QUIZ Next Back Enter Main NO YES Lyrica (Pregabalin) is the only Level A treatment for painful diabetic neuropathy. Would you agree? Next Back View Answer Main NO YES Lyrica (Pregabalin) is recommended as the first-line treatment option for neuropathic pain. Would you agree? Next Back View Answer Main FALSE TRUE Next Back View Answer Main Pain relief with Lyrica (Pregabalin) can be seen as early as week 1 in patients with diabetic peripheral neuropathy. True or false? FALSE TRUE Next Back View Answer Main Lyrica (Pregabalin) has shown significant improvement in treating pain-related sleep interference in diabetic patients with low back pain. True or false? FALSE TRUE Next Back View Answer Main Lyrica (Pregabalin) has shown to be well-tolerated safety over 52-weeks. True or false? FALSE TRUE Next Back View Answer Main Combination of Pregabalin (Lyrica) and Celebrex (Celecoxib) is more effective compared with monotherapy treatment in patients with chronic low back pain with neuropathic component. True or false? FALSE TRUE Next Back View Answer Main Lyrica (Pregabalin) is suitable for patients taking multiple medications and for taking with or without food. True or false? Next Back Main Congratulations You have now finished the Quiz! Your Score Next Back Main For Healthcare Professionals Only Upjohn (Malaysia) Sdn. Bhd. (a Viatris Company) (Formerly known as PF OFG Sdn.Bhd.) Reg. No: 201801018158 (1280174-H) Level 9-2, Wisma Averis, (Tower 2), Avenue 5, Bangsar South, No. 8, Jalan Kerinchi, 59200 Kuala Lumpur. Tel: 603-2281 6000 Fax: 603-2281 6386 PP-LYR-MYS-0125 -8JAN2020 Abbreviated Prescribing Information 2 Composition: Pregabalin 50mg, 75mg and 150mg in hard capsule. Dosage and Indications : The dose range is 150- 600 mg/day given in either 2 or 3 divided doses. Pregabalin may be taken with or without food. Neuropathic Pain: Pregabalin treatment can be started at a dose of 150 mg/day. Based on individual patient response and tolerability, the dosage may be increased to 300 mg/day after an interval of 3-7 days, and if needed, to a maximum dose of 600 mg/day after an additional 7-day interval. Epilepsy: Pregabalin treatment can be started with a dose of150mg/day.Based on individual patient response and tolerability, the dosage may be increased to 300 mg/day after 1 week. The maximum dosage of 600 mg/day may be achieved after an additional week. Generalised Anxiety Disorder: The dose range is 150- 600 mg/day given as 2 or 3 divided doses. The need for treatment should be reassessed regularly. Pregabalin treatment can be started with a dose of 150 mg/day. Based on individual patient response and tolerability, the dosage may be increased to 300 mg/day after 1 week. Following an additional week, the dosage may be increased to 450 mg/day. The maximum dosage of 600 mg/day may be achieved after an additional week. Fibromyalgia: The recommended dose of pregabalin is 300-450 mg/day. Dosing should begin at 75 mg 2 times a day (150 mg/day) and may be increased to 150 mg 2 times a day (300 mg/day) within 1 week based on efficacy and tolerability. Patients who do not experience sufficient benefit with 300 mg/day may be further increased to 225 mg 2 times a day (450 mg/day). The dose may be increased to maximum dosage of 600 mg/day after an additional week if needed. Because Lyrica is eliminated primarily by renal excretion, the dose should be adjusted for patients with reduced renal function (creatinine clearance <60 mL/ min). Discontinuation of pregabalin: In accordance with current clinical practice, if pregabalin has to be discontinued, it is recommended that this should be done gradually over a minimum of 1 week independent of the indication. Special Precautions: Exercise caution when prescribing pregabalin to patients who have had a previous episode of angioedema and discontinue immediately if the symptoms are life-threatening with respiratory compromise requiring emergency treatment. Discontinue pregabalin immediately in patients with hypersensitivity reactions (skin redness, blisters, hives, rash, dyspnea and wheezing). Withdraw pregabalin gradually to minimize the potential of increased seizure frequency in patients with seizure disorders. Monitor patients treated with any AED including pregabalin, for any indication of the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Pregabalin may cause peripheral edema. Exercise caution when using in congestive heart failure patients with NYHA Class III or IV cardiac status. Pregabalin may cause dizziness, somnolence and weight gain. Inform patients of the withdrawal symptoms following abrupt or rapid discontinuation of short and long term treatment with pregabalin. Inform patients to notify their physician if changes in vision occur. Instruct patients to promptly report unexplained muscle pain, tenderness or weakness particularly if these symptoms are accompanied by malaise or fever. Pregabalin treatment was associated with creatinine kinase elevations, decrease in platelet count and PR interval prolongation. There is evidence from case reports, human studies, and animal studies associating pregabalin with serious, life-threatening, or fatal respiratory depression when co- administered with central nervous system (CNS) depressants, including opioids, or in the setting of underlying respiratory impairment. When the decision is made to co-prescribe pregabalin with another CNS depressant, particularly an opioid, or to prescribe pregabalin to patients with underlying respiratory impairment, monitor patients for symptoms of respiratory depression and sedation, and consider initiating pregabalin at a low dose. The management of respiratory depression may include close observation, supportive measures, and reduction or withdrawal of CNS depressants (including pregabalin). There is more limited evidence from case reports, animal studies, and human studies associating pregabalin with serious respiratory depression, without co-administered CNS depressants or without underlying respiratory impairment. Caution should be exercised in patients with a history of substance abuse. Patients with rare hereditary problems of galactose intolerance, the Lapp lactased eficiency or glucose-galactose malabsorption should not take this medicine. Contraindication: Hypersensitivity to the active substance or to any of the excipients. Undesirable effects: The very common( ≥ 1/10) adverse reactions reported were dizziness and somnolence. Other common ( ≥ 1/100, < 1/10), side effects reported are nasopharyngitis, appetite increased, confusion, disorientation, irritability, depression, euphoric mood,libido decreased,insomnia, ataxia,coordination abnormal,balance disorder, amnesia, disturbance in attention, memory impairment, tremor, dysarthria, paraesthesia, hypoesthesia, sedation, lethargy, vision blurred, diplopia, vertigo, vomiting, abdominal distension, constipation, dry mouth, flatulence, muscle cramp, arthralgia, back pain, pain in limb, cervical spasm, oedema peripheral, oedema, gait abnormal, fall, feeling drunk, feeling abnormal, fatigue, weight increased. Presentation: 50mg (56’s), 75mg (56’s), 150mg (56’s). API-LYRICA-0620 Reference: 1. FREEMAN, R. et al. Poster presented at the American Diabetes Association 68th Scientific Sessions. 6-10 Jun 2008, San Francisco, CA. (Abstract #507-P). 2. (Malaysia) LYRICA Prescribing Information. 16 June 2020. Full prescribing information available upon request. Next Back CORRECT Next Back INCORRECT Next Back Adapted from AAN American Academy of Neurology; Evidence based guidelines: treatment of Painful Diabetic Neuropathy; 2011. Lyrica (Pregabalin) is the only Level A treatment or established effective treatment for the painful diabetic neuropathy. 1 Not recommended Recommended drug and dose Pregabalin, 300-600 mg/d Level A Level B Table 1 Summary of recommendations Gabapentin, 900-3,600 mg/d Sodium valproate, 500-1,200 mg/d Venlafaxine, 75-225 mg/d Duloxetine, 60-120 mg/d Amitriptyline, 25-100 mg/d Dextromethorphan, 400 mg/d Morphine sulphate, titrated to 120 mg/d Tramadol, 210 mg/d Oxycodone, mean 37 mg/d, max 120 mg/d Capsaicin, 0.075% QID Isosorbide dinitrate spray Electrical stimulation, percutaneous nerve stimulation x 3-4 weeks Oxcarbazepine Lamotrigine Lacosamide Clonidine Pentoxifylline Mexiletline Magnetic field treatment Low-intensity laser therapy Reiki therapy Reference: 1. ANN American Academy of Neurology; Evidence based guidelines: treatment of Painful Diabetic Neuropathy; 2011. QID=Four Times Daily Next Back Lyrica (Pregabalin) is a first-line treatment in all major international guidelines on the management of painful diabetic neuropathy. 1-11 References: 1 . Attal N, et al. EFNS Guidelines on the Pharmacological Treatment of Neuropathic Pain: 2010 revision. Eur J Neurol. 2010;17(9):1113–e88. 2. Ballantyne J, et al. Pharmacological Management of Neuropathic Pain. Int Assoc Study Pain. 2010;18(9):1– 8. 3. Finnerup NB, et al. Pharmacotherapy for Neuropathic Pain in Adults: A Systematic Review and Meta-Analysis. Lancet Neurol. 2015;14(2):162–73. 4. American Academy of Neurology, AAN Summary of Evidence-based Guideline for Clinicians. Treatment of Painful Diabetic Neurpathy. Accessed on 4 Nov 2019, https://www.aan.com/Guidelines/home/GetGuidelineContent/480. 5. Bohlega S, et al. Guidelines for the Pharmacological Treatment of Peripheral Neuropathic Pain: Expert Panel Recommendations for the Middle East Region. J Int Med Res. 2010;38(2):295–317. 6. Chung K, et al. A Treatment Guideline for Neuropathic Pain. J Korean Soc Spine Surg. 2011;18(4):246–353. 7. Longson D, et al. The Pharmacological Management of Neuropathic Pain in Adults in Non-Specialist Settings. National Institute for Health and Clinical Excellence. 2013;173. 8. Votrubec M, et al. Neuropathic Pain. A Management Update. Aust Fam Physician. 2013;42(3):92–7. 9. Vijayan R, et al. Management of Neuropathic Pain. Malaysian Assoc Study Pain. 2012:1–36. 10. Filipino Neuropathic Pain Technical Committee Compendium of Philippine Medicine. 11th Edition. Philippines: 2009. 11. Moulin D, et al. Pharmacological Management of Chronic Neuropathic Pain: Revised Consensus Statement from the Canadian Pain Society. Pain Res Manag. 2014;19(6):328–35. Next Back Pain relief in diabetic neuropathic patients can be seen as early as week 1 when treated with Lyrica (Pregabalin). 1 Results from pooled studies of patients with baseline demographics and characteristics with painful DPN (VAS Score). Data were pooled across seven double-blind, randomised, placebo-controlled trials using pre- gabalin to treat painful DPN. Patients received LYRICA 150-600 mg/day BID or TID according to treatment response and tolerability. Pain level was evaluated quarterly using Likert-like numeric rating scale 0=no pain to 100=worst possible pain). 1. DPN= diabetic peripheral neuropathy 2. VAS= visual analogue scale 3. BID= twice a day 4. TID= three times a day Reference: 1. Freeman R , et al. Efficacy, safety, and tolerability of pregabalin treatment for painful diabetic peripheral neuropathy: findings from seven randomized, controlled trials across a range of doses. Diabetes Care 2008;31:1448–54.doi:10.2337/dc07- 2105. Placebo LYRICA 150mg/day LYRICA 300 mg/day LYRICA 600 mg/day Significant, sustained pain reduction in patients Weeks Least squares mean change Next Back Lyrica (Pregabalin) has shown significant reduction in pain- related sleep interference for diabetic neuropathy patients with low back pain. 1 A prospective, non-interventional, observational study, where treatment was 8 weeks with pregabalin or usual care alone. Efficacy was assessed using the pain-related Sleep Interference (PRSIS), Roland-Morris Disability Questionaire, quality of life (EuroQol 5D-5L); global assessment of change were evaluated from the clinician and patient perspectives at the final visit. NRS=numeric pain rating scale Reference: 1. Taguchi T. et al. Effectiveness of pregabalin for the treatment of chronic low back pain with accompanying lower limb pain (neuropathic component): a non-interventional study in Japan. J Pain Res 2015;8:487. Next Back No new safety concerns were observed over 52 weeks with Lyrica (Pregabalin). 1 1. VAS= visual analogue scale 2. PPI= proton pump inhibitor 3. SD= standard deviation A 52 week open-label study of Japanese patients (n=123) evaluated the long term efficacy and safety of pregabalin for the relief of painful diabetic neuropathy Time course changes of VAS and PPI VAS value Mean±SD At final (week) Evaluation Mean±SD PPI score At final (week) Evaluation Reference: 1. Satoh J. et al. Efficacy and safety evaluation of pregabalin treatment over 52 weeks in patients with diabetic neuropathic pain extended after a double-blind placebo controlled trial. J Diabetes Investig 2011 Dec;2011;2(6):457-63. Next Back Combination of Lyrica (Pregabalin) and Celebrex (Celecoxib) is more effective in the treatment of chronic low back pain compared to their monotherapy treatments. 1 Reference 1. Romano CL et. al. Pregabalin, Celecoxib and Their Combination for Treatment of Chronic Low-Back Pain, J Orthopead Traumatol. 2009;10:185-91. Mean VAS reduction (self-reported) after treatment in patients with suspected neuropathic pain (LANSS>12) Celecoxib + Pregabalin Pregabalin + placebo Celecoxib + placebo The study evaluated the efficacy for the treatment of chronic low-back pain, a condition known to be due to neuropathic as well as nociceptive pain mechanisms. 1. VAS= visual analogue scale 2. LANSS= leeds assessment of neuropathic symptoms and signs % VAS reduction (mm) Next Back Lyrica (Pregabalin) provides flexible dosing and is suitable for patients taking multiple medications because it has low potential for drug-drug interaction. Frequency of potential DDIs or DCIs in patients with DPN Reference 1. Johnston SS, Udall M, Cappelleri JC, Johnson BH, et al. Cost comparison of drug-drug and drug-condition interactions in patients with painful diabetic peripheral neuropathy treated with pregabalin versus duloxetine. Am J Health Syst Pharm. 2013;70(24):2207-17. LYRICA (n=2,499) Duloxetine (n=1,354) DCI= Drug-Condition Interaction DDI= Drug-Drug Interaction US= United States DPN= Diabetic Peripherl Neuropathy Retrospective cohort study using a large U.S administrative claims database. Patients selected were diagnosed with DPN and were newly initiated on either pregabalin or duloxetine between July 1, 2008 and October 1. 2010. Next Back CORRECT