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Somatuline Depot safe, well tolerated in patients with acromegaly
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Adults with acromegaly controlled with octreotide therapy achieved normal insulin-like growth factor I levels when assigned Somatuline Depot at extended-dose intervals, according to research in European Journal of Endocrinology.
In an open-label, noncomparative trial conducted in 14 countries over 5 years, researchers found that most patients preferred extended dosing with Somatuline Depot (lanreotide, Ipsen) injections when compared with octreotide therapy, and that the drug was safe and well tolerated.
In the LEAD study, Sebastian J.C.M.M. Neggers, MD, PhD, of the department of endocrinology at Erasmus University Medical Center in Rotterdam, Netherlands, and colleagues analyzed data from 124 adults with acromegaly (mean age, 54 years; 37% men; average time from diagnosis, 8.7 years) who were prescribed 10 mg or 20 mg of octreotide every 4 weeks for at least 6 months (average treatment time, 2.5 years) and had normal IGF-I levels. For phase 1 of the study, researchers administered 120 mg lanreotide autogel injection every 6 weeks for 24 weeks. Depending on IGF-I levels at 24 weeks, researchers then administered lanreotide autogel injection every 4, 6 or 8 weeks for 24 additional weeks for phase 2 of the study. Researchers assessed hormone levels, patient-reported outcomes and adverse events.
Within the cohort, 77.4% of patients were assigned to 6- or 8-week extended-dose intervals in the phase 2 portion of the study. After 48 weeks, 75.8% had normal IGF-I levels (95% CI, 68.3-83.3). Among patients assigned to dosing every 6 weeks, 88.7% had normal IGF-I levels at 24 weeks (95% CI, 83.1-94.3). At both 24 and 48 weeks, growth hormone levels were less than 2.5 µg/L in more than 90% of patients, according to researchers.
At week 24, 99 patients reported a preference for lanreotide autogel with a 6-week extended dose; 10 patients preferred octreotide every 4 weeks; three patients had no preference. At 48 weeks, 24 of 26 patients said they preferred lanreotide over octreotide in the 8-week extended-dose group; 53 of 68 patients preferred lanreotide in the 6-week group; 10 of 13 patients preferred lanreotide in the 4-week group.
Within the cohort, 91 patients (73%) reported 341 adverse events. Adverse events were mild or moderate in most patients; the most common symptoms reported were cholelithiasis (11.3%) and diarrhea (10.5%).
“The LEAD study results suggested that patients with acromegaly who previously achieved biochemical control in terms of IGF-I levels while receiving 10 mg or 20 mg of octreotide LAR every 4 weeks are likely to be good candidates for switching to lanreotide autogel 120 mg every 6 or 8 weeks,” the researchers wrote. “The LEAD study results also suggested that such patients are likely to maintain control of IGF-I, GH and symptoms for up to at least 1 year without adverse effects on tolerability or [health-related quality of life].”
The researchers noted that patients with baseline IGF-I levels that are below but close to the upper level of normal may be less suitable candidates for lanreotide and require more careful consideration. – by Regina Schaffer
Disclosure: Neggers reports receiving research grants and consulting fees from Ipsen and Pfizer. Please see the full study for a list of all other authors' relevant financial disclosures.
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