Abstract
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.
Highlights
Lanreotide depot (LD; commercial name SomatulineÒ Depot) is an injectable, extended-release formulation of the synthetic somatostatin analog (SSA) lanreotide
Patients are eligible for inclusion in the SomatulineÒ Depot for Acromegaly (SODA) study if they have a clinical diagnosis of acromegaly, are treated with LD and are competent to give signed informed consent
More patients received injections from their healthcare provider (HCP) (58/166; 35 %) than from other sources; 16 % self-injected, and the remaining 50 % were evenly split between those who had injections administered by their partner and those who used a combination of methods
Summary
Lanreotide depot (LD; commercial name SomatulineÒ Depot) is an injectable, extended-release formulation of the synthetic somatostatin analog (SSA) lanreotide. Injection pain and treatment convenience are assessed using patient-reported questionnaires. Treatment typically entails surgical excision of the pituitary adenoma to normalize GH secretion, and to relieve compression symptoms in cases of larger tumor mass. Over 50 % of patients have active residual disease, defined by increased levels of GH, and/or its physiological mediator, insulin-like growth factor-1 (IGF-I), leading to persistent clinical symptoms, impaired health-related quality of life and increased mortality [6,7,8]. A recent systematic review of the literature determined that mortality, morbidity and cost are all higher in patients with biochemically uncontrolled acromegaly than in those with GH levels \2.5 lg/L and IGF-I normal for age and gender [9]. Patients with uncontrolled disease typically receive pharmacological therapy such as somatostatin analogs (SSAs), the GH receptor antagonist pegvisomant or, less commonly, dopamine agonists or radiotherapy, to further reduce the symptoms and long-term consequences of unregulated GH secretion [1, 10]
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