Abstract
Pasireotide has a broader somatostatin receptor binding profile than other somatostatin analogues. A 16-week, Phase II trial showed that pasireotide may be an effective treatment for acromegaly. An extension to this trial assessed the long-term efficacy and safety of pasireotide. This study was an open-label, single-arm, open-ended extension study (primary efficacy and safety evaluated at month 6). Patients could enter the extension if they achieved biochemical control (GH ≤ 2.5 μg/L and normal IGF-1) or showed clinically relevant improvements during the core study. Thirty of the 60 patients who received pasireotide (200–900 μg bid) in the core study entered the extension. At extension month 6, of the 26 evaluable patients, six were biochemically controlled, of whom five had achieved control during the core study. Normal IGF-1 was achieved by 13/26 patients and GH ≤ 2.5 μg/L by 12/26 at month 6. Nine patients received pasireotide for ≥24 months in the extension; three who were biochemically controlled at month 24 had achieved control during the core study. Of 29 patients with MRI data, nine had significant (≥20 %) tumor volume reduction during the core study; an additional eight had significant reduction during the extension. The most common adverse events were transient gastrointestinal disturbances; hyperglycemia-related events occurred in 14 patients. Twenty patients had fasting plasma glucose shifted to a higher category during the extension. However, last available glucose measurements were normal for 17 patients. Pasireotide has the potential to be an effective, long-term medical treatment for acromegaly, providing sustained biochemical control and significant reductions in tumor volume.Electronic supplementary materialThe online version of this article (doi:10.1007/s11102-013-0478-0) contains supplementary material, which is available to authorized users.
Highlights
Is a serious disorder of growth hormone (GH) hypersecretion that usually develops over many years
Nine patients had at least one episode of sinus bradycardia, of whom three had sinus bradycardia at the last study visit. This Phase II extension study showed that, following 9 months of pasireotide therapy (3 months in the core study and 6 months in the extension study), 23 % (6/26) of patients with acromegaly achieved biochemical control.The response rate observed in the extension is similar to that seen in the core study (27 %) after 3 months’ pasireotide treatment [12] and is consistent with the results of earlier studies of somatostatin analogues that used this definition of biochemical control [15,16,17]
Compared with the core study, an additional five patients achieved GH and/or insulin-like growth factor 1 (IGF-1) control for the first time during the extension study, which suggests that extending pasireotide treatment beyond 3 months may be required to achieve full biochemical control in certain patients
Summary
Is a serious disorder of growth hormone (GH) hypersecretion that usually develops over many years. In more than 90 % of patients, the excessive GH level is produced by a pituitary somatotroph adenoma [1]. GH induces synthesis of insulin-like growth factor 1 (IGF-1) via hepatic GH receptors; elevated levels of GH and IGF-1 can lead to metabolic dysfunction and somatic growth [2]. Control of GH and IGF-1 is important in patients with acromegaly if mortality is to be reduced to expected levels [3]. Transsphenoidal surgery is the recommended first-line treatment for many patients with acromegaly, those with microadenomas [4, 5]. 40–60 % of patients with acromegaly will experience persistent or recurrent disease following surgery, necessitating additional therapy [1, 4, 6]
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