Drug updated on 4/15/2024
| Dosage Form | Injection (subcutaneous; 0.3 mg/mL, 0.6 mg/mL, 0.9 mg/mL) |
| Drug Class | Somatostatin analogs |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of patients with acromegaly who have had an inadequate response to surgery and/or for whom surgery is not an option.
- Indicated for the treatment of patients with Cushing’s disease for whom pituitary surgery is not an option or has not been curative.
Summary
- Pasireotide (Signifor) is indicated for the treatment of patients with acromegaly and Cushing's disease, particularly those who have had an inadequate response to surgery or for whom surgery is not an option. It has been found effective in inducing significant tumor shrinkage in both conditions, offering a considerable advantage over first-generation somatostatin receptor ligands.
- Six studies were reviewed, providing insights into the safety, effectiveness, and comparison of Pasireotide with other drugs used to treat Acromegaly and Cushing’s Disease. These studies also explored its potential use in treating meningiomas and gastro-entero-pancreatic neuroendocrine tumors.
- While no direct data was available on extended dosing intervals (EDIs) using Pasireotide, it suggested that similar maintenance of efficacy, safety, and patient satisfaction could be expected as seen with other treatments like lanreotide and octreotide.
- One study highlighted the low evidence level but potential efficacy of somatostatin analogs including Pasireotide in treating meningiomas when surgical options are exhausted or not viable. This suggests a potentially valuable role for this drug class beyond their primary indications.
- A comparative assessment among different treatments for Cushing's disease noted moderate disease control capability by Pasireotide but also associated risk of hyperglycemia as a significant adverse event. This indicates that while effective to some extent, there may be limitations due to side effects such as hyperglycemia compared to alternative therapies.
- In terms of population type considerations, one study proposed exploration into specific patient subgroups where Pasireotide might be beneficial, especially within combination therapies aimed at increasing progression-free survival rates amongst patients suffering from gastro-entero-pancreatic neuroendocrine tumors.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Signifor (pasireotide) Prescribing Information. | 2020 | Recordati Rare Diseases Inc., Lebanon, NJ |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| A systematic literature review to evaluate extended dosing intervals in the pharmacological management of acromegaly. | 2023 | Pituitary |
| Meningiomas and somatostatin analogs: a systematic scoping review on current insights and future perspectives. | 2023 | International Journal of Molecular Sciences |
| Pasireotide-induced shrinkage in GH and ACTH secreting pituitary adenoma: a systematic review and meta-analysis | 2022 | Frontiers in Endocrinology |
| Effectiveness of medical treatment of Cushing’s disease: a systematic review and meta-analysis. | 2021 | Frontiers in Endocrinology |
| Target therapies plus somatostatin analogs in NETs: a network meta-analysis. | 2021 | Endocrine-Related Cancer |
| Do somatostatin-analogues have the same impact on postoperative morbidity and pancreatic fistula in patients after pancreaticoduodenectomy and distal pancreatectomy? - A systematic review with meta-analysis of randomized-controlled trials. | 2020 | Pancreatology |
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| Second line treatment of acromegaly: pasireotide or pegvisomant? | 2022 | Best Practice & Research Clinical Endocrinology & Metabolism |
| A pituitary society update to acromegaly management guidelines. | 2021 | Pituitary |
| How to position pasireotide LAR Treatment in acromegaly | 2019 | The Journal of Clinical Endocrinology & Metabolism |
| Diagnostics and treatment of acromegaly — updated recommendations of the Polish Society of Endocrinology. | 2019 | Endokrynoligia Polska |