Systematic review of efficacy and safety of pegvisomant alone versus combined therapy with somatostatin analogue in the treatment of Acromegaly

Abstract

Among the treatment options for Acromegaly, trans-sphenoidal surgery is the first choice in most of cases. However, cure rates in macroadenomas with supra and para-sellar extension are lower than 50%. Because of this, more than half of patients will need somatostatin analogue as complementary treatment. Meanwhile, even using the maximum doses of somatostatin analogue some individuals won't achieve the disease control and another therapy will be necessary. For many cases, the pegvisomant will be the next step. It is a selective antagonist of the GH receptor and is the most effective drug in IGF-1 serum level reduction. It is recommended either alone or in combination with somatostatin analogue. The studies that evaluated this combination have shown that it is safe. On the other hand, research that analyzed the substitution therapy have evidenced that pegvisomant is effective and is not associated with tumor growth. Most of Acromegaly treatment centers prefer the combined treatment. So, we aim to perform a systematic review of efficacy and safety of pegvisomant alone versus combined therapy with somatostatin analogue in acromegalic patients who didn´t achieve disease control with analogue. This review will be performed according to Cochrane methodology. When the data from more than one study are homogeneous and with their similar clinical outcomes, they will be plotted in a meta-analysis.