Inibidores do cotransportador de sódio-glicose 2 (iSGLT2) vs terapia padrão otimizada (TPO) em pacientes com DM2 e doença cardiovascular (DCV) estabelecida: network metanalysis e Análise de custo-eficácia no contexto brasileiro

Abstract

Background: Inhibitors of sodium–glucose cotransporter 2 (iSGLT2) are antidiabetogenic drugs, whose recent evidence highlights their impact on cardiovascular outcomes. However, there are no direct comparisons between such drugs, which undermines the comparative assessment of their efficacy and safety as a drug class. Moreover, it is not clear whether its use is economically advantageous in the Brazilian context. Purpose: Evaluate the cost-effectiveness of empagliflozin vs. dapagliflozin vs. canagliflozin or Optimized Standard Therapy (OST) in patients with type 2 diabetes mellitus and cardiovascular disease established, from the perspective of SUS. Methods: Data from clinical trials, phase 3 and 4, involving cardiovascular and safety outcomes related to iSGLT2, were researched together with virtual libraries, to December 31, 2018, and the data were synthesized using network meta-analysis. With the evidence from the meta-analysis, a cost-effectiveness analysis was performed comparing iSGLT2 and TPO, from the SUS perspective. Results: A total of 38 clinical trials (N 52,184) were selected. TPO was compared to iSGT2 considering cardiovascular and safety outcomes. As a class, iSGLT2 compared to TPO, showed a statistically significant difference in the outcomes “Heart Failure Hospitalizations - HR 0.69 (0.51–0.90)” and “Dialysis or GFR reduction in> 40mL / min - HR 0.58 (0.42 – 0.78)”. An incremental cost-effectiveness ratio was set at R$ 6927 (3294,9973) per qualityadjusted life year (QALY). Conclusions: iSGLT2 decreases hospitalizations for heart failure and slows the progression of kidney disease. Being potentially cost-effective in the Brazilian context.