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  1. Article ; Online: A meta-analysis of placebo-controlled clinical trials assessing the efficacy and safety of incretin-based medications in patients with type 2 diabetes.

    Fakhoury, Walid K H / Lereun, Corinne / Wright, Donna

    Pharmacology

    2010  Volume 86, Issue 1, Page(s) 44–57

    Abstract: Aims: A systematic review of the literature, in combination with a meta-analysis of randomized controlled trials comparing treatments with placebo, was conducted to provide an update on the clinical efficacy and safety of incretin-based medications in ... ...

    Abstract Aims: A systematic review of the literature, in combination with a meta-analysis of randomized controlled trials comparing treatments with placebo, was conducted to provide an update on the clinical efficacy and safety of incretin-based medications in adult patients with type 2 diabetes.
    Methods: A literature search (2000-2009) identified 38 placebo-controlled trials (phase II or later - parallel design) comparing exenatide (n = 8), liraglutide (n = 7), vildagliptin (n = 11) and sitagliptin (n = 12) with placebo. Outcomes were change from baseline in HbA(1c) and in weight, and the number of patient-reported hypoglycemic episodes. HbA(1c) and weight outcomes were analyzed as weighted mean differences (WMD), and the number of hypoglycemic episodes as relative risks (RR).
    Results: Patients receiving liraglutide showed greater reduction in HbA(1c) in comparison to placebo (WMD = -1.03, 95% confidence interval, CI = -1.16 to -0.90, p < 0.001) than those on sitagliptin (WMD = -0.79, 95% CI = -0.93 to -0.65, p < 0.001), exenatide (WMD = -0.75, 95% CI = -0.83 to -0.67, p < 0.001) or vildagliptin (WMD = -0.67, 95% CI = -0.83 to -0.52, p < 0.001). Weight was statistically significantly negatively associated with exenatide (WMD = -1.10, 95% CI = -1.32 to -0.87, p < 0.001) and positively associated with sitagliptin (WMD = 0.60, 95% CI = 0.33-0.87, p < 0.001) and vildagliptin (WMD = 0.56, 95% CI = 0.27-0.84, p < 0.001). The number of patient-reported hypoglycemic episodes was statistically significantly associated with the use of sitagliptin (RR = 2.56, 95% CI = 1.23-5.33, p = 0.01) and exenatide (RR = 2.40, 95% CI = 1.30-4.11, p = 0.002).
    Conclusion: Incretin-based therapies are effective in glycemic control and also offer other advantages such as weight loss (exenatide and liraglutide). This may have an important impact on patient adherence to medication.
    MeSH term(s) Adamantane/adverse effects ; Adamantane/analogs & derivatives ; Adamantane/pharmacology ; Adamantane/therapeutic use ; Adult ; Diabetes Mellitus, Type 2/drug therapy ; Dipeptidyl-Peptidase IV Inhibitors/adverse effects ; Dipeptidyl-Peptidase IV Inhibitors/pharmacology ; Dipeptidyl-Peptidase IV Inhibitors/therapeutic use ; Drug Therapy, Combination ; Glucagon-Like Peptide 1/adverse effects ; Glucagon-Like Peptide 1/analogs & derivatives ; Glucagon-Like Peptide 1/pharmacology ; Glucagon-Like Peptide 1/therapeutic use ; Glycated Hemoglobin A/metabolism ; Humans ; Hypoglycemia/chemically induced ; Hypoglycemic Agents/adverse effects ; Hypoglycemic Agents/pharmacology ; Hypoglycemic Agents/therapeutic use ; Liraglutide ; Nitriles/adverse effects ; Nitriles/pharmacology ; Nitriles/therapeutic use ; Peptides/adverse effects ; Peptides/pharmacology ; Peptides/therapeutic use ; Pyrazines/adverse effects ; Pyrazines/pharmacology ; Pyrazines/therapeutic use ; Pyrrolidines/adverse effects ; Pyrrolidines/pharmacology ; Pyrrolidines/therapeutic use ; Sitagliptin Phosphate ; Triazoles/adverse effects ; Triazoles/pharmacology ; Triazoles/therapeutic use ; Venoms/adverse effects ; Venoms/pharmacology ; Venoms/therapeutic use ; Weight Loss/drug effects
    Chemical Substances Dipeptidyl-Peptidase IV Inhibitors ; Glycated Hemoglobin A ; Hypoglycemic Agents ; Nitriles ; Peptides ; Pyrazines ; Pyrrolidines ; Triazoles ; Venoms ; Liraglutide (839I73S42A) ; Glucagon-Like Peptide 1 (89750-14-1) ; exenatide (9P1872D4OL) ; vildagliptin (I6B4B2U96P) ; Adamantane (PJY633525U) ; Sitagliptin Phosphate (TS63EW8X6F)
    Language English
    Publishing date 2010
    Publishing country Switzerland
    Document type Comparative Study ; Journal Article ; Meta-Analysis ; Review
    ZDB-ID 206671-3
    ISSN 1423-0313 ; 0031-7012
    ISSN (online) 1423-0313
    ISSN 0031-7012
    DOI 10.1159/000314690
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    Zs.A 332: Show issues Location:
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  2. Article ; Online: An indirect comparison, via enoxaparin, of rivaroxaban with dabigatran in the prevention of venous thromboembolism after hip or knee replacement.

    Lereun, Corinne / Wells, Phillip / Diamantopoulos, Alex / Rasul, Farhat / Lees, Michael / Sengupta, Nishan

    Journal of medical economics

    2011  Volume 14, Issue 2, Page(s) 238–244

    Abstract: Objective: To compare the efficacy, in the prevention of venous thromboembolism (VTE), and safety, of rivaroxaban and dabigatran relative to the common comparator enoxaparin.: Methods: Two randomized clinical trials of dabigatran, one after total hip ...

    Abstract Objective: To compare the efficacy, in the prevention of venous thromboembolism (VTE), and safety, of rivaroxaban and dabigatran relative to the common comparator enoxaparin.
    Methods: Two randomized clinical trials of dabigatran, one after total hip replacement (THR), RE-NOVATE, and one after total knee replacement (TKR), RE-MODEL, were identified as using the same enoxaparin regimen (40 mg once daily given the evening before surgery) and being of comparable duration to two rivaroxaban trials, RECORD1 and RECORD3. Indirect comparisons were performed on both efficacy and safety endpoints. To enable comparisons, symptomatic VTE results were based on the total study duration period, i.e. including the follow-up period. Major bleeding included surgical-site bleeding events.
    Results: After THR, rivaroxaban 10 mg once daily significantly reduced total VTE and symptomatic VTE relative to dabigatran 220 mg once daily (relative risk 0.34 and 0.19, respectively). After TKR, rivaroxaban significantly reduced total VTE versus dabigatran (relative risk 0.53); symptomatic VTE was not different between dabigatran and rivaroxaban. There was no significant difference in the rates of major bleeding for patients receiving rivaroxaban or dabigatran.
    Conclusions: Based on the indirect comparisons, rivaroxaban was estimated to be more efficacious than dabigatran in the prevention of total VTE after THR and TKR. Our analysis relied upon published data for dabigatran and did not have the advantages of more detailed comparative data obtained directly from a randomized trial, as was the case with rivaroxaban. Further comparative research may be of value, but until available our conclusions represent the best available evidence.
    MeSH term(s) Aged ; Anticoagulants/economics ; Anticoagulants/therapeutic use ; Arthroplasty, Replacement, Hip/adverse effects ; Arthroplasty, Replacement, Hip/economics ; Arthroplasty, Replacement, Knee/adverse effects ; Arthroplasty, Replacement, Knee/economics ; Benzimidazoles/economics ; Benzimidazoles/therapeutic use ; Dabigatran ; Enoxaparin/economics ; Enoxaparin/therapeutic use ; Female ; Health Care Costs ; Humans ; Male ; Middle Aged ; Morpholines/economics ; Morpholines/therapeutic use ; Postoperative Complications/economics ; Postoperative Complications/prevention & control ; Risk ; Risk Factors ; Rivaroxaban ; Thiophenes/economics ; Thiophenes/therapeutic use ; Venous Thromboembolism/prevention & control ; beta-Alanine/analogs & derivatives ; beta-Alanine/economics ; beta-Alanine/therapeutic use
    Chemical Substances Anticoagulants ; Benzimidazoles ; Enoxaparin ; Morpholines ; Thiophenes ; beta-Alanine (11P2JDE17B) ; Rivaroxaban (9NDF7JZ4M3) ; Dabigatran (I0VM4M70GC)
    Language English
    Publishing date 2011
    Publishing country England
    Document type Comparative Study ; Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2270945-9
    ISSN 1941-837X ; 1369-6998
    ISSN (online) 1941-837X
    ISSN 1369-6998
    DOI 10.3111/13696998.2011.564699
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    Zs.A 6450: Show issues Location:
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  3. Article ; Online: Systematic review of the epidemiology of urinary incontinence and detrusor overactivity among patients with neurogenic overactive bladder.

    Ruffion, Alain / Castro-Diaz, David / Patel, Hetal / Khalaf, Kristin / Onyenwenyi, Ahunna / Globe, Denise / Lereun, Corinne / Teneishvili, Mamuka / Edwards, Meredith

    Neuroepidemiology

    2013  Volume 41, Issue 3-4, Page(s) 146–155

    Abstract: Background: The prevalence and incidence of neurogenic overactive bladder (nOAB) are poorly defined. This systematic literature review identified nOAB epidemiological data and estimated the incidence and prevalence of urinary incontinence (UI) and ... ...

    Abstract Background: The prevalence and incidence of neurogenic overactive bladder (nOAB) are poorly defined. This systematic literature review identified nOAB epidemiological data and estimated the incidence and prevalence of urinary incontinence (UI) and detrusor overactivity (DO) in patients with multiple sclerosis (MS), spinal cord injury (SCI), Parkinson's disease (PD), stroke and spina bifida. An initial search of MEDLINE, Embase, PubMed, and the Cochrane library was supplemented by an internet search for grey literature and manual searching of the bibliographies of retrieved articles. Additional study selection identified comparable studies for statistical analysis. A descriptive statistical analysis, single-arm meta-analysis and stratified analysis were conducted using predefined criteria.
    Summary: Initial selection identified 189 articles containing prevalence data. Secondary selection for statistical analysis identified 39 and 52 articles with prevalence of UI and DO, respectively. Random-effect meta-analysis found the prevalence of UI was 50.9% in patients with MS, 52.3% with SCI, 33.1% with PD and 23.6% with stroke. Spina bifida was excluded due to insufficient data. The prevalence of DO may be biased and artificially elevated because it can only be measured with urodynamic investigations.
    Key messages: A substantial proportion of patients with neurological conditions develop UI that may be attributable to nOAB.
    MeSH term(s) Comorbidity ; Humans ; Multiple Sclerosis/epidemiology ; Parkinson Disease/epidemiology ; Spinal Cord Injuries/epidemiology ; Spinal Dysraphism/epidemiology ; Stroke/epidemiology ; Urinary Bladder, Neurogenic/epidemiology ; Urinary Bladder, Overactive/epidemiology ; Urinary Incontinence/epidemiology
    Language English
    Publishing date 2013
    Publishing country Switzerland
    Document type Journal Article ; Research Support, Non-U.S. Gov't ; Review
    ZDB-ID 603189-4
    ISSN 1423-0208 ; 0251-5350
    ISSN (online) 1423-0208
    ISSN 0251-5350
    DOI 10.1159/000353274
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    Zs.A 1722: Show issues Location:
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  4. Article ; Online: Update on the need for a permanent pacemaker after transcatheter aortic valve implantation using the CoreValve® Accutrak™ system.

    Tchetche, Didier / Modine, Thomas / Farah, Bruno / Vahdat, Olivier / Sudre, Arnaud / Koussa, Mohamad / Lereun, Corinne / Nejjari, Mohammed / Choby, Michael / Rosencher, Julien / Sorbets, Emmanuel / Fajadet, Jean

    EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology

    2012  Volume 8, Issue 5, Page(s) 556–562

    Abstract: Aims: High rates of permanent pacemaker (PPM) implantation are reported after transcatheter aortic valve implantation (TAVI) using the Medtronic CoreValve® system. The Accutrak™ catheter is designed to allow a more predictable landing zone. Little is ... ...

    Abstract Aims: High rates of permanent pacemaker (PPM) implantation are reported after transcatheter aortic valve implantation (TAVI) using the Medtronic CoreValve® system. The Accutrak™ catheter is designed to allow a more predictable landing zone. Little is known about the real clinical impact of this catheter. The aims of this paper were to describe the potential impact of the Accutrak™ catheter on the accuracy of positioning a 26 or 29 mm CoreValve® across the aortic annulus and its impact on the need for a pacemaker.
    Methods and results: A total of 134 patients were treated with the CoreValve® Accutrak™ system at two French centres (Lille and Toulouse). Mean age was 82.4 ± 4.7 years; logistic EuroSCORE was 24.3 ± 9.5%. Procedural success rate was 99.2%; mean depth of implantation was 4.9 mm. A final position between 0 and 6 mm was achieved in 85.8% of the patients. All-cause mortality at 30 days was 6%. The PPM implantation rate was 10.6%. Due to a limited number of events, we could not identify any predictor of need for a PPM: pre-existing right bundle branch block (RBBB) (OR 2.72 [0.63-11.87], p=ns), use of a 29 mm prosthesis (OR 2.73 [0.33-22.90], p=ns) and left ventricular septal hypertrophy (OR 2.63 [0.08-83.32], p=ns).
    Conclusions: In this cohort of patients treated with the CoreValve® Accutrak™ system, the incidence of permanent pacemaker implantation was low, which may be a consequence of an average small implantation depth. The Accutrak™ catheter seems to be helpful in achieving higher and more predictable implants. Operators could standardise their technique to place the CoreValve® prostheses less than 6 mm below the aortic annulus.
    MeSH term(s) Aged ; Aged, 80 and over ; Aortic Valve/surgery ; Cardiac Catheterization ; Catheters ; Female ; Heart Valve Prosthesis Implantation/instrumentation ; Heart Valve Prosthesis Implantation/methods ; Humans ; Male ; Pacemaker, Artificial ; Treatment Outcome
    Language English
    Publishing date 2012-09
    Publishing country France
    Document type Journal Article
    ZDB-ID 2457174-X
    ISSN 1969-6213 ; 1774-024X
    ISSN (online) 1969-6213
    ISSN 1774-024X
    DOI 10.4244/EIJV8I5A86
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    Zs.A 6680: Show issues Location:
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  5. Article ; Online: Cerebrovascular events post-transcatheter aortic valve replacement in a large cohort of patients: a FRANCE-2 registry substudy.

    Tchetche, Didier / Farah, Bruno / Misuraca, Leonardo / Pierri, Adele / Vahdat, Olivier / Lereun, Corinne / Dumonteil, Nicolas / Modine, Thomas / Laskar, Marc / Eltchaninoff, Helene / Himbert, Dominique / Iung, Bernard / Teiger, Emmanuel / Chevreul, Karine / Lievre, Michel / Lefevre, Thierry / Donzeau-Gouge, Patrick / Gilard, Martine / Fajadet, Jean

    JACC. Cardiovascular interventions

    2014  Volume 7, Issue 10, Page(s) 1138–1145

    Abstract: Objectives: The aim of this study was to analyze the incidence, impact, and predictors of cerebrovascular events (CVEs) in patients undergoing transcatheter aortic valve replacement (TAVR).: Background: Several issues remain unresolved post-TAVR, ... ...

    Abstract Objectives: The aim of this study was to analyze the incidence, impact, and predictors of cerebrovascular events (CVEs) in patients undergoing transcatheter aortic valve replacement (TAVR).
    Background: Several issues remain unresolved post-TAVR, including CVEs.
    Methods: The FRANCE-2 (French Aortic Nation CoreValve and Edwards-2) registry prospectively included all patients who underwent TAVR in France and Monaco from January 2010 to October 2011. A total of 3,191 patients were analyzed. Six-month follow-up data were obtained. Events were adjudicated according to Valve Academic Research Consortium (VARC)-1 definition.
    Results: Of the cohort, 3.98% experienced a CVE: 55% were major strokes, 14.5% minor strokes, and 30.5% transient ischemic attacks. The mean delay for CVE occurrence was 2 days (interquartile range: 0 to 7 days) with 48.5% of CVEs occurring within 2 days. There was no statistically significant difference in CVE rate with regard to the type of valve (p = 0.899) and the access route (p = 0.128). Patients with a CVE more frequently had new-onset paroxysmal atrial fibrillation (13.6% vs. 7.6%; p = 0.015). During follow-up, the unadjusted mortality rate was higher in patients with a CVE (26% vs. 16.5%; p = 0.002). By multivariate analysis, only advanced age (odds ratio: 1.05; 95% confidence interval: 1.02 to 1.08; p = 0.02) and having 2 valves implanted (odds ratio: 3.13; 95 confidence interval: 1.40 to 7.05; p = 0.006) were associated with a significant risk of CVEs.
    Conclusions: CVEs occur frequently after TAVR and are associated with an increased mortality rate. No difference exists in the CVE rate when exploring the type of valve or the access route. Advanced age and multiple valves implanted during the same procedure are predictors of CVE.
    MeSH term(s) Age Factors ; Aged ; Aged, 80 and over ; Aortic Valve Stenosis/diagnosis ; Aortic Valve Stenosis/mortality ; Aortic Valve Stenosis/therapy ; Atrial Fibrillation/epidemiology ; Cardiac Catheterization/adverse effects ; Cardiac Catheterization/methods ; Cardiac Catheterization/mortality ; Female ; France/epidemiology ; Heart Valve Prosthesis Implantation/adverse effects ; Heart Valve Prosthesis Implantation/methods ; Heart Valve Prosthesis Implantation/mortality ; Humans ; Incidence ; Ischemic Attack, Transient/diagnosis ; Ischemic Attack, Transient/epidemiology ; Ischemic Attack, Transient/mortality ; Kaplan-Meier Estimate ; Logistic Models ; Male ; Monaco/epidemiology ; Multivariate Analysis ; Odds Ratio ; Registries ; Risk Factors ; Severity of Illness Index ; Stroke/diagnosis ; Stroke/epidemiology ; Stroke/mortality ; Time Factors ; Treatment Outcome
    Language English
    Publishing date 2014-10
    Publishing country United States
    Document type Journal Article ; Multicenter Study
    ZDB-ID 2452157-7
    ISSN 1876-7605 ; 1936-8798
    ISSN (online) 1876-7605
    ISSN 1936-8798
    DOI 10.1016/j.jcin.2014.04.018
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    Zs.A 6669: Show issues Location:
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