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Clinical Drug Investigation Mar 2016Iron deficiency is very common in a number of medical conditions. Ferric carboxymaltose is a new stable iron preparation that can be administered in single infusions... (Meta-Analysis)
Meta-Analysis Review
Efficacy and Safety of Ferric Carboxymaltose and Other Formulations in Iron-Deficient Patients: A Systematic Review and Network Meta-analysis of Randomised Controlled Trials.
BACKGROUND
Iron deficiency is very common in a number of medical conditions. Ferric carboxymaltose is a new stable iron preparation that can be administered in single infusions over short periods of time. The aim of this study was to conduct a systematic review of randomised controlled trials (RCTs) regarding the efficacy and safety of the novel complex compared with other iron formulations. In addition, the feasibility of a network meta-analysis for indirect comparisons was investigated.
METHODS
A systematic literature review was performed for published RCTs on the use of ferric carboxymaltose in iron deficiency between July and October 2014. Indirect comparisons were also addressed using terms referring to competing iron formulations. We further supported the qualitative results of the systematic review by a network meta-analysis that allows pooling the evidence around different intervention outcomes in the absence of trials involving a direct comparison.
RESULTS
The initial search yielded 1027 citations, which was decreased to 21 studies eligible for inclusion in the review. Studies were heterogeneous in the number of patients randomised, iron deficiency-related conditions addressed, trial inclusion criteria, time horizon, treatment dosage and outcomes assessed. Six studies with the same time horizon (i.e. 6 weeks) were included in the network meta-analysis. Considering the differences between final and initial outcome values for each iron formulation, the mean difference of these differences (delta) was estimated for each couple of treatments involving ferric carboxymaltose. Significant improvements in serum ferritin (µg/l) were obtained with ferric carboxymaltose compared to oral iron (delta 172.8; 95 % CI 66.7-234.4) and in haemoglobin (g/dl) with respect to ferric gluconate (delta 0.6; 95 % CI 0.2-0.9), oral iron (delta 0.8; 95 % CI 0.6-0.9) and placebo (delta 2.1; 95 % CI 1.2-3.0).
CONCLUSIONS
All currently available intravenous iron preparations appear to be safe and effective, but ferric carboxymaltose seems to provide a better and quicker correction of haemoglobin and serum ferritin levels in iron-deficient patients.
Topics: Administration, Intravenous; Chemistry, Pharmaceutical; Ferric Compounds; Hemoglobins; Humans; Iron Deficiencies; Maltose; Randomized Controlled Trials as Topic
PubMed: 26692005
DOI: 10.1007/s40261-015-0361-z -
Expert Review of Pharmacoeconomics &... 2015The aim of this study was to review and critically assess the health economics literature on post-treatment follow-up for adult cancer survivors. A systematic search was... (Review)
Review
The aim of this study was to review and critically assess the health economics literature on post-treatment follow-up for adult cancer survivors. A systematic search was performed using PubMed, EMBASE and the Cochrane Library. The Consolidated Health Economic Evaluation Reporting Standards checklist was adopted to assess the quality of the included studies. Thirty-nine articles met the eligibility criteria. Around two thirds of the studies addressed the most common cancers (i.e., breast, colorectal, cervical and lung); 21 were based on a single clinical study, while the rest were modeling papers. All types of economic evaluations were represented other than cost-benefit analysis. The overall quality was generally high with an average proportion of 74% of checklist criteria fulfilled. The cost-effectiveness results supported the current trend towards less intensive, primary care-based and risk-adapted follow-up schemes.
Topics: Adult; Aftercare; Checklist; Cost-Benefit Analysis; Humans; Models, Economic; Neoplasms; Primary Health Care; Survivors
PubMed: 26449255
DOI: 10.1586/14737167.2015.1087316 -
Expert Review of Pharmacoeconomics &... Oct 2014Assessing the value of health technologies, through health technology assessment is critically dependent on the existence of relevant and robust clinical data on the... (Review)
Review
Assessing the value of health technologies, through health technology assessment is critically dependent on the existence of relevant and robust clinical data on the efficacy, safety and ideally, effectiveness of the technologies concerned. However, in the case of medical devices, such clinical data may not always be available, because of the different nature of the regulatory requirements in different jurisdictions. Therefore, we conducted a systematic review of the regulatory requirements in seven major jurisdictions in order to identify current challenges and to suggest possible improvements. There are differences in the requirements across jurisdictions and in the balance between pre-market and post-market controls. Several improvements are required in order to generate adequate clinical data for health technology assessment.
Topics: Cost-Benefit Analysis; Device Approval; Equipment and Supplies; Evidence-Based Medicine; Government Regulation; Health Care Costs; Humans; Medical Device Legislation; Patient Safety; Product Surveillance, Postmarketing; Risk Assessment; Technology Assessment, Biomedical
PubMed: 25196848
DOI: 10.1586/14737167.2014.950233