octreotide acetate solution for injection / Generic mfg. - LARVOL DELTA

Octreotide vs. Splenic Artery Ligation for Portal Flow Modulation in Living Donor Liver Transplants (SCALOP Trial) (clinicaltrials.gov) - P4 | N=80 | Not yet recruiting | Sponsor: King Faisal Specialist Hospital & Research Center

New P4 trial • Transplantation

Atypical Presentation of Hematopoietic Stem Cell Transplantation Associated Thrombotic Microangiopathy (ATS 2025) - "His post-transplant course had been complicated by severe graft-versus-host-disease of the skin and gastrointestinal tract treated with tacrolimus, steroids, sandostatin, and photopheresis. His medications included tacrolimus, sirolimus, prednisone, valacyclovir, posaconazole, meropenem, and linezolid...Primary intervention should be withdrawal of calcineurin inhibitors, and although frequently used, plasma exchange results may vary. Our patient presented with DAH likely as a manifestation of his TMA."

Acute Myelogenous Leukemia • Bone Marrow Transplantation • Cough • Dermatology • Gastrointestinal Disorder • Graft versus Host Disease • Hematological Disorders • Hematological Malignancies • Immunology • Leukemia • Oncology • Pulmonary Disease • Respiratory Diseases • Thrombosis • Transplantation • HP

A Case of Pancreatic Fistula Following Left Nephrectomy: A Rare Complication. (PubMed, Cureus) - "The fistula was managed effectively with subcutaneous somatostatin analog (Sandostatin) injections, parenteral nutrition, and a strict nothing by mouth (NPO) regimen. This case underscores the potential risk of pancreatic fistula following radical nephrectomy, highlighting the importance of early diagnosis and appropriate management strategies. Unfortunately, the patient's recovery was complicated by intra-abdominal bleeding and septic shock, which ultimately led to his death."

Journal • Hepatology • Oncology • Renal Cell Carcinoma • Sarcoma • Septic Shock • Solid Tumor • Urothelial Cancer

PANasta: Cattell-Warren Versus Blumgart Techniques of Pancreatico-jejunostomy Following Pancreato-duodenectomy (clinicaltrials.gov) - P3 | N=295 | Completed | Sponsor: University of Liverpool | Active, not recruiting ➔ Completed | N=506 ➔ 295

Enrollment change • Trial completion • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor

Casting a Wide NET: When Is the Optimal Time for 177Lu-Dotatate Treatment? (PubMed, Oncology (Williston Park)) - "3 Prior to 2017, available treatments for advanced NETs included somatostatin analogues (lanreotide [Somatuline] and octreotide [Sandostatin]), targeted therapy (everolimus [Afinitor] and sunitinib [Sutent]), and chemotherapy. 8 Previously these tumors were placed under the umbrella of poorly differentiated neuroendocrine carcinomas. Given that well-differentiated grade 3 NETs are relatively new, standard-of-care treatment options are undefined."

Journal • Endocrine Cancer • Neuroendocrine Tumor • Oncology • Solid Tumor

Effective Control of Pancreatitis-Related Gastric Varices Through Splenic Artery Embolization: A Case Report. (PubMed, Cureus) - "The patient initially received medical management with IV sandostatin for bleeding control, and a splenectomy was planned as the definitive management...Splenic artery embolization led to a successful reduction in gastric variceal size and no recurrence of bleeding. This case report presents a case of pancreatitis-induced splenic vein thrombosis (PISVT) and highlights splenic artery embolization as a viable management strategy in such cases."

Journal • Cardiovascular • Gastrointestinal Disorder • Hematological Disorders • Pancreatitis • Thrombosis

Treatment of Orthostatic Intolerance (clinicaltrials.gov) - P1/2 | N=150 | Active, not recruiting | Sponsor: Satish R. Raj | Trial completion date: Dec 2025 ➔ Dec 2027 | Trial primary completion date: Dec 2025 ➔ Dec 2027

Trial completion date • Trial primary completion date • Cardiovascular

CASE REPORT: A PATIENT WITH MULTIPLE PARAGANGLIOMA TREATED WITH LONG-ACTING SOMATOSTATIN ANALOGUE (ICE-EDEC 2024) - "Medications : Tresiba insulin 16 units once daily, Lymjuv insulin with all meals, doxazosin 8 mg twice daily, Moxinidine 0.4 mcg twice daily, bisoprolol 5 mg twice daily, aspirin 300 mg once daily, atorvastatin 80 mg once daily. Started on Sandostatin 30 mg once monthly in May 22... A case of recurrent metastatic paraganglioma is presented.After 1 year of treatment with LAR octreotide there is improvement in quality of life, reduction in hypertensive crisis and stroke admissions. Research should be continued for targeting SSTRs with second-generation SSAs,chimeric dual receptor-targeting peptides, chemotactic delivery through SSTRs, and other novel methods."

Clinical • Anemia • Cardiovascular • CNS Tumor • Diabetes • Endocrine Cancer • Gynecology • Hematological Disorders • Metabolic Disorders • Neuroendocrine Tumor • Oncology • Solid Tumor • SSTR

Multinuclear 1 H/13 C/15 N chemical shift assignment of therapeutic octreotide acetate performed at natural abundance. (PubMed, Magn Reson Chem) - "Octreotide acetate, the active pharmaceutical ingredient in the long-acting release (LAR) drug product Sandostatin®, is a cyclic octapeptide that mimics the naturally occurring somatostatin peptide hormone...Here, using state-of-the-art 1D and 2D homo- and heteronuclear NMR experiments, octreotide was fully assigned, including water exchangeable amide protons, in aqueous buffer except for 13 CO and 15 NH of F1, 15 NH of C2, and 15 NζHζ of K5 that were not observed because of water exchange or conformational exchange. The solution NMR spectra were then directly compared with 1D 1 H/13 C/15 N solid-state NMR (SSNMR) spectra showing the potential applicability of 13 C/15 N SSNMR for octreotide drug product characterization."

Journal

Quantitative spectrofluorimetric method for determination of octreotide acetate synthetic peptide derivative in pure and its Sandostatin ampules forms. (PubMed, Spectrochim Acta A Mol Biomol Spectrosc) - "Furthermore, this protocol could be perfectly applied for the quantitative estimation of octreotide in its ampoules with a high degree of accuracy and precision. As a result, a developed protocol is ideally appropriate for fast and simple octreotide quantitative estimation in quality control laboratories."

Journal

The effect of preoperative short-term octreotide treatment to surgery in thyrotropin-secreting pituitary adenomas: a retrospective cohort study. (PubMed, BMC Endocr Disord) - "Preoperative octreotide treatment for the purpose of reducing excessive thyroid hormones may not enhance surgical outcomes, and the duration of octreotide treatment needs to be extended to fully benefit from the tumor-shrinking effects of SSAs."

Journal • Retrospective data • Surgery • Oncology • Pituitary Gland Carcinoma

A Rare Case of Emergent Orthotopic Heart Transplantation for Cardiogenic Shock in a Patient With Undiagnosed Acromegaly. (ENDO 2023) - "He was then started on octreotide 50 mcg TID and eventually transitioned to Sandostatin depot 20 mg intergluteal injection every 4 weeks... Acromegaly is often missed due to the insidious onset of physical changes that are observed. Literature review reveals only two other cases of acromegaly related NICM resulting in cardiogenic shock, in which only one patient received an emergent heart transplant. When recognized early, patients can be treated surgically and or/medically before irreversible changes occur."

Clinical • Acromegaly • Cardiomyopathy • Cardiovascular • Coronary Artery Disease • Endocrine Disorders • Fibrosis • Immunology • Oncology • Pituitary Gland Carcinoma • Sexual Disorders • Transplantation • IGF1

Optimization and validation of the liquid chromatography coupled to tandem mass spectrometry method for assessing octreotide release from microspheres during inflammation in rabbit models. (PubMed, J Chromatogr B Analyt Technol Biomed Life Sci) - "To study the effect of acute-phase reaction (APR) of inflammation on the release of octreotide acetate microsphere (Sandostatin®, SLAR) at a clinical dose, a more sensitive liquid chromatography coupled to tandem mass spectrometry analysis method needs to be developed because of the low plasma concentrations of octreotide...The coefficients of variations for intraday and interday precision were less than 4.4 %, and the relative error of accuracy was within 5.7 %. The validated method was successfully applied to pharmacokinetics studies of SLAR in a seven-day inflammation model of rabbits, indicating that the APR did not affected the release and pharmacokinetics of the octreotide microspheres."

Journal • Preclinical • Immunology • Inflammation

PRESTO 2: An International Survey to Evaluate Patients' Injection Experiences with the Latest Devices/Formulations of Long-Acting Somatostatin Analog Therapies for Neuroendocrine Tumors or Acromegaly. (PubMed, Adv Ther) - "Compared with OCT, significantly fewer patients using LAN had injection-site pain lasting > 2 days after their most recent injection. Also, fewer LAN-treated patients experienced technical problems during injection. These findings demonstrate the importance of injection modality for overall LA SSA injection experience for patients with acromegaly or NETs."

Journal • Acromegaly • Endocrine Cancer • Endocrine Disorders • Neuroendocrine Tumor • Oncology • Pain • Solid Tumor

The Role of 68Ga-DOTATATE PET/CT in the Management of Gastrointestinal and Pancreatic Neuroendocrine Tumors (NANETS 2022) - "Of these, 27 patients had a change in medical management with 26 patients starting systemic therapy such as PRRT, chemotherapy or sandostatin and 1 patient being down-staged and taken off sandostatin, 9 patients had a change in surgical management with 7 patients undergoing a surgical resection due to primary or metastatic lesion detection and 2 patients having cancellation of planned primary tumor resection...CONCLUSIONS Our retrospective study demonstrates that 68Ga-DOTATATE PET/CT resulted in a change in therapeutic management in 36.2% of patients with GI or pancreatic NET and improved lesion detection over conventional imaging in 48.4% of patients. This supports its use in the care of patients with GI and pancreatic NETs"

Endocrine Cancer • Gastrointestinal Disorder • Neuroendocrine Tumor • Oncology • Pancreatic Cancer • Solid Tumor

Results from the Phase 1, Randomized, Open-Label, Cross-Over Study to Evaluate Pharmacokinetics of Three Escalating Doses of Oral Octreotide Capsules (NANETS 2022) - "Prior Phase 1 studies showed the comparability of 20 mg OOC to 0.1 mg Sandostatin SC...These results are consistent with a prior pharmacokinetics study undertaken with these higher doses (20 mg, 60 mg and 80 mg) and are comparable with data for injectable SSAs. The data supports dosing requirements for the planned Phase 3 study in patients with carcinoid syndrome associated with NET."

Clinical • P1 data • PK/PD data • Acromegaly • Carcinoid Tumor • Endocrine Cancer • Endocrine Disorders • Neuroendocrine Tumor • Oncology • Pain • Solid Tumor

TYPE 1 MULTIPLE ENDOCRINE NEOPLASIA-ASSOCIATED TRACHEOBRONCHIAL TUMORS MANAGED BY RIGID BRONCHOSCOPY-DIRECTED MULTIMODAL TUMOR DESTRUCTION (CHEST 2022) - "Outpatient therapy included Everolimus and Sandostatin. MEN1 associated with numerous tracheobronchial tumors can cause devastating central airway obstruction. Rigid bronchoscopy with multimodal tumor destruction technique can be a safe and effective option for patients who would not benefit from a surgical approach."

Carcinoid Tumor • Endocrine Cancer • Hepatology • Lung Cancer • Neuroendocrine Tumor • Oncology • Pulmonary Disease • Solid Tumor

Clinically Unsuspected Multiorgan Metastatic Breast Carcinoma Misdiagnosed and Mismanaged as Well-Differentiated Neuroendocrine Tumor (CAP 2022) - "Four months of Sandostatin treatment targeting neuroendocrine tumors showed no effectiveness...Pathologists need to be aware that breast carcinomas can mimic WD-NET clinically and immunophenotypically. Essential ancillary evaluation is warranted when facing a WD-NET–like neoplasm regardless of location and clinical presentation."

Clinical • Breast Cancer • Endocrine Cancer • Gastric Cancer • Gastrointestinal Disorder • Hormone Receptor Breast Cancer • Neuroendocrine Tumor • Oncology • Pain • Respiratory Diseases • Solid Tumor • GATA3 • Mammaglobin • SYP

Clinically Unsuspected Multiorgan Metastatic Breast Carcinoma Misdiagnosed and Mismanaged as Well-Differentiated Neuroendocrine Tumor (CAP 2022) - "Four months of Sandostatin treatment targeting neuroendocrine tumors showed no effectiveness...Pathologists need to be aware that breast carcinomas can mimic WD-NET clinically and immunophenotypically. Essential ancillary evaluation is warranted when facing a WD-NET–like neoplasm regardless of location and clinical presentation."

Clinical • Breast Cancer • Endocrine Cancer • Gastric Cancer • Gastrointestinal Disorder • Hormone Receptor Breast Cancer • Neuroendocrine Tumor • Oncology • Pain • Respiratory Diseases • Solid Tumor • GATA3 • Mammaglobin • SYP

Must we Wait for the Development of Metastasis to be Able to Distinguish Dopamine Resistant Aggressive Prolactinoma from Prolactin Producing Pituitary Carcinomas? Case Report and Literature Review. (ENDO 2022) - "We present the case of a 40 yo male with a 7.4 cm intractable prolactinoma with Ki-67 of up to 8% and positive p53 immunostaining, s/p surgical resection x2, radiation and medical therapy with high dose cabergoline plus Sandostatin. Tumors can only be diagnosed as carcinomas after they have metastasized and they can only be classified as aggressive after treatment failure or unusual growth, which creates a disadvantage for the prognosis and management of these patients. Case reports of atypical presentations of aggressive prolactinomas such as the one here presented, can help broaden our understanding of the predictable signs of poor prognosis."

Clinical • Review • Endocrine Cancer • Oncology • Pituitary Gland Carcinoma

Minimizing the initial burst of octreotide acetate based long-acting microspheres by the solvent evaporation method. (PubMed, Int J Pharm) - "Sandostatin long-acting release (SLAR) depot for 1-month controlled release of octreotide is a somatostatin analogue product that has been used extensively in the pharmacological treatment of acromegaly...Analysis of kinetics of dry Tg of the formulations reflected (a) the elevated residual solvent in SLAR and was not duplicated in the solvent evaporation formulations, and (b) the slightly higher Tg of peptide loaded formulations relative to than blank microspheres, consistent with the interaction of the acetate salt of octreotide with linear PLGA chains in the PLGA-glu. These data indicate that it is possible to prepare peptide loaded microspheres by the solvent evaporation method with extraordinarily similar performance to microspheres, such as those in SLAR, that are prepared by the low-burst release coacervation method."

Journal • Acromegaly • Endocrine Disorders

Investigation of the Effects of Obesity Surgery on Appetitive Behaviour (clinicaltrials.gov) - P=N/A | N=30 | Completed | Sponsor: University College Dublin | Recruiting ➔ Completed

Trial completion • Genetic Disorders • Obesity

A Budget Impact Model for Terlipressin in Treating Bleeding Oesophageal Varices Patients in the Philippines (ISPOR 2022) - "Vasoactive agents such as terlipressin, somatostatin, and sandostatin are widely used for the treatment of BOV... With a population of 110 million in the Philippines, increasing the utilization of terlipressin in patients with BOV from 5% in Year 1 to 7% in Year 5resulted in cost savings of between ₱3.06 million (approximately 61,271 USD) and ₱4.53 million (approximately 90,706 USD) from Year 1 to Year 5. This translated to a Per Member Per Year (PMPY) of -₱0.04 (approximately 0.00 USD) and a Per Member Per Month (PMPM) of ₱0.00 (approximately 0.00 USD) in Year 5. Cost savings were driven mainly by the savings in drug costs and hospitalizations."

Clinical • HEOR • Gastroenterology

Nutritional status in patients with neuroendocrine tumors: A single ENETS Centre of Excellence experience (ENETS 2022) - "11 patients were on sandostatin analogues (SSA) of whom 91% were on pancreatin... Patients with NETS are at risk of developing nutritional deficiencies, PEI and rising HbA1c's. This cohort would benefit from a structured laboratory list of requests according to NET type and treatment."

Clinical • Endocrine Cancer • Hematological Disorders • Neuroendocrine Tumor • Oncology • Solid Tumor

The palliative management of non-islet cell tumour hypoglycaemia with glucocorticoids and somatostatin analogues in an unresectable hepatocellular carcinoma. (PubMed, Ann R Coll Surg Engl) - "Once stabilised, the patient was discharged with NG feeds, prednisolone and a long-acting somatostatin analogue (sandostatin)...Somatostatin analogues had a useful steroid sparing role. Larger case series are warranted to clarify the management of NICTH patients with placebo-controlled studies to determine the role of somatostatin analogues."

Journal • Gastrointestinal Cancer • Hepatocellular Cancer • Hypoglycemia • Neuroendocrine Tumor • Oncology • Palliative care • Pancreatic Cancer • Solid Tumor • IGF1 • IGF2