title: Tolerability and Biological Effects of Long-Acting Octreotide in Patients With Continuous Flow Left Ventricular Assist Devices.
abstract: Patients with implanted continuous, nonpulsatile, left ventricular assist devices (LVADs) have increased the occurrence of gastrointestinal bleeding (GIB). Although the pathophysiology is multifactorial, there are few treatments beyond supportive care. Octreotide acetate is a somatostatin analog that reduces GIB in various patient populations. However, there are sparse case series that suggest octreotide acetate may reduce GIB in LVAD patients. This 10 patient, 28 week phase I study evaluated the safety and tolerability of octreotide acetate long-acting release (LAR) 20 mg depot injection every 4 weeks until week 16 after LVAD placement. Secondary aims were occurrence of GIB and measurement of vascular endothelial growth factor, fibrinogen, von Willebrand factor, and platelet aggregation across the study period. Ten patients were enrolled, and eight completed the study. The two study dropouts were not related to octreotide. None of the patients experienced side effects or safety concerns related to octreotide nor did GIB occur in the study population. Vascular endothelial growth factor levels were maintained in the reference range throughout the duration of the study. There did appear to be laboratory evidence of acquired von Willebrand syndrome, with mildly low platelet aggregation studies. In conclusion, octreotide acetate LAR 20 mg depot injection was safe and effective in this population.
authors.affiliation: From the *Division of Pulmonary and Critical Care Medicine, Virginia Commonwealth University (VCU), Richmond, Virginia; †Division of Cardiology, Pauley Heart Center, VCU, Richmond, Virginia; ‡Department of Internal Medicine, VCU, Richmond, Virginia; §Johnson Center for Critical Care and Pulmonary Research, VCU, Richmond, Virginia; and ¶Department of Pharmacotherapy and Outcomes Science, VCU, Richmond, Virginia.
authors.forename: Rajiv
authors.initials: R
authors.lastname: Malhotra
authors.forename: Keyur B
authors.initials: KB
authors.lastname: Shah
authors.forename: Raveen
authors.initials: R
authors.lastname: Chawla
authors.forename: Sammy
authors.initials: S
authors.lastname: Pedram
authors.forename: Melissa C
authors.initials: MC
authors.lastname: Smallfield
authors.forename: Anna G
authors.initials: AG
authors.lastname: Priday
authors.forename: Christine T
authors.initials: CT
authors.lastname: DeWilde
authors.forename: Donald F
authors.initials: DF
authors.lastname: Brophy
mesh_terms: D000328:Adult; D000368:Aged; D005260:Female; D006471:Gastrointestinal Hemorrhage / Q000188:drug therapy*; D006353:Heart-Assist Devices / Q000009:adverse effects*; D006801:Humans; D008297:Male; D008875:Middle Aged; D015282:Octreotide / Q000009:adverse effects / Q000627:therapeutic use*; D042461:Vascular Endothelial Growth Factor A / Q000097:blood
chemical_list: D042461:Vascular Endothelial Growth Factor A; D015282:Octreotide