An open label, controlled study to assess the ability of patients with acromegaly, or their partners, to administer Somatuline Autogel®
JS Bevan1, J Newell-Price2, JAH Wass3 & JAH on behalf of the Autogel Self-Injection Study Group1
Somatostatin analogues are the mainstay of medical therapy for acromegaly. The introduction of ready-to-use Somatuline Autogel (Autogel) raised the possibility of self/partner-injection. This study explored whether patients could administer monthly injections of Autogel, without compromising efficacy. After ethical approval, thirty patients treated with Autogel for acromegaly chose either the Control or Test group. Control group patients (n=15) received injections from a healthcare professional (HCP) for 40 weeks. Test group patients (n=15) received training to self inject and participated for between 32 and 40 weeks, depending on training requirements. Test patients had to fulfil competency requirements prior to unsupervised injections. Plasma GH, IGF-1, and lanreotide were measured at Baseline, Interim Assessment (Week 20) and Completion. Adverse events and symptoms were recorded. Disease control was maintained if GH & IGF-1 values obtained on completion were comparable to baseline. On completion GH levels were maintained in 14 Test and 15 Control patients. Mean GH (mcg/l) levels were 2.5±1.8 at Baseline and 2.3±1.8 on Completion in the Test group and 2.2±2.9 at Baseline and 1.9±1.9 on Completion in the Control group. IGF-1 levels were maintained in 15 Test and 14 Control patients. Mean serum lanreotide levels tended to increase in the Test group, but tended to decrease in the Control group. On completion 14/15 patients were deemed competent to perform unsupervised injections based on completion of training and maintenance of GH & IGF-1 control throughout the study. The pattern of injection site reactions seen at Baseline (HCP injections) did not change significantly in either group.
Conclusion: Suitably motivated patients with acromegaly (or their partners) can be trained to administer unsupervised Somatuline Autogel injections without compromise of disease control. This may confer advantages in terms of clinic visits and independence.