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Endocrine Abstracts (2015) 37 EP710 | DOI: 10.1530/endoabs.37.EP710

Pituitary: basic and neuroendocrinology

Patient reported outcomes comparing octreotide capsules to somatostatin analogues injections: results from a multicentre, baseline controlled, phase 3 study in acromegaly

Asi Haviv1, Gary Patou1 & Susan Mathias2

1Chiasma Pharmaceuticals, Newton, Massachusetts, USA; 2Health Outcomes Solutions, Winter Park, Florida, USA.

Background: Somatostatin analogues are the most widely used medical treatment in acromegaly. The available long-acting formulations are administered parenterally (i.m. or deep s.c. injections). Results of a multicentre, baseline controlled, phase 3 study have recently showed that octreotide capsules are an effective and safe treatment in acromegaly. The Treatment Satisfaction Questionnaire for Medication (TQ15M), assessed in the phase 3 study, as exploratory endpoint, compared patient reported outcomes (PRO) in responders to injections vs. responders to oral treatment.

Methods: TQ15M, a validated PRO, consists of 14 multiple choice items encompassing four domains: effectiveness, side effects, convenience, and overall satisfaction. Additional supplemental items were developed specifically for this study and relate to wear-off effects/breakthrough symptoms and direct comparison of the overall satisfaction on octreotide capsules to injections. The results herein include a cohort of 88 patients (of 151 enrolled), who were controlled on oral and continued treatment with octreotide capsules up to 13 months.

Results: More patients reported improvement than deterioration in all domain scores for effectiveness, side effects, convenience, and overall satisfaction (improvement 41, 38, 48, and 39% respectively vs deterioration 28, 13, 39, and 29%, while others maintained their scores). The improved effectiveness score supported the improvement in acromegaly symptoms (AIS score), reported in the phase 3. Mean satisfaction with oral therapy compared to injections based on the direct comparative supplemental question – was 5.2 (scores 0–7), reflecting the answer ‘I am satisfied with this medication compared to others’ and aligned with 86% of core study completers electing voluntarily to continue into the extension phase.

Conclusions: Patients’ satisfaction with octreotide capsules was high. Improvements were noted compared to injections in all TQ15M domain scores, and specifically for effectiveness and side effects. these results correlates with patients electing to continue oral treatment and the improvements noted for acromegaly symptoms.

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