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Acromegaly patients could gain greater biochemical control with new treatment
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Patients with inadequately controlled acromegaly on first-generation somatostatin analogues could see improvement with pasireotide long-acting release, based on results from a phase 3 trial presented at the 16th European Congress of Endocrinology.
For the multicenter, double blind trial, Monica Gadelha, MD, PhD, of the Federal University of Rio de Janeiro, and colleagues randomly assigned 198 patients with inadequate disease control on the maximum approved doses of octreotide LAR (Sandostatin, Novartis) or lanreotide (Somatuline Autogel, Ipsen) for at least 6 months into two cohorts of pasireotide (Signifor, Novartis): pasireotide LAR 40 mg or pasireotide LAR 60 mg vs. continued open-label treatment with octreotide LAR 30 mg or lanreotide 120 mg.
The researchers examined whether patients, selected regardless of prior surgical status, achieved biochemical control as measured by the mean growth hormone levels of <2.5 mcg/L and normalized insulin-like growth factor I after 24 weeks.
“Historically, we have evaluated somatostatin analogues for the treatment of acromegaly by the decrease in either growth hormone or insulin-like growth factor levels,” Gadelha said in a press release. “With more sensitive assays and more stringent evaluation criteria, a recent meta-analysis indicates that up to 45% of patients can have either GH or IGF-I still elevated. As the health risks associated with acromegaly may persist until both GH and IGF-I levels are normalized, this study further supports the importance of monitoring for and achieving full biochemical control.”
Results of the study showed greater biochemical control reached by 15.4% (95% CI, 7.6-26.5) of patients assigned pasireotide LAR 40 mg and 20% of patients assigned 60 mg (95% CI, 11.1-31.8) compared with 0% in the control group (95% CI, 0-5.3).
Secondary endpoints evaluated included percentage of patients achieving normalized IGF-I, percentage of patients achieving normalized GH levels, tumor reduction and safety.
IGF-I normalization was achieved by 24.6% (95% CI, 14.8-36.9) of patients assigned pasireotide LAR 40 mg and 26.2% (95% CI, 16-38.5) of patients assigned pasireotide LAR 60 mg, but it was not achieved by those in the control group.
Of the patients in the pasireotide LAR 40 mg and 60 mg groups, 35.4% (95% CI, 23.9-48.2) and 43.1% (95% CI, 30.8-56), respectively, reached mean GH levels of <2.5 mcg/L vs. 13.2% in the control group (95% CI, 6.2-23.6).
More patients assigned pasireotide LAR 40 mg (18.5%; 95% CI, 9.9-30) and 60 mg (10.8%; 95% CI, 4.4-20.9) experienced a 25% reduction in tumor size compared with those in the control groups (1.5%; 95% CI, 0-7.9).
Some adverse events were seen in the pasireotide LAR 40 mg, 60 mg and control groups: hyperglycemia (33.3%, 30.6% and 13.6%), diabetes (20.6%, 25.8% and 7.6%) and diarrhea (15.9%, 19.4% and 4.5%), respectively.
For more information:
Gadelha M. #35 P907. Presented at: 16th European Congress of Endocrinology; May 3-7, 2014; Wroclaw, Poland.
Disclosure: This study was sponsored by Novartis.
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