Additionally , the following databases were searched using the same search terms: Cochrane Database of Systematic Evaluations (2005 to December 2013); Database of Abstracts of Review of Effects (December 2013); Cochrane Central Register of Controlled Trials (December 2013)

Additionally , the following databases were searched using the same search terms: Cochrane Database of Systematic Evaluations (2005 to December 2013); Database of Abstracts of Review of Effects (December 2013); Cochrane Central Register of Controlled Trials (December 2013). For efficacy data, almost all randomized managed trials (RCTs), quasi-RCTs and observational trials in nephrology practice were included. To get safety data, case series, case reports, review articles in nephrology practice and pharmacovigilance programs were included as well. == Results == Only epoetin SEBs trials were published in the literature. 10 studies including three diverse epoetin SEBs (epoetin zeta, HX575 and epoetin theta) were included. The mean epoetin dose used did not differ significantly between the SEBs and the research product. To get epoetin zeta and epoetin theta, the mean hemoglobin levels achieved in the studies were similar between the SEBs and the research epoetin. The HX 575 studies reported a mean total change in hemoglobin within the predefined equivalence margin, when compared with the reference biologic. In terms of security data, 2 cases of pure-red-cell aplasia were linked to the subcutaneous government of HX 575. Otherwise, the rate of adverse drug reactions was similar when epoetin SEBs were compared with the research biologic. == Limitations == Our analysis is limited by the paucity of information available on SEB use in nephrology with the exception of epoetin SEBs. Methodological flaw was found in one of the epoetin zeta studies which accounted for 45% of pooled results. == Conclusions == Little clinical difference was found between epoetin SEBs and the research product. Although not deemed clinically important, the financial implication of a possible dose difference between Daminozide epoetin zeta and reference product should be considered in pharmacoeconomic studies. Ongoing trials are expected to address the risk of pure-red-cell aplasia with HX 575. Keywords: Subsequent entry biologic, Rituximab, Darbepoetin, Tissue plasminogen activator, Epoetin alpha, Epoetin beta, Epoetin zeta, HX 575, Epoetin theta == Abrg == == Contexte == Il est possible que les produits biologiques ultrieurs (PBU) soient bientt utiliss en nphrologie. Afin de guider la pratique en nphrologie au Canada, il est important de comprendre lensemble des expriences produites, lchelle mondiale, en matire defficacit et dinnocuit de ces agents. == Objectifs == Comparer les donnes relatives lefficacit et linnocuit entre les PBU utiliss en nphrologie et leurs mdicaments biologiques Daminozide de rfrence. == Type dtude == Revue systmatique. == Sources de donnes == La recherche en vue de la revue de littrature a t effectue en interrogeant les Daminozide Daminozide facets de donnes suivantes: Ovid Medline, Embase, la foundation de donnes de revues systmatiques Cochrane Reviews, la Database of Abstracts of Reviews of Effects, et la Cochrane Central Register Controlled Trials. == Patients == Daminozide Les patients dge adulte atteints de nphropathie chronique. == Mthodes == Notre revue systmatique suit la mthode suggre doble la Collaboration Cochrane (Cochrane Reviews). Put les donnes Rabbit Polyclonal to p90 RSK se rapportant lefficacit, lensemble des essais randomiss contrls (ERC) et des modles quasi exprimentaux et des tudes observationnelles du domaine de la nphrologie ont to comptabiliss. Put les donnes se rapportant linnocuit, tous les ERC, les modles quasi exprimentaux, les tudes observationnelles, les tudes ou sries de cas, ainsi que les revues darticles en nphrologie clinique et de programmes en pharmacovigilance ont to comptabiliss. == Rsultats == Nous nous sommes attards lpotine biologique ultrieure, puisquaucune documentation sur dautres produits biologiques ultrieurs (PBU) ntait disponible. Nous avons utilis dix tudes prsentant trois potines biologiques ultrieures diffrentes (potine zeta, potine HX575 et potine thta). Il nexistait pas de diffrence significative entre les doses moyennes des PBU et dpotine biologique de rfrence. La dose moyenne dpotine utilise ne variait pas de faon significative entre les PBU et le produit de rfrence. Put les potines zeta et thta, les taux moyens dhmoglobine obtenus dans les diverses tudes entre les PBU et les potines de rfrence taient similaires. Les tudes se rapportant lpotine HX575 montraient un changement absolu du taux moyen dhmoglobine lintrieur de lintervalle dquivalence prdfini, lorsque compar au mdicament biologique de rfrence. En ce qui concerne les donnes dinnocuit, deux cas drythroblastopnie chronique acquise ont to lis ladministration sous-cutane de lpotine HX575. Sinon, les taux deffets indsirables recenss pour lpotine biologique ultrieure et child mdicament biologique de rfrence taient similaires. == Limites de ltude == Notre analyse est limite doble la raret de linformation accessible sur lutilisation des PBU en nphrologie, lexception de lpotine.