Badia X, Forsythe A, Nelson LM, Coles TM, McLeod LD, Webb SM. Improvements in health-related quality of life in acromegaly with pasireotide LAR and octreotide LAR: results from a large, randomized, double-blind phase III trial. Poster presented at the 2012 ISPOR 15th Annual European Congress; November 2012. Berlin, Germany. [abstract] Value Health. 2012 Nov; 15(7):A505.

OBJECTIVES: Patients with acromegaly have significantly impaired health-related quality of life (HRQOL). Results from a randomized, phase 3 study demonstrate superior biochemical control for pasireotide LAR, a novel multireceptor somatostatin analog, compared with octreotide LAR. The study also assessed patient-reported HRQOL.

METHODS: Medically naïve (after pituitary surgery or de novo) patients with active acromegaly (GH level 5 g/L; elevated IGF-1) were randomized to receive pasireotide LAR 40mg (n176) or octreotide LAR 20mg (n182) injections once every 28 days for 12 months. Biochemical control was defined as GH2.5 g/L and normal IGF-1 at month 12. The AcroQoL questionnaire was used to assess HRQOL. A change in AcroQoL total score of 9.8 was considered meaningful based on a distribution-based estimate (1/2 standard deviation at baseline). This analysis was conducted on patients with baseline and month 12 data (N275).

RESULTS: HRQoL improved from baseline to month 12 with both pasireotide LAR (n132; mean [SD]  7.1 [14.7]) and octreotide LAR (n143; 5.1 [15.6]). Mean scores were 58.5 and 55.9, respectively, at baseline and 65.3 and 61.5, respectively, at month 12 for pasireotide LAR and octreotide LAR. These scores are consistent with those previously reported for patients before and after effective treatment (56 [20]; 65 [18]).1 Overall, 38.6% of pasireotide LAR patients met the AcroQoL criteria for a clinically meaningful change vs. 34.3% of octreotide LAR patients. This pattern was consistent for the AcroQoL physical and psychological subscales. For both treatments at baseline and month 12, HRQOL was better in patients who achieved biochemical control at month 12 (baseline: 62.9 [18.9] vs. 55.1 [19.5]); month 12: 66.9 [19.6] vs. 61.9 [22.0]).

CONCLUSIONS: Pasireotide LAR treatment decreases GH and IGF-1 and improves HRQOL.

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