New onset diabetes mellitus (NODM) is a serious complication of transplantation. This meta-analysis evaluates the reported incidence of NODM after solid organ transplantation in patients receiving CNI treatment.Databases from January 1992 to April 2002 were searched. Fifty-six publications providing NODM incidence data were reviewed. Sixteen prospective, randomized comparative studies providing information on incidence of insulin-dependent diabetes mellitus (IDDM) were subjected to meta-analysis.New onset diabetes mellitus was reported in 13.4% of patients after solid organ transplantation, with a higher incidence in patients receiving tacrolimus than cyclosporine (16.6% vs. 9.8%). This trend was observed across renal, liver, heart and lung transplant groups. Meta-analysis of 16 studies included patients receiving either tacrolimus (n = = 1636) or cyclosporine (n = = 1407). The incidence of IDDM was significantly higher among tacrolimus-treated patients (10.4% vs. 4.5%, p < 0.00001), an effect observed in renal (9.8% vs. 2.7% p < 0.00001) and nonrenal (11.1% vs. 6.2%; p < 0.003) groups, and among patients receiving equal doses of concomitant medication in both treatment arms (12.0% vs. 3.0%; p < 0.00001).The reported incidence of NODM during the past decade was significantly higher among patients receiving tacrolimus than cyclosporine. These data provide a quantitative foundation for studies designed to reduce the rates of NODM following solid organ transplantation.
In this five-country observational study, nearly 20% of sulphonylurea-treated Muslim subjects with type 2 diabetes experienced symptomatic hypoglycaemia while fasting during Ramadan, with variations across sulphonylureas and countries.
Haemophan and polyamide dialysers do not induce changes in plasma cytokine levels both during short-term and long-term use. However, they significantly differ in complement activation as well as preactivation of monocytes. Preactivated monocytes are prone to secrete high amounts of proinflammatory cytokines when exposed to a second stimulus like endotoxin. Secretion of the regulatory cytokine IL-10 is not influenced by the dialyser type.
Objectives: Real world evidence (RWE) is critical for the assessment of health technologies. This study was conducted to define and compare the governance of, and data sources available for, real world research (RWR) in Latin America (LA) and Canada. MethOds: Systematic literature review was conducted to examine administrative and clinical data for 10 major countries ranked by population. Research terms were defined by an international team, and reports were reviewed and assessed for content, quality and bias by two investigators. Data was summarized in major and minor domains for each country. Results: Governance of RWR differed between countries, both from a regulatory and an ethics committee review perspective. Regulatory review was required for non-interventional studies in 4/10 countries. Ethics review varied importantly in complexity, site (local, central) and duration (which could exceed 1 year). Administrative and clinical search terms returned over 1800 reports from LA, principally from Brazil, Mexico, Argentina and Chile, of which over 700 contained contributory information on data sources for RWE. Of these, 156 addressed international registries or databases including countries in LA, 245 reported national registries or databases within one country in LA, and 308 reported registries or databases from a single or multiple institutions within a country. Principal administrative categories included claims, prescription and economic data sources, while principal clinical categories included data sources relating to cancer, cardiology, neurology, respirology, and diabetes. In contrast, a total of over 2000 reports were obtained for Canada alone, with a similar categorical distribution to that observed in LA. cOnclusiOns: Latin America is a region with diverse health systems, inputs and outcomes. While sources for RWE exist in several larger countries, comprehensive national or regional databases are uncommon compared with a mature public health care system such as Canada. Improvement of database quality and well-designed prospective population studies are critical to enhance the RWE base. PRM44 evaluation of cuRRent data souRces in euRoPe foR the conduct of Real-woRld studies on lung and Renal cell caRcinoMa: a systeMatic liteRatuRe Review
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