Okay to start off today, these are the fundamentals that we are going to use for the whole system.

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2 Good morning, Today we are going to start our lecture about the endocrine pharmacology. we will be having 7 lectures covering most of the topics. As you have got accustomed to my style, I am not going to focus on many things that are not required and not valid for your level. But this time you have grown up and in this system you have to start memorizing drugs names, be particular and specific about their uses and their pharmacological indications and contraindications. Another change that will happen this time, I am not going too much in the physiology or the pathology. I will state few things today that will cover this lecture and the subsequent lectures. An important thing is that I am not going into the physiology or the pathology for the sake of that, I am going to link each one of these four or five concepts to their pharmacological consequences. Okay to start off today, these are the fundamentals that we are going to use for the whole system. You know that there is the hypothalamus and the anterior pituitary. The connection between them is the portal system. The hypothalamus releases the RH (releasing hormone) and that will induce the synthesis or the synthesis and the release of the TH (Tropic hormone) like the TSH (thyrotropin stimulating hormone). Then the TH (which is the TSH in our example) will go to the thyroid, producing its effect on it.(the picture is just for illustration) Tropic hormones are hormones that have other endocrine glands as their target. Most tropic hormones are produced and secreted by the anterior pituitary. 1 P a g e

3 Why is that valid for us today? Let s start from a down streaming effect. The target hormones are almost always used for the replacement therapy. So the ES is very simple, there is a deficiency versus excess, in the deficiency you have to replace and in the excess you have to suppress. So there are two types of treatment, suppressive or replacement therapy. Now those target hormones, if they are available pharmacologically, then they have to be used in the replacement therapy. What about the releasing hormone or the TH? Most of the times, we use it for diagnostic purposes. If I want to diagnose or see whether the pituitary is functioning or not. I might check the level of RH to see if there is a production of that TH or not. So if there is a production of that (TH) hormone that means the pituitary is functioning well and vice versa. And we are going to go over that in the next slides. I might also use the tropic hormone to test whether the target organ is producing that target hormone. What if you don t have that target hormone or it is not available as a pharmacological option? You might go upstream to the TH and use it. But that requires one condition; that this target organ is functioning well and is able to synthesize the target hormone. Another important thing in this system is the short and the long loops of the negative feedback inhibition. As you can see form the target organ to the anterior pituitary, from the anterior pituitary to the hypothalamus and the long loop from the target organ to the hypothalamus. This is called the negative feedback mechanism or the feedback inhibition. Another interesting thing is that it also has another loop of inhibition coming from upstream. Which means that the hypothalamus is not always secreting a releasing hormone, it sometimes releases an inhibitory hormones or a releases inhibiting hormone. This is called the feedforward inhibition. How could we use that pharmacologically? 2 P a g e

4 Simply, the negative feedback loops can be used in the diagnostic purposes as I ve said before. I can give this TH from the anterior pituitary and to see whether it inhibit the elevated level of the RH. What about the feedforward inhibition, how could we use that in pharmacology? We can use it in other treatment types; such as suppressive therapy. When there is an increase in the target hormone or the TH coming from the anterior pituitary. The hypothalamus will secrete the inhibitory hormones. Now another concept we are going to mention is very interesting, it s the pulsatile release (circadian rhythm).now this is simple, as you expect it is related to the day-night cycle. It is most commonly caused by the change in the biological clock. Which is one of the factor that determines this pulsatile release. (The picture is just for illustration) There is also environmental factors, including most of the mode status of the individuals that could affect such pulsatile release of hormone. This is evident all over the ES. It also could be related to age; we have hormones that are modal in their secretions according to the age of the individual. In females, it is related to the days of the month (menstrual cycle). Also it can be explained by the presence of the opposing mechanisms or an opposing hormone to the action of the first hormone. We call it the counter regulatory mechanisms of the ES. 3 P a g e

5 The bottom line, in treatment we need to simulate the normal circadian rhythm of secretion of that hormone we are talking about. If you don t do it, you might affect the endogenous type of the secretions from the body. And that hormone might not produce the effects you want in the patients. So you have to have knowledge of the physiology of the hormone you are going to give. Most of the hypothalamus and the anterior pituitary hormones are peptide or LMW protein hormones. For example if you look at the GH (growth hormone) its 191 AA while the PRL (prolactin) is 198 AA.who cares? Now the first thing we care about out of this concept is the fact that these hormones are found mostly in trace amounts and they will have local effects within the neighborhood of that secreting cells. So what? 1- Identify initially They are hard to: 2- purify 3- Chemically synthesize. And it is not a strange fact that the endocrinology as a science was discovered just recently. You will see that it is a recent advancement in the knowledge and in the science. It is also related to the (hard rule) that I ve mentioned previously. That made most of the endocrinological diseases fatal.in the beginning, can you imagine that the DM was extremely fatal until they were able to apply the hard rule measures! Now the other thing that is important for us as clinicians; is the fact that these peptides if they are given orally, there is a huge chance that they will be hydrolyzed as soon they get to the GI by the peptidases enzymes. Also once they get into the intestine their absorption will be impaired. There will be no absorption for these compounds IF they made it to the intestine. So they can t be given orally in most of cases, unless you make something magical to their structures! As a result, most of these hormones (peptides) are given by injections. So you have to deal with the fears, phobias and the refusal of patients to take such drugs. Now the anterior pituitary will release its hormones, like the TSH that will be further discussed in the thyroid lecture, the ACTH that will be discussed in the adrenals lecture, the LH and the FSH that we are going to discuss in the UGS. 4 P a g e

6 Today our lecture will be limited to the GH and the PRL (But ما رح نلحق (. so by the end of these two terms I am expecting you to be aware of the endocrinology in general. 1- The GH system: Let s go over the general organization of this system. We know that there is GHRH (growth hormone releasing hormone) from the hypothalamus, which leads to the synthesis and the secretion of the GH from the anterior pituitary. Most of the actions of the GH could be done directly by the hormone on the cell. But none the less, the GH can also produce certain mediators to prolong and sustain its action. These mediators come mostly from the liver, but they are not exclusive to the liver. They are called somatomedins or the IGF -1, 2 (insulin or insulin like GF). From its name, they are structurally related to the insulin, they can bind the insulin receptors and produce insulin like effects, which is encountered in the therapy as you will see. The functions of this hormone are literally a GH; it is important to know that it can induces: 1- The cell proliferation and replication. 2- inside the cells it induces: a-the protein synthesis b-lipolysis c- the hepatic glucose output. The growth of bone In general that will lead to increase in the lean body mass. 5 P a g e Now which of those effects are produced by the GH and which are produced by the somatomedins? It is not well understood. Now just for the fun of science, the GH induces the lipolysis and the hepatic glucose output, but in the other hand you know that the insulin induce lipogenesis and increase the glucose uptake. So these are counter-regulatory! The functions of the GH are done directly (most of the times) by inducing the cartilage, bone growth or the increase in the lean body mass. But to a lesser extent it can be mediated by somatomedins. Now, since it is literally a GH and this is evident in its release throughout the years. so it increases in the childhood, early adulthood and then platues and goes down later on.

7 That s why some people think that this hormone could be the antiaging elixir. Since it is the elixir, then a lot of people will be abusing it (particularly the athletes). Now plus that modal secretions of GH, it has circadian rhythm (day-night cycle).it is important to know that it is increased during the early hours of the night. So when the individuals is not having enough sleep, or he is having insomnia, the GH cycle secretion will not take place. Which means that it will affects his or her growth. Now just like this whole system, it has both the negative feedback loops and the feedforward inhibitory loop. The negative feedback loops coming from the somatomedins into the GH and back to the GHRH. And the feedforward inhibitory loop which comes from the presence of the somatostatins (particularly from the hypothalamus) then it will go and inhibits the whole systems. So that it can be used is suppressive therapy. As you expect, we have the cases of deficiencies or excess of the secretion of the GH at any part of that axis: 1-the deficiency cases called the pituitary dwarfism, which is responsible of the short stature and the stunted growth of that individual 2-we have cases of excess of GH.it depends on the age of the onset: A-gigantism cases. b- Acromegaly cases. For the treatment, let s start from upstream: GHRH, if it is available for you in counter, how and where could you use it? Some may think that it can be used for treatment, but again the concept is concept. It is mostly used in diagnostic purposes. If you give it and there is an increase in the GH hormone level, that s means that the problem is from the hypothalamus and not from the pituitary. Now the GRHR problems are: 1-it is a short peptide 44aa 2-it has very short half- life (the IV half-life 4 min) So it used for researches only. In such cases we produce analogues. 6 P a g e

8 1- Sermorelin -it is the most commonly used analogues for GHRH. -it is a fragment of the GHRH (1-29 AA). -it is used for diagnostic purposes in 90% of cases, but it requires a properly functioning pituitary (like the full GHRH). - We can give it in dwarfism (hypo-secretory functioning pituitary). - It was approved for the use in growth hormone deficiency in ** Again the pituitary should be functioning well, otherwise we can t use it. - (IV/SC/IN) **IT IS NOT USED as a first choice, since we have the target hormone or the tropic hormone, so why we would go to the upstream?! So it is a recent into the guideline, we use it when everything fails. - now the problem is that it was used for doping purposes by athletes and it is currently one of the things that are tested for frequently in athletes; to see whether they took such doping drugs. What is the major problem that happen to these athletes when they take the GH or the GHRH frequently? Now as we will be discussing the glucose metabolism next week. It is regulated tightly by the insulin itself and the counter- regulatory mechanisms. GH is one of these counter acting hormones against the insulin. So most of these athletes when they start to use this drug, they will have abnormality in their glucose metabolism and they would be prone to the development of DM. SIDE NOTE, when you give something exogenously you have to know that it will affect the endogenous production of that hormone firstly, secondly if you stop it abruptly or suddenly that will miss up the whole system,because these organs ( producing endogenous hormone ) using that hormone will be atrophied and it will have a rest or vacation or they are not working at all.and all of the sudden you are asking them to be active again, we are going to give it a hard look when we are going to discuss the corticosteroids next week inshallah. A student asked about the relation between GH and cancer development, the doctor stated that a recent meta-analysis are not very definitive about the risk of malignancies associated with GH, but the only thing that we are certain about that it induces DM, but it is not a big deal in our clinical practice. 7 P a g e

9 2-GH An important thing we should mention when we talk about GH is Lionel Messi. He was diagnosed with GH deficiency, and that s why he was indicated to take these injections. So Barcelona fans should not be very proud of themselves. The only reason that Messi moved to Barcelona was the fact that they offered him the growth hormone treatment. They took him from his club in Argentina and paid for the GH treatment; that s why he moved to Barcelona. First of all, when they identified it they started to purify it and take it from animals and using it for humans, but the problem is that it was too antigenic and it wasn t effective in humans. So the only advancement that served this growth hormone treatment was the introduction of the recombinant DNA technology. At that time we were able to synthesize the human GH itself from this technology and we could use it. Now the drug we know now is somatropin, you know that the growth hormone is called somatotropin, so it is easy to remember. It s given by injections. Indications: 1- It is given in GH deficiency cases. 2-Chronic wasting conditions, like cachexia in general, AIDS and cancer. A recent advancement in the guidelines says that you should use the GH in chronic wasting conditions, like cachexia in general, AIDS and cancer. We know that in cachexia cases, like in AIDs, the wasting of the muscles is something very bad for the patient. So by using the GH, the only thing you are targeting is the increase in the lean body mass and the growth of the bone. which means that we are strengthening the patient. Now the effect on the cartilage will be good. But the balance is toward increasing the lean body mass mostly when you give this drug to such conditions. The cause of wasting in cancer can be due to: A- The cancer itself, if it s affecting the hematopoietic system for example. B- The chemotherapy sometimes. C- it can also be related to the psychological stress on patient) 8 P a g e

10 3- Normal short stature It s a recent indication, so what does that mean? There is something that we call the constitutional short stature or in other terms the normal short stature, the GH levels in the patient are okay and within the normal range. A study, a big clinical study, was done over these individuals. when They ve achieved the supra physiological levels of the growth hormones in those individuals.it was found that this can increase their lean body mass and bone growth, and might give them a few CMs in length. But it is not like a 100% proven fact that if you give it to these patients they are going to grow. Now the problem is: 1 it has to be used 3-7X/week 2-it is extremely expensive. (SC, IM). Since this was very frequent, 3-7X a week. Now we have the depot preparations. So you could use it once or twice per month. Which has cut the difficulty of giving the drug, but at the same time you know that it will be even more expensive. C/I (contraindications): 1-doping purposes: You know that the Olympic anti-doping committees test for this growth hormone frequently. If it was not taken for a medical reason, athletes will get banned. Messi was not banned because it was for a medical reason. 2-Diabetic retinopathy. Diabetes in general and particularly when we start to have the complications of diabetes. One of the earliest complications of diabetes is retinopathy. Whether the active proliferative retinopathy or even the severe non-proliferative retinopathy. that s an absolute contraindication for the use of GH, because again the patient is having the complications and that s means the diabetes is extremely hard to treat. 3-pediatrics with closed epiphysis: If you give somatropin to a child with closed epiphysis, there will be an induction of bone growth. But at the same time it s a closed epiphysis. So that s mean there will be derangements in this bone growth, so it s contraindicated. 9 P a g e

11 4-Increased ICP (intracranial pressure): The brain tissue is also in a closed space. So if the patient is known to have an increased ICP (intracranial pressure) for whatever cause, it s contraindicated to use GH due to two possible causes: a- Induction of the growth in a closed space. b- The other thing is that from our practice we know that giving the GH might induce the fluid retention. So induction of this fluid retention in a closed space that has an already increased pressure will complicate matters for the patient, so it s contraindicated. 5-obesity: - If a diabetic patient is obese we don t use it. -if the patient is having GH deficiency or short stature and he is obese, would you use it or not? -If we have a morbid obesity so the BMI is more than 35 or something that s an absolute contraindication. -Now if you have a child with a growth hormone deficiency, and he is a little bit obese or overweight. You can use it. Because it will shift this metabolism into more use of fat. -Unless we have a mentally retarded patient with a growth hormone deficiency. We have for example a syndrome called Prader-Willi syndrome or the funny child syndrome. The first one who talked about it and described it was Charles dickens in one of his stories, then it was known as a syndrome. Those children have some mental retardation and growth abnormalities. So if a child with Prader-Willi syndrome was obese and having GH deficiency, we don t use somatropin. Because the eating systems and lifestyles will not change for that patient if he stayed in his home doing nothing. 3-Somatostatin -It s extremely hard to understand it for a reason or another. - It affects the anterior pituitary leading to the inhibition of the secretion of the GH. And at the same time it inhibits the secretion of the TSH (thyrotropic stimulating hormone), okay that s manageable. 10 P a g e

12 - We know that it s secreted frequently from the pancreatic cells. Now these pancreatic cells within the islets are secreting the insulin and glucagon. The secretion of the somatostatin will inhibit both systems, which again doesn t any make sense! If you inhibit insulin how could you inhibit glucagon! We ll come to that in a minute. In addition to that, it s just an enemy for any type of GI secretions. First, it inhibits the release of VIP (vasoactive intestinal peptide).the VIP increases the blood flow to the intestine, so if it inhibits that, it ll inhibit the blood flow. But that s not the only thing it do, any type of secretions from the stomach down to the intestine will be inhibited; gastrin, HCl, CCK. they will be inhibited by somatostatin. So in a way or another, it resembles one condition, which is the malabsorption syndrome. In a way or another, it s inhibiting the gastric emptying, the gastric activity and the intestinal activity. So that s will lead to a picture similar to the malabsorption syndrome. Now somatostatin is not used clinically for two main reasons: 1- It has too short half-life even when it s given IV (1-3 minutes). 2- It produces just too much insulin effects. And when I say insulin effects I mean insulin inhibitory effects. It inhibits insulin more than inhibiting glucagon, which again doesn t make any sense! Because it inhibits GH, and GH is counter regulatory to insulin. So if you inhibits GH, insulin should increase! And how does it inhibit GH and then it has a minimal inhibition to glucagon?! Okay, in general what is the result of the effect of somatostatin on the glucose system? It s called dysglycemia. When Dys- is used in clinical practice, it means nobody knows what will happen. Sometimes the patient will have hyperglycemia and sometimes the patient will have hypoglycemia, now is there a clear cut explanation for that? Not really. From the autonomic nervous system, you remember dopamine. Dopamine can have several effects on several types of receptors. But we know for sure (from clinical practice) that the dose of dopamine will decide which type of receptors will be affected. In the case of somatostatin it s not clear too, nobody knows that! 4- OCTEROTIDE Because we can t use somatostatin, we have produced the somatostatin analogue. That analogue, from its name OCTEROTIDE, is an octa peptide of the somatostatin. 11 P a g e

13 In what conditions we use it? (Indications) 1-the secretory diarrhea. 2-VIPomas (it is an increase in the VIP; vasoactive intestinal peptide) 3- Acromegaly. 4-upper GI bleeding. (If it is coming from a defined source like esophageal varices) Octreotide compared to the somatostatin itself it has a longer half-life (90 min) and higher selectivity. Which means: it has less insulin effects and more effects on the GH secreting tumors. - It is given SC 3X/day, but we have also depot preparations (IM).which can be given once per month. What are the expected side effects? The side effects of octreotide are related to what I mentioned which is the malabsorption like clinical picture. Which means the patient will end having: 1- Diarrhea. 2-flatulence. 3-stateorrhea. 4- Gallstones. Because the patient is not digesting food, and he s not absorbing the ingredients of that food. So it s a malabsorption syndrome. At the same time it also inhibits the motility of the gallbladder and that leads to gallstone (the production of these gallstones). 5- Pegvisomant The last thing we will take about in the GH system is the GH receptor antagonists; pegvisomant. It is a GH receptor antagonist KEEP IT IN MIND. Now when you see this Peg- (prefix); in pharmacology it means this drug has polyethylene glycol added to it. -SC injections. The mechanism of action: Pegvisomant blocks the action of growth hormone at the growth hormone receptor to reduce the production of GH mediated release of IGF-1 & 2 (somatomedins). 12 P a g e

14 -An important thing about it that it has mainly a higher selectivity for certain receptor. That s why we can use efficiently in resistant Acromegaly. That s possibly the most important indication for this drug. S/E: 1-Liver toxicity. 2- Injection related side effects. (Wasn t mentioned by the doctor) The side effects are not that common and not that bad. Except for one, which is the liver toxicity. It is not something you see very frequently, but we know for sure that it affects the liver function. So you might need to do the LFT routinely in these patients. So if I have acromegaly, what s your first choice? OCTEROTIDE will be our first choice. If it is a resistance type of acromegaly, you might not target the GH itself but target the receptor that leads to the production of IGF 1-2. So you will give PEGVISOMANT. As a summary: In the GH hormone deficiency conditions like DWARFISM (pituitary type). Somatropin as first choice Sermorelin (drug releasing hormone) as a second choice. the cases of GH excess like in ACROMEGALY or GIGANTISM. OCTEROTIDE as a first choice If it s a resistant type of ACROMGALY we might use something to target the GHR itself that is PEGVISOMANT. We can t use SOMATOSTATIN A student asked if octreotide can lead to dysglycemia, and Lecturer answer was: It could lead to dysglycemia. But what I have mentioned that is mostly encountered in practice, which is the malabsorption like clinical picture (OCTEROTIDE), which means what? It means that you have to be cautious in prescribing such drugs in patients that have DM or glucose intolerance. 13 P a g e

15 Another student asked a question, but we couldn t hear he said. The answer was: As I explained earlier, now the idea mostly; they might act on the insulin receptor itself, because they are structurally related. Now if you act on the insulin receptor, that s will lead to increase in the glucose uptake and increase in glycogenesis. Which is opposite to GH drugs. Now how do we differentiate between those effects? The fact is that the IGF is targeting some specific structures in the body. Particularly the cartilage, and they can produce their effects on it. They don t go too much into the adipose tissue, and they don t have too much effects on the glucose metabolism itself. Unless you give it in very high dose and for a very sustained and continuous manner. So you start producing insulin like effects, which has a counter regulatory effects with the GH; which is in another way will have a negative feedback inhibition in the secretion of the GH itself. How could we understand that? Simply the GH comes down from the pituitary producing certain effects. Most of these effects will be on the liver, inducing the production of somatomedins. Somatomedins will start the negative feedback on the GH and it may not last way too long to start producing the insulin effects. but if you have a GH secreting tumor ; which means it is not coming from the hypothalamus, the GH is secreted from outside. OKAY and that will keep giving somatomedins, and the somatomedins will have the negative feedback on the pituitary. But the GH is not coming from the pituitary! It is coming from a secreting tumor. ************************************ Those who are going to specialize in endocrinology will be very happy; because it is A TRIAL AND ERROR practice. They don t know facts, they DON T know guidelines. SO I bring a patient and I give it a dose of drug, wait and see what will happen. If something bad occurs we modify the dose. If something good occurs, we will continue. Then you will come after couple of months, and we will do the same concept again, why? It is because of the complexity of the system. On Monday we will continue the PRL and start with the thyroid. This sheet includes all slides, and it is more than enough. Done by: Baha Eldeen BaniFawwaz & Ahmad Dwairy. The End اهداء الى التوابع..! 14 P a g e

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