Vapreotide
Also known as: RC-160, RC‑160, Sanval, vapreotide acetate
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Summary
Vapreotide is an investigational somatostatin analogue administered intravenously or subcutaneously. It has been studied as an adjunct in pancreatic surgery and as a vasoactive agent for acute esophageal variceal bleeding in patients with portal hypertension. Research suggests it may lower postoperative complications after distal pancreatectomy and improve bleeding control in variceal hemorrhage, though it remains unapproved for routine clinical use.
Mechanism of Action
Vapreotide mimics the natural hormone somatostatin and binds to somatostatin receptors (SSTRs), especially SSTR2 with lower affinity for SSTR3 and SSTR5, while showing minimal interaction with SSTR1 and SSTR4. Receptor activation inhibits adenylate cyclase, reduces cyclic AMP, and suppresses secretion of gastrointestinal hormones, pancreatic enzymes, and vasoactive substances. In portal hypertension, this leads to decreased splanchnic blood flow and lower portal pressure, contributing to hemostasis during variceal bleeding.
What the Research Shows
Systematic reviews and meta‑analyses of randomized trials have examined vapreotide alongside other somatostatin analogues. In mixed pancreatic surgery cohorts, somatostatin analogues reduced overall morbidity (RR 0.71) and, specifically after distal pancreatectomy, lowered postoperative pancreatic fistula rates (RR 0.41). However, in pancreaticoduodenectomy, no significant impact on fistula formation or mortality was observed. A separate meta‑analysis of prophylactic use after pancreaticoduodenectomy found no statistically significant benefit for any grade of fistula (OR 0.73, p = 0.09). In gastro‑hepatology, early intravenous vapreotide administration during acute variceal hemorrhage improved bleeding control and reduced re‑bleeding and mortality, with few minor side effects reported. A pivotal trial and a meta‑analysis of four RCTs confirmed these benefits, but head‑to‑head comparisons with other analogues are lacking.
Reported Benefits
Evidence indicates vapreotide may decrease postoperative morbidity after distal pancreatectomy and reduce the incidence of pancreatic fistulas in that setting. In acute esophageal variceal bleeding, early intravenous dosing has been associated with better hemostasis, lower re‑bleeding rates, and reduced mortality, while being easy to administer and generally well tolerated. Minor adverse events have been reported, but serious toxicity appears uncommon in the studied populations.
Limitations of the Evidence
The surgical data are limited by small, under‑powered trials and heterogeneous study designs; benefits were not seen after pancreaticoduodenectomy, and overall conclusions remain tentative. Comparative studies versus other somatostatin analogues are absent, and the variceal bleeding literature, while promising, consists of a limited number of randomized trials. Vapreotide is still classified as investigational, and regulatory approval for any indication has not been established.
Safety Considerations
Published studies describe vapreotide as having a favorable safety profile, with side effects generally described as minor and infrequent. Reported adverse events include transient gastrointestinal discomfort, mild hyperglycemia, and occasional injection‑site reactions. No serious contraindications or organ toxicity have been documented in the limited trial data, but comprehensive safety evaluation is constrained by the modest size and duration of existing studies.
How It Is Administered
Vapreotide is supplied as an acetate formulation for intravenous or subcutaneous injection. In clinical investigations it has been given as a bolus or short infusion shortly before endoscopic therapy for variceal bleeding, and perioperatively in pancreatic surgery protocols. Dosing regimens vary across studies, and the drug is not currently approved for routine clinical use.
Routes of Administration
Goals & Uses
- Carcinoid syndrome and neuroendocrine tumorsOncologyLow
- Acromegaly managementEndocrinologyLow
- Pancreatic fistula preventionSurgeryLow
- Control of acute variceal bleedingHemostasis / GastroenterologyHigh
- Inhibition of pancreatic exocrine secretionGastrointestinalModerate
- Acute esophageal variceal bleedingGastroenterologyModerate
Contraindications
- Hypersensitivity to vapreotide or somatostatin analoguesAllergyHigh
- Hypersensitivity to vapreotide or any excipientAllergyHigh
- PregnancyPopulationModeratePotential fetal risk or insufficient safety data
Adverse Effects
- HyperglycemiaMetabolicUncommonAbnormally high blood glucose
- Hyperglycemia or hypoglycemiaMetabolic/EndocrineUncommon
- Injection site reactionsLocalCommon
- Gallstone formationHepatobiliaryUncommon
- Nausea and vomitingGastrointestinalCommon
- NauseaGastrointestinalCommonFeeling of sickness or urge to vomit
- Injection site reactionLocalCommonRedness, swelling, itching, bruising, or pain at the injection site
- BradycardiaCardiovascularUncommon
- Abdominal painGastrointestinalCommonPain or discomfort in the abdomen
Drug Interactions
- Insulin and oral hypoglycemicsModerate
- Beta-blockersModerate
- Other somatostatin analoguesLow
- CyclosporineModerate
Population Constraints
- Renal impairmentOrgan ImpairmentRelative
- Pediatric patientsAgeRelative
- Pediatric populationAgeRelative
- Patients with cholelithiasisHepatobiliaryRelative
- Elderly (>75 y)AgeRelative
- Diabetic PatientsMetabolicRelative
Regulatory Status
- European UnionUnapprovedNo marketing authorization in European Union.
- United StatesUnapprovedNot submitted for FDA approval.
- United KingdomUnapprovedNot licensed by MHRA.
Vapreotide has not received FDA or EMA approval for any indication. It has been investigated in clinical trials for esophageal variceal bleeding and acromegaly. Developed by Debio/Biomeasure; limited commercial development followed.
Evidence & Sources
- Journal ArticleHighSchorn S, et al.2020-01-01T00:00:00.000000Z
- Journal ArticleModerateFortune BE, et al.2009-01-01T00:00:00.000000Z
- Journal ArticleHighAdiamah A, et al.2019-01-01T00:00:00.000000Z
- Journal ArticleModerateShan L2004-01-01T00:00:00.000000Z
- Journal ArticleModerateCalès P2008-01-01T00:00:00.000000Z
- Journal ArticleModerateChopra A2004-01-01T00:00:00.000000Z
Frequently Asked Questions
What type of drug is vapreotide?
Vapreotide is a synthetic analogue of somatostatin that binds to somatostatin receptors, especially SSTR2, to inhibit hormone secretion and reduce splanchnic blood flow.
Has vapreotide been proven effective for preventing pancreatic fistulas?
Meta‑analyses suggest a reduction in fistula rates after distal pancreatectomy, but no benefit was observed after pancreaticoduodenectomy, and the evidence is limited to small, under‑powered trials.
Is vapreotide approved for treating variceal bleeding?
No. Vapreotide remains investigational; however, early‑phase studies report improved bleeding control and lower mortality when given intravenously during acute variceal hemorrhage.
What side effects should be expected?
Reported side effects are generally mild, such as transient gastrointestinal discomfort, mild hyperglycemia, or injection‑site irritation. Serious adverse events have not been documented in the limited trials.
How is vapreotide administered in research settings?
It is administered as an acetate solution by intravenous or subcutaneous injection, often given as a bolus or short infusion before endoscopic therapy or during the peri‑operative period.
What is Vapreotide?
Vapreotide is an investigational somatostatin analogue administered intravenously or subcutaneously. It has been studied as an adjunct in pancreatic surgery and as a vasoactive agent for acute esophageal variceal bleeding in patients with portal hypertension. Research suggests it may lower postoperative complications after distal pancreatectomy and improve bleeding control in variceal hemorrhage, though it remains unapproved for routine clinical use.
What is Vapreotide used for?
Vapreotide is educationally associated with: Carcinoid syndrome and neuroendocrine tumors, Acromegaly management, Pancreatic fistula prevention, Control of acute variceal bleeding, Inhibition of pancreatic exocrine secretion, Acute esophageal variceal bleeding. Educational only — not medical advice.
How is Vapreotide administered?
Recorded routes of administration: Intravenous, Subcutaneous.
What are the potential side effects of Vapreotide?
Reported adverse effects include: Hyperglycemia, Hyperglycemia or hypoglycemia, Injection site reactions, Gallstone formation, Nausea and vomiting, Nausea, Injection site reaction, Bradycardia, Abdominal pain. This list is not exhaustive — consult a qualified clinician.
Who should avoid Vapreotide?
Recorded contraindications: Hypersensitivity to vapreotide or somatostatin analogues, Hypersensitivity to vapreotide or any excipient, Pregnancy. Consult a qualified clinician before use.