Effectiveness of self- or partner-administration of an extended-release aqueous-gel formulation of lanreotide in lanreotide-naïve patients with acromegaly
Open Access
- 8 November 2009
- journal article
- clinical trial
- Published by Springer Science and Business Media LLC in Pituitary
- Vol. 13 (2), 115-122
- https://doi.org/10.1007/s11102-009-0207-x
Abstract
Surgical resection is often not curative in patients with acromegaly and long-acting somatostatin analogues (lanreotide or octreotide) are often needed. This study assessed the efficacy and safety of self- or partner-administration of lanreotide in patients with acromegaly. This was a six-month, single-arm, open-label study conducted at 13 endocrinology clinics. Fifty-nine patients received deep subcutaneous lanreotide injections every 28 days. Twelve patients started on 120 mg lanreotide and forty-seven started on 90 mg lanreotide. At week 16, the dose was adjusted to 60, 90 or 120 mg based on insulin-like growth factor-1 (IGF-1) levels at week 12. Fifty-nine patients with acromegaly either switched from long-acting octreotide (switch; n = 33) or were somatostatin analogue treatment-naïve or not currently taking long-acting octreotide (“other”; n = 26). The key endpoints included the percentage of patients/partners able to self- or partner-inject lanreotide and those with normal IGF-1 or growth hormone (GH) levels at week 24/early termination. 100% of patients/partners correctly self- (n = 41) or partner-injected (n = 18) lanreotide by week 4. By week 24/early termination, IGF-1 levels were controlled in 93.7% of switch and 46.2% of “other” patients, while GH levels were controlled in 76.9% and 39.1% of patients, respectively. Both IGF-1 and GH were controlled in 73.1% of switch and 30.4% of “other” patients. Most switch patients (81%) reported they preferred lanreotide over long-acting octreotide for future use (P = 0.0001). Self- or partner-administration of lanreotide is generally well tolerated and associated with IGF-1 and GH control in many lanreotide-naïve patients with acromegaly.Keywords
This publication has 15 references indexed in Scilit:
- The Utility of Oral Glucose Tolerance Testing for Diagnosis and Assessment of Treatment Outcomes in 166 Patients with AcromegalyJournal of Clinical Endocrinology & Metabolism, 2009
- Prevalence of discordant GH and IGF-I levels in acromegalics at diagnosis, after surgical treatment and during treatment with octreotide LAR®Growth Hormone & IGF Research, 2008
- Radiation therapy in acromegalyReviews in Endocrine and Metabolic Disorders, 2007
- Home administration of lanreotide Autogel® by patients with acromegaly, or their partners, is safe and effectiveClinical Endocrinology, 2007
- AcromegalyNew England Journal of Medicine, 2006
- Consensus statement: medical management of acromegalyActa Endocrinologica, 2005
- Pharmacokinetic profile of lanreotide Autogel® in patients with acromegaly after four deep subcutaneous injections of 60, 90 or 120 mg every 28 daysClinical Endocrinology, 2005
- A Critical Analysis of Pituitary Tumor Shrinkage during Primary Medical Therapy in AcromegalyJournal of Clinical Endocrinology & Metabolism, 2005
- Efficacy of the New Long-Acting Formulation of Lanreotide (Lanreotide Autogel) in the Management of AcromegalyJournal of Clinical Endocrinology & Metabolism, 2002
- Octreotide as Primary Therapy for AcromegalyJournal of Clinical Endocrinology & Metabolism, 1998