DOCSLIB.ORG

GP093 ID#2490.Pdf

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
GP093 ID#2490.Pdf Comparison of the effectiveness of four major drugs prescribed for chronic low back pain in Japan ーNationwide multicenter study Gen Inoue, Takashi Kaito, Yukihiro Matsuyama, Toshihiko Yamashita Mamoru Kawakami, Kazuhisa Takahashi, Munehito Yoshida Shiro Imagama, Seiji Ohtori, Toshihiko Taguchi, Hirotaka Haro Hiroshi Taneichi, Masashi Yamazaki, Kotaro Nishida, Hiroshi Yamada Daijiro Kabata, Ayumi Shintani, Motoki Iwasaki, Manabu Ito Naohisa Miyakoshi, Hideki Murakami, Kazuo Yonenobu Tomoyuki Takura, Joji Mochida The Project Committee of the Japanese Society for Spine Surgery and Related Research (JSSR) Disclosures The authors have nothing to disclose. Purpose To compare the effectiveness of acetaminophen, celecoxib, loxoprofen, and the tramadol / acetaminophen combination drug (T+A CD) using several outcome measures, and to establish evidence of the optimal pharmacological treatment option for cLBP. Project research of JSSR • Started in 2014 as Japanese nationwide multicenter study to examine the cost-effectiveness of drug therapy for cLBP • Subjects are patients with cLBP treated with four major drugs, loxoprofen, celecoxib, acetaminophen, and T+A CD used for cLBP in Japan • Total 602 patients were included from January 2014 to June 2016, and prospectively analyzed for 6 months. Materials and Methods Patients who were treated with one of the major drugs for cLBP in Japan, Acetaminophen, Celecoxib, Loxoprofen, or tramadol / acetaminophen combination drug (T+A CD). Inclusion cliteria n=471 (male: 269, female: 202) Ø LBP lasting for ≥ 3 months Ø Age: 20 -85 years old mean 73.0 years old Ø BS-POP <10 on the physician version mean BMI: 23.4 and <15 on the patient version duration of LBP: 24.3 months Exclusion cliteria Occupation +: 74.1%, -: 25.9% Ø prescription of two or more drugs from among 4 drugs Diagnosis Ø coexistence of a gastrointestinal disorder with lumbar spinal stenosis: 28.4% hemorrhage Ø severe cardiac, hepatic, or renal disease lumbar spondylosis: 21.1% Ø hematologic disease, as with bleeding diathesis Ø dementia or another psychiatric disorder chronic low back pain: 15.6% Ø coexistent or previous history of alcohol or drug lumbar spondylolisthesis: 5.6% dependence Ø history of a malignant neoplasm within five years Evaluations Visual analogue scale (VAS) for LBP, EQ-5D, JOA score,Rolland- Morris Disability Questionnaire (RDQ), JOABPEQ, SF-8 These treatment measures were evaluated every months until 6 months after allocation Statistics ØVariables were compared among treatment groups using baseline data and Kruskal–Wallis and chi-square tests for continuous and categorical variables, respectively. ØMultivariable linear regression analyses was conducted to compare these treatments’ effects on the change in each outcome measure at one and 6 months after allocation. ØThe analysis included the change from baseline for each outcome at each time point as a dependent variable. ØIndependent variables indicated that the medicine was prescribed continuously from baseline, observation, and cross-product terms. Baseline and mean dose of 4 groups Acetaminophen Celecoxib Loxoprofen T+A CD VAS for LBP 50mm 55mm 53mm 50mm EQ-5D 0.65 0.65 0.65 0.65 JOA score 19.0 20.0 20.0 18.0 * RDQ 9.0 10.0 10.0 10.0 LBP 43.0 43.0 43.0 43.0 Lumbar function 33.0 33.0 33.3 33.0 JOABPEQ Walking ability 43.0 43.0 50.0 43.0 Social life function 51.0 51.0 51.0 50.5 Mental health 51.0 50.0 53.0 50.0 PCS 37.3 38.0 37.6 35.6 SF8 MCS 48.5 49.8 49.0 49.1 Mean Dose 1,137±31.7mg 209±1.5mg 2.4±0.1T 2.9±0.1T *JOA score showed statistical difference at baseline. VAS for LBP JOA score N.S. * Acetaminophen Celecoxib Loxoprofen T+A CD N.S. N.S. SF8 Physical component summary Mental component summary N.S. N.S. N.S. N.S. LBP Lumbar function JOABPEQ Acetaminophen Celecoxib Loxoprofen T+A CD NS NS NS NS Walking ability Social life function Mental health * NS NS NS NS NS Discussion JOA score JOABPEQ_mental health Acetaminophen Celecoxib Loxoprofen T+A CD Significant difference Acetaminophen：Activation of the descending pain modulatory system via receptors in the midbrain and medulla oblongata Inhibits cyclooxygenase (COX) but few anti-inflammatory effect Influence of inflammatory pain component may be limited in cLBP status. JOABPEQ_mental health SF8- MCS Acetaminophen Celecoxib Loxoprofen T+A CD As effectiveness on mental aspect, almost no difference was observed among 4 drugs. Mental component summary of SF8 continued worsening during 6months Pharmacological treatment for cLBP is difficult to improve patients’ symptom, especially in mental component. Conclusions Ø The treatment effect of the four major drugs on cLBP was compared during 6 months. Ø Statistical comparisons were performed at 1 and 6 months, and the mental health component of JOABPEQ at 1 month and the JOA score at 6 months showed significant differences among the four drugs, and acetaminophen showed the greatest effect. Ø The effects on pain were not significantly different between the four drugs, and no improvement in mental aspect was obtained throughout the 6 months. Ø To identify the small difference of the treatment effect on cLBP, multiple, comprehensive evaluations using several treatment measures should be desirable, but still hard to detect the difference..
Load more

Recommended publications
  • What Are the Acute Treatments for Migraine and How Are They Used?
    2. Acute Treatment CQ II-2-1 What are the acute treatments for migraine and how are they used? Recommendation The mainstay of acute treatment for migraine is pharmacotherapy. The drugs used include (1) acetaminophen, (2) non-steroidal anti-inflammatory drugs (NSAIDs), (3) ergotamines, (4) triptans and (5) antiemetics. Stratified treatment according to the severity of migraine is recommended: use NSAIDs such as aspirin and naproxen for mild to moderate headache, and use triptans for moderate to severe headache, or even mild to moderate headache when NSAIDs were ineffective in the past. It is necessary to give guidance and cautions to patients having acute attacks, and explain the methods of using medications (timing, dose, frequency of use) and medication use during pregnancy and breast-feeding. Grade A Background and Objective The objective of acute treatment is to resolve the migraine attack completely and rapidly and restore the patient’s normal functions. An ideal treatment should have the following characteristics: (1) resolves pain and associated symptoms rapidly; (2) is consistently effective; (3) no recurrence; (4) no need for additional use of medication; (5) no adverse effects; (6) can be administered by the patients themselves; and (7) low cost. Literature was searched to identify acute treatments that satisfy the above conditions. Comments and Evidence The acute treatment drugs for migraine generally include (1) acetaminophens, (2) non-steroidal anti-inflammatory drugs (NSAIDs), (3) ergotamines, (4) triptans, and (5) antiemetics. For severe migraines including status migrainosus and migraine attacks refractory to treatment, (6) anesthetics, and (7) corticosteroids (dexamethasone) are used (Tables 1 and 2).1)-9) There are two approaches to the selection and sequencing of these medications: “step care” and “stratified care”.
    [Show full text]
  • The Effectiveness of Patches Containing Loxoprofen Sodium
    22 Japanese Journal of Comprehensive Rehabilitation Science (2013) Original Article The effectiveness of patches containing Loxoprofen Sodium Hydrate (LX-P) in the conservative therapy of muscular back pain – Clinical results using the Japanese Orthopaedic Association Back Pain Evaluation Questionnaire (JOABPEQ) Toyoko Asami, MD, PhD,1 Naoya Yamanouchi, MD,1 Akihiko Asami, MD, PhD,2 Hisato Tanaka, MD,3 PhD, Norihiko Nogami, MD, PhD4 1Department of Rehabilitation Medicine, Saga University Hospital, Saga, Japan. 2Saga Social Insurance Hospital, Saga, Japan. 3Tanaka Hospital (Anju Medical Corporation), Saga, Japan. 4Wakakusu Ryoikuen, Tosu, Saga, Japan. ABSTRACT life disability. The rate of effectiveness of LX-P against Asami T, Yamanouchi N, Asami A, Tanaka H, Nogami pain-related disabilities in the fourth week was 62.2%. N. The effectiveness of patches containing Loxoprofen Conclusion: LX-P showed satisfactory analgesic Sodium Hydrate (LX-P) in the conservative therapy of effect and QOL improvement. We believe it is effective muscular back pain - Clinical results using the Japanese for clinical practice. Orthopaedic Association Back Pain Evaluation Keywords: loxoprofen sodium, JOABPEQ, VAS, Questionnaire (JOABPEQ). Jpn J Compr Rehabil Sci QOL, muscular back pain 2013; 4: 22-29. Objectives: We investigated the analgesic effect, Introduction degree of patient satisfaction, and QOL improvement provided by patches containing loxoprofen sodium According to the Ministry of Health, Labour and hydrate (LX-P) using a questionnaire based on the Welfare’s Comprehensive Survey of Living Conditions evaluation criteria of the Japanese Orthopaedic (several surveys conducted in fiscal 2004, 2007, 2010), Association Back Pain Evaluation Questionnaire pain in the locomotive organs, including “lower back (JOABPEQ). pain,” “stiff shoulders,” and “joint pain,” is one of the Methods: In this study of 53 patients (18 men, 35 most common subjective symptoms reported.
    [Show full text]
  • Biological and Pharmaceutical Bulletin Regular Article Association
    Biological and Pharmaceutical Bulletin Advance Publication by J-STAGE Advance Publication DOI:10.1248/bpb.b17-00547 November 28, 2017 Biological and Pharmaceutical Bulletin Regular article Association Between Concomitant Use of Acyclovir or Valacyclovir with NSAIDs and an Increased Risk of Acute Kidney Injury:Data Mining of FDA Adverse Event Reporting System Zhihua Yue1, Jinhai Shi2 , Haona Li3 ,Huiyi Li1 1Chinese Pharmacopoeia Commission, Beijing, China 2Tianjin international Joint Academy of Biotechnology & Medicine, Tianjin, China 3Huaihe Hospital of Henan University, Kaifeng, China. Corresponding Author: Zhihua Yue, Ph.D. Chinese Pharmacopoeia Commission, Beijing, China, No.11 Fahua Nanli, Dongcheng District, Beijing,100061, P.R.China E-Mail: [email protected] Ⓒ 2017 The Pharmaceutical Society of Japan SUMMARY NSAIDs are likely to be used concomitantly with acyclovir or valacyclovir in clinical practice, but the study on the safety of such combinations was seldom reported. The objective of the study was to investigate reports of acute kidney injury(AKI) events associated with the concomitant use of oral acyclovir or valacyclovir with an NSAID by using the United States Food and Drug Administration(FDA) Adverse Event Reporting System (AERS) database between January 2004 and June 2012. The frequency of AKI events in patients while simultaneously taking either acyclovir or valacyclovir and an NSAID was compared using the Chi-square test. The effect of concomitant use of acyclovir or valacyclovir and individual NSAIDs on AKI was analyzed by the reporting odds ratio (ROR).The results showed that AKI was reported as the adverse event in 8.6% of the 10,923 patients taking valacyclovir compared with 8.7% of the 2,556 patients taking acyclovir (p=NS).However, AKI was significantly more frequently reported in patients simultaneously taking valacyclovir and an NSAID(19.4%)than in patients simultaneously taking acyclovir and an NSAID(10.5%)(p<0.01).
    [Show full text]
  • Pharmaceuticals and Medical Devices Safety Information No
    Pharmaceuticals and Medical Devices Safety Information No. 264 December 2009 Table of Contents 1. Safety measures for anaphylaxis and anaphylactoid symptoms associated with injectable antibiotics ............................................... 4 2. Important Safety Information .................................................................. 7 .1. Salazosulfapyridine ···················································································· 7 .2. Pethidine hydrochloride, pethidine hydrochloride/levallorphan tartrate ··················· 9 3. Revision of PRECAUTIONS (No. 211) Indometacin (oral dosage form) (and 7 others) ...........................................................13 4. List of products subject to Early Post-marketing Phase Vigilance ............................................... 15 This Pharmaceuticals and Medical Devices Safety Information (PMDSI) is issued based on safety information collected by the Ministry of Health, Labour and Welfare. It is intended to facilitate safer use of pharmaceuticals and medical devices by healthcare providers. PMDSI is available on the Pharmaceuticals and Medical Devices Agency website (http://www.pmda.go.jp/english/index.html) and on the MHLW website (http://www.mhlw.go.jp/, Japanese only). Published by Translated by Pharmaceutical and Food Safety Bureau, Pharmaceuticals and Medical Devices Agency Ministry of Health, Labour and Welfare Pharmaceutical and Food Safety Bureau, Office of Safety I, Ministry of Health, Labour and Welfare Pharmaceuticals and Medical Devices Agency 1-2-2
    [Show full text]
  • S1 Table. List of Medications Analyzed in Present Study Drug
    S1 Table. List of medications analyzed in present study Drug class Drugs Propofol, ketamine, etomidate, Barbiturate (1) (thiopental) Benzodiazepines (28) (midazolam, lorazepam, clonazepam, diazepam, chlordiazepoxide, oxazepam, potassium Sedatives clorazepate, bromazepam, clobazam, alprazolam, pinazepam, (32 drugs) nordazepam, fludiazepam, ethyl loflazepate, etizolam, clotiazepam, tofisopam, flurazepam, flunitrazepam, estazolam, triazolam, lormetazepam, temazepam, brotizolam, quazepam, loprazolam, zopiclone, zolpidem) Fentanyl, alfentanil, sufentanil, remifentanil, morphine, Opioid analgesics hydromorphone, nicomorphine, oxycodone, tramadol, (10 drugs) pethidine Acetaminophen, Non-steroidal anti-inflammatory drugs (36) (celecoxib, polmacoxib, etoricoxib, nimesulide, aceclofenac, acemetacin, amfenac, cinnoxicam, dexibuprofen, diclofenac, emorfazone, Non-opioid analgesics etodolac, fenoprofen, flufenamic acid, flurbiprofen, ibuprofen, (44 drugs) ketoprofen, ketorolac, lornoxicam, loxoprofen, mefenamiate, meloxicam, nabumetone, naproxen, oxaprozin, piroxicam, pranoprofen, proglumetacin, sulindac, talniflumate, tenoxicam, tiaprofenic acid, zaltoprofen, morniflumate, pelubiprofen, indomethacin), Anticonvulsants (7) (gabapentin, pregabalin, lamotrigine, levetiracetam, carbamazepine, valproic acid, lacosamide) Vecuronium, rocuronium bromide, cisatracurium, atracurium, Neuromuscular hexafluronium, pipecuronium bromide, doxacurium chloride, blocking agents fazadinium bromide, mivacurium chloride, (12 drugs) pancuronium, gallamine, succinylcholine
    [Show full text]
  • Anti-Inflammatory Analgesic Plaster Entzundungshemmendes, Analgetisches Pflaster Sparadrap Analgesique Anti-Inflammatoire
    _ <v Europaisches 111111111111111111111111111111111 JGV/l Eur°Pean Patent Office <*S Office europeen des brevets (11) EP 0 607 434 B1 (12) EUROPEAN PATENT SPECIFICATION (45) Date of publication and mention (51) int. CI.6: A61 K 31/19, A61K31/215, of the grant of the patent: A61 K 9/70, A61K31/40 27.01.1999 Bulletin 1999/04 (86) International application number: ..... - ...number: 92916806.0 (21) Application PCT/JP92/01022 (22) Date of filing: 10.08.1992 x 7 3 (87) International. 4 4..... publication 4. number: WO 93/04677 (18.03.1993 Gazette 1993/08) (54) ANTI-INFLAMMATORY ANALGESIC PLASTER ENTZUNDUNGSHEMMENDES, ANALGETISCHES PFLASTER SPARADRAP ANALGESIQUE ANTI-INFLAMMATOIRE (84) Designated Contracting States: • TATEISHI, Tetsuro, AT BE CH DE FR GB IE IT LI LU NL SE Hisamitsu Pharmaceutical Co Inc Tosu-shi, Saga 841 (JP) (30) Priority: 30.08.1991 J P 246665/91 (74) Representative: (43) Date of publication of application: Bond, Bentley George 27.07.1994 Bulletin 1994/30 Haseltine Lake & Co., Imperial House, (73) Proprietor: 15-19 Kingsway HISAMITSU PHARMACEUTICAL CO. INC. London WC2B 6UD (GB) Tosu-shi Saga 841 (JP) (56) References cited: (72) Inventors: JP-A- 1 040 420 JP-A-55133 310 • NAKAGAWA, Akira, JP-A-56 020 515 JP-A-59 227 819 Hisamitsu Pharmaceutical Co. Inc. JP-A-60152 413 JP-A-63 246 327 Tosu-shi, Saga 841 (JP) • HIRANO, Munehiko, CHEMICAL ABSTRACTS, vol. 109, no. 12, 19 Hisamitsu Pharmaceutical Co Inc. September 1988, Columbus, Ohio, US; abstract Tosu-shi, Saga 841 (JP) no. 98839x, & JP-A-62 240 612 (HISAMITSU PHARMACEUTICAL CO.,INC.) 21 October 1987 CO CO o Note: Within nine months from the publication of the mention of the grant of the European patent, give CO any person may notice to the European Patent Office of opposition to the European patent granted.
    [Show full text]
  • Clinical Outcomes of Aspirin Interaction with Other Non-Steroidal Anti- Inflammatory Drugs: a Systematic Review
    J Pharm Pharm Sci (www.cspsCanada.org) 21, 48s – 73s, 2018 Clinical Outcomes of Aspirin Interaction with Other Non-Steroidal Anti- Inflammatory Drugs: A Systematic Review Zuhair Alqahtani and Fakhreddin Jamali Faculty of Pharmacy and Pharmaceutical Science, University of Alberta, Edmonton, Alberta, Canada. Received, March 16, 2018; Revised, March 30, 2018; Accepted, April 25, 2018; Published, April 27, 2018. ABSTRACT - Purpose: Concomitant use of some non-Aspirin nonsteroidal anti-inflammatory drugs (NANSAIDs) reduces the extent of platelet aggregation of Aspirin (acetylsalicylic acid). This is while many observational studies and clinical trials suggest that Aspirin reduces cardiovascular (CV) risk attributed to the use of NANSAIDs. Thus, the therapeutic outcome of the interaction needs to be assessed. Methods: We searched various databases up to October 2017 for molecular interaction studies between the drugs and long-term clinical outcomes based on randomized clinical trials and epidemiological observations that reported the effect estimates of CV risks (OR, RR or HR; 95% CI) of the interacting drugs alone or in combinations. Comparisons were made between outcomes after Aspirin alone, NANSAIDs alone and Aspirin with naproxen, ibuprofen, celecoxib, meloxicam, diclofenac or rofecoxib. Results: In total, 32 eligible studies (20 molecular interactions studies and 12 observational trials) were found. Conflicting in vitro/in vivo/ex vivo platelet aggregation data were found for ibuprofen, naproxen and celecoxib. Nevertheless, for naproxen, the interaction at the aggregation level did not amount to a loss of cardioprotective effects of Aspirin. Similarly, for ibuprofen, the results overwhelmingly suggest no negative clinical CV outcomes following the combination therapy. Meloxicam and rofecoxib neither interacted with Aspirin at the level of platelet aggregation nor altered clinical outcomes.
    [Show full text]
  • Flow Injection Chemiluminescence Determination of Loxoprofen and Naproxen with the Acidic Permanganate-Sulfite System
    J Pharm Anal Vol 1, No 1, 51- 56 (2011) ORIGINAL ARTICLES Flow injection chemiluminescence determination of loxoprofen and naproxen with the acidic permanganate-sulfite system 2 2 Li-Juan Wang· , Yu-Hai Thng *, Yang-Hao Lilt I Medical School, Xi'an ]iaotong University, Xi'an 710061, China; 2 Institute of Analytical Sciences, Xi'an ]iaotong University, Xi'an 710061, China. Abstract: A novel flow injection chemiluminescence (CL) method for the determination of loxoprofen and naproxen was proposed based on the CL system of KMnO, and Na,SOJ in acid media. The CL intensity of KMnO,-Na,SOJ was greatly enhanced in the presence of loxoprofen and naproxen. The mechanism of the CL reaction was studied by the kinetic process and UV-vis absorption and the conditions were optimized. Under optimized conditions, the CL intensity was 8 5 7 linear with loxoprofen and naproxen concentration in the range of 7.0 X 10- -1. 0 x 10- glmL and 2.0 x 10- - 4.0 X 10-· glmL with the detection limit of 2.0 x 10- 8 glmL and 3.0 x 10- 8 glmL (SIN = 3), respectively. The relative standard deviations were 2.39% and 1.37% for 5.0 x 10- 7 glmL naproxen and 5.0 x 10- 7 glmL loxoprofen (n = 10), respectively. The proposed method was satisfactorily applied to the determination of loxoprofen and naproxen in pharmaceutical prepa­ rations. Keywords: chemiluminescence; KMnO, ; loxoprofen; naproxen 1 Introduction which does not require sophisticated instruments and too many chemical reagents. CL method has been developed to Nonsteroidal anti-inflammatory drugs (NSAIDs) are a detect arylpropionic acid derivatives, such as ketoprofen, group of analgesics and anti-inflammatory drugs that are naproxen, ibuprofen, and fenbufen [21-25].
    [Show full text]
  • E-Table 1. Drug Classification Category Name Generic Name
    BMJ Publishing Group Limited (BMJ) disclaims all liability and responsibility arising from any reliance Supplemental material placed on this supplemental material which has been supplied by the author(s) Thorax e-Table 1. Drug classification Category Name Generic Name Antiplatelets clopidogrel, cilostazol, ticlopidine2, beraprost, beraprost–long acting, complavin Anticoagulants 2,3 dabigatran Statins1,2,3 atorvastatin2, simvastatin, pitavastatin, fluvastatin, pravastatin, rosuvastatin, amlodipine/atorvastatin Sodium channel blockers4,5† mexiletine, aprindine, cibenzoline Beta blocker acebutolol2 Class III antiarrhythmic drugs amiodarone1–6 Calcium channel blockers bepridil1, amlodipine/atorvastatin, telmisartan/amlodipine, valsartan/amlodipine, valsartan/cilnidipine, candesartan/amlodipine Angiotensin/converting enzyme enalapril inhibitor2‡ Thiazides trichlormethiazide, hydrochlorothiazide3,5, benzylhydrochlorothiazide/reserpine/carbazochrome, mefruside, telmisartan/hydrochlorothiazide, valsartan/hydrochlorothiazide, candesartan/hydrochlorothiazide, candesartan/trichlormethiazide, losartan/hydrochlorothiazide NSAIDs diclofenac2, celecoxib, loxoprofen, etodolac, nabumetone, pranoprofen Anti-rheumatics actarit, iguratimod, tofacitinib, penicillamine2–5, leflunomide1,3, sodium aurothiomalate2–6#, bucillamine Leukotriene receptor antagonist2* pranlukast 5-ASA mesalazine, salazosulfapyridine5 Tricyclic antidepressant Imipramine5, cromipramine, maprotiline Antiepileptics valproate, phenytoin2,3,5, ethotoin, carbamazepine2–5, zonisamide Interferon1,2,3
    [Show full text]
  • Study Protocol);
    Tanezumab A4091058 Final Protocol Amendment 2, 15 May 2016 CLINICAL PROTOCOL A PHASE 3 RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROLLED, MULTICENTER STUDY OF THE LONG-TERM SAFETY AND EFFICACY OF SUBCUTANEOUS ADMINISTRATION OF TANEZUMAB IN SUBJECTS WITH OSTEOARTHRITIS OF THE HIP OR KNEE Compound: PF-04383119 Compound Name: Tanezumab United States (US) Investigational New BB-IND 11,680 Drug (IND) Number: European Clinical Trial Database 2012-003721-22 ) (EudraCT) Number: Protocol Number: A4091058 GMT ( Phase: 3 This document contains confidential information belonging to Pfizer. Except as otherwise agreed to in writing, by accepting or reviewing this document, you agree to hold this information in confidence and not copy or disclose it to others (except where required by applicable law) or use it for unauthorized purposes. In the event of any actual or suspected breach of this obligation, Pfizer must be promptly notified. roved On: 06-Jun-2016 11:33 pp roved\A pp 090177e191ffa88c\Approved\Approved On: 03-Oct-2019 14:27 (GMT) 090177e1883c9873\A PFIZER CONFIDENTIAL Page 1 Tanezumab A4091058 Final Protocol Amendment 2, 15 May 2016 Document History Document Version Date Summary of Changes and Rationale Amendment 2 15 May 2016 Inclusion criterion #4 and associated text throughout the protocol has been updated to expand the number of pre-study, non-steroidal anti-inflammatory drug (NSAID) osteoarthritis pain treatment regimens that are considered to be qualifying. The following pre- study NSAID treatment regimens are now considered to be qualifying for prospective study subjects: Ibuprofen 1200 – 3200 mg/day Loxoprofen 120 – 180 mg/day Meloxicam 5 - 15 mg/day Nabumetone 1000 – 2000 mg/day ) Aceclofenac 200 mg/day GMT ( Sulindac 200 – 400 mg/day Ketoprofen 200 mg/day To account for formulations of naproxen that include the sodium salt of naproxen, the lowest qualifying dose of naproxen is set at 440 mg/day.
    [Show full text]
  • Analgesic Anti-Inflammatory Adhesive Preparations
    Europaisches Patentamt (19) European Patent Office Office europeeneen des brevets EP 0 71 3 697 A1 (12) EUROPEAN PATENT APPLICATION (43) Date of publication: (51) |nt Cl.e: A61K9/70 29.05.1996 Bulletin 1996/22 (21) Application number: 95307605.6 (22) Date of filing: 25.10.1995 (84) Designated Contracting States: • Orihara, Masamichi DE ES FR GB IT Minamisatama-gun Saitama-ken (JP) • Sugimoto, Yoshio (30) Priority: 26.10.1994 J P 284573/94 Saitama-ken (JP) • Yamazaki, Masaru (71) Applicant: Tokuhon Corporation Kitakatsushika-gun Saitama-ken (JP) Tokyo (JP) • Hoshino, Mitsunari Saitama-ken (JP) (72) Inventors: • Uchikawa, Masumasa • Sasaki, Yasuhiko Saitama-ken (JP) Saitama-ken (JP) • Arai, Hiroshi • Matsumura, Yukihiro Saitama-ken (JP) Saitama-ken (JP) • Imai, Susumu (74) Representative: Thomas, Roger Tamlyn et al Kitatsushika-gun Saitama-ken (JP) D. Young & Co. • Tooyama, Tetsuhiro 21 New Fetter Lane Saitama-ken (JP) London EC4A 1 DA (GB) (54) Analgesic anti-inflammatory adhesive preparations (57) A non-steroidal analgesic anti-inflammatory phenylyl)propionic acid and a modified copolymer in adhesive preparation obtained by coating one surface which methylmethacrylate is allowed to graft-polymer- of support with an adhesive containing S-(+)-2- ize on said copolymer, or with an adhesive containing ( 2-fluoro-4-biphenylyl)propionic acid and a styrene-iso- S-(+)-2-(2-fluoro-4-biphenylyl) propionic acid, sodium prene-styrene block copolymer or S-(+)-2-(2-fluor-4-bi- carboxymethyl cellulose and sodium polyacrylate. Is- O) CO CO o a. LU Printed by Jouve, 75001 PARIS (FR) EP 0 713 697 A1 Description The present invention concerns a non-steroidal analgesic anti-inflammatory adhesive preparation which contains as the pharmacologically effective component S-(+)-2-(2-fluoro-4-biphenylyl) propionic acid [abbreviated S-(+)-FP 5 hereinafter] which may be optically resolved from the racemic form 2-(2-fluoro-4-biphenylyl) propionic acid (also called: flurbiprofen).
    [Show full text]
  • Drug Class Review Nonsteroidal Antiinflammatory Drugs (Nsaids)
    Drug Class Review Nonsteroidal Antiinflammatory Drugs (NSAIDs) Final Update 4 Evidence Tables November 2010 The purpose of Drug Effectiveness Review Project reports is to make available information regarding the comparative clinical effectiveness and harms of different drugs. Reports are not usage guidelines, nor should they be read as an endorsement of or recommendation for any particular drug, use, or approach. Oregon Health & Science University does not recommend or endorse any guideline or recommendation developed by users of these reports. Update 3: November 2006 Update 2: May 2004 Update 1: September 2003 Original Report: May 2002 The literature on this topic is scanned periodically Kim Peterson, MS Marian McDonagh, PharmD Sujata Thakurta, MPA: HA Tracy Dana, MLS Carol Roberts, BS Roger Chou, MD Mark Helfand, MD, MPH Drug Effectiveness Review Project Marian McDonagh, PharmD, Principal Investigator Oregon Evidence-based Practice Center Mark Helfand, MD, MPH, Director Copyright © 2010 by Oregon Health & Science University Portland, Oregon 97239. All rights reserved. Final Update 4 Evidence Tables Drug Effectiveness Review Project The medical literature relating to this topic is scanned periodically. (See http://www.ohsu.edu/xd/research/centers-institutes/evidence-based-policy- center/derp/documents/methods.cfm for description of scanning process). Prior versions of this report can be accessed at the DERP website. Nonsteroidal antiinflammatory drugs (NSAIDs) 2 of 90 Final Update 4 Evidence Tables Drug Effectiveness Review Project TABLE OF CONTENTS Abbreviations used in evidence tables ..................................................................................................... 4 Evidence Table 1. Data abstraction of randomized controlled trials ........................................................ 7 Evidence Table 2. Quality assessment of randomized controlled trials ................................................. 67 Evidence Table 3. Data abstraction of observational studies ...............................................................
    [Show full text]