Safety and Efficacy of Secondary Prophylactic in Patients with Severe Hemophilia Type A and B: A Systematic Review and Meta-Analysis Study

Abstract

Context: Patients with hemophilia receive coagulation factor replacement for a lifetime. In Iran, on-demand treatment method is used as a standard. Clinical studies have shown significant improvements in clinical and economic outcomes as a result of the use of prophylaxis compared with other therapies. The aim of this study was to evaluate the safety and efficacy of prophylaxis in patients with severe hemophilia type A and B.

Evidence Acquisition: This is a systematic review and meta-analysis in order to evaluate the safety and efficacy of prophylaxis treatment in patients with severe hemophilia. To this response, all clinical trials, cohorts, and case-control studies, which have been investigated, were published between 1970 to Sep of 2017. STROBE and CONSORT checklists have been used according to the type of study to assess the quality of the study reports, and the results have been analyzed in STATA by meta-analysis methods.

Results: A total of 1439 studies were found in primary search and 17 of them had an inclusion criteria. The mean annual bleeding rate in prophylays treatment was 2.8 times per person/year. This study also showed that in prophylaxis, the average incidence of adverse effects was 0.13 cases, and the severe adverse effects was 0.06 cases per person/year.

Conclusions: The analysis of the studies entered in this evaluation showed that the adverse effects were significantly lower in patients treated with prophylaxis than in patients treated with on-demand treatment. This difference was observed in severe adverse effect, however, it was not statistically significant; this shows that prophilaxis is safer than the on-demand method. The lower annual bleeding rate in prophylaxis compared with the on-demand treatment method is also a sign of the effectiveness of prophilaxis.