TY - JOUR
T1 - Lanreotide extended-release aqueous-gel formulation, injected by patient, partner or healthcare provider in patients with acromegaly in the United States
T2 - 1-year data from the SODA registry
AU - Salvatori, Roberto
AU - Woodmansee, Whitney W.
AU - Molitch, Mark
AU - Gordon, Murray B.
AU - Lomax, Kathleen G.
N1 - Funding Information:
Acknowledgments The authors express their gratitude to all SODA patients, investigators, and study coordinators for their commitment to this observational study. The authors accept direct responsibility for this paper and are grateful for the contribution made by Esther Nathanson, MD at Watermeadow Medical USA (supported by Ipsen) in the development of the outline and first draft, and in collating comments for subsequent drafts. The authors are also thankful for the statistical support provided by Rongdean Chen, PhD and Weiyuan Chung, MS. This study was sponsored by Ipsen Biopharmaceuticals, Inc. (Basking Ridge, NJ, US).
PY - 2014/2
Y1 - 2014/2
N2 - Lanreotide depot (LD; commercial name Somatuline® Depot) is an injectable, extended-release formulation of the synthetic somatostatin analog (SSA) lanreotide. In recent clinical trials, LD was found to be suitable for self or partner administration, avoiding the need to travel to a medical facility. The Somatuline® Depot for Acromegaly (SODA) study is an ongoing, multicenter, observational study in the US investigating the efficacy, safety, convenience and symptom relief provided by LD in patients with acromegaly. Sub-analyses explore outcomes according to who administered the injection: patient, partner, healthcare provider (HCP) or a combination. Data reported here reflect one year of patient experience. Patients are eligible for inclusion if they have a diagnosis of acromegaly, are treated with LD and can give signed informed consent. Baseline data include patient demographics, previous acromegaly treatment and investigations, GH and IGF-I levels, LD dose and dose adjustment frequency. Symptom frequency, injection pain and treatment convenience are assessed using patient-reported questionnaires. As of 18 April 2012, 166 patients had enrolled in SODA. Most (72 %) achieved normal IGF-I levels after 12 months of LD treatment. Disease control was similar in self or partner injectors and in patients who received injections from their HCP, although self or partner injecting was deemed more convenient. LD was well-tolerated irrespective of who performed the injection. Self injection led to more injection-site reactions, but this did not increase the rate of treatment interruption. Acromegaly symptoms remained stable. Biochemical, safety and convenience data support the clinical validity of injecting LD at home.
AB - Lanreotide depot (LD; commercial name Somatuline® Depot) is an injectable, extended-release formulation of the synthetic somatostatin analog (SSA) lanreotide. In recent clinical trials, LD was found to be suitable for self or partner administration, avoiding the need to travel to a medical facility. The Somatuline® Depot for Acromegaly (SODA) study is an ongoing, multicenter, observational study in the US investigating the efficacy, safety, convenience and symptom relief provided by LD in patients with acromegaly. Sub-analyses explore outcomes according to who administered the injection: patient, partner, healthcare provider (HCP) or a combination. Data reported here reflect one year of patient experience. Patients are eligible for inclusion if they have a diagnosis of acromegaly, are treated with LD and can give signed informed consent. Baseline data include patient demographics, previous acromegaly treatment and investigations, GH and IGF-I levels, LD dose and dose adjustment frequency. Symptom frequency, injection pain and treatment convenience are assessed using patient-reported questionnaires. As of 18 April 2012, 166 patients had enrolled in SODA. Most (72 %) achieved normal IGF-I levels after 12 months of LD treatment. Disease control was similar in self or partner injectors and in patients who received injections from their HCP, although self or partner injecting was deemed more convenient. LD was well-tolerated irrespective of who performed the injection. Self injection led to more injection-site reactions, but this did not increase the rate of treatment interruption. Acromegaly symptoms remained stable. Biochemical, safety and convenience data support the clinical validity of injecting LD at home.
KW - Acromegaly
KW - Extended-release
KW - Lanreotide depot
KW - Observational study
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U2 - 10.1007/s11102-012-0460-2
DO - 10.1007/s11102-012-0460-2
M3 - Article
C2 - 23314980
AN - SCOPUS:84895076332
SN - 1386-341X
VL - 17
SP - 13
EP - 21
JO - Pituitary
JF - Pituitary
IS - 1
ER -