The Experts below are selected from a list of 318 Experts worldwide ranked by ideXlab platform
Edoardo Mannucci - One of the best experts on this subject based on the ideXlab platform.
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dipeptidyl peptidase 4 inhibitors and heart failure a meta analysis of Randomized Clinical Trials
Nutrition Metabolism and Cardiovascular Diseases, 2014Co-Authors: Matteo Monami, Ilaria Dicembrini, Edoardo MannucciAbstract:Abstract Background & aims Recently, the SAVOR TIMI-53 (Saxagliptin Assessment of Vascular Outcomes Recorded in patients with diabetes mellitus – Thrombolysis in Myocardial Infarction-53) reported a significant increase in the risk of hospitalizations for heart failure in patients treated with saxagliptin in comparison with placebo. Aim of the present meta-analysis is the systematic collection and synthesis of information on treatment-emergent cases of acute heart failure described in Randomized Clinical Trials with DPP4. Methods & results Data sources: An extensive Medline, Embase, and Cochrane Database search for "vildagliptin", "sitagliptin", "saxagliptin", "alogliptin", "linagliptin", and "dutogliptin" was performed, collecting all Randomized Clinical Trials on humans up to October 1st, 2013. Studies were included if they satisfied the following criteria: i) Randomized Trials, ii) duration ≥24 weeks; iii) on type 2 diabetes; iv) comparison of DPP4i with placebo or active drugs. The principal outcome was the effect of DPP4i on the incidence of acute heart failure. A total of 84 eligible Trials was identified. The overall risk of acute heart failure was higher in patients treated with DPP4i in comparison with those treated with placebo/active comparators (MH–OR: 1.19[1.03; 1.37]; p = 0.015). When Trials with non-cardiovascular outcomes were analysed separately no signal of risk was detectable. Conclusion Available data from RCTs suggest that DPP4i could be associated with an increased risk of heart failure, without any clear evidence of differences among drugs of the class. Although it is plausible that the risk is greater in some sub-populations of patients, current evidence is not yet sufficient to identify susceptible patients.
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safety of dipeptidyl peptidase 4 inhibitors a meta analysis of Randomized Clinical Trials
Current Medical Research and Opinion, 2011Co-Authors: Matteo Monami, Ilaria Dicembrini, Daniele Martelli, Edoardo MannucciAbstract:AbstractObjective:Dipeptidyl peptidase-4 inhibitors (DPP4i) have been recently associated with increased risk of pancreatitis and cancer. The aim of the present meta-analysis of Randomized Clinical Trials is the assessment of the effect of DPP4i on the incidence of major cardiovascular events (MACE), cancer, and pancreatitis.Research design and methods:An extensive Medline and Embase search for ‘vildagliptin’, ‘sitagliptin’, ‘saxagliptin’, ‘alogliptin’, ‘linagliptin’, and ‘dutogliptin’ was performed, collecting all Randomized Clinical Trials on humans up to March 1, 2011. The present meta-analysis was therefore performed including all Randomized Clinical Trials with a duration of at least 24 weeks, enrolling patients with type 2 diabetes, comparing DPP4i with either placebo or active drugs. Completed but still unpublished Trials were identified through a search of www.ClinicalTrials.gov, Food and Drug Administration, and European Medicines Agency website.Results:Fifty-three Trials enrolling 20,312 and 13,...
Habib Samady - One of the best experts on this subject based on the ideXlab platform.
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meta analysis of Randomized Clinical Trials comparing biodegradable polymer drug eluting stent to second generation durable polymer drug eluting stents
Jacc-cardiovascular Interventions, 2017Co-Authors: Georges Elhayek, Sripal Bangalore, Abel Casso Dominguez, Chandan Devireddy, Wissam Jaber, Gautam Kumar, Kreton Mavromatis, Jacqueline E Tamisholland, Habib SamadyAbstract:AbstractObjectives: The authors sought to perform a meta-analysis of Randomized Clinical Trials (RCTs) comparing the safety and efficacy of biodegradable polymer drug-eluting stents (BP-DES) to sec...
Matteo Monami - One of the best experts on this subject based on the ideXlab platform.
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dipeptidyl peptidase 4 inhibitors and heart failure a meta analysis of Randomized Clinical Trials
Nutrition Metabolism and Cardiovascular Diseases, 2014Co-Authors: Matteo Monami, Ilaria Dicembrini, Edoardo MannucciAbstract:Abstract Background & aims Recently, the SAVOR TIMI-53 (Saxagliptin Assessment of Vascular Outcomes Recorded in patients with diabetes mellitus – Thrombolysis in Myocardial Infarction-53) reported a significant increase in the risk of hospitalizations for heart failure in patients treated with saxagliptin in comparison with placebo. Aim of the present meta-analysis is the systematic collection and synthesis of information on treatment-emergent cases of acute heart failure described in Randomized Clinical Trials with DPP4. Methods & results Data sources: An extensive Medline, Embase, and Cochrane Database search for "vildagliptin", "sitagliptin", "saxagliptin", "alogliptin", "linagliptin", and "dutogliptin" was performed, collecting all Randomized Clinical Trials on humans up to October 1st, 2013. Studies were included if they satisfied the following criteria: i) Randomized Trials, ii) duration ≥24 weeks; iii) on type 2 diabetes; iv) comparison of DPP4i with placebo or active drugs. The principal outcome was the effect of DPP4i on the incidence of acute heart failure. A total of 84 eligible Trials was identified. The overall risk of acute heart failure was higher in patients treated with DPP4i in comparison with those treated with placebo/active comparators (MH–OR: 1.19[1.03; 1.37]; p = 0.015). When Trials with non-cardiovascular outcomes were analysed separately no signal of risk was detectable. Conclusion Available data from RCTs suggest that DPP4i could be associated with an increased risk of heart failure, without any clear evidence of differences among drugs of the class. Although it is plausible that the risk is greater in some sub-populations of patients, current evidence is not yet sufficient to identify susceptible patients.
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safety of dipeptidyl peptidase 4 inhibitors a meta analysis of Randomized Clinical Trials
Current Medical Research and Opinion, 2011Co-Authors: Matteo Monami, Ilaria Dicembrini, Daniele Martelli, Edoardo MannucciAbstract:AbstractObjective:Dipeptidyl peptidase-4 inhibitors (DPP4i) have been recently associated with increased risk of pancreatitis and cancer. The aim of the present meta-analysis of Randomized Clinical Trials is the assessment of the effect of DPP4i on the incidence of major cardiovascular events (MACE), cancer, and pancreatitis.Research design and methods:An extensive Medline and Embase search for ‘vildagliptin’, ‘sitagliptin’, ‘saxagliptin’, ‘alogliptin’, ‘linagliptin’, and ‘dutogliptin’ was performed, collecting all Randomized Clinical Trials on humans up to March 1, 2011. The present meta-analysis was therefore performed including all Randomized Clinical Trials with a duration of at least 24 weeks, enrolling patients with type 2 diabetes, comparing DPP4i with either placebo or active drugs. Completed but still unpublished Trials were identified through a search of www.ClinicalTrials.gov, Food and Drug Administration, and European Medicines Agency website.Results:Fifty-three Trials enrolling 20,312 and 13,...
Christian Gluud - One of the best experts on this subject based on the ideXlab platform.
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The Necessity of Randomized Clinical Trials
British Journal of Medicine and Medical Research, 2013Co-Authors: Janus Christian Jakobsen, Christian GluudAbstract:Aims: The hierarchy of evidence-based medicine determines the inferential powers of different Clinical research designs. We want to address the difficult question if observational evidence under some circumstances can validate intervention effects. Methodology: Assessment of previous argumentation aiming at a clear conclusion for future decision-making. Results: We present five arguments demonstrating the fundamental need of Randomized Clinical Trials to sufficiently validate intervention effects. Furthermore, we argue that hindrances to the conduct of Randomized Clinical Trials can be lessened through education, collaboration, infrastructure, and other measures. Our arguments validate why the Randomized Clinical trial should and must be the study design evaluating interventions. By choosing the Randomized Clinical trial as the primary study design, effective preventive, prognostic, diagnostic, and therapeutic interventions will reach more patients earlier. Conclusion: Clinical experience or observational studies should never be used as the sole basis for assessment of intervention effects — Randomized Clinical Trials are always needed. Therefore, always randomize the first patient as Thomas C Chalmers suggested in 1977. Observational studies should primarily be used for quality control after treatments are included in Clinical practice. Policy Paper
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the journal impact factor as a predictor of trial quality and outcomes cohort study of hepatobiliary Randomized Clinical Trials
The American Journal of Gastroenterology, 2005Co-Authors: Lise Lotte Gluud, Peter C Gøtzsche, Thorkild I. A. Sørensen, Christian GluudAbstract:The Journal Impact Factor as a Predictor of Trial Quality and Outcomes: Cohort Study of Hepatobiliary Randomized Clinical Trials
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funding disease area and internal validity of hepatobiliary Randomized Clinical Trials
The American Journal of Gastroenterology, 2002Co-Authors: Lise Lotte Kjaergard, Christian GluudAbstract:OBJECTIVE: The aim of this study was to assess whether funding and the disease area are related to the internal validity of hepatobiliary Randomized Clinical Trials. METHODS: We gathered data on funding, disease area, methodological quality (randomization and double blinding), and sample size from 616 hepatobiliary Randomized Clinical Trials published from 1985 to 1996 in 12 MEDLINE indexed journals. RESULTS: The internal validity (methodological quality and sample size) of Trials funded by profit or nonprofit organizations was not significantly different. Compared with these Trials, Trials without funding were significantly less likely to report adequate generation of the allocation sequence (55% vs 41%, p = 0.001) and to be double blind (42% vs 25%, p < 0.001), but the proportion with adequate allocation concealment and the sample size were not significantly different. The Trials covered 12 disease areas. The proportion of funded Trials did not differ significantly in different disease areas. The disease area was significantly associated with the proportion of Trials with adequate generation of the allocation sequence (p < 0.001), allocation concealment (p = 0.003), and double blinding (p < 0.001) as well as the sample size (p < 0.001). This association was not explained by the proportion of Trials with funding. CONCLUSIONS: External funding was significantly associated with adequate methodological quality, but not with the sample size. Irrespective of funding, the disease area was significantly associated with the methodological quality and sample size. Accordingly, external funding and the disease area are significant predictors of the internal validity of hepatobiliary Randomized Clinical Trials.
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Funding, disease area, and internal validity of hepatobiliary Randomized Clinical Trials
The American journal of gastroenterology, 2002Co-Authors: Lise Lotte Kjaergard, Christian GluudAbstract:Abstract OBJECTIVE: The aim of this study was to assess whether funding and the disease area are related to the internal validity of hepatobiliary Randomized Clinical Trials. METHODS: We gathered data on funding, disease area, methodological quality (randomization and double blinding), and sample size from 616 hepatobiliary Randomized Clinical Trials published from 1985 to 1996 in 12 MEDLINE indexed journals. RESULTS: The internal validity (methodological quality and sample size) of Trials funded by profit or nonprofit organizations was not significantly different. Compared with these Trials, Trials without funding were significantly less likely to report adequate generation of the allocation sequence (55% vs 41%, p = 0.001) and to be double blind (42% vs 25%, p CONCLUSIONS: External funding was significantly associated with adequate methodological quality, but not with the sample size. Irrespective of funding, the disease area was significantly associated with the methodological quality and sample size. Accordingly, external funding and the disease area are significant predictors of the internal validity of hepatobiliary Randomized Clinical Trials.
Edzard Ernst - One of the best experts on this subject based on the ideXlab platform.
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Guided imagery for non musculoskeletal pain: a systematic review of Randomized Clinical Trials.
Journal of pain and symptom management, 2012Co-Authors: Paul Posadzki, Edzard Ernst, Wendy Lewandowski, Rohini Terry, Anthony StearnsAbstract:Abstract Context Our previous review of the literature concluded that there is encouraging evidence that guided imagery alleviates musculoskeletal pain, but the value of guided imagery in the management of non-musculoskeletal pain remains uncertain. Objectives The objective of this systematic review was to assess the effectiveness of guided imagery as a treatment option for non-musculoskeletal pain. Methods Six databases were searched from their inception to February 2011. Randomized Clinical Trials were considered if they investigated guided imagery in human patients with any type of non-musculoskeletal pain in any anatomical location and assessed pain as a primary outcome measure. Trials of motor imagery and hypnosis were excluded. The selection of studies, data extraction, and validation were performed independently by two reviewers. Results Fifteen Randomized Clinical Trials met the inclusion criteria. Their methodological quality was generally poor. Eleven Trials found that guided imagery led to a significant reduction of non-musculoskeletal pain. Four studies found no change in non-musculoskeletal pain with guided imagery in comparison with progressive relaxation, standard care, or no treatment. Conclusion The evidence that guided imagery alleviates non-musculoskeletal pain is encouraging but remains inconclusive.
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Yoga for Asthma? A Systematic Review of Randomized Clinical Trials
The Journal of asthma : official journal of the Association for the Care of Asthma, 2011Co-Authors: Paul Posadzki, Edzard ErnstAbstract:Objective. The objective of this systematic review was to assess the effectiveness of yoga as a treatment option for asthma. Method. Seven databases were searched from their inception to October 2010. Randomized Clinical Trials (RCTs) and non-Randomized Clinical Trials (NRCTs) were considered, if they investigated any type of yoga in patients with asthma. The selection of studies, data extraction, and validation were performed independently by two reviewers. Results. Six RCTs and one NRCT met the inclusion criteria. Their methodological quality was mostly poor. Three RCTs and one NRCT suggested that yoga leads to a significantly greater reduction in spirometric measures, airway hyperresponsivity, dose of histamine needed to provoke a 20% reduction in forced expiratory volume in the first second, weekly number of asthma attacks, and need for drug treatment. Three RCTs showed no positive effects compared to various control interventions. Conclusions. The belief that yoga alleviates asthma is not supported b...
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qigong for hypertension a systematic review of Randomized Clinical Trials
Journal of Hypertension, 2007Co-Authors: Max H Pittler, Edzard ErnstAbstract:ObjectivesTo assess systematically the Clinical evidence of qigong for hypertension.MethodsDatabases were searched up to August 2006. All Randomized Clinical Trials (RCTs) testing qigong in patients with hypertension of any origin and assessing Clinically relevant outcomes were considered. Trials us
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homeopathy for childhood and adolescence ailments systematic review of Randomized Clinical Trials
Mayo Clinic Proceedings, 2007Co-Authors: Umut Altunc, Max H Pittler, Edzard ErnstAbstract:OBJECTIVE To assess the evidence of any type of therapeutic or preventive intervention testing homeopathy for childhood and adolescence ailments. METHODS Systematic literature searches were conducted through January 2006 in MEDLINE, EMBASE, AMED, CINAHL, Cochrane Central, British Homeopathic Library, ClinicalTrials.gov, and the UK National Research Register. Bibliographies were checked for further relevant publications. Studies were selected according to predefined inclusion and exclusion criteria. All double-blind, placebo-controlled Randomized Clinical Trials of any homeopathic intervention for preventing or treating childhood and adolescence ailments were included. According to the classification of the World Health Organization, the age range defined for inclusion was 0 to 19 years. Study selection, data extraction, and assessment of methodological quality were performed independently by 2 reviewers. RESULTS A total of 326 articles were identified, 91 of which were retrieved for detailed evaluation. Sixteen Trials that assessed 9 different conditions were included in the study. With the exception of attention-deficit/hyperactivity disorder and acute childhood diarrhea (each tested in 3 Trials), no condition was assessed in more than 2 double-blind Randomized Clinical Trials. The evidence for attention-deficit/hyperactivity disorder and acute childhood diarrhea is mixed, showing both positive and negative results for their respective main outcome measures. For adenoid vegetation, asthma, and upper respiratory tract infection each, 2 Trials are available that suggest no difference compared with placebo. For 4 conditions, only single Trials are available. CONCLUSION The evidence from rigorous Clinical Trials of any type of therapeutic or preventive intervention testing homeopathy for childhood and adolescence ailments is not convincing enough for recommendations in any condition.
