Tuesday, June 21, 2011

Octreotide hydrogel implant safe, effective in acromegaly

Patients with acromegaly who received a 52-mg octreotide hydrogel implant for 6 months achieved consistent biochemical control and reduced tumor size, according to results of a study presented in early April at the Endo Society conference in San Diego.

The phase 2, open-label, randomized study evaluated the safety and efficacy of a subcutaneous 52-mg octreotide hydrogel implant (Endo Pharmaceuticals) for the treatment of acromegaly. Octreotide is contained in the middle of a cartridge made of hydrogel, the same material found in soft contact lenses, which is implanted subcutaneously in the upper forearm.

The small study included 11 patients (mean age, 47 years) at a single center in Brazil who were randomly assigned to receive one (n=5) or two (n=6) 52-mg implants. The implants were inserted on day 1 of the study and removed at month 6. Patients were then followed for the 6 months and for 1 month after the implants were removed.

“This is the first study to evaluate the effectiveness and safety of octreotide hydrogel implant,” Theodore Danoff, MD, PhD, vice president of clinical development, endocrinology/urology, Endo Pharmaceuticals, said during a late-breaking session.

According to the results, the octreotide hydrogel implant suppressed mean insulin-like growth factor I levels during the 6 months; however, levels increased after the implants were removed. One patient in the one-implant group achieved normalization of IGF-I for the entirety of the study, as did two patients in the two-implant group. Those who did not achieve IGF-I normalization had a mean 40% reduction in IGF-I levels.

Tumor size was reduced by 23% among patients who received one implant and by 38% in patients who received two implants.

The researchers also measured quality of life, using a series of questions that examined efficacy, satisfaction with treatment, discomfort and other factors. Danoff said patient ratings of efficacy and satisfaction were high and patient ratings of discomfort, pain and disruption of daily activities was low.
“Patients were highly satisfied and felt it was effective for their treatment,” Danoff said.

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