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Cost-Effectiveness and Efficacy of a Novel Combination Regimen in Acromegaly: A Prospective, Randomized Trial.
Bonert, Vivien; Mirocha, James; Carmichael, John; Yuen, Kevin C J; Araki, Takako; Melmed, Shlomo.
Afiliação
  • Bonert V; Pituitary Center, Department of Medicine, Cedars-Sinai Medical Center, Los Angeles, California.
  • Mirocha J; Biostatistics and Bioinformatics Research Center, Samuel Oschin Comprehensive Cancer Institute, Cedars-Sinai Medical Center, Los Angeles, California.
  • Carmichael J; Division of Endocrinology and Metabolism, Keck School of Medicine, University of Southern California, Los Angeles, California.
  • Yuen KCJ; Department of Neuroendocrinology and Neurosurgery, Barrow Neurological Institute, University of Arizona College of Medicine and Creighton School of Medicine, Phoenix, Arizona.
  • Araki T; Division of Diabetes, Endocrinology and Metabolism, University of Minnesota, Minneapolis, Minnesota.
  • Melmed S; Pituitary Center, Department of Medicine, Cedars-Sinai Medical Center, Los Angeles, California.
J Clin Endocrinol Metab ; 105(9)2020 09 01.
Article em En | MEDLINE | ID: mdl-32754748
CONTEXT: Combination therapy with somatostatin receptor ligand (SRL) plus pegvisomant for patients with acromegaly is recommended after a maximizing dose on monotherapy. Lower-dose combination regimens are not well studied. OBJECTIVE: To compare cost-effectiveness and efficacy of 3 lower-dose combination regimens in controlled and uncontrolled acromegaly. DESIGN AND SETTING: Prospective, randomized, open-label, parallel arm study at a tertiary referral pituitary center. PATIENTS: Adults with acromegaly regardless of response to prior SRL and biochemical control status at baseline, stratified by an SRL dose required for insulin-like growth factor (IGF)-I normalization during any 3-month period within 12 months preceding enrollment. INTERVENTION: Combination therapy for 24 to 32 weeks on arm A, high-dose SRL (lanreotide 120 mg/octreotide long-acting release [LAR] 30 mg) plus weekly pegvisomant (40-160 mg/week); arm B, low-dose SRL (lanreotide 60 mg/octreotide LAR 10 mg) plus weekly pegvisomant; or arm C, low-dose SRL plus daily pegvisomant (15-60 mg/day). MAIN OUTCOME MEASURE: Monthly treatment cost in each arm in participants completing ≥ 24 weeks of therapy. RESULTS: Sixty patients were enrolled and 52 were evaluable. Fifty of 52 (96%) demonstrated IGF-I control regardless of prior SRL responsiveness (arm A, 14/15 [93.3%]; arm B, 22/23 [95.7%]; arm C, 14/14 [100%]). Arm B was least costly (mean, $9837 ±â€…1375 per month), arm C was most expensive (mean, $22543 ±â€…11158 per month), and arm A had an intermediate cost (mean, $14261 ±â€…1645 per month). Approximately 30% of patients required pegvisomant dose uptitration. Rates of adverse events were all < 10%. CONCLUSIONS: Low-dose SRL plus weekly pegvisomant represents a novel dosing option for achieving cost-effective, optimal biochemical control in patients with uncontrolled acromegaly requiring combination therapy.
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Texto completo: 1 Coleções: 01-internacional Contexto em Saúde: 1_ASSA2030 Base de dados: MEDLINE Assunto principal: Peptídeos Cíclicos / Acromegalia / Somatostatina / Octreotida / Hormônio do Crescimento Humano Tipo de estudo: Clinical_trials / Health_economic_evaluation / Risk_factors_studies Limite: Adult / Female / Humans / Male / Middle aged Idioma: En Revista: J Clin Endocrinol Metab Ano de publicação: 2020 Tipo de documento: Article

Texto completo: 1 Coleções: 01-internacional Contexto em Saúde: 1_ASSA2030 Base de dados: MEDLINE Assunto principal: Peptídeos Cíclicos / Acromegalia / Somatostatina / Octreotida / Hormônio do Crescimento Humano Tipo de estudo: Clinical_trials / Health_economic_evaluation / Risk_factors_studies Limite: Adult / Female / Humans / Male / Middle aged Idioma: En Revista: J Clin Endocrinol Metab Ano de publicação: 2020 Tipo de documento: Article