Mean baseline
insulin-like growth factor-1 (IGF-1) at diagnosis was 3.1 ± 1.3 × ULN. All but five patients have undergone pituitary surgery and six received sellar
radiotherapy. All remained with active
acromegaly despite first-generation
somatostatin analogue (SSA) treatment. Immediately before
pasireotide-LAR initiation, eighteen patients were under SSA monotherapy and one with
pegvisomant. The remaining patients received combination
therapy with SSA and
pegvisomant, n = 9 (two received
cabergoline also); SSA and
cabergoline, n = 4;
pegvisomant and
cabergoline, n = 1. Two were untreated. Mean
IGF-1 was 1.76 ± 0.9 ULN before
pasireotide.
Pasireotide-LAR starting dose was 40 mg/4 weeks in most patients.
IGF-1 normalized in 19 patients,
IGF-1 between 1-1.2 × ULN was reached in five, and in additional two patients
IGF-1 was significantly suppressed. No effect was seen in nine patients.
Pasireotide dose was reduced by 20 mg in six patients with excellent response, with preserved
IGF-1 control in five. Severe
headaches in six patients disappeared or improved with
pasireotide. Side effects consisted of symptomatic
cholelithiasis in one patient and deterioration of
glucose control in 22 patients, requiring initiation or intensification of
antidiabetic treatment in seventeen. One patient developed
diabetic ketoacidosis.
CONCLUSIONS: In the real-life scenario ~54% of patients with
acromegaly resistant to first-generation SSA, may normalize
IGF-1 with
pasireotide; however, 63% experienced
glucose control deterioration.