Summary
Synopsis
Octreotide is an analogue of somatostatin. Like endogenous somatostatin, it exerts a potent inhibitory effect on the release of anterior pituitary growth hormone and thyroid-stimulating hormone, and peptides of the gastroenteropancreatic endocrine system, while overcoming some of the shortcomings of exogenously administered somatostatin, namely a short duration of action, a need for intravenous administration and postinfusion rebound hypersecretion of hormone.
Clinical studies have shown that octreotide is effective in the treatment of acromegaly and thyrotrophinomas. In comparative trials octreotide was significantly superior to bromocriptine in patients with acromegaly. Octreotide also appears to provide a significant advantage over existing therapies in the management of the carcinoid syndrome and offers considerable therapeutic potential in reversing carcinoid crises which may be life- threatening. Trials in patients with tumours producing vasoactive intestinal peptide demonstrated that octreotide may be an effective first-line choice for this condition, which has usually metastasised and become refractory to traditional symptomatic therapy. In limited studies in patients with high-output secretory diarrhoea, including cryptosporidium-related diarrhoea associated with AIDS and in patients with small bowel fistulas, octreotide has been shown to be effective in reducing stool/fistula output. However, well-designed clinical trials are still required to confirm its long term usefulness in these disorders. Similarly, although the use of octreotide in other conditions such as neonatal hypoglycaemia caused by nesidioblastosis, reactive pancreatitis, insulin- dependent diabetes mellitus, postprandial hypotension and the dumping syndrome has provided encouraging preliminary results, more studies are needed to clarify the place of octreotide in their treatment.
Overall, octreotide appears to be well tolerated with the most frequently reported reactions being pain at the site of injection and gastrointestinal symptoms such as abdominal cramps, nausea, bloating, flatulence, diarrhoea and steatorrhoea. These adverse effects usually abate with time. Additionally, octreotide, like endogenous somatostatin, may also result in cholelithiasis, presumably by altering fat absorption and possibly by decreasing motility of the gallbladder.
Thus, octreotide represents a new departure from traditional therapies in the treatment of various pathophysiological states associated with excessive peptide production and secretion. It offers a significant advantage over existing therapies in the medical management of patients with acromegaly, thyrotrophinomas, the carcinoid syndrome, tumours producing vasoactive intestinal peptide and severe secretory diarrhoea in whom conventional management options have either become exhausted or have provided suboptimal symptomatic relief.
Pharmacodynamic Properties
Octreotide is a long acting synthetic octapeptide analogue of naturally occurring somatostatin which suppresses secretion of anterior pituitary growth hormone and thyroid-stimulating hormone, in addition to a wide variety of peptide hormones from the gastroenteropancreatic endocrine system. Glucagon, gastric inhibitory, peptide, pancreatic polypeptide and motilin are the most sensitive to the inhibitory action of octreotide while gastrin is the least affected.
Various animal models have demonstrated that octreotide is highly resistant to enzymatic degradation and that it selectively inhibits growth hormone secretion more powerfully than it does insulin secretion. In healthy subjects octreotide produces a mild transient postprandial hyperglycaemic action, probably related to the postprandial suppression of insulin release. This suppression appears to override the other actions of octreotide (namely glucagon suppression and delayed nutrient absorption) which would tend to improve glucose tolerance.
Results from studies in patients with acromegaly generally confirm the effects of octreotide on growth hormone secretion in normal volunteers, with octreotide producing a potent and prolonged inhibitory effect. Octreotide 50µg appears to provide maximal inhibition although there is evidence that a higher dose (100µg) causes a prolongation of the period of inhibition. Additionally, no rebound hypersecretion of growth hormone is observed when the suppressive effect of octreotide has worn off. Single-dose studies comparing the growth hormone-inhibitory effects of octreotide and bromocriptine in patients with acromegaly clearly demonstrate significantly greater growth hormone-lowering activity for octreotide. Moreover, the combination of these 2 agents significantly inhibited growth hormone release in patients not responding to either drug administered separately.
Octreotide produces a clear symptomatic improvement in flushing episodes and diarrhoea with a concomitant significant reduction in serotonin levels in patients with carcinoid tumours. Furthermore, the reduction in urinary excretion of 5-hydroxyindole acetic acid (a metabolite of serotonin) in such patients following octreotide administration appears to be dose related. Significant octreotide-induced suppression of postprandial pancreatic polypeptide, gastric inhibitory peptide and insulin release confirm earlier findings reported in healthy volunteers.
Administration of octreotide to patients with vasoactive intestinal peptide-producing tumours rapidly controls secretory diarrhoea and causes a marked reduction in mean plasma vasoactive intestinal peptide levels, although these values still remains well above the upper limit of normal. This discrepancy between symptomatic relief and hormone response may be explained by the presence of larger, possibly less biologically active, forms of circulating vasoactive intestinal peptide during octreotide therapy.
Results from intestinal perfusion studies suggest that the octreotide-induced increases in fluid and electrolyte absorption from the jejunum and ileum may be associated with a direct action of octreotide on intestinal fluid, pancreatic fluid and electrolyte transport, or a secondary response to a reduction in the release of vasoactive intestinal peptide and other peptides from the tumour mass. Short term studies performed in patients with glucagonomas have demonstrated that octreotide dramatically reduces elevated plasma glucagon levels and produces rapid symptomatic improvement in the necrolytic migratory erythema associated with this syndrome. Similarly, plasma gastrin levels and basal acid output are rapidly suppressed, usually to within normal limits, following octreotide administration to patients with gastrinomas. Sustained improvement in hypoglycaemia in association with a marked increase in plasma glucose levels have been reported in patients with insulinomas who were administered single doses of octreotide. Changes in plasma insulin concentrations, however, have been equivocal.
Pharmacokinetic Studies
While additional well-designed studies involving larger numbers of volunteers and patients are required for a better understanding of the pharmacokinetic profile of octreotide, published reports have shown that following subcutaneous administration octreotide is rapidly and completely absorbed, with peak plasma concentrations occurring between 30 minutes and 1 hour. Peak plasma concentrations and areas under the plasma concentration-time curves (AUCs) appear to increase in direct proportion to dosage after both intravenous and subcutaneous administration of octreotide.
Using the equation for a 2-compartment model the volume of distribution of octreotide in healthy volunteers ranged from 18.1 to 30.4L following intravenous administration.
Preliminary reports suggest that octreotide is extensively metabolised in the liver with up to 30 to 40% hepatic extraction in healthy subjects. Approximately 11% of parent drug is recovered from the urine and less than 2% from faeces in all species tested. The plasma elimination half-life of octreotide ranged from 72 to 113 minutes in most studies with a total body clearance of approximately 11.4 L/h. Since pharmacokinetic data from patients with liver disease are not available, octreotide should be used with caution in such patients given the importance of metabolic routes in its elimination.
Therapeutic Trials
Pituitary and gut neuroendocrine tumours are rare and consequently a large proportion of published data consist of case reports involving small numbers of patients with various syndromes. Accordingly, the findings of these various trials should be interpreted carefully bearing in mind the methodological difficulties in drawing conclusions from a collection of case reports.
In a short term placebo-controlled study subcutaneous octreotide 50 to 100µg 3 times daily effectively reduced plasma growth hormone levels in 4 of 5 patients with acromegaly although this effect was sustained only in those patients with the lowest basal growth hormone levels. Indeed, it appears that long term therapy is more likely to be effective in patients with a relatively low basal plasma growth hormone levels (15 µg/L)- Many long term non-comparative studies show octreotide up to 1500 µg/day administered for periods of up to 27 months to be effective in acromegaly as assessed by an improvement in clinical signs and symptoms, suppression of circulating somatomedin C and mean 24-hour growth hormone levels, and a slight decrease (20 to 30%) in pituitary tumour size observed in approximately 30 to 50% of patients. Short term comparative trials have demonstrated that octreotide produces a more rapid and powerful reduction of growth hormone than does bromocriptine, with combined therapy suppressing plasma growth hormone levels in patients unresponsive to either drug administered alone. These findings were confirmed in long term comparative studies of up to 12 months’ duration.
Octreotide ( 100 to 1500 µg/day) for periods of up to 16 months effectively controlled thyrotrophin-induced hyperthyroidism (as estimated by reductions in serum thyrotrophin and α-subunit secretion) in non-comparative trials involving patients with thyrotrophinomas.
Studies in patients with the carcinoid syndrome have shown that octreotide 100 to 600 µg/day for up to 18 months’ duration clearly improved symptoms (flushing and/or diarrhoea) and reduced 24-hour urinary 5-hydroxyindole acetic acid excretion (an objective marker of disease activity). Additionally, several case reports documented prompt reversal of the potentially lethal carcinoid crises by intravenous or intra-arterial administration of octreotide.
A dramatic and immediate reduction in diarrhoea was reported in patients with tumours producing vasoactive intestinal peptide following administration of octreotide 50 to 1500 µg/day for up to 38 months in many non-comparative trials. This rapid symptomatic improvement was accompanied by a marked reduction in plasma vasoactive intestinal peptide levels in the majority of patients although those effects were sometimes only temporary despite increasing the dose of octreotide to 1500 µg/day. Octreotide has also been shown to improve electrolyte and water imbalances in these patients, often without the need for oral or intravenous fluid and electrolyte supplementation. Importantly, the quality of life of such patients was greatly improved with octreotide with removal of the significant social handicap of profuse and uncontrollable diarrhoea.
In a number of case reports involving patients with metastatic growth hormone releasing hormone-secreting tumours, octreotide 100 to 500 µg/day for up to 12 months effectively reduced plasma growth hormone-releasing hormone and growth hormone levels in addition to producing a clear improvement in symptoms (excessive perspiration, fatigue and paraesthesias). Patients with glucagonomas treated with octreotide 50 to 450 µg/day for up to 30 months usually experienced rapid resolution of rash and reduction in elevated plasma glucagon levels. Recurrences of the rash during continued treatment with octreotide responded to an increase in dosage. Similarly, octreotide in dosages of up to 1500 µg/day improved primary symptoms, and suppressed plasma gastrin levels and gastric acid secretion in the majority of patients with gastrinomas. Indeed, in 1 study ranitidine dosage was reduced by 25 and 50% in 2 patients. Nevertheless, severe rebound hypergastrinaemia was observed by a number of investigators when octreotide therapy was discontinued.
Data from studies evaluating the efficacy of octreotide in the symptomatic treatment of patients with insulinomas indicated that octreotide 100 to 1500 µg/day for up to 15 months elevated plasma glucose levels in most patients with moderately high plasma insulin concentrations (< 50 mU/L). Sustained symptomatic improvement was often achieved despite plasma insulin levels remaining elevated in some patients. However, in patients with grossly elevated insulin levels (> 100 mU/L) results were not encouraging, with hypoglycaemia either not improving or becoming worse.
In a randomised blind crossover study involving patients with postoperative small bowel fistulas octreotide 225 to 300 µg/day significantly reduced fistula output compared with placebo, while other comparative studies found that subcutaneous octreotide up to 400 µg/day was at least as efficacious as intravenous somatostatin in treating patients with external pancreatic fistulas. Case reports of patients with severe refractory secretory diarrhoea demonstrated that octreotide in doses of up to 600 µg/day for 1 to 9 months dramatically reduced stool/ileostomy output compared with baseline values, enabling withdrawal of parenteral nutrition in some instances. Furthermore, a few case reports have shown that octreotide (usually 600 to 900 µg/day) for periods of up to 8 months dramatically reduced stool volume and frequency in patients with cryptosporidium-related diarrhoea associated with the acquired immunodeficiency syndrome.
Despite encouraging results, clinical evaluation of octreotide in other therapeutic areas, such as upper gastrointestinal bleeding, neonatal hypoglycaemia caused by nesidioblastosis, reactive pancreatitis, insulin-dependent diabetes mellitus, postprandial hypotension and the dumping syndrome, has been of a preliminary nature. Firm conclusions regarding the usefulness of octreotide in these areas await further research.
Adverse Effects
Overall, octreotide has been well tolerated in studies reported to date, albeit in relatively small numbers of patients. The most frequently reported adverse effects include pain at the site of injection and gastrointestinal symptoms such as abdominal cramps, nausea, bloating, flatulence, diarrhoea and steatorrhoea. Such symptoms abate with time, and those associated with the gastrointestinal tract may be alleviated by avoiding administration of octreotide at meal times.
Octreotide suppresses insulin and glucagon release and this has the potential to significantly affect glycaemic metabolic control. Indeed, oral hypoglycaemic drug therapy needed to be instituted in 2 patients who developed type II diabetes mellitus whilst on long term treatment with octreotide. Furthermore, caution should be exercised if octreotide is to be administered to patients being treated with drugs to control episodes of hypoglycaemia. In patients with insulinomas, octreotide occasionally exacerbated hypoglycaemia and careful monitoring of such patients seems warranted.
Dosage and Administration
Octreotide dosage should be adjusted to meet the specific needs of the individual. Usually treatment is intiated at a dosage of 50µg twice daily between meals, administered subcutaneously, and then titrated upwards until optimal relief is obtained. Clinical signs and symptoms associated with acromegaly and endocrine tumours of the gastroenteropancreatic system have generally responded to subcutaneous octreotide 100 to 450 µg/day in 2 or 3 divided doses, although doses as high as 1500 µg/day have been required in some patients. In instances where a gradual reduction in sensitivity to octreotide occurs, it would seem prudent to gradually increase the dose according to the symptomatic response of the patient rather than the inhibitory effect of octreotide on tumoural hormone secretion.
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Various sections of the manuscript reviewed by: S. Bonfilo, Unité de Recherches de Gastro-Entérologie, Hôpital Bichat, Paris, France; K. Hanew, Tohoku University School of Medicine, Sendai, Japan; R. Horikawa, National Children’s Medical Research Center, Tokyo, Japan; S. Longnecker, Department of Pharmacy Services, Westmoreland Hospital, Philadelphia, USA; F. Muggia, Kenneth Norris Jr. Comprehensive Cancer Center, University of Southern California, Los Angeles, California, USA; T. O’Dorisio, Department of Internal Medicine, Ohio State University College of Medicine, Columbus, Ohio, USA; P. Rosen, Kenneth Norris Jr. Comprehensive Cancer Center, University of Southern California, Los Angeles, California, USA; J. Souquet, Hôpitaux de Lyon, Lyon, France; G. Tolis, Ippokration Hospital, Athens, Greece; J. Wass, Department of Endocrinology Medical College of St. Bartholomew’s Hospital, London, England
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Battershill, P.E., Clissold, S.P. Octreotide. Drugs 38, 658–702 (1989). https://doi.org/10.2165/00003495-198938050-00002
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DOI: https://doi.org/10.2165/00003495-198938050-00002