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Dr. Deb Muth
0:00 Welcome back to Let’s Talk Wellness Now. I’m your host, Dr. Zab, and we are continuing our discussion this week on
0:08 peptides. And so, if you haven’t heard our first conversation about peptides,
0:13 please go back and look at that episode. We talk all about the manufacturing, the safety, the quality of peptides, and we
0:20 dove into GLP1s. And today we’re going to dive into peptides for sexual
0:26 wellness, immune function, growth hormone, and all the amazing fun things
0:32 we can do with peptides. So, as usual, grab your cup of coffee or tea, settle
0:37 in, and let’s talk wellness now. And we’re going to take a short pause from our sponsor. I know we’ve got to do
0:44 that, you guys. They’re who keep us on the air. So, I’m going to pause for just a minute and be right back after this
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1:10 Serenity Health. Because every queen deserves to feel in her prime. All
1:15 right, everybody. We are back. And are you ready? We are talking all things peptide and I am opening the show today
1:23 with sexual wellness. Yes, I’m going there, you guys. I am going there. You
1:29 know, this has really become a big issue for people um of all ages. It’s not just
1:3 4us older people. It’s younger people, too. And there’s a whole variety of reasons why we have sexual dysfunction.
1:42 And when we’re talking about sexual dysfunction, we’re not just talking about it doesn’t work, right? Or I can’t
1:48 reach orgasm. A lot of it is around desire and um the thought of it and
1:54 wanting to connect, wanting to be kinder to one another, wanting to be touching
2:00 one another. A lot of it resolves or revolves around that. And so there are some peptides that can help us and I’m
2:08 really excited to be able to talk about those today. So the first one is called PT-141.
2:14 This targets the brain not the periphery. Right? So for many women I
2:20 will always tell you sex starts between here. It is a brain thing for us. It is
2:26 not necessarily a physical thing. For guys that’s a little different. It’s very physical. For women it’s all in our
2:32 brain. So tip for you men that are listening. You have to prime your woman’s brain first if you want her to
2:38 have sex with you that night. You have to be nice to her. You have to bring her flowers. Do the dishes for her. Do
2:45 something kind. Bring her a cup of coffee or tea or a glass of wine. Take her to dinner. You have to woo her. And
2:51 I don’t care how long you’ve been married. That has to happen. And tip number two, don’t say anything stupid
2:57 that day. I’m just being honest. When you guys say things that make us upset,
3:03 that lingers with us for the rest of the day. And it’s it’s a turnoff for us. And
3:08 for a lot of women, we can’t get past that when it comes time to snuggle at night. And sex doesn’t always have to be
3:14 at night either. So, you can tell I really love talking about this conversation, but we’re going to get into the peptide part of it because this
3:21 is going to help people. So, um, PT-141 is marketed as I’m going to slaughter
3:28 this name, Vali, and it represents a fundamentally different approach to
3:34 sexual dysfunction than the PDE5s inhibitors like Slenden, Viagra,
3:40 Tedataphil, which is Seialis. And while the PDE5 inhibitors work specifically by
3:47 enhancing blood flow to the genital tissues, PT-141 works centrally in the brain by
3:54 modulating neural s neural circuits involved in the sexual desire and
4:00 arousal. Now PT-41 is a cyclic hpatipeptide. It’s seven amino acid
4:07 peptide arranged in a cyclic structure that acts as a melanoortin receptor
4:13 agonist and with particularly the infinity for MC3R and MC4R subtypes.
4:20 It’s actually a metabolite of the melanotan 2, a peptide originally
4:26 developed for tanning that was also found to enhance sexual desire in early
4:31 studies. Now the melanoortin system in the brain is involved in multiple functions including energy homeostasis
4:39 but it also is involved in sexual motivation and arousal behaviors. The FDA approved PT-141 in 2019 specifically
4:48 for the treatment of acquired generalized hypoactive sexual desire
4:54 HSDD in permenopausal women. So for the first time we have a medication that was
5:01 approved by the FDA to use for women for sexual dysfunction. We have had all of
5:07 these seialis tedataphil viagros for men but we had nothing for women. And so
5:12 this is amazing that this is available for women and approved by the FDA. It’s a big deal. This represents the first
5:19 and only FDA approved medication specifically targeting these circuits of sexual desire rather than the peripheral
5:27 arousal mechanisms. And this indication is quite specific, meaning it was developed at some point, not lifelong.
5:35 So I if you’ve had sexual dysfunction your entire life, this medication was
5:40 not approved for you. But if it’s something that you developed over time, like when you went through pmenopause or
5:46 menopause or some women have this experience happen after childirth, that’s what we’re talking about here.
5:53 Now, it’s also not just um supposed to be used if you dislike your partner,
5:59 right? If your relationship is bad and you dislike your partner, this probably isn’t going to fix a ton. It might help
6:05 a little bit, but that’s not what it’s meant for. So, you really have to know what you’re using it for and why. And
6:11 the other thing that I would say is this is something that we don’t go to if your hormones are not balanced properly. You
6:17 have to balance your hormones properly before using something like this because it still may not work. Now, the only
6:24 caveat to that is if you’re a woman that has a risk of breast cancer and can’t use hormones, then that’s a different
6:31 story and we would have that conversation about whether or not this medication would be appropriate for you. Now, the FDA label specifies PTA1 uh
6:39 PT-141 as it not being indicated for HSDD in causes where low sexual desire
6:46 is due to coexisting medical or psychiatric conditions, problems with relationships, like we had talked about,
6:53 side effects to medications or other substance use. This specifically reflects the importance of differential
6:59 diagnosis. Low sexual desire can have many root causes and PT-41 is only
7:05 appropriate when those causes have been ruled out. Now, I have I used PT41 in
7:10 people who have sexual dysfunction issues as a result of using
7:16 anti-depressants. Yes, I have. I’ve used Flynn in that effect as well. And it
7:21 does work sometimes, but it doesn’t work completely. But you need to know that that is not what the approval is for the
7:27 FDA. So that is done in something that we call off label use. So very important
7:33 to know. Now in these clinical trials leading to FDA approval, this was published by Kinsburg and colleagues in
7:40 obstetrics and gyne gynecology in 2019. PT-141 demonstrated statistically
7:46 significant improvements in sexual desire and decreases in distress related
7:51 to low desire compared to placebo. The effects manifest over 45 minutes to
7:56 several hours after the injection and the mechanisms involved modulation of dopamine and melanoorton pathways in the
8:04 hypothalamus and the brain regions that involved sexual motivation. Now cardiovascular effects of PT 141 require
8:12 careful attention. This drug causes transient increases in blood pressure about 3 to four points and transient
8:20 decreases in heart rate. And because of this, it is contraindicated in patients
8:25 with uncontrolled hypertension or known cardiovascular disease. And it has been studied in patients who’ve had recent
8:32 cardiovascular events or sorry hasn’t been studied hasn’t been studied in patients who’ve had recent
8:39 cardiovascular events. So patients need to have their blood pressures checked before starting therapy. Nausea is
8:45 extremely common. It is one of the biggest things I often will tell people to take an anti-nausea medicine if
8:52 they’re going to do this because the last thing you want to do is inject this medication and think it’s going to give
8:57 you this great time with your partner and you’re so nauseated that you can’t even perform, don’t want to kiss, don’t
9:05 want to do anything. It it can be pretty profound for some people. um it does affect about 40% of the patients in
9:12 clinical trials which is why many clinicians require or recommend an
9:17 anti-nausea medication like I had just said other common adverse effects include flushing injection site
9:24 reactions headache in about 13% of the population which I have seen worse if
9:30 people are prone to headaches and the headaches are pretty intense so I will also have them premedicate if they have
9:36 that um sensitivity ity with a Tylenol or Advil, Alie, whatever it is they
9:42 typically use for their headaches to help prevent that from occurring. Now, some patients also experience a
9:50 generalized hyperpigmentation of their skin, particularly in areas with chronic friction, and this may not be reversible
9:57 after discontinuation. So from an integrative perspective, PT-41
10:03 represents one tool in addressing female sexual dysfunction, but it should never be the first or only intervention. And
10:11 low sexual desire in women is complex. Multiffactorial involving hormonal imbalances, low testosterone, estrogen
10:18 deficiency, progesterone imbalances, thyroid dysfunction, adrenal dysfunction, and with elevated or
10:24 disregulated cortisol levels, sleep deprivation, relationship issues, unresolved trauma, including sexual
10:31 trauma, chronic pain, body image concerns, and medication side effects such as SSRIs are notorious for this. So
10:39 a comprehensive hormone panel including total and free testosterones, estradile,
10:45 progesterone, DHEA, thyroid function in cortisol assessment, ideally four-point
10:51 cortisol, salivary should precede any pharmacological intervention. And additionally, addressing the
10:57 psychological component and relationship dimensions through appropriate therapy is necessary. I have a lot of patients
11:03 that say, “This is just too much work for sex. I don’t want the side effects. I don’t want to deal with this.” and that’s totally fine. But for some
11:09 people, their sexual dysfunction is actually causing more problems on their
11:14 relationship and they want to do something to fix that. And just know that if you’re using a peptide like this
11:20 that comes with some of these side effects and you have to premedicate for it, it is not the end of the world. Um,
11:27 but it may be a possibility that you may need that. So, let’s dive into body composition and growth hormone access.
11:34 So Tesmarellin is the only FDA approved GH
11:40 analog. Tesarelin is marketed as Agrifta and Agria SV. It is a synthetic analog
11:48 of human growth hormone releasing hormone. So GH RH human growth hormone
11:53 releasing hormone. These things are such long names it’s confusing and it’s difficult to spit out, right? It
11:59 consists of 44 amino acids. The structure is identical to our own
12:05 body’s growth hormone GHR um with the addition of trans3 hexonol group which
12:14 stabilizes the molecule that extends its half-life compared to the native GHR.
12:19 The mechanism of tesmarellin is elegant in its preservation of physiological
12:24 growth hormone GH secretion patterns and rather than administering an exogenous
12:30 growth hormone directly, tesmarillin binds to the GH receptor in the anterior
12:36 pituitary gland stimulating the indogenous pulsatile release of GH. So
12:42 you know it it’s slower in that stimulation and it pulsates instead of a direct rise and fall. This pusile
12:49 pattern more closely mimics natural GH secretion which occurs in bursts
12:54 primarily during sleep. The GH then stimulates the liver to produce insulin-like growth factor IGF-1 which
13:01 exerts many of the downstream metabolic effects including lipolytic effects on
13:07 the atapost tissue. So fat atapose and how we break that down. The FDA approved
13:13 tesmarellin in 2010 for a very specific narrow indication, the reduction of
13:19 excess abdominal fat in HIV infected patients with lipodistrophe. This
13:25 condition characterized by abnormal fat redistribution with accumulation of visceral body fat and the loss of
13:32 subcutaneous fat in face and limbs developed as a complication of an
13:37 antiviral therapy particularly with older protease inhibitor reg uh
13:42 regimens. The visceral fat accumulation in patients is not just cosmetic. It’s associated with increased cardiovascular
13:49 risk, insulin resistance, and inflammatory markers. The pivotal trial that led to the FDA approval included
13:56 work by Stanley and colleagues published in the annuals of internal medicine in 2014. It demonstrated that tesmarillan
14:03 significantly reduced the visceral atapose measured by CT scan by approximately 15 to 20% which is a
14:10 significant difference to placebo over a short period of time only 26 weeks. Now,
14:16 interestingly, the total body uh weight typically remained stable or even
14:21 increased slightly as the reduction of visceral fat was sometimes offset by increases in lean body mass or
14:28 subcutaneous fat. This highlights an important point. Tesmearellin is not a weight loss drug in its conventional
14:34 sense. Its effects are specifically on body composition and fat redistribution.
14:40 Now the glucose metabolism effects of tesmarellin do require careful monitoring because GH and IGF1 can
14:47 induce insulin resistance. Tesmearellin can increase glucose levels and hemoglobin A1C and in these clinical
14:54 trials glucose tolerance and new onset diabetes occurred in some patients. So
14:59 this creates a therapeutic paradox while res reducing visceral fat we should theoretically improve metabolic health.
15:07 The GH mediated insulin resistance can worsen the glycemic control and patients
15:12 with diabetes require particularly close monitoring. The potential need for adjustment in diabetic medications can
15:19 occur. So I already know what you guys are thinking. Can I use Tesmarellin and
15:24 GLP1 at the same time? And the answer is yes. Especially in those people that we
15:30 know have an insulin resistance already or are prone to that, we can use lowd
15:36 dose micro doing GLP-1 along with tesmarellin to help prevent this from
15:42 occurring um or reduce the risk of it occurring. Now there are some other adverse related problems to growth
15:49 hormone access which include fluid retention which can uh manifest as uh
15:55 ankle swelling, joint pain, muscle pain, paristhesas, carpal tunnel syndrome is
16:01 common to see. Of course you can always see injection site reactions reported about 26 to 30% of the time in the trial
16:08 participants. And this also theoretically has a concern about IGF-1 elevation potentially promoting
16:14 malignancy through long-term data is limited. So we have to be cautious about
16:20 this but it is a growth hormone and anything that is a growth hormone can cause cells to grow and it cannot
16:26 necessarily differentiate between healthy cells and bad cells. So the drug is contraindicated is contraindicated in
16:33 patients with active cancer and in patients with the disruption of the HPA access from conditions like pituitary
16:40 tumors, pituitary surgery, head of radiation um and traumatic brain injury.
16:46 Now off label use of tesmarellin for general anti-aging or body composition
16:51 optimization in non-HIV population, it doesn’t have FDA approval. There is no
16:58 FDA studies. um that promote this, but practitioners do prescribe it for these
17:04 purposes under an experimental and not supported by FDA approved indications.
17:10 And um from an integrative medical standpoint, optimizing natural growth
17:15 hormone secretion through lifestyle interventions, high quality sleep is important. GH primarily is excreted
17:22 during sleep and deep sleep waves. So improving your deep sleep is important. Intermittent fasting can also increase
17:28 growth hormone by five-fold as demonstrated in a Hartman and colleagues uh study from the journal of clinical
17:35 endocrinology and metabolism in 1992. And highintensity interval training, adequate dietary protein, blood sugar
17:42 control, these all can help naturally increase your growth hormone. So, let’s
17:47 dive in now and talk about bone health. peptide hormones um such as oh I’m gonna
17:54 I’m gonna really slaughter this name. Terraparatide is a true bonebuilding
18:01 peptide. It’s marketed as forio. It’s a recumbent form of the first 34 amino
18:08 acids out of 85 of the human parathyroid hormone PTH. It represents a unique
18:13 approach to osteoporosis treatment because it’s one of the few truly anabolic anabolic bone therapies meaning
18:21 it actively binds new bone rather than simply preventing bone loss. The biology
18:26 of parathyroid is fascinating and seemly contraindicated or uh contradictory.
18:32 Continuously sustained elevations of PTH as occurs in hyperarathyroidism
18:37 is catabolic to bone. So people who have hyperarothyroidism typically have significant bone loss
18:44 especially before it’s diagnosed and it causes causes increased bone
18:49 reabsorption loss of bone density increased fracture risk and however
18:55 intermittent exposure to PTH as achieved with once daily uh injections of forio
19:01 has the opposite effect. This intermittent exposure preferentially stimulates osteoblasts bone building
19:08 cells over osteoclasts bone reabsorbing cells and it leads to
19:13 the net bone formation. So terraparatide binds to the PTH receptors on
19:20 osteoblasts and renal tubular cells in bone. It increases the number of
19:25 activity of osteoblasts stimulating the differentiation of osteoblast precursor cells and may
19:32 reduce osteoblast apoptosis basically programmed cell death allowing this bone
19:37 building cell to work longer. The result is increased bone formation, improved bone architecture and tbacular
19:45 connectivity and ultimately increased bone mineral density um particularly in the hip and the spine which is so
19:51 difficult to regain. The FDA approved this medication in 2002 based on pivotal
19:57 studies by Near and colleagues published in the New England Journal of Medicine in 2001 which demonstrated significant
20:05 reductions in vertebral and non-vebral fractures in post-menopausal women with
20:11 osteoporosis. specifically uh reduced new vertebral fractures by
20:17 65% and nonvettebral fragility fractures by 53%
20:23 compared to placebo over a median followup of 21 months. This is really
20:29 incredible because we have not seen this kind of um change uh in other
20:35 medications that we’ve used for osteoporosis. So current FDA approval
20:40 indicates uh this for post-menopausal women with osteoporosis at high risk for
20:46 fracture, men with primary or hypoconatal osteoporosis at high risk for fracture
20:53 and men and women with glucocord cord glucocordide
21:00 induced osteoporosis at high risk for fracture. The high risk qualifier is
21:05 important. uh terrapeptide is reserved for patients with severe osteoporosis,
21:11 multiple fractures, very low low bone density and those who have failed or are
21:16 intolerant of other therapies. The most significant concern for this medication
21:21 is highlighted in a boxed warning with rat toxicology studies where it caused
21:27 osteioaroma which is a bone cancer in a dose dependent and treatment duration dependent manner. The revolence of this
21:34 finding to humans is debated. Rats have fundamentally different bone biology than humans with continuous bone growth
21:41 throughout life and different PTH receptors. Now post marketing
21:46 surveillance in humans hasn’t shown a clear increase in osteocaroma risk but
21:51 theoretically concerns persist and because of this terapeptide is
21:57 contraindicated in patients at risk baseline risk for osteioaroma
22:02 including those with pageantss disease of the bone unexplained elevations of alkaline phosphate prior skeletal
22:10 radiations bone metastases or skeletal malignancies and pediatric patients or young adults
22:16 with open hyes. There’s also a lifetime treatment duration of only 2 years and
22:22 terrapeptide can cause transient hypercalcemia. So an elevated blood calcium and as PTH normally increases
22:31 calcium levels by enhancing bone reabsorption, increasing renal calcium
22:36 reabsorption and promoting activation of vitamin D which increases intestinal calcium absorption. Some patients
22:43 experience orthostatic hypotension within 4 hours of injecting requiring
22:48 caution in at risk populations for blood pressure. Common side effects include
22:53 muscle pain, joint pain, pain in the limbs, nausea, headache, and dizziness. So from an integrative bone health
23:00 perspective, terrapeptides should be part of a comprehensive strategy. Adequate calcium intake, 500 to a,000
23:08 milligrams of calcium a day from food and supplements combined. and vitamin D.
23:13 Getting vitamin D levels of at least 50 to 80 are essential for the drug to work
23:20 optimally. But beyond this, bone health requires vitamin K2, which directs calcium into the bones rather than soft
23:27 tissues, magnesium as a co-actor in bone metabolism, trace minerals like boron,
23:33 copper, silica, and of course, adequate protein intake, which many of us, especially as women, don’t do 0.8 8 to 1
23:42 gram of protein per kilogram of body weight, weightbearing exercise. Of
23:47 course, these all provide mechanical signals that complement the biochemical
23:52 symbol uh signals of terrapeptide. Sequential therapy is also critical. The
23:58 bone mass gains from terraparatide can be lost if patients don’t transition to
24:05 an anti-resorbbitive agent a bisphosphinate after completing this therapy and the anabolic effects to
24:12 build bone but maintaining the new bone requires preventing excess reabsorption.
24:18 So positive things about this but there are definitely some concerns as well. So
24:23 the next one we’re going to talk about is Lu Prolrooide. It is marketed under
24:29 the multiple brand names of Lupron, Depo, Eligard, and it’s a synthetic
24:34 nonapeptide analog of naturally occurring ginonadotropen releasing
24:39 hormone G&R, also called luteinizing hormone releasing hormone, LHR.
24:46 It’s a fascinating example of how manipulating natural hormonal feedback systems can create therapeutic effects.
24:53 So, G&RH is normally secreted in a pulsatile fashion by the hypothalamus
24:59 and travels to the anterior pituitary where it binds to G&R receptors and
25:05 stimulates the release of luteinizing hormone LH and follical stimulating hormone FSH. These ginatotropins signal
25:13 the ovaries or the testes to produce sex hormones, estrogen, progesterone in
25:18 women, testosterone in men. Uh, luoprololi lupron as a GNR agonist
25:26 initially mimics the action of natural G&R causing an acute flare response with
25:33 uh increased LHFSH secretion which temporarily increases sex hormone
25:38 production. However, the continuous administration which is in the depo
25:44 formulations, the GNR receptors in the pituitary become desensitized and
25:50 downregulated. And after about 2 to four weeks of continuous exposure, LH and FSH
25:56 secretion is profoundly suppressed, leading to what’s termed as chemical
26:01 castration. Testosterone levels in men drop to castrated levels less than 50
26:08 and estrogen production is marketkedly suppressed in women. This bifphasic
26:13 response creates both therapeutic applications and management challenges in prostate cancer where tumor growth is
26:20 typically androgen dependent and the ultimate goal is testosterone suppression. However, the initial
26:27 testosterone surge during the flare phase can temporarily worsen symptoms potentially causing increased bone pain,
26:34 urinary obstruction, or even spinal cord compression in patients with metastatic
26:40 disease. This is why uh luoprolide is often started with an anti-ad androgen
26:47 like bicladamide for the first two to four weeks to block the effects of the
26:52 testosterone surge. The FDA has approved lupalide for multiple indications across
26:59 formulations. In oncology, it’s used for palletive treatment of advanced prostate cancers. In gynecology, various
27:06 formulations are approved for endometriosis, for pain management and lesion reduction and for fibroids.
27:13 Typically for pre-operative uh hematological improvement in anemic patients. In pediatrics, it’s used for
27:20 central precocious p puberty basically to halt the premature sexual development of these young people. Now, there are
27:28 adex uh adverse effect profile that reflects profound hormonal suppression.
27:34 In men treated for prostate cancer, hot flashes affect about 59% of the patients. Other common effects include
27:41 general pain, swelling, bone pain. Um long-term use of these medications leads
27:47 to metabolic changes. It increases fat mass. It decreases lean mass. It worsens
27:53 insulin sensitivity, disrupts the cholesterol uh lipid panels, increases
27:59 diabetic risk, has some concerns over cardiovascular disease. And the metaanalysis have shown increased risks
28:06 of heart infarction, myocardial inffection, sudden cardiac death, and stroke in populations receiving
28:13 long-term androgen deprivation therapy. The bone effects are particularly dramatic. Without sex hormones, bone
28:20 density decreases significantly, typically 3 to 4% per year during the
28:26 first two to three years of therapy. And this bone loss may not fully be reversible after the the therapy
28:32 discontinues. The American Society of Clinical Oncology recommends bone density monitoring and consideration of
28:39 bisphosphinates uh in men receiving long-term androgen deprivation. In women treated for
28:46 endometriosis or fibroids, the estrogen suppression creates a hypoestrogenetic state similar
28:54 to menopause. Hot flashes affect 90% of patients with other common effects
29:00 including headaches, emotional irritability, decreased sex drive, vaginal dryness, bone density loss. And
29:08 because of these bone concerns and treatment duration with endometriosis, typically limited to six months, though
29:14 some formulations allow for longer use with adback hormonal therapy to
29:20 partially mitigate these side effects. The mood and cognitive effects can be s
29:25 significant. I’ve seen it over the years. the depression, the memory impairment, difficulty focusing and
29:31 concentrating. It can be very very traumatic and the quality of life that
29:37 happens for these uh women and men can be unbearing for many of them. Um, from
29:44 an integrative perspective, patients receiving this medication need comprehensive support care. Bone health
29:51 interventions using calcium, vitamin D, vitamin K2, weightbearing exercise,
29:58 cardiovascular risk management becomes critical, including blood pressure monitoring, lipid management, diabetes
30:05 screening. For hot flashes management, some patients respond to black coohos,
30:10 sage, or vitamin E. Though evidence is mixed and individual response varies,
30:16 omega-3s may help with the mood and the inflammation, resistance training becomes specifically important to
30:22 preserve lean muscle mass in the face of hormonal suppression.
30:27 Now there’s something called calcetonin salamon which is marketed as miaelin.
30:34 It is a nasal spray. It is now discontinued. And foral is the new
30:39 synthetic polyeptide hormone of 32 amino acids identical to calcetonin of salamon
30:47 origin. It represents an interesting case study in how initial promise gives
30:52 way to safety concerns that regulate a therapy to historical footnote status.
30:58 Calcetonin is naturally occurring hormone in humans. It’s secreted by the paraphalicular sea cells in the thyroid
31:04 gland. Its primary physiological role is to lower blood calcium levels by
31:10 directly inhibiting osteoclast activity, reducing bone reabsorption, increasing
31:16 renal calcium secretion or excretion, and possibly reducing the intestinal
31:21 calcium absorption. So, salamon calcetonin is used therapeutically because it’s more potent and longer
31:27 acting than human calcetonin. The FDA initially approved calceton and salmon
31:34 for several indications post-menopausal osteoporosis in women more than five
31:39 years post-menopausal when alternative treatments are not sustainable. Padet’s
31:44 disease for bone and hypercalcemium as emergency treatments. The nasal spray formulation is particularly popular for
31:53 osteoporosis because it offered a non-injectable alternative to bisphosphinates.
31:58 However, in 2012, the European Medicine’s Agency, EMA, conducted a
32:05 comprehensive safety safety review after a poolled analysis of 21 clinical trials
32:10 involving over 10,000 patients showed a statistically significant increase in
32:15 malignancy risk in patients treated with calceton salamon compared to compared to
32:21 placebo. The overall malignancy rate was 4.1% in calcetonin treated patients
32:28 versus 2.9% in placebo patients. The types of cancer
32:34 varied with no single cancer type predominating, making it difficult to establish a clear mechanistic link.
32:41 However, the signal was concerning enough that the EMA restricted the use of calcetonin containing medicines. In
32:48 the United States, the FDA issued communications about malignancy signal and conducted its own review. While they
32:56 didn’t fully withdraw the drug, the cons consensus shifted dramatically. The nasal spray formulations miaelson was
33:03 voluntarily discontinued by the manufacturer and current clinical practice guidelines now consider
33:10 calcetonin salamon as a second line or lower option for osteoporosis. While
33:15 behind bisphosphinates, dennism mob, uh, terrapeptide, the analesic effect of
33:21 calcetonin in bone pain, particularly in acute vitibbral, uh, compression
33:26 fractions from osteoporosis or pageantss disease may still provide a role for short-term use in these selected
33:32 patients. The mechanism of this pain relief is unclear, but may involve
33:38 effects of endorphin systems and/or direct actions on pathways. The history serves as an important reminder in
33:45 peptide medicine. Initial approval and early clinical use does not guarantee
33:50 long-term safety effects. Post marketing surveillance and poolled analysis of the clinical trial data can reveal adverse
33:58 effects that weren’t apparent in initial studies. It also underscores why newer
34:04 agents with better safety profiles um have largely replaced calcetonin in
34:10 clinical practice. So this is really an important thing. Not one thing stays the same forever. We have to change as we
34:18 identify new and better products as we identify problems and concerns. I will
34:24 always tell my patients if you are uncertain of taking a new drug which we
34:30 all should be wait five years. Within five years we are going to find the
34:36 problems that they didn’t find in the clinical studies. Remember, a lot of these clinical studies are small, small
34:43 groups, short periods of time. It’s expensive to do these trials. So, if you
34:49 wait for five years, in the first two to three years, you will see the problem start to emerge. And what are you going
34:55 to look for? You’re going to look for the the news um commercials from lawyers
35:02 suing a drug. And they will tell you what the problem is. and then you can decide, is this something that I want to
35:09 use or not. Don’t jump on bandwagon and be the first one to do this, especially
35:14 if you’re sensitive. You know, give it time so you can see exactly what’s going on. So, I’m going to end our show on
35:22 this and we are going to pick up on part three of peptide therapy in our next
35:28 segment where we’re going to talk about the investigational peptides and some
35:34 exciting things that are happening with that. So, I want to thank you for joining me today on Let’s Talk Wellness
35:39 Now. It’s always a pleasure having a conversation with you guys and I hope this brings value to you with what we’re
35:45 talking about. If you have ideas for topics that you want me to discuss,
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