patients when incorporated as part of a multidisciplinary approach to pain management
Zautra AJ, et al. Clin J Pain 2005;21:471-477.
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*Standard treatment = analgesia any drug except oxycodone and physiotherapy as determined by investigator eberall MA, Mueller-Schwefe G. Abstract no. 681-P287 11th World Congress on Pain; 2126 August 2005,. Sydney, Australia.
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Oxycodone controlled-release and immediaterelease tablets efficacy in moderate-to-severe low back pain
Double-blind, randomised, crossover study1
57 patients with moderate-to-severe chronic low back pain Treatment started with oxycodone controlled-release tablets (10mg, 12hourly) or IR oxycodone tablets 5mg, q.i.d.
Pain relief with oxycodone controlled-release tablets was maintained for 12 hours.
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* Calculated by adding up all the pain relief scores recorded over 12 hours. Pain relief scores were recorded using a categorical scale where 0 = none, 1 = a little, 2 = moderate, 3 = a lot and 4 = complete.
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McCroskery E et al. Abstract no.348 - p.606. Proceedings of the 9th World Congress on Pain; 1999 Aug 22 -27; Vienna, Austria.
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Oxycodone tablets
Efficacy in visceral pain
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Visceral pain is typically referred to other areas of the body1 Visceral pain is less understood than other pain types often confounded by its symptomology1
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Analgesic effect of oxycodone immediate release injection is mediated by the opioid receptor
The -selective antagonist effects morphine
% of peak effect
+ Nalz
Baseline nociception (tail flick latency) similar but earlier onset with oxycodone
% of peak effect
Time (m)
% of peak effect
Time (m)
77
120
Threshold changes
**
**
**
**
**
**
* #* * * * *
100 80 60
40
20 0 0 30 60 90
Min Pinch pain tolerance threshold (skin)
Oxycodone immediate release oral solution ( and agonist) has a significant effect on mechanically evoked visceral pain than morphine ( - agonist)
Staahl C et al. Pain 2006;123(1-2):28-36.
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* *
Time (minutes)
Time (minutes)
Healthy individuals1
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Oxycodone tablets
Proven efficacy in severe cancer pain
80
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Long-term administration of oxycodone controlledrelease tablets for the treatment of cancer pain
Oxycodone controlled-release tablets are effective for long-term therapy of chronic cancer pain1
% Patients reporting adverse drug reactions
Patients mean pain intensity remained between slight-tomoderate throughout the study and the acceptability of therapy was fair to good throughout the study.
Related common opioid adverse events
Study week
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Efficacy of oxycodone controlled-release tablets in the treatment of cancer pain in Chinese patients
Rapid onset of analgesic action occurred within 1 hour in 198 cases (91.7%) of patients following administration of oxycodone controlled-release tablets1
% of patients
Time of onset
84
Oxycodone controlled-release tablets maximise the Quality of Life of patients with cancer pain
Within 4 weeks, oxycodone controlled-release tablets significantly improved all Quality of Life scores in patients with moderate-to-severe 1 cancer pain (p<0.01)
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Oxycodone tablets
A preferred choice to morphine?
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The coefficients of variation for morphine controlled-release tablets were approximately 33% higher than those for oxycodone controlled-release tablets
The absorption of oxycodone from oxycodone controlled-release tablet is significantly more consistent than the absorption of morphine from morphine controlled-release tablets
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*Oxymorphone below measurable concentration (<0.2ng.ml-1) in six of the seven volunteers. 1. Kaiko RF et al. Clin Pharmacol Ther 1996;59(1):52-61.
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The pharmacokinetics of oxycodone controlled-release tablet is altered in renal impairment, hepatic impairment and, to a lesser extent, by gender and age
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Oxycodone controlled-release tablets and morphine controlled-release tablets have comparable efficacy
Oxycodone controlled-release tablets have comparable efficacy to morphine controlled-release tablets in controlling cancer pain1
Categorical scale: 1 = very poor, 2 = poor, 3 = fair, 4 = good, 5 = excellent; Significant increase (P = 0.0001); Significant increase (P = 0.0061)
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Total healthcare charges were significantly higher for patients who switched therapy than those who did not
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Oxycodone tablets
Common side effects
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WHO recommends all patients receiving strong opioids are treated for constipation with an adjuvant medication6
Respiratory depression is a potentially serious side effect with all opioid analgesics
Appropriate monitoring and careful prescribing should minimise the risk
Oxycodone tablets must never be crushed, chewed or broken as this could lead to a potentially fatal overdose
1. Mucci-LoRusso P et al. Eur J Pain 1998;2(3): 239-249; 2. Watson C, et al. Neurol 1998;50(6):1837-1841; 3. Watson CP et al. Pain 2003;105:71-78; 4. McCroskery E et al. Proceedings of EFIC; 2000 Sep 26-29; Nice, France; 5. Roth SH et al. Arch Intern Med 2000;160(6):853-860.;6. World Health Organization. 2nd ed. Geneva: The Organization; 1996.
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Oxycodone tablets
Summary
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Summary
Treatment of severe chronic pain is an important unmet need
Chronic pain has a substantial impact both on patients and on society
Severe chronic pain often requires treatment with strong opioids Oxycodone tablets are a prolonged-release or controlled release formulation of oxycodone that has advantages over controlledrelease morphine in terms of metabolism, receptor binding, etc. Oxycodone tablets are effective for severe chronic pain, including:
Neuropathic Somatic
Oxycodone tablets are also effective for experimental models of visceral pain1
1. Staahl C et al. Pain 2006;123(1-2):28-36.
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Summary
Neuropathic pain is the result of injury or malfunction in the central or peripheral nervous system
The efficacy of oxycodone tablets has been demonstrated in several conditions associated with neuropathic pain:
Postherpetic neuralgia1 Diabetic neuropathy2
Somatic pain occurs at pain receptors at the body surface or in musculoskeletal tissue
Oxycodone tablets are highly effective in the treatment of severe osteoarthritis pain3 and moderate-to-severe low back pain4
1. Watson C et al. Neurology.1998;50(6):1837-1841; 2. Watson CP et al. Pain 2003;105(1-2):71-78; 3. Markenson J et al, Clin J Pain 2005;21(6): 524-535; 4. Richards P et al. Pain Med 2002;3:176.
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Summary
Visceral pain is caused by activation of pain receptors in internal areas of the body, such as thoracic or abdominal cavities
A number of models have been developed to assess analgesia in visceral pain where oxycodone has proven efficacy1
1. Staahl C et al. Pain 2006; 123:28-36. 2. Mucci-LoRusso P et al. Eur J Pain 1998;2: 239-249. 3. Citron et al. Cancer Invest 1998, 16: 562-571. 4. Parris WC-V et al. J Pain Symptom Manage 1998;16:205-211. 5. Hagen NA et al. Cancer 1997;79:1428-1437. 6. Kalso E et al. Clin Pharmacol Ther 990;47:639-646; 7. Kalso E et al. Pharmacol Toxicol 1990;67:322 -328. 8. Maddocks I et al. J Pain Symptom Manage 1996;12 :182-189. 9. Gagnon B et al. Support Care Cancer 1999;7:265-270. 10. Riley J et al. Supp Care Cancer 100 2006;14:56-64. 11. Pan H et al. Clin Drug Invest 2007; 27 (4): 259-267.
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Oxycodone: summary
Oxycodone prolonged release and controlled-release tablets are an effective treatment in moderate-to-severe pain Oxycodone tablets provide an effective analgesia with rapid onset and sustained control of pain Oxycodone tablets exhibit improved adverse effect profile Oxycodone tablets offer optimal individualised pain control
For detailed information, please refer to the full Prescribing Information of OxyContin tablets.
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Conclusions
1. McCroskery E et al. Proceedings of EFIC; 2000 Sep 26-29; Nice, France; 2. Roth SH et al. Arch Intern Med 2000;160(6):853-860; 3. Richards P et al. Pain Med 2002;3:176; 4. Riley J et al. Supp Care Cancer 2006;14(1):56-64.
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Expert opinion
A multidisciplinary group of specialists across Asia Pacific convened to form the Regional Chronic Pain Communications Council (RCPC). Aim of the RCPC: to address the mounting problem of chronic pain in the region The RCPC has developed the first Asia Pacific Declaration for Chronic Pain Relief:
A call to action to improve management and outcomes for people affected by this devastating condition.
Asia Pacific Declaration for Chronic Pain Relief. Backgrounder. 1st Congress of the Association of Southeast Asian Pain Societies 2006; (http://www.masp.org.my/index.cfm?menuid=19&parentid=12).
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2. To improve awareness and knowledge of chronic pain management among healthcare professionals to help sufferers find relief across the Asia Pacific region.
Asia Pacific Declaration for Chronic Pain Relief. Backgrounder. 1st Congress of the Association of Southeast Asian Pain Societies 2006; (http://www.masp.org.my/index.cfm?menuid=19&parentid=12).
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RM-OXYC-0072-V1-0310