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A Double-Blind Placebo-Controlled Study of Auranofin in Patients with Psoriatic Arthritis
158 A DOUBLE-BLIND PLACEBO-CONTROLLED STUDY OF AURANOFIN IN PATIENTS WITH PSORIATIC ARTHRITIS SIMON CARETTE, ANDRE1 CALIN, JIM P. McCAFFERTY, BRUCE A. WALLIN, and THE AURANOFIN COOPERATING GROUP Two hundred thirty-eight patients with psoriatic treatment was statistically superior to placebo treat- arthritis were entered into a 6-month, multicenter, ment, according to physician’s global assessment and double-blind trial comparing auranofin and placebo. functional scores. A trend in favor of auranofin treat- Polyarthritis (>5 tender joints) was present in 90% of ment was seen for each of the other disease parameters the patients, and 94% were seronegative. Auranofin studied. Psoriasis worsened in 6 auranofin-treated pa- tients and in 3 placebo-treated patients. The incidence Simon Carette, MD: Le Centre Hospitalier de I’Universitt and nature of other side effects were similar to those Laval, Quebec City, Canada: Andrei Calin, MD: Royal National observed in similar trials of patients with rheumatoid Hospital, Bath, UK; Jim P. McCafferty, BSc: Smith Kline & French arthritis. Our observations suggest that the use of Laboratories, Philadelphia, PA; Bruce A. Wallin, MD: Smith Kline & French Laboratories, Philadelphia, PA; Michael H. Weisman, auranofin in the treatment of psoriatic arthritis is safe, MD: University of California, San Diego; Susan G. Perlman, MD: although its therapeutic advantage over treatment with Northwestern University Medical School, Chicago, 1L; Robert F. nonsteroidal antiinflammatory drugs alone is modest. Willkens, MD: University of Washington, Seattle; Stephen J. Farber, MD: Toledo Clinic, Inc., Toledo, OH: H. Ralph Schuma- cher, Jr., MD: University of Pennsylvania, Philadelphia; Suthin Psoriatic arthritis is an inflammatory erosive Songcharoen, MD: Jackson Arthritis Clinic, Jackson, MS; Ronald joint disease characterized by its association with L. -
United States Patent (19) 11 Patent Number: 5,955,504 Wechter Et Al
USOO5955504A United States Patent (19) 11 Patent Number: 5,955,504 Wechter et al. (45) Date of Patent: Sep. 21, 1999 54 COLORECTAL CHEMOPROTECTIVE Marnett, “Aspirin and the Potential Role of Prostaglandins COMPOSITION AND METHOD OF in Colon Cancer, Cancer Research, 1992; 52:5575–89. PREVENTING COLORECTAL CANCER Welberg et al., “Proliferation Rate of Colonic Mucosa in Normal Subjects and Patients with Colonic Neoplasms: A 75 Inventors: William J. Wechter; John D. Refined Immunohistochemical Method.” J. Clin Pathol, McCracken, both of Redlands, Calif. 1990; 43:453-456. Thun et al., “Aspirin Use and Reduced Risk of Fatal Colon 73 Assignee: Loma Linda University Medical Cancer." N Engl J Med 1991; 325:1593-6. Center, Loma Linda, Calif. Peleg, et al., “Aspirin and Nonsteroidal Anti-inflammatory Drug Use and the Risk of Subsequent Colorectal Cancer.” 21 Appl. No.: 08/402,797 Arch Intern Med. 1994, 154:394–399. 22 Filed: Mar 13, 1995 Gridley, et al., “Incidence of Cancer among Patients With Rheumatoid Arthritis J. Natl Cancer Inst 1993 85:307-311. 51) Int. Cl. .......................... A61K 31/19; A61K 31/40; Labayle, et al., “Sulindac Causes Regression Of Rectal A61K 31/42 Polyps. In Familial Adenomatous Polyposis” Gastroenterol 52 U.S. Cl. .......................... 514/568; 514/569; 514/428; ogy 1991 101:635-639. 514/416; 514/375 Rigau, et al., “Effects Of Long-Term Sulindac Therapy On 58 Field of Search ..................................... 514/568, 570, Colonic Polyposis” Annals of Internal Medicine 1991 514/569, 428, 416, 375 11.5:952-954. Giardiello.et al., “Treatment Of Colonic and Rectal 56) References Cited Adenomas With Sulindac In Familial Adenomatous Poly U.S. -
Comparing the Effects of Salts of Diclofenac and Almioprofen with Aspirin on Serum Electrolytes, Creatinine and Urea Levels in Rabbits
Comparing the effects of salts of diclofenac and almioprofen with aspirin on serum electrolytes, creatinine and urea levels in rabbits Nawazish-i-Husain Syed*, Farnaz Zehra, Amir Ali Rizvi Syed, Sabiha Karim and Farrakh Zia Khan University College of Pharmacy, University of the Punjab, Lahore, Pakistan Abstract: The effects of diclofenac sodium, diclofenac potassium, alminoprofen and aspirin on serum electrolytes (serum Na+ and K+), urea and creatinine were compared in rabbits in acute and chronic phases of treatment. The data suggested that all the four drugs markedly increased the serum electrolytes, urea and creatinine levels in both post- treatment phases. In conclusion, present study does not present any advantage of diclofenac sodium over diclofenac potassium at electrolyte levels on short and long term treatment. Nevertheless, current data support the evidence of renal function impairment by all the four drug therapies used in the present study, which is generally caused by NSAIDS. Keywords: NSAIDs, renal function, serum electrolytes. INTRODUCTION were given fodder twice daily, while water was available ad libitum. Throughout the study, environmental Inflammatory diseases including rheumatoid arthritis and conditions remained constant. Rabbits were divided into osteoarthritis are initially treated with non-steroidal anti- five groups, each of six animals. Same group of animals inflammatory drugs (NSAIDS) (Patrono and Rocca, were used for acute and chronic phases of the study. In 2009). Previously, steroids were prescribed to manage the both studies, rabbits of each group were orally chronic inflammatory diseases, however, due to their administered diclofenac Na+, diclofenac K+, severe adverse effects, NSAIDS has become the first alminoprofen, acetyl salicylic acid in a doses of 2.5mg, choice to treat these diseases. -
Table S1: Sensitivity, Specificity, PPV, NPV, and F1 Score of NLP Vs. ICD for Identification of Symptoms for (A) Biome Developm
Table S1: Sensitivity, specificity, PPV, NPV, and F1 score of NLP vs. ICD for identification of symptoms for (A) BioMe development cohort; (B) BioMe validation cohort; (C) MIMIC-III; (D) 1 year of notes from patients in BioMe calculated using manual chart review. A) Fatigue Nausea and/or vomiting Anxiety Depression NLP (95% ICD (95% CI) P NLP (95% CI) ICD (95% CI) P NLP (95% CI) ICD (95% CI) P NLP (95% CI) ICD (95% CI) P CI) 0.99 (0.93- 0.59 (0.43- <0.00 0.25 (0.12- <0.00 <0.00 0.54 (0.33- Sensitivity 0.99 (0.9 – 1) 0.98 (0.88 -1) 0.3 (0.15-0.5) 0.85 (0.65-96) 0.02 1) 0.73) 1 0.42) 1 1 0.73) 0.57 (0.29- 0.9 (0.68- Specificity 0.89 (0.4-1) 0.75 (0.19-1) 0.68 0.97 (0.77-1) 0.03 0.98 (0.83-1) 0.22 0.81 (0.53-0.9) 0.96 (0.79-1) 0.06 0.82) 0.99) 0.99 (0.92- 0.86 (0.71- 0.94 (0.79- 0.79 (0.59- PPV 0.96 (0.82-1) 0.3 0.95 (0.66-1) 0.02 0.95 (0.66-1) 0.16 0.93 (0.68-1) 0.12 1) 0.95) 0.99) 0.92) 0.13 (0.03- <0.00 0.49 (0.33- <0.00 0.66 (0.48- NPV 0.89 (0.4-1) 0.007 0.94 (0.63-1) 0.34 (0.2-0.51) 0.97 (0.81-1) 0.86 (0.6-0.95) 0.04 0.35) 1 0.65) 1 0.81) <0.00 <0.00 <0.00 F1 Score 0.99 0.83 0.88 0.57 0.95 0.63 0.82 0.79 0.002 1 1 1 Itching Cramp Pain NLP (95% ICD (95% CI) P NLP (95% CI) ICD (95% CI) P NLP (95% CI) ICD (95% CI) P CI) 0.98 (0.86- 0.24 (0.09- <0.00 0.09 (0.01- <0.00 0.52 (0.37- <0.00 Sensitivity 0.98 (0.85-1) 0.99 (0.93-1) 1) 0.45) 1 0.29) 1 0.66) 1 0.89 (0.72- 0.5 (0.37- Specificity 0.96 (0.8-1) 0.98 (0.86-1) 0.68 0.98 (0.88-1) 0.18 0.5 (0-1) 1 0.98) 0.66) 0.88 (0.69- PPV 0.96 (0.8-1) 0.8 (0.54-1) 0.32 0.8 (0.16-1) 0.22 0.99 (0.93-1) 0.98 (0.87-1) NA* 0.97) 0.98 (0.85- 0.57 (0.41- <0.00 0.58 (0.43- <0.00 NPV 0.98 (0.86-1) 0.5 (0-1) 0.02 (0-0.08) NA* 1) 0.72) 1 0.72) 1 <0.00 <0.00 <0.00 F1 Score 0.97 0.56 0.91 0.28 0.99 0.68 1 1 1 *Denotes 95% confidence intervals and P values that could not be calculated due to insufficient cells in 2x2 tables. -
Modifying Antirheumatic Drugs in Active Rheumatoid Arthritis: a Japan Phase 3 Trial (HARUKA)
MODERN RHEUMATOLOGY 2020, VOL. 30, NO. 2, 239–248 https://doi.org/10.1080/14397595.2019.1639939 ORIGINAL ARTICLE Sarilumab monotherapy or in combination with non-methotrexate disease- modifying antirheumatic drugs in active rheumatoid arthritis: A Japan phase 3 trial (HARUKA) Hideto Kamedaa, Kazuteru Wadab, Yoshinori Takahashib, Owen Haginoc, Hubert van Hoogstratend, Neil Grahame and Yoshiya Tanakaf aDivision of Rheumatology, Department of Internal Medicine, Faculty of Medicine, Toho University (Ohashi Medical Center), Tokyo, Japan; bSanofi K.K., Tokyo, Japan; cSanofi, Bridgewater, NJ, USA; dSanofi-Genzyme, Cambridge, MA, USA; eRegeneron Pharmaceuticals, Inc., Tarrytown, NY, USA; fFirst Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Downloaded from https://academic.oup.com/mr/article/30/2/239/6299750 by guest on 01 October 2021 Japan, Kitakyushu, Japan ABSTRACT ARTICLE HISTORY Objectives: To determine long-term safety and efficacy of sarilumab as monotherapy or with non- Received 13 March 2019 methotrexate (MTX) conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) in Accepted 1 July 2019 Japanese patients with active rheumatoid arthritis (RA). KEYWORDS Methods: In this double-blind, randomized study (NCT02373202), patients received subcutaneous sari- Rheumatoid arthritis; lumab 150 mg q2w (S150) or 200 mg q2w (S200) as monotherapy or with non-MTX csDMARDs for 52 sarilumab; Japan; phase III; weeks. The primary endpoint was safety. anti-IL-6 receptor Results: Sixty-one patients received monotherapy (S150, n ¼ 30; S200, n ¼ 31) and 30 received combin- ation therapy (S150 þ csDMARDs, n ¼ 15; S200 þ csDMARDs, n ¼ 15). Rates of treatment-emergent adverse events (TEAEs) were 83.3%/90.3%/93.3%/86.7% for S150/S200/S150 þ csDMARDs/ S200 þ csDMARDs, respectively. -
Characterising the Risk of Major Bleeding in Patients With
EU PE&PV Research Network under the Framework Service Contract (nr. EMA/2015/27/PH) Study Protocol Characterising the risk of major bleeding in patients with Non-Valvular Atrial Fibrillation: non-interventional study of patients taking Direct Oral Anticoagulants in the EU Version 3.0 1 June 2018 EU PAS Register No: 16014 EMA/2015/27/PH EUPAS16014 Version 3.0 1 June 2018 1 TABLE OF CONTENTS 1 Title ........................................................................................................................................... 5 2 Marketing authorization holder ................................................................................................. 5 3 Responsible parties ................................................................................................................... 5 4 Abstract ..................................................................................................................................... 6 5 Amendments and updates ......................................................................................................... 7 6 Milestones ................................................................................................................................. 8 7 Rationale and background ......................................................................................................... 9 8 Research question and objectives .............................................................................................. 9 9 Research methods .................................................................................................................... -
Study Protocol);
PF-06651600 B7981006 Final Protocol Amendment 1, 26 October 2016 A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP, PLACEBO-CONTROLLED, MULTI-CENTER STUDY TO ASSESS THE EFFICACY AND SAFETY PROFILE OF PF-06651600 IN SUBJECTS WITH MODERATE TO SEVERE ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE Investigational Product Number: PF-06651600 Investigational Product Name: Not Applicable (N/A) United States (US) Investigational New 131274 Drug (IND) Number: European Clinical Trials Database 2016-002862-30 (EudraCT) Number: Protocol Number: B7981006 Phase: 2a Page 1 PF-06651600 B7981006 Final Protocol Amendment 1, 26 October 2016 Document History Document Version Date Summary of Changes and Rationale Amendment 1 26 October 2016 In the Schedule of Activities, and Section 7.2.12, added audiogram testing Rationale: To monitor for potential changes in hearing between baseline [between Visit 1 and Visit 2 (inclusive)] and at the end of the study [between Visit 7 and Visit 9 (inclusive)]. The following exclusion criteria has been added in Section 4.2: Have current or recent history of clinically significant severe or progressive hearing loss or auditory disease. Subjects with hearing aids will be allowed to enter the study provided their hearing impairment is considered controlled/ clinically stable. Rationale: This has been added to ensure that subject hearing for safety is fully evaluated prior to study entry. Several additional minor changes were made to protocol language for the purposes of clarification. Original protocol 31 August 2016 Not applicable (N/A) This amendment incorporates all revisions to date, including amendments made at the request of country health authorities and institutional review boards (IRBs)/ethics committees (ECs). -
The In¯Uence of Medication on Erectile Function
International Journal of Impotence Research (1997) 9, 17±26 ß 1997 Stockton Press All rights reserved 0955-9930/97 $12.00 The in¯uence of medication on erectile function W Meinhardt1, RF Kropman2, P Vermeij3, AAB Lycklama aÁ Nijeholt4 and J Zwartendijk4 1Department of Urology, Netherlands Cancer Institute/Antoni van Leeuwenhoek Hospital, Plesmanlaan 121, 1066 CX Amsterdam, The Netherlands; 2Department of Urology, Leyenburg Hospital, Leyweg 275, 2545 CH The Hague, The Netherlands; 3Pharmacy; and 4Department of Urology, Leiden University Hospital, P.O. Box 9600, 2300 RC Leiden, The Netherlands Keywords: impotence; side-effect; antipsychotic; antihypertensive; physiology; erectile function Introduction stopped their antihypertensive treatment over a ®ve year period, because of side-effects on sexual function.5 In the drug registration procedures sexual Several physiological mechanisms are involved in function is not a major issue. This means that erectile function. A negative in¯uence of prescrip- knowledge of the problem is mainly dependent on tion-drugs on these mechanisms will not always case reports and the lists from side effect registries.6±8 come to the attention of the clinician, whereas a Another way of looking at the problem is drug causing priapism will rarely escape the atten- combining available data on mechanisms of action tion. of drugs with the knowledge of the physiological When erectile function is in¯uenced in a negative mechanisms involved in erectile function. The way compensation may occur. For example, age- advantage of this approach is that remedies may related penile sensory disorders may be compen- evolve from it. sated for by extra stimulation.1 Diminished in¯ux of In this paper we will discuss the subject in the blood will lead to a slower onset of the erection, but following order: may be accepted. -
Classification of Medicinal Drugs and Driving: Co-Ordination and Synthesis Report
Project No. TREN-05-FP6TR-S07.61320-518404-DRUID DRUID Driving under the Influence of Drugs, Alcohol and Medicines Integrated Project 1.6. Sustainable Development, Global Change and Ecosystem 1.6.2: Sustainable Surface Transport 6th Framework Programme Deliverable 4.4.1 Classification of medicinal drugs and driving: Co-ordination and synthesis report. Due date of deliverable: 21.07.2011 Actual submission date: 21.07.2011 Revision date: 21.07.2011 Start date of project: 15.10.2006 Duration: 48 months Organisation name of lead contractor for this deliverable: UVA Revision 0.0 Project co-funded by the European Commission within the Sixth Framework Programme (2002-2006) Dissemination Level PU Public PP Restricted to other programme participants (including the Commission x Services) RE Restricted to a group specified by the consortium (including the Commission Services) CO Confidential, only for members of the consortium (including the Commission Services) DRUID 6th Framework Programme Deliverable D.4.4.1 Classification of medicinal drugs and driving: Co-ordination and synthesis report. Page 1 of 243 Classification of medicinal drugs and driving: Co-ordination and synthesis report. Authors Trinidad Gómez-Talegón, Inmaculada Fierro, M. Carmen Del Río, F. Javier Álvarez (UVa, University of Valladolid, Spain) Partners - Silvia Ravera, Susana Monteiro, Han de Gier (RUGPha, University of Groningen, the Netherlands) - Gertrude Van der Linden, Sara-Ann Legrand, Kristof Pil, Alain Verstraete (UGent, Ghent University, Belgium) - Michel Mallaret, Charles Mercier-Guyon, Isabelle Mercier-Guyon (UGren, University of Grenoble, Centre Regional de Pharmacovigilance, France) - Katerina Touliou (CERT-HIT, Centre for Research and Technology Hellas, Greece) - Michael Hei βing (BASt, Bundesanstalt für Straßenwesen, Germany). -
Health Reports for Mutual Recognition of Medical Prescriptions: State of Play
The information and views set out in this report are those of the author(s) and do not necessarily reflect the official opinion of the European Union. Neither the European Union institutions and bodies nor any person acting on their behalf may be held responsible for the use which may be made of the information contained therein. Executive Agency for Health and Consumers Health Reports for Mutual Recognition of Medical Prescriptions: State of Play 24 January 2012 Final Report Health Reports for Mutual Recognition of Medical Prescriptions: State of Play Acknowledgements Matrix Insight Ltd would like to thank everyone who has contributed to this research. We are especially grateful to the following institutions for their support throughout the study: the Pharmaceutical Group of the European Union (PGEU) including their national member associations in Denmark, France, Germany, Greece, the Netherlands, Poland and the United Kingdom; the European Medical Association (EMANET); the Observatoire Social Européen (OSE); and The Netherlands Institute for Health Service Research (NIVEL). For questions about the report, please contact Dr Gabriele Birnberg ([email protected] ). Matrix Insight | 24 January 2012 2 Health Reports for Mutual Recognition of Medical Prescriptions: State of Play Executive Summary This study has been carried out in the context of Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients’ rights in cross- border healthcare (CBHC). The CBHC Directive stipulates that the European Commission shall adopt measures to facilitate the recognition of prescriptions issued in another Member State (Article 11). At the time of submission of this report, the European Commission was preparing an impact assessment with regards to these measures, designed to help implement Article 11. -
PRESCRIBING INFORMATION RIDAURA®Auranofin Capsules
RIDAURA- auranofin capsule Prometheus Laboratories Inc. ---------- PRESCRIBING INFORMATION RIDAURA® Auranofin Capsules Rx Only RIDAURA® (auranofin) contains gold and, like other gold-containing drugs, can cause gold toxicity, signs of which include: fall in hemoglobin, leukopenia below 4,000 WBC/cu mm, granulocytes below 1,500/cu mm, decrease in platelets below 150,000/cu mm, proteinuria, hematuria, pruritus, rash, stomatitis or persistent diarrhea. Therefore, the results of recommended laboratory work (See PRECAUTIONS) should be reviewed before writing each RIDAURA prescription. Like other gold preparations, RIDAURA is only indicated for use in selected patients with active rheumatoid arthritis. Physicians planning to use RIDAURA should be experienced with chrysotherapy and should thoroughly familiarize themselves with the toxicity and benefits of RIDAURA. In addition, the following precautions should be routinely employed: 1. The possibility of adverse reactions should be explained to patients before starting therapy. 2. Patients should be advised to report promptly any symptoms suggesting toxicity. (See PRECAUTIONS—Information for Patients.) DESCRIPTION RIDAURA (auranofin) is available in oral form as capsules containing 3 mg auranofin. Auranofin is (2,3,4,6-tetra-O-acetyl-1-thio-ß-D-glucopyranosato-S-) (triethyl–phosphine) gold. Auranofin contains 29% gold and has the following chemical structure: Each RIDAURA capsule, with opaque brown cap and opaque tan body, contains auranofin, 3 mg, and is imprinted with the product name RIDAURA. Inactive ingredients consist of benzyl alcohol, cellulose, cetylpyridinium chloride, D&C Red No. 33, FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, lactose, magnesium stearate, povidone, sodium lauryl sulfate, sodium starch glycolate, starch, titanium dioxide and trace amounts of other inactive ingredients. -
Fatal Hepatitis Associated with Diclofenac
Gut: first published as 10.1136/gut.27.11.1390 on 1 November 1986. Downloaded from Gut, 1986, 27, 1390-1393 Case reports Fatal hepatitis associated with diclofenac E G BREEN, J McNICHOLL, E COSGROVE, J MCCABE, AND F M STEVENS From the Department of Medicine, Regional Hospital, Galway, Eire SUMMARY Non-steroidal anti-inflammatory agents (NSAIDS) are a well recognised cause of hepatotoxicity. Diclofenac, a relatively new NSAID, was first introduced into the UK in 1979. Five cases of hepatitis have recently been reported, principally in the French literature. -5 We report the first fulminant case of hepatitis in the English literature in a patient taking diclofenac and indomethacin. Diclofenac is a member of the arylalkanoic group of 100 mg per day for five weeks. Ferrous sulphate one NSAIDS (Fig. 1). Three other agents in this group tablet daily was added on 16 May. The patient was have been shown to be significantly hepatotoxic. admitted to hospital on 26 June. A week before this Ibufenac was withdrawn from circulation because of he had felt unwell with anorexia, nausea, abdominal the frequent rise in transaminases,6 7 the use of discomfort, and dark urine. On admission he was benoxaprofen was stopped in Britain after 10 icteric, the liver edge was palpable 4 cm below the patients died with hepatitis8 9 and more recently a costal margin and there were no signs of chronic fatal case of hepatitis due to pirprofen has been liver disease. Ultrasound showed early ascites with reported."' Early reports about diclofenac showed no obstruction of the biliary tract.