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Pasireotide versus octreotide in acromegaly: a head-to-head superiority study
A Colao1, M D Bronstein, P Freda
1Dipartimento di Medicina Clinica e Chirurgia (A.C.), Università Federico II di Napoli, 80131 Naples, Italy; Neuroendocrine Unit (M.D.B.), Division of Endocrinology and Metabolism, University of São Paulo Medical School, 3858-Jardim Paulista, São Paulo, Brazil; Department of Medicine (P.F.), Columbia University College of Physicians and Surgeons, New York, New York 10032; Department of Endocrinology (F.G.), Key Laboratory of Endocrinology, Ministry of Health, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, China; Department of Neurosurgery (C.-C.S.), Taichung Veterans General Hospital, Taichung 40705, Taiwan; Department of Physical Therapy (C.-C.S.), Hungkuang University, Taichung 43302, Taiwan; Department of Medicine and Tri-Service General Hospital (C.-C.S.), National Defense Medical Center, Taipei 11490, Taiwan; Endocrine Unit (M.G.), Hospital Universitário Clementino Fraga Filho, Universidade Federal do Rio de Janeiro, Rio de Janeiro, 22421020, Brazil; Department of Medicine and Neurological Surgery (M.F.), Northwest Pituitary Center, Oregon Health and Science University, Portland, Oregon 97239; Department of Medicine (A.J.v.d.L.), Erasmus University Medical Center, 3000 CA Rotterdam, The Netherlands; Brain Research Imaging Centre (A.J.F.), University of Edinburgh, Edinburgh EH4 2XU, United Kingdom; Clinical Development (K.H.R., Y.C.), Novartis Pharmaceuticals Corporation, Florham Park, New Jersey 07932; Clinical Development (M.R.), Oncology Business Unit, Novartis Pharma AG, CH-4057 Basel, Switzerland; and Centre for Endocrinology, Diabetes, and Metabolism (M.S.), University of Birmingham, Edgbaston, Birmingham, B152TT.
Context:
Biochemical control reduces morbidity and increases life expectancy in patients with acromegaly. With current medical therapies, including the gold standard octreotide long-acting-release (LAR), many patients do not achieve biochemical control.
Objective:
Our objective was to demonstrate the superiority of pasireotide LAR over octreotide LAR in medically naive patients with acromegaly.
Design And Setting:
We conducted a prospective, randomized, double-blind study at 84 sites in 27 countries.
Patients:
A total of 358 patients with medically naive acromegaly (GH >5 μg/L or GH nadir ≥1 μg/L after an oral glucose tolerance test (OGTT) and IGF-1 above the upper limit of normal) were enrolled. Patients either had previous pituitary surgery but no medical treatment or were de novo with a visible pituitary adenoma on magnetic resonance imaging.
Interventions:
Patients received pasireotide LAR 40 mg/28 days (n = 176) or octreotide LAR 20 mg/28 days (n = 182) for 12 months. At months 3 and 7, titration to pasireotide LAR 60 mg or octreotide LAR 30 mg was permitted, but not mandatory, if GH ≥2.5μg/L and/or IGF-1 was above the upper limit of normal.
Main Outcome Measure:
The main outcome measure was the proportion of patients in each treatment arm with biochemical control (GH <2.5 μg/L and normal IGF-1) at month 12.
Results:
Biochemical control was achieved by significantly more pasireotide LAR patients than octreotide LAR patients (31.3% vs 19.2%; P = .007; 35.8% vs 20.9% when including patients with IGF-1 below the lower normal limit). In pasireotide LAR and octreotide LAR patients, respectively, 38.6% and 23.6% (P = .002) achieved normal IGF-1, and 48.3% and 51.6% achieved GH <2.5 μg/L. 31.0% of pasireotide LAR and 22.2% of octreotide LAR patients who did not achieve biochemical control did not receive the recommended dose increase. Hyperglycemia-related adverse events were more common with pasireotide LAR (57.3% vs 21.7%).
Conclusions:
Pasireotide LAR demonstrated superior efficacy over octreotide LAR and is a viable new treatment option for acromegaly.
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