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Dialysis patients treated with Epoetin alfa show improved anemia symptoms: A new analysis of the Canadian Erythropoietin Study Group trial.

https://arctichealth.org/en/permalink/ahliterature144639
Source
Hemodial Int. 2010 Apr;14(2):168-73
Publication Type
Article
Date
Apr-2010
Author
Paul A Keown
David N Churchill
Melanie Poulin-Costello
Lei Lei
Sandeep Gantotti
Irene Agodoa
Matthew Gitlin
Shravanthi R Gandra
Tracy J Mayne
Author Affiliation
University of British Columbia, Vancouver, Canada. keown@interchange.ubc.ca
Source
Hemodial Int. 2010 Apr;14(2):168-73
Date
Apr-2010
Language
English
Publication Type
Article
Keywords
Adult
Aged
Anemia - drug therapy - etiology
Canada
Data Interpretation, Statistical
Erythropoietin - administration & dosage
Fatigue - drug therapy - etiology
Female
Health status
Hematinics - administration & dosage
Humans
Kidney Failure, Chronic - complications - therapy
Male
Middle Aged
Placebos
Quality of Life
Randomized Controlled Trials as Topic - methods - standards - statistics & numerical data
Recombinant Proteins
Renal Dialysis
Abstract
The health-related quality of life (HRQOL) claims in the current Epoetin alfa label are based on the reanalyses of the exercise and physical function data from the Canadian Erythropoietin Study Group trial. The reanalysis was done to comply with the Food and Drug Administration's requirement of using statistical methods that are currently standard in evaluating clinical trial data. Presented here are HRQOL results associated with anemia. The Canadian Erythropoietin Study Group trial was a multicenter, double blind, randomized, placebo-controlled trial evaluating the effects of Epoetin alfa on HRQOL in anemic hemodialysis patients. A total of 118 patients who were 18-75 years old, on hemodialysis for >3 months, who had a hemoglobin
PubMed ID
20345390 View in PubMed
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Effectiveness and safety of etanercept in patients with psoriatic arthritis in a Canadian clinical practice setting: the REPArE trial.

https://arctichealth.org/en/permalink/ahliterature134507
Source
J Rheumatol. 2011 Jul;38(7):1355-62
Publication Type
Article
Date
Jul-2011
Author
Dafna D Gladman
Claire Bombardier
Carter Thorne
Boulos Haraoui
Majed Khraishi
Proton Rahman
William Bensen
Jerry Syrotuik
Melanie Poulin-Costello
Author Affiliation
Toronto Western Hospital (University of Toronto) and University Health Network, Toronto, Ontario, Canada. dafna.gladman@utoronto.ca
Source
J Rheumatol. 2011 Jul;38(7):1355-62
Date
Jul-2011
Language
English
Publication Type
Article
Keywords
Adult
Antirheumatic Agents - adverse effects - therapeutic use
Arthritis, Psoriatic - drug therapy - physiopathology
Canada
Disability Evaluation
Efficiency - physiology
Fatigue - epidemiology - physiopathology
Female
Health status
Humans
Immunoglobulin G - adverse effects - therapeutic use
Incidence
Interviews as Topic
Longitudinal Studies
Male
Middle Aged
Receptors, Tumor Necrosis Factor - therapeutic use
Treatment Outcome
Tumor Necrosis Factor-alpha - antagonists & inhibitors
Abstract
To describe the longterm effectiveness and safety of etanercept in Canadian patients with psoriatic arthritis (PsA), treated over 24 months in clinical practice.
Patients with active PsA (= 3 tender and = 3 swollen joints) were recruited from 22 centers. Etanercept was administered at 50 mg/week subcutaneously. In addition to clinical assessment of skin and joint disease, conducted at baseline and at Months 6, 12, 18, and 24, regular patient interviews were conducted by telephone. Patient responses related to health status, disability, and work productivity were scored using the patient global assessment tool, the Health Assessment Questionnaire (HAQ), the Health and Labour Questionnaire (HLQ), and the Fatigue Severity Scale.
Out of 110 patients, 71 (65%) maintained etanercept treatment through the end of our study. All clinical measures of disease severity, including joint tenderness/pain, joint swelling, and Psoriasis Area and Severity Index score, improved significantly between baseline and Month 6 of etanercept treatment and remained constant thereafter. By the end of our study, 79% of patients achieved a Psoriatic Arthritis Response Criteria response, and 56% of patients achieved a 0.5-point improvement on HAQ, indicating clinically significant improvement in disability; 14% of patients finished our study free of disability (HAQ = 0). Patients' work productivity and fatigue improved significantly in parallel with these clinical and functional improvements.
Continuous treatment with etanercept over 2 years in a clinical setting improved clinical symptoms of PsA while reducing fatigue, improving work productivity, and ameliorating or eliminating disability.
PubMed ID
21572156 View in PubMed
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Etiology of community-acquired pneumonia treated in an ambulatory setting.

https://arctichealth.org/en/permalink/ahliterature176451
Source
Respir Med. 2005 Jan;99(1):60-5
Publication Type
Article
Date
Jan-2005
Author
Thomas J Marrie
Melanie Poulin-Costello
Michael D Beecroft
Zeljka Herman-Gnjidic
Author Affiliation
Department of Medicine, University of Alberta, Edmonton, AB, 2F1.30 WMC, 8440 112 Street, Edmonton, Alberta, Canada T6G 2B7. tom.marrie@ualberta.ca
Source
Respir Med. 2005 Jan;99(1):60-5
Date
Jan-2005
Language
English
Publication Type
Article
Keywords
Adult
Aged
Ambulatory Care
Bacterial Typing Techniques - methods
Canada
Chlamydia Infections - diagnosis
Chlamydophila pneumoniae
Community-Acquired Infections - diagnosis - microbiology
Double-Blind Method
Female
Humans
Male
Middle Aged
Pneumonia, Bacterial - diagnosis - microbiology
Pneumonia, Mycoplasma - diagnosis
Prospective Studies
Sputum - microbiology
Abstract
Very few studies have addressed the etiology of community-acquired pneumonia (CAP) treated in an ambulatory setting.
Patients were recruited from physicians' offices and from Emergency Rooms in Canada. Pneumonia was defined as two or more respiratory symptoms and signs and a new opacity on chest radiograph interpreted by a radiologist as pneumonia. Blood and sputum for culture as well as acute and convalescent serum samples for serology were obtained. Antibodies to Mycoplasma pneumoniae and Chlamydia pneumoniae were determined using enzyme-linked immunosorbent assays.
Five hundred and seven patients were enrolled in the study; 419 (82%) had blood cultures done, seven (1.4%) of which were positive for Streptococcus pneumoniae; 241 (47.5%) had a sputum processed for culture, 31% of which were positive for a potential respiratory pathogen. 437 (86.2%) had both acute and convalescent serum samples obtained, 148 (33.8%) of which gave a positive result. Overall an etiological diagnosis was made in 48.4% of the patients. M. pneumoniae accounted for 15% of the cases, C. pneumoniae 12%, S. pneumoniae 5.9% and Haemophilus influenzae 4.9%.
Despite considerable effort an etiological diagnosis of CAP treated on an ambulatory basis was made in only half the patients. The most commonly identified pathogens were M. pneumoniae, C. pneumoniae, S. pneumoniae,
PubMed ID
15672850 View in PubMed
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Intravenous immune globulin use in Canada.

https://arctichealth.org/en/permalink/ahliterature185931
Source
Can J Clin Pharmacol. 2003;10(1):11-6
Publication Type
Article
Date
2003
Author
Kim Hanna
Melanie Poulin-Costello
Mark Preston
Neil Maresky
Author Affiliation
Bayer Inc, Etobicoke, Canada. Kim.Hanna.b@bayer.com
Source
Can J Clin Pharmacol. 2003;10(1):11-6
Date
2003
Language
English
Publication Type
Article
Keywords
Adolescent
Adult
Canada
Child
Drug Labeling
Drug Utilization Review
Guideline Adherence
Hospital Information Systems
Humans
Immunoglobulins - administration & dosage - adverse effects - therapeutic use
Injections, Intravenous
Physician's Practice Patterns - statistics & numerical data
Product Surveillance, Postmarketing
Retrospective Studies
Abstract
To determine the amount of intravenous immune globulin (IVIG) used across indications in Canada and which Canadian medical specialties prescribe IVIG. To assess the proportion of IVIG that was used in appropriate off-label and labelled indications versus those deemed to be inappropriate off-label indications.
In Canada, all IVIG is distributed by the Canadian Blood System to Canadian blood banks within the hospital setting. Hospital blood banks then dispense IVIG to individual patients as it is prescribed and, as such, many institutions maintain a comprehensive database inventory on IVIG use. This study is a retrospective review of IVIG use as obtained from 10 teaching and community hospital blood bank databases in Ontario, Quebec, Alberta and British Columbia. Two of these 10 institutions were pediatric teaching hospitals whereas the remaining eight centres were adult care sites. Product usage was assessed between 1997 and 1999 in adult care sites, and 1997 and 1998 in the pediatric hospitals. The information collected included the number of grams of IVIG dispensed, the indications, the prescribing physician's specialty and the number of patients treated for a given indication, all assessed on an annual basis. A separate analysis was performed to determine the appropriateness of IVIG use where appropriateness was based on the published 1997 and 1999 Canadian Consensus Guidelines for IVIG use.
IVIG was prescribed for 90 different indications, six of which are licensed in Canada. When considered as separate populations, adult and pediatric use accounted for 61 and 65 different indications, respectively. Licensed use for all known indications represented approximately 47% and 62% in adult and pediatric settings, respectively. Twenty-nine per cent of IVIG use in adult and 17% in pediatric settings was not reported and is therefore unknown. Although off-label use by definition is approximately 53% in adults and 38% in pediatrics, the majority of overall IVIG use (89% in both populations) is considered appropriate by guideline definition. Hematologists and neurologists were the most prevalent prescribers of IVIG.
Based on guideline definition, appropriate off-label use of IVIG is very high in Canada.
PubMed ID
12687032 View in PubMed
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One-year, multicenter, open-label, single-arm study evaluating the safety and effectiveness of etanercept for the treatment of moderate-to-severe plaque psoriasis in a Canadian population.

https://arctichealth.org/en/permalink/ahliterature114778
Source
J Cutan Med Surg. 2013 Mar-Apr;17(2):129-38
Publication Type
Article
Author
Ronald Vender
Charles Lynde
Martin Gilbert
Vincent Ho
Sheetal Sapra
Melanie Poulin-Costello
Author Affiliation
Dermatrials Research, Hamilton, ON.
Source
J Cutan Med Surg. 2013 Mar-Apr;17(2):129-38
Language
English
Publication Type
Article
Keywords
Adult
Canada
Confidence Intervals
Female
Headache - chemically induced
Humans
Immunoglobulin G - adverse effects - therapeutic use
Immunologic Factors - adverse effects - therapeutic use
Male
Middle Aged
Nasopharyngitis - chemically induced
Psoriasis - drug therapy
Quality of Life
Questionnaires
Receptors, Tumor Necrosis Factor - therapeutic use
Respiratory Tract Infections - chemically induced
Severity of Illness Index
Abstract
Although etanercept is well tolerated and effective in moderate-to-severe plaque psoriasis, data are limited in Canadian practice settings.
To assess the effectiveness and safety of etanercept in Canadian patients with moderate-to-severe plaque psoriasis (Physician Global Assessment [PGA] = 3) in routine practice.
A 1-year, multicenter, open-label trial of 246 patients enrolled from March 2006 to July 2009 was conducted. Patients received etanercept 50 mg subcutaneously twice weekly for 3 months and then 50 mg once weekly for 9 months. The primary end point was the proportion of patients achieving a PGA score = 2 at month 12. Secondary end points included the proportion of patients achieving PGA score = 2 at months 3, 6, and 9 and change from baseline at month 12 for Patient Global Assessment (PtGA), body surface area, and Dermatology Life Quality Index (DLQI). Adverse events were reported.
At month 12, 73.5% (95% CI 67.2-79.1) achieved a PGA score = 2. The response was similar regardless of the previous response to systemic or phototherapy. The proportion of patients achieving this score improved from 2.2% (95% CI 0.3-4.2) at baseline to 73.5% (95% CI 67.2-79.1) at 12 months. At 12 months, patients with a DLQI score of 0 or = 5-point improvement was 28.8% (95% CI 22.9-34.7) and 47.3% (95% CI 40.8-53.9), respectively. No new safety signals were reported.
The majority of this Canadian population demonstrated a meaningful improvement in PGA and DLQI scores over 1 year.
PubMed ID
23582167 View in PubMed
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Work productivity and healthcare resource utilization outcomes for patients on etanercept for moderate-to-severe plaque psoriasis: results from a 1-year, multicentre, open-label, single-arm study in a clinical setting.

https://arctichealth.org/en/permalink/ahliterature121796
Source
Appl Health Econ Health Policy. 2012 Sep 1;10(5):343-53
Publication Type
Article
Date
Sep-1-2012
Author
Ronald Vender
Charles Lynde
Vincent Ho
Dina Chau
Melanie Poulin-Costello
Author Affiliation
Dermatrials Research, Hamilton, ON, Canada. ron.vender@me.com
Source
Appl Health Econ Health Policy. 2012 Sep 1;10(5):343-53
Date
Sep-1-2012
Language
English
Publication Type
Article
Keywords
Canada
Clinical Trials, Phase IV as Topic - statistics & numerical data
Economics, Pharmaceutical
Efficiency
Female
Health Services - economics - utilization
Humans
Immunoglobulin G - administration & dosage - economics - therapeutic use
Immunosuppressive Agents - administration & dosage - economics - therapeutic use
Injections, Subcutaneous
Male
Middle Aged
Multicenter Studies as Topic - statistics & numerical data
Psoriasis - complications - drug therapy - economics
Receptors, Tumor Necrosis Factor - administration & dosage - therapeutic use
Sick Leave - economics - statistics & numerical data
Treatment Outcome
Work Schedule Tolerance
Abstract
Data investigating the effect of etanercept on work productivity and healthcare resource utilization in Canadian patients in a clinical setting is limited.
The aim of the study was to describe work productivity and healthcare resource utilization in patients with psoriasis prescribed etanercept.
A 12-month, phase IV, non-randomized, multicentre, open-label, single-arm prospective trial of patients with moderate-to-severe plaque psoriasis was conducted between March 2006 and July 2009 in 37 community dermatology practice sites across Canada. A total of 246 patients were enrolled. Major eligibility criteria: =18 years of age; diagnosis of moderate-to-severe plaque psoriasis at baseline (Physician Global Assessment [PGA] =3, scale 0-5); able to start etanercept therapy as per product monograph. Patients received etanercept (Enbrel(®)) 50 mg subcutaneously twice weekly for 3 months, then 50 mg once weekly for 9 months. Outcomes were measured by average change and average percent change from baseline at months 3, 6, 9 and 12 on the Work Productivity and Activity Impairment (WPAI) and Healthcare Resource Utilization (HRU) questionnaires.
The mean degree of impairment while working ± standard deviation (SD) in the total population decreased from 22.7% ± 23.2 at baseline to 6.6% ± 14 after 3 months of treatment (p
PubMed ID
22877226 View in PubMed
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6 records – page 1 of 1.