Implications for treating appropriate patients with the somatostatin analogues octreotide or lanreotide based on clinical data.

Octreotide is a man-made peptide that mimics the activity of somatostatin, a hormone created by the hypothalamus gland. Somatostatin inhibits the release of growth hormone from the pituitary gland and regulates the tears of various other hormonal agents, consisting of the hormone insulin and glucagon. Octreotide is made use of to manage a assortment of problems, featuring acromegaly, carcinoid syndrome, and gastroenteropancreatic neuroendocrine cysts.

One possible side result of octreotide therapy is weight loss. In some individuals, this can easily be a preferable end result, specifically if they are over weight or overweight. However, in others it can easily be...


The smart Trick of "The Science Behind Octreotide and Its Effects on Weight" That Nobody is Talking About



Octreotide is a man-made peptide that mimics the activity of somatostatin, a hormone created by the hypothalamus gland. Somatostatin inhibits the release of growth hormone from the pituitary gland and regulates the tears of various other hormonal agents, consisting of the hormone insulin and glucagon. Octreotide is made use of to manage a assortment of problems, featuring acromegaly, carcinoid syndrome, and gastroenteropancreatic neuroendocrine cysts.

One possible side result of octreotide therapy is weight loss. In some individuals, this can easily be a preferable end result, specifically if they are over weight or overweight. However, in others it can easily be challenging and require interference.

The device by which octreotide leads to weight reduction is not completely clear. One possibility is that it reduces cravings by restraining ghrelin tears. Ghrelin is a hormone produced in the stomach that activates food cravings and food consumption. Studies have presented that octreotide can minimize ghrelin degrees in well-balanced volunteers and in individuals along with acromegaly or kind 2 diabetes mellitus mellitus.

An additional potential device for octreotide-induced body weight reduction is change of blood sugar metabolic rate. Octreotide has been presented to boost blood insulin level of sensitivity in patients along with type 2 diabetes mellitus through reducing hepatic glucose manufacturing and raising outer sugar uptake. This impact may likewise add to weight reduction through decreasing distributing blood sugar amounts and ensuring fatty tissue oxidation.

In enhancement to these metabolic results, octreotide may possess straight impacts on adipose cells physiology. In vitro studies have revealed that somatostatin receptors are current on adipocytes (body fat tissues) and that somatostatin can easily inhibit lipolysis (the break down of stashed fat). It is feasible that octreotide has actually comparable effects on adipose tissue metabolism in vivo.

Clinical research studies have shown the effectiveness of octreotide for weight loss in various patient populaces. For instance, a randomized controlled test published in JAMA in 2008 matched up the effects of octreotide and inactive drug on body weight reduction in overweight adults with type 2 diabetic issues mellitus. After 16 full weeks of therapy, the octreotide team shed an standard of 4.4 kilograms (9.7 lbs) matched up to a unpleasant body weight increase of 0.5 kilograms (1.1 pounds) in the inactive medicine group.

An additional research study posted in the Journal of Clinical Endocrinology and Metabolism in 2013 analyzed the results of octreotide on physical body weight and structure in individuals along with acromegaly. After six months of treatment, clients experienced substantial declines in physical body weight, body mass mark, and waist circumference.

While octreotide can easily be efficient for body weight reduction, it is not without dangers and side effects. Popular side results feature gastrointestinal disturbances such as nausea or vomiting, diarrhea, and stomach pain. Uncommon but significant edge results feature gallstones, pancreatitis, and heart arrhythmias.

In final thought, octreotide is a artificial peptide that copies the activity of somatostatin and has actually a range of restorative make use of. One possible side impact is body weight reduction, which might be mediated by modifications in appetite regulation, sugar rate of metabolism, and adipose tissue anatomy. While successful for some patients, it is important to carefully evaluate the dangers and perks just before initiating treatment with octreotide for body weight reduction functions.

Octr...

Monica Gadelha, DR, PhD, University of Rio De Janeiro studying Acromegaly discusses Paltusotine and its positive impact on patients suffering from Acromegaly.

Transcription:
GH is secreted, controlled by somatostatin. Somatostatin is a molecule that produces the hypothalamus that is above the pituitary. There are drugs that are called somatostatin receptor ligands. These drugs act like they were somatostatin, so they block GH secretion, and they can control the size of the tumor or even decrease the tumor. This is a class of drugs that we call first-generation somatostatin receptor ligands or agonists. The ones that we use now is octreotide LAR and lanreotide autogel both in Brazil. In the US, there is also oral octreotide.

But in the vast majority of the world there is octreotide LAR, lanreotide autogel that are what we call SST2 agonists. These drugs will block GH secretion and control the tumor. The problem with these drugs is that they are injectable, and they are painful. The patient has to go to the healthcare unit every month to get the shot because this is not a simple shot. It has to be done by a specialized healthcare profession. At the end of the period of the injection, some patients before the next one, complain about relapse of some symptoms as headache is very common.

There is a very nice French study that show that IGF-1 is not stable with the injections during the whole month. We have all these problems with injections. The problem with acromegaly is that these patients will have to take these medications probably for the rest of their lives, so to end, 30, 40 years. If the problem, if they needed these drugs for only six months, that's okay, that they had to go to the hospital for six months, but it's for the rest of their life. An oral drug that they can take at home is very expected by the patients.

Paltusotine is an oral medication that binds to this same receptor that is called SST2. An important difference from the other oral, that's oral octreotide that was launched in US, is that the oral octreotide must be taken twice a day. This is complicated because we know that the second few, many patients forget. The one in the morning when the patient has to take as soon as the patient wakes up, it's okay. But the second one, sometimes the patient is at dinner, out of the house, or at work. So, it's more complicated. The oral octreotide needs fasting. A second fasting is difficult. Paltusotine is once daily, oral, and very stable drug. In terms of I would say, posology is very convenient for the patient.

Regarding efficacy, we had good data in the Phase II, but now the first Phase III, that's PET Finder 1, was finished and the efficacy was demonstrated because in this trial we included the control of the patients on octreotide or lanreotide. I mean, the patients had normal IGF-1 on one of the injectable medications, and they were randomized to receive paltusotine or placebo, so 30 to paltusotine and 28 to placebo. They were treated with paltusotine for 36 weeks.

At the end of this core phase of the study, it was compared the percentage of patients that maintained control of IGF-1 in the paltusotine group and on the placebo group. The difference was huge as expected. It was 83% in the paltusotine and 4% in the placebo. The study met its primary endpoint. Additionally, there is an evaluation of the symptoms of the patient through acromegaly symptoms diary. Again, the paltusotine maintain the control of the symptoms of the patients. Biochemically effective, maintains the symptoms.

In terms of tumors, there was no tumor increase. The tumor was stable. Then regarding safety, we only saw side effects, very typical of acromegaly or with the class of the drug that is the first-generation somatostatin receptor ligands. I mean abdominal pain, nausea, diarrhea that's associated with octreotide, lanreotide, paltusotine, all these drugs. Some are [inaudible 00:06:55] and [inaudible 00:06:56] that's associated more with acromegaly. I think that the drug has efficacy very close to the injectable one, and it's safe.

But for me, the most interesting thing is that during the study, I was telling other investigations and people that I was very impressed with the patients. Because the patients before having a neural option, I have been very honest, I didn't know how bad the injections were because we only had that. We scheduled the patient, so please come to the hospital this day to get our shot and we will see you for three months in the outpatient clinic. We didn't know how bad the injection was. It hurts, it's painful, the patient lost half a day of work to go to the hospital.

General information regarding Sandostatin (octreotide). Content created leveraging AI with the goal of bridging access across communities. Please flag any suggestions or errors in the comment section. Thank you!

Implications for treating appropriate patients with the somatostatin analogues octreotide or lanreotide based on clinical data.

Clinical Toxicology video for Health Science Students

Susan L Samson, MD, PhD, FRCPC, FACE, Chair of Endocrinology at Mayo Clinic in Jacksonville, Florida, discusses positive efficacy data from the open-label extension of the OPTIMAL study of oral octreotide, a drug that was approved for the treatment of acromegaly in 2020. Data from the open-label extension was presented at the ENDO 2022 Annual Conference.

Acromegaly is a rare endocrine disorder in which the body secretes too much growth hormone in adulthood, usually as a result of a pituitary tumor. Since the increased growth hormone occurs past puberty, the changes in bone structure can be very gradual. As a result, it can take several years for a person with acromegaly to be diagnosed.

As Dr. Samson explains, the OPTIMAL trial (NCT03252353) was a randomized, double-blind, placebo-controlled, phase 3 clinical trial of octreotide capsules in 56 adult acromegaly patients whose disease was controlled by injectable somatostatin analogs (octreotide or lanreotide). Eligible patients were then randomized 1:1 to octreotide capsules or placebo. The primary endpoint of the trial was the proportion of patients who maintained their biochemical response (insulin-like growth factor I (IGF-1 levels less than 1.0 × upper limit of normal [ULN]), at the end of the 9-month, double-blind, placebo-controlled period. The OPTIMAL study met the primary endpoint and all secondary endpoints which led to the US approval of oral octreotide, the first oral somatostatin analog, for the long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with injectable octreotide or lanreotide.

After the 9-month, double-blind, placebo-controlled period, patients were eligible for enrollment in the open-label extension study to evaluate the long-term efficacy and safety of oral octreotide. One of the key findings presented at ENDO 2022 was that maintenance of biochemical response (defined as IGF-I levels below ULN) to oral octreotide was durable up to 96 weeks. 100% of subjects (n= 17) who were responders at week 48 and 93% of subjects overall (n=29) demonstrated a biochemical response at week 96. Median exposure to oral octreotide was 2.1 years, with exposure great than 3 years for 5 patients.

Pharmacology of Octreotide
Octreotide is a synthetic analog of somatostatin, a naturally occurring growth hormone inhibiting peptide. It is primarily used to treat certain hormonal disorders and symptoms associated with certain types of tumors2.

Mechanism of Action
Octreotide mimics the action of natural somatostatin but has a longer duration of effect. It binds to somatostatin receptors (SSTR2 and SSTR5) and inhibits the secretion of several hormones, including:

Growth hormone (GH)

Glucagon

Insulin

By binding to these receptors, octreotide helps regulate the hormonal imbalances in conditions like acromegaly and certain types of neuroendocrine tumors.

Pharmacokinetics
Absorption: Octreotide can be administered via subcutaneous (SC), intramuscular (IM), or intravenous (IV) routes. The bioavailability of octreotide is approximately 100% for SC administration and 60% for IM administration1.

Distribution: It is widely distributed throughout the body and binds to plasma proteins at a rate of 40-65%.

Metabolism: Octreotide is metabolized primarily by the liver.

Elimination: It has a half-life of approximately 1.7-1.9 hours and is excreted mainly through the urine.

Clinical Uses
Acromegaly: Used to reduce growth hormone levels.

Neuroendocrine Tumors: Helps manage symptoms such as diarrhea and flushing associated with carcinoid syndrome and vasoactive intestinal peptide (VIP)-secreting tumors (VIPomas).

Variceal Bleeding: Octreotide is used in the management of esophageal varices secondary to portal hypertension.

Adverse Effects
Some common side effects of octreotide include:

Gastrointestinal disturbances (such as nausea, vomiting, and abdominal pain)

Altered blood glucose levels (both hyperglycemia and hypoglycemia)

Gallbladder issues, including gallstones

Octreotide plays a crucial role in managing hormone-related conditions, but it requires careful monitoring due to its potential side effects.

#Octreotide

Octreotide Injection Uses, Mode Of Action And Side Effects | Octride 100 Injection Review

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Q&A NET Patient Network Patient Day 2013
Kilkenny, 9th November 2013

How Octreotide Works.
Octreotide is a synthetic version of the hormone somatostatin. Somatostatin is a hormone that is naturally produced in the body and plays a role in regulating the production of other hormones. By mimicking the effects of somatostatin, octreotide is able to reduce the production of certain hormones that can cause symptoms in conditions like acromegaly, carcinoid syndrome, and Cushing's disease.
In acromegaly, for example, the body produces too much growth hormone, which can cause excessive growth of the hands, feet, and face, as well as other symptoms like joint pain and fatigue. By reducing the production of growth hormone, octreotide can help to alleviate these symptoms. In carcinoid syndrome, the body produces too much serotonin, a hormone that can cause diarrhea, flushing, and other symptoms. Octreotide can help to reduce the production of serotonin, which can lead to a reduction in symptoms.
Conditions Treated by Octreotide.
Octreotide is primarily used to treat rare conditions like acromegaly, carcinoid syndrome, and Cushing's disease. In addition to these conditions, the drug has also been used to treat certain types of cancer. For example, octreotide can be used to treat neuroendocrine tumors, which are a type of cancer that affects the cells that produce hormones. These tumors can produce excessive amounts of hormones, which can cause a range of symptoms. By reducing the production of these hormones, octreotide can help to alleviate symptoms and slow the progression of the cancer.
Benefits of Octreotide Treatment.
One of the biggest benefits of octreotide treatment is that it can significantly improve quality of life for those suffering from rare diseases. Many of these conditions can be debilitating, making it difficult for people to perform everyday tasks or enjoy their lives. By reducing symptoms like excessive growth, diarrhea, and fatigue, octreotide can help people with these conditions to feel better and regain some of their independence.
In addition to improving quality of life, octreotide treatment has also been shown to be effective in slowing the progression of certain types of cancer. For example, in one study, patients with neuroendocrine tumors who received octreotide had a longer time to disease progression than those who received a placebo. This suggests that octreotide may be an effective treatment for certain types of cancer.
Side Effects of Octreotide Treatment.
Like any medication, octreotide can cause side effects. Some of the most common side effects include nausea, vomiting, diarrhea, and abdominal pain. These side effects are usually mild and go away on their own after a few days. In rare cases, more serious side effects can occur, such as allergic reactions or changes in heart rate.
Dosage and Administration of Octreotide.
Octreotide is typically administered by injection, either subcutaneously (under the skin) or intravenously (into a vein). The dosage and frequency of the injections will depend on the condition being treated and the patient's individual needs. For example, in the treatment of acromegaly, octreotide is usually given by injection every four weeks. In the treatment of carcinoid syndrome, octreotide may be given by injection two to three times per day.
Octreotide vs Other Treatment Options.
Before the discovery of octreotide, treatment for rare diseases like acromegaly, carcinoid syndrome, and Cushing's disease was limited. Surgery to remove tumors or glands that were producing excessive hormones was often the only option. While surgery can be effective, it is not always possible or advisable, especially in cases where the tumors are not easily accessible.

"DISCLAIMER: The content of this video is for informational and educational purposes only. It should not be used as a substitute for medical consultation. You should always seek the advice of your doctor or healthcare professional before taking any medication or starting any treatment. Treatments and medications should be prescribed and supervised by a qualified medical doctor only. Individual results may vary and the effectiveness of any treatment mentioned in this video is not guaranteed. Do not self-medicate, if you have any health problems, it is important to seek medical help immediately.



"

Eric Liu, MD, FACS, explains how to appropriately dose and manage patients on either octreotide or lanreotide.

octreotide - Indications, Dosage, Side Effects and Precautions
The Official Guide to octreotide - Indications, Dosage, Side Effects and Precautions

Patient Day 2014

Susan Samson, MD, PhD, of Baylor College of Medicine talks about the recently approved Mycapssa (octreotide) capsules as long-term maintenance therapy for people with acromegaly.

Mycapssa is the only oral form of octreotide, a somatostatin analog, approved by the US Food and Drug Administration (FDA) to treat acromegaly.

Acromegaly is a rare endocrine disorder usually caused by a benign pituitary tumor and is characterized by excess production of growth hormone and insulin-like growth factor-1 hormone.

As Dr. Samson explains in this interview, the approval was largely based on the pivotal phase 3 CHIASMA OPTIMAL clinical trial showing Mycapssa to be superior to placebo in the randomized, double-blind, placebo-controlled, nine-month study.

The most common adverse events observed with Mycapssa were: cholelithiasis and complications of cholelithiasis; hyperglycemia and hypoglycemia; thyroid function abnormalities; cardiac function abnormalities; and decreased vitamin B12 levels and abnormal Schilling’s tests.

Octreotide is a artificial peptide that copies the activity of somatostatin, a hormonal agent made through the hypothalamus. Somatostatin hinders the release of growth hormonal agent coming from the pituitary glandular and manages the secretion of other hormonal agents, including the hormone insulin and glucagon. Octreotide is used to deal with a range of problems, including acromegaly, carcinoid syndrome, and gastroenteropancreatic neuroendocrine growths.

One possible edge impact of octreotide therapy is body weight reduction. In some patients, this can easily be a desirable end result, specifically if they are overweight or obese. However, in others it may be challenging and...


"The Science Behind Octreotide and Its Effects on Weight" for Beginners



Octreotide is a artificial peptide that copies the activity of somatostatin, a hormonal agent made through the hypothalamus. Somatostatin hinders the release of growth hormonal agent coming from the pituitary glandular and manages the secretion of other hormonal agents, including the hormone insulin and glucagon. Octreotide is used to deal with a range of problems, including acromegaly, carcinoid syndrome, and gastroenteropancreatic neuroendocrine growths.

One possible edge impact of octreotide therapy is body weight reduction. In some patients, this can easily be a desirable end result, specifically if they are overweight or obese. However, in others it may be challenging and require assistance.

The mechanism through which octreotide causes weight loss is not entirely clear. One probability is that it lowers hunger through decreasing ghrelin secretion. Ghrelin is a hormone produced in the stomach that boosts hunger and food items consumption. Studies have presented that octreotide can minimize ghrelin degrees in healthy and balanced volunteers and in patients along with acromegaly or style 2 diabetic issues mellitus.

One more potential device for octreotide-induced weight loss is change of blood sugar metabolism. Octreotide has been presented to enhance blood insulin sensitivity in clients with kind 2 diabetes mellitus by decreasing hepatic glucose development and enhancing outer blood sugar uptake. This impact might additionally contribute to weight reduction by minimizing spreading sugar amounts and advertising fat oxidation.

In addition to these metabolic impacts, octreotide may possess direct effects on adipose tissue physiology. In vitro studies have presented that somatostatin receptors are present on adipocytes (fatty tissue cells) and that somatostatin can prevent lipolysis (the break down of saved fat). It is possible that octreotide has actually comparable results on adipose cells metabolic rate in vivo.

Professional studies have illustrated the effectiveness of octreotide for weight loss in various patient populaces. For example, a randomized controlled trial published in JAMA in 2008 matched up the effects of octreotide and inactive medicine on body weight loss in overweight grownups along with type 2 diabetes mellitus mellitus. After 16 weeks of therapy, the octreotide group shed an standard of 4.4 kilograms (9.7 lbs) matched up to a nasty weight increase of 0.5 kg (1.1 lbs) in the inactive medicine team.

An additional research study released in the Journal of Clinical Endocrinology and Metabolism in 2013 analyzed the results of octreotide on physical body body weight and make-up in clients along with acromegaly. After six months of procedure, individuals experienced substantial decreases in body weight, body mass index, and waistline circumference.

While octreotide can easily be helpful for weight reduction, it is not without risks and edge effects. Usual edge effects feature intestinal disturbances such as nausea or vomiting, diarrhea, and stomach pain. Unusual but serious side effects feature gallstones, pancreatitis, and heart arrhythmias.

In conclusion, octreotide is a man-made peptide that imitates the activity of somatostatin and has actually a range of therapeutic usage. One prospective side impact is body weight loss, which may be mediated by alterations in appetite guideline, glucose metabolic process, and adipose tissue anatomy. While successful for some clients, it is important to meticulously consider the risks and advantages just before initiating treatment along with octreotide for body weight loss functions.

Octreotide is a synthetic peptide that imitates the action of somatostatin, a hormone produced through the hypoth...

#aetcm

Sandostatin is a hormone drug that is used to treat some types of cancer.  Sandostatin is classified as an somatostatin analog. 
Sandostatin injection contains the active ingredient octreotide, which is a type of medicine called a somatostatin analogue. It is similar to a naturally-occurring hormone in the body called somatostatin. Somatostatin is produced in various parts of the body, including the brain, gut and pancreas. Its function is to stop the release of certain other hormones, such as growth hormone and insulin.

Could be:
SandoSTATIN
SandoSTATIN LAR Depot
Octreotide Acetate Omega
Class
Antidiarrheal
Antidote
Somatostatin analog

Forms
Intramuscular kit:
SandoSTATIN LAR Depot== 10mg, 20mg, 30mg

Injection:
SandoSTATIN 50ug/ml, 100ug/ml, 200ug/ml, 500ug/ml, 1000ug/ml


Through I.V/SubQ/ I.M/ Depot

Uses
1. DM
2. Chemotherapy
3. HIV
4. Graft vs Host
5. Carcinoid
6. Medullary Thyroid CA
7. VIPoma's
8. Short Bowel Syndrome
9. Bone Marrow Transplant
10. All Chronic Diarrhea
11. Zollinger – Ellison Syndrome
12. Thymoma/ Advanced Thymic Malignancy
13. Sulfonylurea – induced hypoglycemia
14. Malignant Bowel Obstruction
15. Hepatorenal Syndrome
16. Gastroesophageal variceal hemorrhage
17. Gastro –Entero- Pancreatic neuroendocrine tumors[metastic]
18. Acromegaly
19. Hypothalamic Obesity

Acromegaly
Sub or I.V
50ug TID
Up to 100ug TID
Maximum range is 300ug to 1500ug/day
Have med stopped for 4/52 every one year
Check GH, IGF[Insulin-like Growth factor 1]
Switching to Depot from SubQ:
Stability on SubQ x 2/52, then
Switch to the Depot
Give 20mg l.M. q 4/52 x 3/12
Review your parameters if the GH is less than or equal to 1ng/ml
IGF – 1 i.e. insulin, like growth factor-1 is normal,
then reduce Octreotide to 10mg I.M q 4/52
Titrate the dose based on GH and IGF – 1 levels

e.g. if GH is greater than 2.5ng/ml and IGF – 1 is elevated, then increase octreotide to 30mg I.M q4/52

If you have used maximum octreotide and not winning, add Pegvisomant [growth hormone receptor antagonist] or a Dopamine agonist
Carcinoid Crisis (Intra-operatively)
With hypotension
I.V. 500 to 1000ug bolus
Repeat at 5 minute intervals
Until symptoms are controlled
OR the bolus to be followed by 50-200ug per hour continuous infusion during the procedure
AND MANY MORE FACTS,ENJOY LISTENING!

Welcome to MediInsights, where we unlock the wonders of wellness! In today's video, we delve into the essential details of Octreotide Injection, a crucial medication in the management of specific hormonal disorders and tumors.

Use of Octreotide Injection:
Octreotide injection is a powerful medication used primarily for treating symptoms related to metastatic carcinoid tumors and VIPomas, such as severe diarrhea and flushing. It's also a key treatment for acromegaly, a condition caused by excess growth hormone, and is utilized to prevent complications following pancreatic surgery.

Dosage of Octreotide Injection:
The dosage of octreotide varies depending on the condition and patient response. For acromegaly, the starting dose is typically 50 micrograms injected subcutaneously two or three times daily, with adjustments based on the patient’s needs. For treating carcinoid tumors and VIPomas, the initial dose can range from 100 to 600 micrograms per day, divided into multiple doses. Long-acting formulations like Sandostatin LAR are administered intramuscularly every four weeks, with dosages between 20 to 30 mg.

Mechanism of Action of Octreotide Injection:
Octreotide is a synthetic analog of somatostatin, a natural hormone that inhibits various other hormones. It binds to somatostatin receptors, reducing the secretion of growth hormone, serotonin, and other peptides like insulin and glucagon. This action helps manage symptoms by controlling excessive hormone production and secretion.

Side Effects of Octreotide Injection:
While octreotide is effective, it can cause some side effects. Common issues include gastrointestinal disturbances such as nausea, vomiting, abdominal pain, and diarrhea. Patients might also experience injection site reactions and gallstones due to reduced bile flow. Other potential side effects include blood sugar imbalances (hyperglycemia or hypoglycemia), bradycardia, hypothyroidism, and, with long-term use, vitamin B12 deficiency.

Important Advice for Using Octreotide Injection:
It's crucial to follow your healthcare provider's instructions carefully. Regular monitoring of blood glucose and thyroid function is recommended due to the endocrine effects of octreotide. Rotate injection sites to avoid tissue damage and report any severe side effects, such as intense abdominal pain or symptoms of gallstones, to your healthcare provider immediately. Regular check-ups are essential to adjust the dosage and ensure the treatment's effectiveness.

Thank you for watching MediInsights! If you found this video helpful, please like, comment, and subscribe to our channel for more in-depth health insights. Don't forget to hit the bell icon to get notified about our latest videos. Unlock the wonders of wellness with us!

Disclaimer: This video is intended for educational and informational purposes only. The content provided is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified healthcare provider with any questions you may have regarding a medical condition or the use of medications. The information presented here is based on general knowledge and research and may not be applicable to individual circumstances. The creators of this video do not endorse or promote any specific medical products or treatment regimens. Viewers are encouraged to consult their healthcare provider for personalized medical advice. The content provided in this video complies with YouTube's community guidelines and policies.

CHAPTERS:
0:00 :INTRO
0:44 :USE OF OCTREOTIDE INJECTION
1:16 :DOSAGE OF OCTREOTIDE INJECTION
1:59 :MECHANISM OF ACTION OF OCTREOTIDE INJECTION
2:32 :SIDE EFFECTS OF OCTREOTIDE INJECTION
2:59 :IMPORTANT ADVICES FOR USING OCTREOTIDE INJECTION

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Susan L Samson, MD, PhD, FRCPC, FACE, Chair of Endocrinology at Mayo Clinic in Jacksonville, Florida, discusses the positive safety data from the open-label extension of the OPTIMAL study of oral octreotide, a drug approved for the treatment of acromegaly. Data from the open-label extension was presented at the ENDO 2022 Annual Conference.
Acromegaly is a rare endocrine disorder in which the body secretes too much growth hormone in adulthood, usually as a result of a pituitary tumor. Since the increased growth hormone occurs past puberty, the changes in bone structure can be very gradual. As a result, it can take several years for a person with acromegaly to be diagnosed.

As Dr. Samson explains, the OPTIMAL trial (NCT03252353) was a randomized, double-blind, placebo-controlled, phase 3 clinical trial of octreotide capsules in 56 adult acromegaly patients whose disease was controlled by injectable somatostatin analogs (octreotide or lanreotide). Eligible patients were then randomized 1:1 to octreotide capsules or placebo. The primary endpoint of the trial was the proportion of patients who maintained their biochemical response (insulin-like growth factor I [IGF-1] levels less than 1.0 × upper limit of normal [ULN]), at the end of the 9-month, double-blind, placebo-controlled period. The OPTIMAL study met the primary endpoint and all secondary endpoints which led to the US approval of oral octreotide, the first oral somatostatin analog, for the long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with injectable octreotide or lanreotide.

After the 9-month, double-blind, placebo-controlled period, patients were eligible for enrollment in the open-label extension study to evaluate the long-term efficacy and safety of oral octreotide. Overall, the safety profile of oral octreotide during the open-label extension period was consistent with previous studies and with that of injectable somatostatin analogs. No serious adverse events were reported in the open-label extension study. Interestingly, Dr. Samson notes that patients who entered the open-label extension study naive to oral octreotide tended to have fewer adverse events compared to patients who were in the treatment arm of the clinical trial. One potential reason for this is that patients in the placebo arm were initially given 60 mg of oral octreotide when they entered the open-label extension, while those in the treatment arm were dose titrated from 40 mg per day to up to a maximum of 80 mg per day. Dr. Samson suggests that the higher dose may have better control of the manifestations of acromegaly which could explain the reduction in adverse events. Further evaluation is needed to determine this.