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Although the patient received high doses of diazoxide, esidrex, and octreotide approximately for 2 months, hypoglycemic episodes continued. Then the patient had near-total pancreatectomy, and pathology confirmed a diffuse form of CHI. During octreotide discontinuation, the patient developed non-hypoglycemic seizures, which were controlled by re-starting the previous doses. In the light of in-vitro and in-vivo studies on anti-epileptic effects of somatostatin, the authors believed that seizures in this case have developed secondary octreotide discontinuity.

Diazoxide is the first-line medical treatment for CHI. In case of failure, a somatostatin analogue called octreotide is used. A prolonged QT interval is an unusual side effect of octreotide which can be lethal if unrecognized. These investigators reported on a day old infant who was diagnosed with CHI on the 3rd day of his life and underwent pancreatectomy due to failure of medical treatment at 8 months.

His genetic analysis revealed a compound heterozygosity for a novel missense mutation p. MetVal and a nonsense mutation p. Furthermore, at the 6th month of follow-up, a long QT 0. Thus, the long QT was considered to be secondary to octreotide medication.

The authors recommended ECG monitoring before and during octreotide treatment in order to recognize a prolonged QT interval and to prevent related complications in cases with CHI. Durmaz et al noted that hyperinsulinemic hypoglycemia HH is the commonest cause of persistent hypoglycemia in the neonatal and infancy periods. The first-line drug in the treatment of HH is diazoxide. Octreotide and glucagon can be used in patients who show no response to diazoxide. Nifedipine has been shown to be an effective treatment in a small number of patients with diazoxide-unresponsive HH.

WX who underwent a near-total pancreatectomy at 2 months of age due to a lack of response to diazoxide and octreotide treatment. Severe hypoglycemic attacks continued following surgery, while the patient was being treated with octreotide. These attacks resolved when nifedipine was introduced. While this patient responded well to nifedipine, the dosage could not be increased to 0. This patient, now aged 4 years, is receiving a combination of nifedipine and octreotide treatment.

He is under good control and shows no side effects. The authors concluded that nifedipine treatment can be started in patients with HH who showed a poor response to diazoxide and octreotide treatment. Minute et al stated that CHI due to diffuse involvement of the pancreas is a challenging and severe illness in children. Sirolimus, a mammalian target of rapamycin inhibitor, was reported to be effective in treating CHI in infants.

These investigators reported the case of an 8-year old boy affected by a severe form of CHI due to a bi-allelic heterozygous ABCC8 mutation who responded to sirolimus with a dramatic improvement in his glucose blood level regulation and quality of life, with no serious adverse events after 6 months of follow-up.

The authors concluded that this was the first report of a successful intervention in an older child. It provided a promising basis for further studies comparing sirolimus with other treatments, particularly in older children.

Crohn's Disease-Associated Refractory Diarrhea: Martelli and associates stated that diarrhea is one of the main symptoms of Crohn's disease CD. It is usually significantly improved with specific CD treatments, loperamide or cholestyramine. However, in some cases, diarrhea becomes refractory. In an uncontrolled, open-label study, these researchers evaluated the safety and effectiveness of octreotide in this situation.

A total of 15 patients with CD refractory diarrhea defined by at least an average of 5 smooth or liquid stools per day despite an optimized CD treatment were included from 3 Belgian centers; 2 patients were lost to follow-up. The primary end-point was to assess the effect on the mean number of smooth or liquid stools per day. The authors concluded that octreotide appeared safe and effective in CD refractory diarrhea, in addition to CD treatments.

These preliminary findings need to be validated by well-designed studies. Patel and colleagues stated that hyponatremia in the setting of cirrhosis is a common electrolyte disorder with few therapeutic options. The free water retention is due to non-osmotic vasopressin secretion resulting from the cirrhosis-associated splanchnic vasodilatation. Thus, vaso-constrictive therapy may correct this electrolyte abnormality.

In an observational study, these researchers evaluated effectiveness of midodrine and octreotide as a therapeutic approach to increasing urinary electrolyte-free water clearance EFWC in the correction of cirrhosis-associated hyponatremia. This trial consisted of 10 patients with cirrhosis-associated hyponatremia; hypovolemia was ruled out as the cause of the hyponatremia with a hour albumin challenge 25 g IV q6 h.

These investigators assessed urinary EFWC and serum sodium concentration before and 72 hours after treatment. The authors concluded that these findings showed a statistically significant increase in serum sodium concentration and urinary EFWC with the use of midodrine and octreotide in the treatment of cirrhosis-associated hyponatremia. Moreover, they stated that larger RCTs are needed to validate these observations that treatment with midodrine and octreotide can improve cirrhosis-associated hyponatremia.

This study had several drawbacks: Gastrointestinal Bleeding from Vascular Malformations: These investigators provided an up-to-date review on the use of octreotide in bleeding from both hereditary and acquired vascular malformations of the GI tract. They performed a systematic literature search using the keywords "gastrointestinal vascular malformation", "octreotide", "angiodysplasia", "portal hypertensive gastropathy", "gastric antral vascular ectasia", and "hereditary vascular malformations".

In the setting of difficult-to-treat patients, octreotide has been proposed as an alternative therapeutic strategy. Studies reported in the literature showed octreotide to be safe and effective, 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.

The authors concluded that 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 therapeutic option for patients without available alternatives. Lymphorrhea Reduction in Gynecological Malignancies: Weinberger and co-workers stated that the effect of octreotide on lymphorrhea reduction in gynecological malignancies has only been examined in case studies.

In there was a prospective, randomized, single-institution study. Patients underwent surgery including pelvic or pelvic and para-aortic lymphadenectomy for cervical, uterine and ovarian cancers. In follow up period, within 1 year after surgery, these investigators searched for lymphocele, lymph-edema of lower extremities and lymphatic ascites in relation to lymphorrhea. A total of 44 patients 9 cervical, 19 endometrial and 16 ovarian cancers were enrolled in 2 statistically comparable randomized groups.

The authors concluded that octreotide did not reduce lymphorrhea and the incidence of lymphocele, lymphedema of lower extremities and lymphatic ascites within 1 year of follow-up period after surgery. Ovejero and colleagues noted that tumor-induced osteomalacia TIO is a rare paraneoplastic syndrome in which unregulated hyper-secretion of fibroblast growth factor 23 FGF23 by phosphaturic mesenchymal tumors PMT causes renal phosphate wasting, hypophosphatemia, and osteomalacia.

The resulting mineral homeostasis abnormalities and skeletal manifestations can be reversed with surgical resection of the tumor. Unfortunately, PMTs are often difficult to locate, and medical treatment with oral phosphate and vitamin D analogs is either insufficient to manage the disease or not tolerated.

Octreotide's effects were examined by comparing group means of the biochemical parameters at each time-point to mean baseline values. Somatuline Depot Lanreotide is an octapeptide analog of natural somatostatin. The mechanism of action is believed to be similar to that of natural somatostatin. Somatuline Depot lanreotide is indicated for: After three months, dosage may be adjusted as follows: Lanreotide may reduce gallbladder motility and lead to a gallstone formation therefore, patients may need to be monitored periodically.

Patients treated with lanreotide may experience hypoglycemia or hyperglycemia. Blood glucose levels should be monitored when lanreotide treatment is initiated or when the dose is altered, and antidiabetic treatment should be adjusted accordingly. Decrease in heart rate may occur. Samonakis et al noted that somatostatin SST acts as an inhibitory peptide of various secretory and proliferative processes.

Apart from neuroendocrine tumors, where SST analogs have an established role, they have been tested in other tumors such as hepatocellular carcinoma HCC. Several positive reports have been published. A usual misunderstanding in trial designs is that, although SST is not a rescue drug, selection of patients is inappropriate, with mostly moribund patients being recruited.

Mitsogiannis and colleagues stated that despite initial sensitivity to hormone treatment, prostate cancer eventually progresses to a castration-resistant stage CRPC , which carries an ominous prognosis. Lanreotide has been shown to be highly effective in treating various hyper-secretory disorders and tumors.

It has been given to patients with CRPC within a novel treatment concept, with the aim of targeting not only cancer cells but also various factors secreted in the tumor cell milieu that confer protection from apoptosis. Within this concept, lanreotide has been administered as part of the "anti-survival factor therapy" in combination with dexamethasone and a gonadotropin releasing hormone GnRH analog.

It has also been given combined with estrogens in patients with CRPC. The so far published series have documented a clinical response in many patients treated along with significant improvement in parameters related to quality of life.

Volumes of kidney structures were evaluated by a 2-slice computed tomography CT scanner; while glomerular filtration rate GFR was estimated by iohexol plasma clearance. The "parenchymal" volume non-significantly increased by 2. The GFR did not change significantly during both treatment periods. This may reflect an inhibited growth in particular of smallest cysts beyond the detection threshold of CT scan evaluation.

Whether this effect may prove reno-protective in the long-term should be tested in additional trials of longer duration. Edelstein noted that ADPKD is the most common life-threatening hereditary disease in the United States and causes end-stage renal failure requiring dialysis and renal transplantation. However, there are now multiple clinical trials testing a host of therapeutic interventions in children and adults with ADPKD.

These researchers randomly assigned 42 patients in a 2: The primary end point was percent change in liver volume from baseline to 1 year, measured by MRI. Secondary end points were changes in total kidney volume, GFR, quality of life, safety, vital signs, and clinical laboratory tests. Liver volume decreased by 4. Changes in GFR were similar in both groups. Octreotide was well-tolerated; treated individuals reported an improved perception of bodily pain and physical activity.

The authors concluded that octreotide slowed the progressive increase in liver volume and total kidney volume, improved health perception among patients with PLD, and had an acceptable side effect profile. Hutchinson et al described a case of obscure gastrointestinal bleeding in a male with non-cirrhotic portal hypertension who required multiple admissions and repeated blood transfusions over a 5-month period.

Upper and lower gastrointestinal endoscopy failed to establish a cause for bleeding, which was eventually ascribed to universal portal hypertensive stigmata in stomach, small bowel and colon, which were not amenable to endoscopic therapy.

On account of extensive venous thrombosis, neither surgical shunting nor interventional radiology was an option. Initial management with prothrombotic agents failed. This patient was successfully stabilized on long-acting somatostatin SMS analog therapy using lanreotide, resulting in avoidance of further admissions and blood transfusion and restoration of his independence and quality of life.

The use of short-acting SMS analogs is recognized in acute variceal hemorrhage secondary to portal hypertension in cirrhosis, and long-acting SMS analog therapy has been described in obscure gastrointestinal bleeding though secondary to angiodysplasia.

However, the potential role of long-term SMS analogs in non-cirrhotic portal hypertensive bleeding of this type has not been reported earlier. This case supports its use in this scenario in the absence of surgical options and when only palliative approaches are available. Brown et al reviewed pooled clinical response rates from prospective studies using somatostatin analogs for prevention of recurrent bleeding from gastrointestinal angiodysplasia and quantified the effects that therapy has on the use of blood transfusions.

These investigators searched several electronic databases including PubMed for full journal articles published after reporting on the use of somatostatin analogs in the treatment of gastrointestinal angiodyplasia.

They hand searched the reference lists of all retrieved articles. Heterogeneity between the studies was assessed using the I2 statistic. The proportional meta-analysis showed a clinical response to treatment of 0. The weighted MD in transfusion requirements before starting therapy control group and after treatment initiation treatment group was No significant heterogeneity was seen between the studies.

They stated that, however, as all the included studies had small sample sizes, multi-center randomized trials are needed to confirm these findings. In a Cochrane review, Gurusamy et al examined if prophylactic somatostatin analogs should be used routinely in pancreatic surgery.

They included randomized controlled trials comparing prophylactic somatostatin or one of its analogs versus no drug or placebo during pancreatic surgery irrespective of language or publication status. Two authors independently assessed trials for inclusion and independently extracted data.

They analyzed data with both the fixed-effect and the random-effects models using Review Manager RevMan. The overall number of patients with post-operative complications was lower in the somatostatin analog group RR 0.

The incidence of pancreatic fistula was lower in the somatostatin analog group RR 0. The proportion of these fistulas that were clinically significant was not mentioned in most trials. On inclusion of trials that clearly distinguished clinically significant fistulas, there was no difference between the two groups RR 0.

Subgroup analysis revealed a shorter hospital stay in the somatostatin analog group than the controls for patients with malignant etiology MD The authors concluded that somatostatin analogs reduce peri-operative complications but do not reduce peri-operative mortality. In those undergoing pancreatic surgery for malignancy, they shorten hospital stay. Further adequately powered trials with low risk of bias are necessary.

Based on the current available evidence, the authors recommended somatostatin and its analogs for routine use in patients undergoing pancreatic resection for malignancy. There is currently no evidence to support their routine use in pancreatic surgeries performed for other indications. O'Toole and colleagues stated that the somatostatin analogs lanreotide and octreotide have previously been shown to be effective in controlling flushing and diarrhea in patients with carcinoid syndrome.

A total of 33 patients with carcinoid syndrome were included in an open, multi-center, cross-over study. Quality-of-life assessments were performed at each visit and patient preference for one of the two treatments evaluated.

The number and intensity of flushing episodes and bowel movements, urinary 5- hydroxy indole acetic acid 5-HIAA levels, and plasma serotonin levels were recorded. No significant differences were found between lanreotide and octreotide in terms of quality-of- life. Disappearance or improvement in flushes occurred in A disappearance or improvement of diarrhea in Lanreotide and octreotide were equally effective in reducing urinary 5-HIAA levels and plasma serotonin levels.

The authors concluded that lanreotide and octreotide are equally efficacious in terms of symptom control and reduction in tumor cell markers for patients with carcinoid syndrome. Due to its simplified mode of administration, most patients prefer treatment with lanreotide. In a 6-month, open, non-controlled, multi-center, dose-titration study, Ruszniewski et al evaluated the efficacy and safety of day prolonged-release PR lanreotide in the treatment of carcinoid syndrome.

Six treatments of day PR lanreotide were administered by deep subcutaneous injection. Subsequent doses could be titrated 60, 90, mg according to symptom response. A total of 71 patients were treated. Flushing decreased from a mean of 3. Diarrhea decreased from a mean of 5. Symptom frequency decreased further after the second and third injections, and reached a plateau after the 4rth injection. By month 6, flushing and diarrhea had significantly decreased from baseline by a mean of 1.

Treatment was well-tolerated; day PR lanreotide was effective in reducing the symptoms and biochemical markers associated with carcinoid syndrome. Khan et al presented long-term results of prolonged release lanreotide in a large cohort of patients with malignant carcinoid syndrome, assessing clinical and objective response and tolerance.

A total of 76 patients with metastatic midgut neuroendocrine tumors and carcinoid syndrome were included in this 9-year retrospective study. Eleven patients who were switched from octreotide LAR had return of symptomatic control. No significant adverse effects were experienced. The authors concluded that prolonged release lanreotide provides good symptomatic control of diarrhea and flushing as well as tumor stability in patients with malignant carcinoid syndrome. Also, an UpToDate review on "Treatment of the carcinoid syndrome" Goldfinger and Strosberg, states that "[w]e usually begin therapy with octreotide LAR 20 to 30 mg every four weeks.

Depot lanreotide is another alternative to octreotide LAR". Meningiomas - Treatment for surgically inaccessible recurrent or progressive meningiomas when further radiation is not possible. Lung neuroendocrine tumors - Consider for stage IIIb T4 due to multiple lung nodules -IV if octreotide scan positive or for symptoms of carcinoid syndrome.

Neuroendocrine tumors of the adrenal gland - Consider for symptom control if somatostatin scintigraphy positive in patients with non-adrenocorticotropic hormone-dependent Cushing's syndrome with tumors less than 4 cm, benign imaging characteristics, and abnormal contralateral gland and symmetric cortisol production.

Neuroendocrine tumors of the gastrointestinal tract, lung, and thymus Treatment of underlying Zollinger-Ellison syndrome. Neuroendocrine tumors of the pancreas Treatment of symptoms related to hormone hypersecretion. Thymomas and thymic carcinomas - Second-line therapy with or without prednisone following radiation therapy for locally advanced unresectable disease short-acting octreotide only.

Lanreotide has a similar mechanism of action as octreotide and may be preferable in patients who have difficulty tolerating an intramuscular IM versus subcutaneous SC injection.

Maximal reductions in growth-hormone levels may not be seen for years after institution of radiotherapy, during which time medical therapy may continue to be required. One series evaluated 73 patients treated with octreotide 50 to micrograms given subcutaneously two or three times daily , most of whom had already undergone surgery …. The most appropriate therapy for patients with TSH-secreting pituitary adenomas is transsphenoidal resection of the tumor.

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Somatostatin Analogs

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