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Marotta P.,London Health Sciences Center | Bailey R.,University of Alberta | Elkashab M.,Toronto Liver Center | Farley J.,Dr. John Farley Inc. | And 7 more authors.
European Journal of Clinical Microbiology and Infectious Diseases | Year: 2016

The purpose of this investigation was to assess the real-life effectiveness of pegylated interferon (peg-IFN) α-2b with ribavirin (RBV) in a cohort of treatment-naïve patients with chronic genotypes 2 (G2) or 3 (G3) hepatitis C virus (HCV) infection. A post-hoc pooled analysis of two Canadian multicenter, observational studies, RediPEN and PoWer, was carried out. A total of 1242 G2- or G3-infected patients were included. The primary outcome was sustained virologic response (SVR). Secondary endpoints included early virologic response (EVR), end-of-treatment (EOT) response, and relapse. Multivariate logistic regression was used to identify independent predictors of treatment response. SVR in G2 and G3 was 74.4 % and 63.6 %, respectively. Relapse occurred in 12.7 % and 19.1 % of G2- and G3-infected patients achieving EOT response, respectively. Overall, G3 was found to independently predict reduced SVR [odds ratio (OR) = 0.20; p = 0.007] and increased relapse (OR = 6.84; p = 0.022). Among G3-infected patients, increasing fibrosis score was the most important factor predicting reduced SVR [F2 vs. F0/F1 (OR = 0.41; p = 0.009); F3 vs. F0/F1 (OR = 0.72; p = 0.338); F4 vs. F0/F1 (OR = 0.27; p = 0.001)]. Male gender (OR = 13.16; p = 0.020) and higher fibrosis score [F2 vs. F0/F1 (OR = 9.72; p = 0.016); F3/F4 vs. F0/F1 (OR = 4.23; p = 0.113)] were associated with increased relapse in G3 patients. These results support the real-life effectiveness of peg-IFN α-2b plus ribavirin in HCV G2- and G3-infected patients. Overall, genotype was identified as the most significant predictor of treatment outcome. Fibrosis score and gender were key outcome predictors in the G3-infected population. In clinical settings, peg-INF/RBV offers an alternative for patients without access to all oral direct-acting antivirals. © 2016, The Author(s).


PubMed | Dr. John Farley Inc., Atlantic Hepatology Services, JSS Medical Research Inc., London Health Sciences Center and 7 more.
Type: Journal Article | Journal: European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology | Year: 2016

The purpose of this investigation was to assess the real-life effectiveness of pegylated interferon (peg-IFN) -2b with ribavirin (RBV) in a cohort of treatment-nave patients with chronic genotypes 2 (G2) or 3 (G3) hepatitis C virus (HCV) infection. A post-hoc pooled analysis of two Canadian multicenter, observational studies, RediPEN and PoWer, was carried out. A total of 1242G2- or G3-infected patients were included. The primary outcome was sustained virologic response (SVR). Secondary endpoints included early virologic response (EVR), end-of-treatment (EOT) response, and relapse. Multivariate logistic regression was used to identify independent predictors of treatment response. SVR in G2 and G3 was 74.4% and 63.6%, respectively. Relapse occurred in 12.7% and 19.1% of G2- and G3-infected patients achieving EOT response, respectively. Overall, G3 was found to independently predict reduced SVR [odds ratio (OR)=0.20; p=0.007] and increased relapse (OR=6.84; p=0.022). Among G3-infected patients, increasing fibrosis score was the most important factor predicting reduced SVR [F2 vs. F0/F1 (OR=0.41; p=0.009); F3 vs. F0/F1 (OR=0.72; p=0.338); F4 vs. F0/F1 (OR=0.27; p=0.001)]. Male gender (OR=13.16; p=0.020) and higher fibrosis score [F2 vs. F0/F1 (OR=9.72; p=0.016); F3/F4 vs. F0/F1 (OR=4.23; p=0.113)] were associated with increased relapse in G3 patients. These results support the real-life effectiveness of peg-IFN -2b plus ribavirin in HCV G2- and G3-infected patients. Overall, genotype was identified as the most significant predictor of treatment outcome. Fibrosis score and gender were key outcome predictors in the G3-infected population. In clinical settings, peg-INF/RBV offers an alternative for patients without access to all oral direct-acting antivirals.


Racine N.,Montreal Heart Institute | Hamet P.,University of Montréal | Sampalis J.S.,JSS Medical Research Inc. | Sampalis J.S.,McGill University | And 2 more authors.
Journal of Human Hypertension | Year: 2010

The impact of an ARB, with or without hydrochlorothiazide (HCTZ), on glycaemic factors and the risk for developing diabetes in hypertensive patients with the metabolic syndrome have not been fully assessed. This was a 52-week multicentre, prospective, phase-IV, open-label, cohort study of losartan or losartan/HCTZ in hypertensive patients with metabolic syndrome. All subjects were treated initially with losartan 50 mg day-1. Those not achieving target blood pressure (BP <140/90 mm Hg) were titrated sequentially to losartan 100 mg, losartan 100 mg/HCTZ 12.5 mg, losartan 100 mg/HCTZ 25 mg and finally to losartan 100 mg/HCTZ 25 mg and calcium-channel blocker (CCB), as required. The primary glycaemic outcome measure was change in fasting blood glucose (FBG) and glycosylated haemoglobin A1c (HbA1c) at 52 weeks of treatment. Among the 1897 potentially eligible patients enrolled in the study, 1714 fulfilled the screening criteria. During the 52-week treatment period of the study, FBG and HbA1c did not change significantly. Clinically important and statistically significant changes were observed for both the systolic (SBP) and diastolic BP (DBP) during the study treatment period, with an overall mean decrease of 16.95 mm Hg in SBP (P=0.001) and 9.84 mm Hg in DBP (P=0.001). The majority of the patients (77.3%) achieved a target BP of <140/90 mm Hg. In conclusion, losartan, either alone or in combination with HCTZ, is effective in managing hypertension without inducing any change in glycaemic parameters or increasing the risk for developing diabetes in hypertensive patients with the metabolic syndrome. © 2010 Macmillan Publishers Limited All rights reserved.


Aisen P.S.,University of California at San Diego | Gauthier S.,ll Center for Studies in Aging | Ferris S.H.,New York University | Ferris S.H.,Nathan Kline Institute | And 9 more authors.
Archives of Medical Science | Year: 2011

Introduction: The aim of the study was to assess the clinical efficacy, safety, and disease-modification effects of tramiprosate (homotaurine, ALZHEMED™) in mild-to-moderate Alzheimer's disease (AD). Material and methods: Double-blind, placebo-controlled, randomized trial in 67 clinical centres across North America. Patients aged ≥ 50 years, with mild-to-moderate AD (Mini-Mental State Examination score between 16 and 26) and on stable doses of cholinesterase inhibitors, alone or with memantine. Intervention: 78-week treatment with placebo, tramiprosate 100 mg or tramiprosate 150 mg BID. Measurements: Alzheimer Disease Assessment Scale - cognitive subscale (ADAS-cog) and Clinical Dementia Rating - Sum of Boxes (CDR-SB) assessments were performed at baseline and every 13 weeks. Baseline and 78-week magnetic resonance imaging (MRI) hippocampus volume (HV) measurements were conducted in a subgroup of patients. Results: A total of 1,052 patients were enrolled and 790 (75.1%) completed the 78-week trial. Patient discontinuation and reasons for withdrawal were similar across groups. Planned analyses did not reveal statistically significant between-group differences. Lack of adequate statistical validity of the planned analysis models led to the development of revised predictive models. These adjusted models showed a trend toward a treatment effect for ADAS-cog (P = 0.098) and indicated significantly less HV loss for tramiprosate 100 mg (P = 0.035) and 150 mg (P = 0.009) compared to placebo. The incidence of adverse events was similar across treatment groups. Conclusions: The primary planned analyses did not show a significant treatment effect, but were confounded by unexplained variance. Post-hoc analyses showed a significant treatment-related reduction in HV loss. However, there was only a trend towards slowing of decline on the ADAS-cog and no slowing of decline on the CDR-SB. These results must be interpreted in consideration of the limitations of clinical and disease-modification outcome measures and their relationship, the heterogeneity of the disease and the impact of confounding demographic and clinical variables. Copyright © 2011 Termedia & Banach.


Ismaila A.,Glaxosmithkline | Ismaila A.,McMaster University | Corriveau D.,Glaxosmithkline | Vaillancourt J.,JSS Medical Research Inc. | And 5 more authors.
Current Medical Research and Opinion | Year: 2014

Objective: Low adherence with asthma treatment may be associated with suboptimal outcomes and hence create a treatment gap in the real-life setting. The objective of this study was to assess the long-term association between adherence to treatment with fixed-dose fluticasone propionate/salmeterol (FSC) and the risk of exacerbations and health care utilization in patients with asthma. Research design and methods: Observational single cohort study utilizing the Quebec Health Insurance databases. All patients (age >12 years) with a diagnosis of asthma (ICD9-CM 493.xx) between 2001 and 2010 were entered into the study cohort at the time of their first prescription for FSC at any dose. Follow-up continued to the last known claim or death. Adherence to treatment was ascertained as compliance (medication possession ratio ≥80%) and persistence (absence of treatment gap ≥30 days). Main outcome measures: Outcomes assessed were exacerbations defined as one of the following: use of oral corticosteroid (OCS), emergency room (ER) visit for asthma or hospitalization for asthma. Asthma related health care resource utilizations ascertained were number of prescription claims for rescue medications, ER visits, hospitalizations, intensive care unit (ICU) stay, intubations, and general practitioner (GP) and respirologist visits. Results: A total of 19,126 patients were included in the study. The proportion of compliant and persistent patients were 42.7% and 29.3% respectively. Multivariate logistic regression analyses showed a significantly reduced adjusted odds of exacerbations for compliant (OR=0.48; 95% CI: 0.44-0.54) and persistent patients (OR=0.42; 95% CI: 0.38-0.48). Similarly, significantly lower rates of health care utilization were observed for compliant and persistent patients. Conclusions: The results of this large population-based study have shown that increased adherence to treatment with FSC is associated with lower risk for exacerbations, lower rescue medication use and lower health care utilization in asthma patients. Despite the typical limitations of an administrative database study including validity of the diagnosis, the fact that compliance and persistence are calculated based on filled claims which does not guarantee that the patients actually took their medications, and the absence of clinical and laboratory data, the findings have implications for physician and patient awareness of the importance of adherence in the management of asthma. © 2014 All rights reserved.


Ismaila A.,Glaxosmithkline | Ismaila A.,McMaster University | Corriveau D.,Glaxosmithkline | Vaillancourt J.,JSS Medical Research Inc. | And 5 more authors.
Current Medical Research and Opinion | Year: 2014

Objective: Poor adherence to treatment may contribute to the treatment gap in chronic obstructive pulmonary diseases (COPD). The aim of the current study was to describe the association between adherence to treatment and the risk of COPD moderate (ME) and severe (SE) exacerbations, and health care utilization. Research design and methods: Observational single cohort study utilizing the Quebec Provincial Health Insurance databases. All patients older than 40 years with a diagnosis of COPD between 2001 and 2010 were entered in the study cohort at the time of their first prescription for tiotropium (TIO) alone or co-administered with fluticasone propionate/salmeterol (TIO+FSC). Follow-up continued to the last known claim or death. Adherence was measured by the medication possession ratio (MPR) ≥80% and persistence defined as no treatment gap ≥30 days. Main outcome measures: ME was defined as use of an oral corticosteroid or antibiotic, SE as COPD related hospitalization or an emergency room (ER) visit. COPD related health care resource utilization ascertained was prescription of rescue medications, ER visits, hospitalizations, intensive care unit (ICU) admissions, intubations, and general practitioner (GP) and respirologist visits. Results: There were 23,707 patients included in this study. Compliance and persistence with TIO for monotherapy patients were 61.1% and 47.6% respectively. For patients treated with TIO+FSC, compliance and persistence for TIO were 62.9% and 45.3% respectively, and for FSC they were 35.4% and 33.0%. Multivariate analyses showed a significant (P<0.001) adjusted odds ratios for ME (ORME) and SE (ORSE) for TIO compliant vs. non-compliant patients (TIO: ORME=0.543, ORSE=0.712; TIO+FSC: ORME=0.436, ORSE=0.570). Similarly for FSC compliance: ORME=0.546; ORSE=0.749. Similar results were observed for persistence. Compliance and persistence with TIO and FSC were associated with significantly reduced rates of health care utilization. Conclusions: Despite the typical limitations of an administrative database study, the results of this large population-based study have shown that reduced adherence to treatment with TIO and FSC is associated with increased risk for exacerbations and higher health care utilization in COPD patients. © 2014 All rights reserved.


PubMed | JSS Medical Research Inc.
Type: Journal Article | Journal: Archives of medical science : AMS | Year: 2012

Antibiotic associated diarrhea (AAD) is a frequently encountered adverse event following antibiotic administration. Evidence suggests that probiotics may be beneficial in preventing and decreasing the severity of AAD.Adult patients who were prescribed antibiotics for 3-14 days were enrolled from eight Canadian centers. Study treatment was randomized at a 1 : 1 ratio of BIO-K+CL1285( () ) or placebo and was administered within 24 h of initiation to 5 days after termination of antibiotherapy. Patients were followed for 21 days after last dose of study treatment. The primary outcome was severity and incidence of AAD. Severity was measured by the total number of days with diarrhea and incidence was defined as the number of patients with at least one day with diarrhea over the total number of patients enrolled in the study.216 patients were randomized to BIO-K+ and 221 to placebo. The mean (SD) number of days with diarrhea was 1.19. (3.20) days for the placebo and 0.67 (2.05) days for BIO-K+CL1285( () ) (p = 0.040). Adjusted multivariate linear regression results showed that the duration of diarrhea for BIO-K+CL1285 ()vs. placebo was reduced by 51.5% (b[SE] = 0.515 [0.256], p = 0.045). The incidence of diarrhea was 21.8% for the BIO-K+ and 29.4% for the placebo group (OR = 0.667, p = 0.067). Multivariate logistic regression, showed that the adjusted odds ratio of AAD in patients receiving BIO-K+ vs. placebo was 0.627 (p = 0.037). Study treatment was well tolerated.BIO-K+ is effective for preventing and reducing the severity of AAD in patients receiving antibiotic therapy in a hospital setting.


Current use of prescribed or over the counter non-steroidal anti-inflammatory drugs (NSAIDs) for pain and osteoarthritis (OA) have untoward gastrointestinal and cardiovascular related side effects, as a result the need for a safe and effective alternative has become unequivocally crucial.A randomized, double blind, placebo and active controlled pilot study of a novel dual pathway, COX1/2 and LOX, inhibitor anti-inflammatory agent of botanical origin, UP446 was conducted. Sixty subjects (age 40-75) with symptomatic OA of the hip or knee were assigned to 4 treatment groups (n = 15); Group A0 (Placebo, CMC capsule), Group A1 (UP446 250 mg/day), Group A2 (UP446 500 mg/day) and Group A3 (Celecoxib, 200 mg/day). MOS-SF-36 and Western Ontario and McMaster University Osteoarthritis Index (WOMAC) data were collected at baseline and after 30, 60 and 90 days of treatment as a measure of efficacy. Erythrocyte sedimentation rate, C-reactive protein, plasma thrombin time (PTT), fructosamine, Hematology, clinical chemistry and fecal occult blood were monitored for safety.Statistically significant decrease in WOMAC pain score were observed for Group A1 at day 90, Group A2 at 30 and 90 days and Group A3 at 60 and 90 days. Statistically significant decrease in WOMAC stiffness score were observed for Group A1 and Group A2 at 30, 60 and 90 days; but not for Group A0 and Group A3. The mean change in WOMAC functional impairment scores were statistically significant for Group A1 and Group A2 respectively at 30 days (p = 0.006 and p = 0.006), at 60 days (p = 0.016 and p = 0.002) and at 90 days (p = 0.018 and p = 0.002), these changes were not significant for Group A0 and Group A3. Based on MOS -SF-36 questionnaires, statistically significant improvements in physical function, endurance and mental health scores were observed for all active treatment groups compared to placebo. No significant changes suggestive of toxicity in routine hematologies, serum chemistries, liver enzymes or PTT were noted in any of the treatment groups.Based on current findings UP446 is safe and efficacious alternative to established anti-inflammatory medications for alleviating OA symptoms as measured by the WOMAC Index.


Crichton A.C.S.,University of Calgary | Harasymowycz P.,Institute Of Glaucome Of Montreal | Hutnik C.M.L.,Ivey Eye Institute | Behki R.,Ottawa Hospital | And 6 more authors.
Journal of Ocular Pharmacology and Therapeutics | Year: 2010

Purpose: The aim of this study was to assess the effectiveness of dorzolamide-timolol (DT) in the management of open-angle glaucoma (OAG) and ocular hypertension. Methods: An open-label, 12-week, multicenter, Canadian study was conducted. Patients with untreated OAG or ocular hypertension received DT for 12 weeks to reduce intraocular pressure (IOP). If target IOP was not reached after the first 6-week treatment period, a prostaglandin (PG) (latanoprost) was added for the remaining 6 weeks. Primary outcome measures were changes in IOP from baseline to 6 and 12 weeks of treatment, and secondary outcome measures included the proportion of patients achieving target IOP and the proportion of patients achieving therapeutic response defined as a reduction of 5.0 mmHg or 20% in IOP from baseline. IOP values were the mean of 2 measures taken before and at least 2 h after patients administered the study medication. Results: A total of 164 patients were enrolled. Mean [standard deviation (SD)] population age was 63.0 (12.3) years and 53.0% of the patients were men. At week 6, the mean (SD) absolute and percent change in IOP for the total population was -11.1 (4.9) and -36.4% (13.9%), respectively, and 92.1% of the patients achieved a reduction in IOP of at least 5 mmHg. Therapeutic target was achieved by 136 (82.9%) patients (DT subgroup) at 6 weeks, whereas 28 (17.1%) patients were changed to a combination therapy of DT and latanoprost [DT plus PG (DT & PG) subgroup]. Between weeks 6 and 12, DT was effective in sustaining the IOP within therapeutic target, whereas addition of latanoprost reduced the IOP of the DT & PG subgroup by an additional 6.3 mmHg or 22.1% (20.1%). At week 12, patients in the DT subgroup experienced a clinically and statistically significant mean (SD) decrease in IOP from a baseline of 12.2 mmHg or 40.4% (11.9%) (P < 0.001), whereas these values corresponded to 13.4 mmHg and 39.7% (15.7%) (P < 0.001), respectively, in the DT & PG subgroup. The proportion of patients who achieved therapeutic response during the entire 12-week study period was over 82%. Treatment-related adverse events (AEs) were reported by 19 (14.0%) patients in the DT subgroup and by 6 (21.4%) patients in the combination subgroup. Eye disorders and nervous system disorders were among the most common treatment-related AEs in both subgroups. No serious AEs were reported during the study period. Conclusion: DT alone and DT in combination with a PG are effective in significantly reducing IOP in patients with untreated OAG or ocular hypertension. The treatment was safe and well tolerated with a low incidence of AEs. © Copyright 2010, Mary Ann Liebert, Inc.


News Article | November 1, 2016
Site: www.prweb.com

EY today announced that the President and CEO Adrian Schauer of AlayaCare, the first outcome focused home healthcare software, received the EY Entrepreneur of the Year® 2016 Award in the Emerging Entrepreneur category in Quebec. This award recognizes outstanding Quebec entrepreneurs for their financial performance, vision, leadership, personal integrity and entrepreneurial spirit. “Receiving the EY award for Emerging Entrepreneur in Quebec is truly an honour and a very exciting milestone for AlayaCare,” said Schauer. “This recognition reflects the efforts of our entire team and I couldn’t be more proud of our accomplishments to date.” AlayaCare has produced home healthcare’s most advanced software platform, which enables home care providers to deliver better patient outcomes. AlayaCare’s technology streamlines home care delivery, digitizes clinical documentation and uses advanced technologies, such as artificial intelligence and wearable technologies, to predict clinical events such as falls and hospital re-admissions. Since 1986, EY has honored entrepreneurs whose ingenuity, spirit of innovation and discipline have propelled their companies’ success, invigorated their industries, and benefited their communities. The Quebec program of EOY has honored the inspirational leadership of such entrepreneurs as Guy Laliberté of Cirque du Soleil, Mark Cohen of Lasik MD, and John Sampalis JSS Medical Research Inc. As a Quebec award winner, Schauer is now eligible for consideration in the Entrepreneur of the Year 2016 national program. Award winners in several national categories will be announced at the Entrepreneur of the Year National Awards gala in Toronto, Ontario on November 22, 2016. About EY Entrepreneur Of The Year® EY Entrepreneur Of The Year is the world’s most prestigious business award for entrepreneurs. The unique award makes a difference through the way it encourages entrepreneurial activity among those with potential and recognizes the contribution of people who inspire others with their vision, leadership and achievement. As the first and only truly global award of its kind, Entrepreneur Of The Year celebrates those who are building and leading successful, growing and dynamic businesses, recognizing them through regional, national and global awards programs in more than 145 cities in more than 60 countries. About EY EY is a global leader in assurance, tax, transaction and advisory services. The insights and quality services we deliver help build trust and confidence in the capital markets and in economies the world over. We develop outstanding leaders who team to deliver on our promises to all of our stakeholders. In so doing, we play a critical role in building a better working world for our people, for our clients and for our communities. EY refers to the global organization, and may refer to one or more, of the member firms of Ernst & Young Global Limited, each of which is a separate legal entity. Ernst & Young Global Limited, a UK company limited by guarantee, does not provide services to clients. For more information about our organization, please visit ey.com. About AlayaCare AlayaCare is a provider of revolutionary cloud-based home healthcare software. With a product spanning clinical documentation, back office functionality, client and family portals, remote patient monitoring, and mobile care worker functionality, AlayaCare offers a platform for agencies to propel towards innovation and home care of the future. For more information, visit: http://www.alayacare.com

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