Safety Of Octreotide Research Articles

Gastrointestinal bleeding from vascular malformations: Is octreotide effective to rescue difficult-to-treat patients?

Gastrointestinal vascular malformations are responsible for 2-8% of all cases of bleeding and 30-40% of all obscure hemorrhages, being the most frequent cause of occult bleeding in older people. The aim of this review was to provide an up-to-date report about the use of octreotide in bleeding from both hereditary and acquired vascular malformations of the gastrointestinal tract. A systematic literature search was performed, using the keywords "gastrointestinal vascular malformation", "octreotide", "angiodysplasia", "portal hypertensive gastropathy", "gastric antral vascular ectasia", and "hereditary vascular malformations". The first line therapy of acute/chronic bleeding from digestive vascular malformations is endoscopy, followed by angiographic embolization and surgical resection when this is unsuccessful. In the setting of difficult-to-treat patients, octreotide has been proposed as an alternative therapeutic strategy. Studies reported in the literature show a high efficacy and safety of octreotide, but described only a small number of enrolled patients, heterogeneous therapeutic schedules and short-term follow-up, with the exception of acute bleeding from esophageal varices. As a consequence, the use of octreotide is not approved in this setting and it is currently still prescribed as an off-label drug. Studies in larger populations are needed to confirm the promising results observed in the small case series reports, so as to provide physicians with a treatment option for patients without available alternatives. Octreotide could also determine a strong decrease in the management costs of these clinical conditions, and especially, could dramatically reduce hospital admission costs.

Safety of octreotide in hospitalized infants

BackgroundOctreotide is used off-label in infants for treatment of chylothorax, congenital hyperinsulinism, and gastrointestinal bleeding. The safety profile of octreotide in hospitalized infants has not been described; we sought to fill this information gap. MethodsWe identified all infants exposed to at least 1 dose of octreotide from a cohort of 887,855 infants discharged from 333 neonatal intensive care units managed by the Pediatrix Medical Group between 1997 and 2012. We collected laboratory and clinical information while infants were exposed to octreotide and described the frequency of baseline diagnoses, laboratory abnormalities, and clinical adverse events (AEs). ResultsA total of 428 infants received 490 courses of octreotide. The diagnoses most commonly associated with octreotide use were chylothorax (50%), pleural effusion (32%), and hypoglycemia (22%). The most common laboratory AEs that occurred during exposure to octreotide were thrombocytopenia (47/1000infant-days), hyperkalemia (21/1000infant-days), and leukocytosis (20/1000infant-days). Hyperglycemia occurred in 1/1000infant-days and hypoglycemia in 3/1000infant-days. Hypotension requiring pressors (12%) was the most common clinical AE that occurred during exposure to octreotide. Necrotizing enterocolitis was observed in 9/490 (2%) courses, and death occurred in 11 (3%) infants during octreotide administration. ConclusionRelatively few AEs occurred during off-label use of octreotide in this cohort of infants. Additional studies are needed to further evaluate the safety, dosing, and efficacy of this medication in infants.

Octreotide for primary moderate to severe acute pancreatitis: A meta-analysis.

To systematically evaluate the effect and safety of octreotide on primary moderate to severe acute pancreatitis.The Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library, PubMed, EMBASE, Science Citation Index Expanded (SCI-E), and Chinese Biomedicine Database (CBM) were searched in September 2011. Major outcomes contained mortality, incidence rate of complications, rate of surgical intervention, and length of hospital stay.Eleven randomized clinical trials with 720 participants were included and evaluated, only two of which had a high study quality and were combined in meta-analysis. The pool estimate of RR of mortality was 0.88 (95% CI: 0.53, 1.45) and that of incidence rate of complication was 1.08 (95% CI: 0.94, 1.26), both of which had no significant difference. The other two outcomes could not be combined for lack of enough data.Present evidence does not approve octreotide's benefit in the major outcomes of moderate to severe acute pancreatitis and further randomized controlled trials with high quality and large sample size are required.

Evaluation of the Use and Safety of Octreotide as Antidotal Therapy for Sulfonylurea Overdose in Children

The objectives of this study were to evaluate the effect of octreotide on number of hypoglycemic episodes and blood glucose concentrations (BGCs) in a case series of young children who received octreotide for treatment of sulfonylurea-induced hypoglycemia and to identify the frequency of adverse effects associated with octreotide's use for this indication. A retrospective review of 9 years of National Poison Data System pediatric sulfonylurea overdoses treated with octreotide was conducted. Inclusion criteria were age younger than 6 years with acute sulfonylurea overdose managed in a health care facility. Redacted poison center charts were obtained, and data on pretreatment and posttreatment number of hypoglycemic episodes and BGCs as well as medical outcomes and adverse reactions were extracted and analyzed. There were 121 octreotide cases. Patients experienced a median of 2.0 and 0.0 hypoglycemic episodes before and after treatment, respectively (P < 0.0001). The median lowest BGC was significantly higher after octreotide administration (P < 0.001). In 73% of children, only 1 dose of octreotide was given. Hyperglycemia was noted in 3 children who also received dextrose in whom adverse effects to therapy were coded. Octreotide administration decreases number of hypoglycemic events and increases BGCs. The majority of children who receive octreotide require only 1 dose. There were no adverse effects documented in these children who received octreotide as an antidote for sulfonylurea-induced hypoglycemia.

Octreotide acetate is efficacious and safe in children for treating diarrhea due to chemotherapy but not acute graft versus host disease

The Common Toxicity Criteria of the National Cancer Institute evaluates diarrhea as an adverse event of chemotherapy administration. Acute graft versus host disease (aGVHD) causes diarrhea in allogeneic hematopoietic stem cell transplant patients. Guidelines for treating grade 3 and 4 chemotherapy induced diarrhea (CID) include octreotide acetate, a somatostatin analogue. These recommendations are based on adult octreotide trials. Data on octreotide use for treatment of CID in pediatric oncology patients are limited. This study evaluated the efficacy and safety of octreotide in the treatment of CID or aGVHD induced diarrhea in pediatric patients. This is a retrospective review of 34 patients of average age 6 years who received octreotide between 1994 and 2008 for treatment of CID or aGVHD induced diarrhea. Thirty-eight courses of intravenous octreotide were administered. A complete response was achieved during 25/27 (92%) CID and 5/11 (45%) aGVHD induced diarrhea courses. A partial response was achieved during 4/38 courses, all in the aGVHD induced diarrhea group. No response was observed for 3 of the aGVHD induced diarrhea courses and 1 for the CID course. Octreotide was initiated at 2 mcg/kg/day and increased to a maximum of 9 mcg/kg/day. The mean total duration of treatment was 9 days. Common adverse effects observed were hyperglycemia, hyberbilirubinemia, nausea/vomiting, and abdominal cramping. In pediatric patients, octreotide exhibits 92% efficacy in treating CID and 45% efficacy in aGVHD induced diarrhea. Further studies to better characterize the starting dose and dose escalation algorithm for treating CID in children are required.

Octreotide for the treatment of chylothorax in neonates

Routine care for chylothorax in neonate includes either conservative or surgical approaches. Octreotide, a somatostatin analogue, has been used for the management of patients with refractory chylothorax not responding to conservative management. To assess the efficacy and safety of octreotide in the treatment of chylothorax in neonates. We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library), MEDLINE and EMBASE (to March 7, 2010). We assessed the reference lists of identified trials and abstracts from the annual meetings of the Pediatric Academic Societies published in Pediatric Research (2002 to 2009) without language restrictions. We planned to include randomised or quasi-randomised controlled trials of octreotide in the treatment of congenital or acquired chylothorax in term or preterm neonates, with any dose, duration or route of administration. Data on primary (amount of fluid drainage, respiratory support, mortality) and secondary outcomes (side effects) were planned to be collected and analysed using mean difference, relative risk and risk difference with 95% confidence intervals. No randomised controlled trials were identified. Nineteen case reports of 20 neonates with chylothorax in whom octreotide was used either subcutaneously or intravenously were identified. Fourteen case reports described successful use (resolution of chylothorax), four reported failure (no resolution) and one reported equivocal results following use of octreotide. The timing of initiation, dose, duration and frequency of doses varied markedly. Gastrointestinal intolerance and clinical presentations suggestive of necrotizing enterocolitis and transient hypothyroidism were reported as side effects. No practice recommendation can be made based on the evidence identified in this review. A prospective registry of chylothorax patients and a subsequent multicenter randomised controlled trial are needed to assess the safety and efficacy of octreotide in the treatment of chylothorax in neonates.

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Soporte nutricional y tratamiento con octreótido del quilotórax

Patients with chylothorax present a high risk for malnourishment since continuous loss of chylo leads to a significant impairment of their nutritional status. Chylothorax treatment, which initially is conservative, includes dietary measures and medications such as octreotide that decreases chylothorax flow. In this paper we present the case of a patient with chylothorax treated by means of pleural drainage, parenteral nutrition, and octreotide, and we review the most appropriate nutritional support as well as the efficacy and safety of octreotide in chylothorax therapy. The types of nutritional intervention that may be done are a low-fat diet supplemented with intermediate-chain triglycerides (ICT), fatfree enteral nutrition or EN with a high percentage of ICT, and parenteral nutrition. There is no consensus on which is the most appropriate measure. We found very few comparative studies, and the literature is based on single cases or case series. Some authors consider parenteral nutrition as the first choice, whereas others recommend starting with a specific diet and using parenteral nutrition only in specific cases. Parenteral nutrition must cover the patient’s demands together with compensating the protein and energy losses due to chylothorax. The use of lipid emulsions is no contraindicated since they do not reach the lymphatic system. With regards to EN, the formulations may be lipid-free or with low lipid content. There is no agreement on when to start them once the drainage of chylo decreases. There are cases and case series indicating that octreotide use in chylothorax seems to be safe and effective. There is no consensus on when to start the therapy, the most appropriate dose, or the time to withdraw the treatment.

Clinical Efficacy and Safety of Octreotide (SMS201-995) in Terminally Ill Japanese Cancer Patients with Malignant Bowel Obstruction

In patients with advanced cancer, malignant bowel obstruction (MBO) causes gastrointestinal symptoms such as nausea and vomiting leading to severely impaired oral food intake. Thus, MBO markedly diminishes the quality of life (QOL) of these patients because placement of a nasogastric tube becomes necessary. Many studies have shown that octreotide (SMS201-995; SMS), a synthetic analog of somatostatin, is effective for controlling the symptoms of MBO. This study was conducted to assess the efficacy and safety of 300-microg/day initial dose of SMS in Japanese patients with MBO and to investigate the clinical benefit of patients achieved by the improvement of nausea/vomiting based on subjective assessment. The subjects were patients with MBO that was refractory to other medical treatment and who had suffered at least two vomiting episodes per day for two consecutive days or had required a nasogastric tube. After enrollment, patients received SMS (300 microg/day) subcutaneously as a continuous injection for 6 days. Patients who responded to this 6-day course of treatment continued to receive the drug. Among 25 patients who were enrolled, 11 (44.0%) responded to treatment with resolution or improvement of nausea/vomiting. Their symptomatic improvement was assessed by quantitatively measuring the level of control of nausea/vomiting and by using a self-administered QOL questionnaire that evaluated the frequency and severity of nausea/vomiting, the proportion of patients enjoying recreational activities and the overall patient satisfaction with the therapy. SMS was well tolerated, and nausea and agitation were the only adverse events potentially related to this drug. The results of the study confirmed that the 300-microg/day dose of SMS is safe and effective for patients with MBO uncontrolled by other therapies and suggested that the relief of symptoms with nausea/vomiting by SMS could contribute to improvement of the QOL of patients.

Octreotide for Conservative Management of Postoperative Chylothorax

Postoperative chylothorax after lung resection is a major problem leading to morbidity and mortality and requiring reoperation in a large number of cases. The most advisable and least aggressive option is conservative management in progressive stages: a diet rich in medium-chain fatty acids and/or total parenteral nutrition, in addition to chest tube drainage. Including octreotide in this regimen seems to be related to a higher success rate without the need for surgery. We report a case in which the effectiveness and safety of octreotide in the resolution of postoperative chylothorax was excellent.

Efficacy of Octreotide and Sclerotherapy in the Treatment of Acute Variceal Bleeding in Cirrhotic Patients: A Prospective, Multicentric, and Randomized Clinical Trial

Background: Sclerotherapy is the most widely used method for treatment of acute variceal bleeding. Previous reports have suggested that octreotide infusion is as effective as sclerotherapy. Our aim was to investigate the efficacy and safety of octreotide in comparison with sclerotherapy in controlling variceal bleeding. Methods: Seventy-six cirrhotic patients were randomized to receive either sclerotherapy (n = 37) or octreotide (n