Acromegaly Disease

Combating Acromegaly: Developing Health Advantages through Industry Insights Analysis

Rare in nature, Acromegaly is primarily brought on by over-secretion of the hormone that stimulates tissue development and other metabolic abnormalities by the anterior pituitary gland.

According to NIH, around 3000 individuals have been identified in the UK and 15000 in the USA; however, it is plausible that there are additional cases that are not receiving clinical attention. Acromegaly is more common than previously thought, with data from Italy suggesting an incidence of up to 6.9 per 100,000 people and Iceland reporting 7.7 patients per million annually.

Acromegaly has a prevalence of ~4,600 cases per million people worldwide, with an annual rate of ~116-119 new cases, and its incidence is on the rise. On average, a diagnosis is made for men and women at 40 and 45 years of age, respectively. Acromegaly usually appears in the third decade of life.

Overproduction of growth hormone (GH) by the pituitary gland results in acromegaly. Acromegaly primarily affects men and women in middle age. Several hormones are stored in the pituitary gland, a tiny gland close to the base of the skull, and are released into the bloodstream when the body requires them. These hormones regulate numerous physiological processes. The majority of patients experience acromegaly as a result of a benign tumor (adenoma) growing on the pituitary gland.

The conditions of gigantism and acromegaly are caused by the overproduction of growth hormone (GH). The distinction lies in the individuals affected by the conditions: adults experience acromegaly while growing children and teenagers experience gigantism.

Pituitary adenoma, a benign (noncancerous) tumor of the pituitary gland, is the primary cause of excess growth hormone in most patients. A pituitary cell known as a somatotrope cell—the pituitary cell that typically secretes growth hormone—grows excessively and causes the majority of adenomas. The disease is sporadic and not caused by an inherited genetic mutation in the vast majority of patients.

Growth hormone (GH) is a hormone that plays a variety of roles in the body's physiological functions, one of which is assisting in controlling the body's physical development. Insulin-like growth factor-1 (IGF-1) is a hormone that is produced in response to growth hormone (GH).

Rarely acromegaly brought on by the hypothalamus's (the brain's gland that controls hormone secretions) inability to effectively regulate growth hormone-secreting cells. Excess growth hormone occasionally results from overstimulation caused by the hypothalamus or other tissues secreting excessive amounts of growth hormone-releasing hormone (GHRH).

Acromegaly also occurs in patients with multiple endocrine neoplasia type 1, familial isolated pituitary adenoma, Carney complex, and McCune-Albright syndrome, among other genetic syndromes. The cause of X-linked acro gigantism, which results from X chromosome microduplications, is gigantism.

Sign & Symptoms

Acromegaly usually develops gradually, with symptoms becoming more obvious as the affected person ages. The particular symptoms that manifest differ significantly from person to person. Many different physical findings and symptoms are caused by Acromegaly.

Soft tissue and cartilage overgrowth cause facial features to become coarse progressively. The lower jaw protrudes (prognathism), the facial bones gradually become more noticeable, and an underbite results in a large gap and misalignment between the teeth (malocclusion). The hands and feet gradually enlarge as a result of acromegaly. Increased bone growth (hypertrophy) and cartilage enlargement in the joints cause inflammation and slow joint degeneration (osteoarthritis).

Some individuals with acromegaly have abnormal curvatures of the spine from front to back and side to side (kyphoscoliosis). Tissue overgrowth ensnakes nerves, resulting in hand weakness and numbness (carpal tunnel syndrome). The heart is among the organs that enlarge abnormally in acromegaly. Dyspnea, or difficulty breathing during physical exertion, and/or arrhythmias, or irregular heartbeats, are among the symptoms.

Acromegaly also manifests as abnormal enlargement of the kidneys, intestines, spleen, and/or liver (splenomegaly and hepatomegaly). Adrenal glands or thyroid (goiter) also develop abnormally large glands.

Acromegaly affects women in two ways: it causes irregular menstrual flow (oligomenorrhea) and abnormal milk flow from the breasts (galactorrhea). Acromegaly in males results in impotence and a reduction in libido, or sexual drive. Individuals who suffer from acromegaly are more susceptible to colon polyps. Colon cancer is a little more common in people with acromegaly than in the general population.

Later-onset symptoms of acromegaly include weakness of the muscles and impaired function of the peripheral nerves, which are the nerves that are not part of the brain or spinal cord. Some affected people experience vision problems that lead to blindness.

Diagnostic Analysis of Acromegaly

Blood Test

• IGF-1 Test- Over the day, blood levels of GH fluctuate. Measuring the blood level of IGF-I is a dependable method of monitoring GH levels in the body. A high IGF-I level typically indicates the presence of acromegaly.
• Oral Glucose Tolerance Test- The doctor administers an oral glucose tolerance test to confirm the diagnosis. The patient consumed a sugary beverage for this test. After that, a medical practitioner draws blood every 30 minutes for two hours to check growth hormone levels. The drink's sugar typically lowers GH levels. However, if the patient's body is producing too much of the hormone, the levels won't decrease sufficiently, supporting the acromegaly diagnosis.

Imaging Test

To identify and measure the tumor causing the issue, doctors use imaging tests if blood tests show that the body is producing too much growth hormone.

• Magnetic resonance Imaging- MRIs (magnetic resonance imaging) are the preferred test for observing a pituitary tumor (NIH external link scan). The MRI scan produces finely detailed images of soft tissues and internal organs using radio waves and magnets. A pituitary tumor’s location and size is determined via MRI.
• Computed Tomography Scan- In cases where an MRI is not a suitable option due to factors such as a pacemaker or other metal implant, the doctor recommends a computed tomography (CT) NIH external link scan. The CT scan creates images of the organs and other internal body parts by combining computer technology and X-rays.

Other Tests

A colonoscopy to evaluate colon health and set a baseline for future testing, tests to detect the presence of sleep apnea, and echocardiography to evaluate whether the heart is involved are some additional tests that are conducted to determine the extent of acromegaly in an individual. Acromegaly increases a patient's risk of bone fractures; therefore, X-ray testing or a dual X-ray absorptiometry (DXA) scan is ordered to evaluate bone mineral density.

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Treatment Analysis

Radiation therapy, medications, and surgery are available as forms of treatment. Controlling tumor size, restoring normal GH and IGF-I levels, symptom relief, and managing associated health issues are the objectives of treatment.

Surgery

Transsphenoidal surgery, in which a pituitary tumor is partially or completely removed, is the standard of care for acromegaly. Surgery frequently produces a quick therapeutic response, releasing pressure on nearby brain structures right away and reducing growth hormone levels. Soft tissue swelling goes down in a matter of days if surgery is successful. Patients with small tumors (microadenomas) respond better to surgery than those with large tumors (macroadenomas). Certain symptoms, like headaches, are not completely relieved by surgery, and in certain patients, the tumor is removed entirely, leaving growth hormone levels too high.

when the surgery is successful, pressure on surrounding brain regions is released, and GH levels immediately decrease. Improvements in soft tissue swelling occur in a few days, while improvements in facial changes take longer.

Medications

Acromegaly is currently treated with three different kinds of medications either singly or in combination.

• Somatostatin Analogue (SSA)- Somatostatin analogs (SSAs) are the most commonly prescribed medications for the treatment of acromegaly. These medications inhibit the pituitary tumor's growth and also stop the release of growth hormone. These medications are safe and effective for long-term treatment, according to several studies. Currently, scientists are researching other options, like pills, to administer the medications instead of injecting them. The most typical SSA side effects include diarrhea, gas, and cramping. Usually mild, these effects fade with time. Gallstones typically don't cause any symptoms, but they develop in some people.
• Growth Hormone Receptor Antagonist- GH-receptor antagonists inhibit the body from receiving signals from GH to produce more IGF-I. Patients self-administer the medication by injecting it under the skin once a day. Liver issues are possible side effects.
• Dopamine Agonist- These medications block the growth of tumors and the production of GH, but not as effectively as SSAs. Those with mild growth hormone excess and those with both acromegaly and hyperprolactinemia (too much prolactin) are most likely to benefit from dopamine agonists. The medications are consumed orally. Nausea, stuffy nose, fatigue, headache, standing dizziness, nightmares, and mood swings are some of the possible side effects.

Radiation Therapy

High-energy X-rays or particle waves are used in radiation therapy to destroy tumor cells. If surgery is not an option or is ineffective in removing all of the tumor tissue, this kind of treatment is suggested.

Two types of radiation therapies are used;

• Stereotactic Radiosurgery- Stereotactic radiation therapy is the preferred form of radiation therapy because it precisely targets high doses of radiation to the tumor from multiple angles using 3-D imaging. Sometimes the procedure is completed in a single session, which lowers the possibility of damaging neighboring tissue. However, very large tumors and tumors near nerves that affect vision do not respond well to a single dose.
• Conventional/ Traditional Radio Therapy- It is a traditional radiation treatment, which uses external beams to target the tumor. Small doses of radiation are administered during a course of treatments lasting four to six weeks with this kind of radiation therapy. Although conventional fractionated radiation therapy lowers growth hormone levels by 50% over four to six weeks with daily treatments, effective outcomes do not show up for two to five years. Radiation therapy is rarely used alone to treat acromegaly; it is usually combined with medication therapy or surgery due to its delayed results.

Ayurvedic medicines

Shirodhara and other Panchakarma procedures were used to treat the patient over the course of 15 days, along with Ayurvedic medications. Every single symptom that was present improved significantly after two sessions of Shirodhara, spaced one month apart. Together with the patient's improved general health, the symptoms of growing sole size, blurred vision, and excessive perspiration were notably reduced. To treat Arthropathy caused by Acromegaly, anupana was prescribed consisting of Shiva gutika and Ppathyadi Kwatha.

Recent Developments in Acromegaly Treatment

• The first generic lanreotide, MYRELEZ (lanreotide), was introduced in Norway in November 2021 by ADVANZ PHARMA, a specialty pharmaceutical company with a strategic focus on complex medicines in Europe. Acromegaly, grade 1, and a subset of grade 2 gastroenteropancreatic neuroendocrine tumors, as well as symptoms related to neuroendocrine tumors, all be treated with MYRELEZ.
• The two companies successfully collaborated on research to develop AZP-3813 as a potential treatment for acromegaly, and in September 2021, Amolyt Pharma and PeptiDream Inc. announced that Amolyt Pharma had exercised its option to globally license a portfolio of macrocyclic peptide growth hormone receptor antagonists (GHRA) under the terms of their research collaboration agreement. For patients who do not respond well to somatostatin analogs (SSAs) alone, AZP-3813, an optimized drug candidate, is being developed as a potential treatment for acromegaly.

Regulatory Framework

DiseaseLandscape Insights (DLI) examines the regulatory environment for autoimmune diseases in different countries. DLI gives the major players information about import/export laws, risk assessment laws, and surveillance. For the safety and well-being of the affected population, market participants unquestionably prevent and respond to acromegaly outbreaks by selecting DLI services.

In January 2023, a draft guideline was released by the US Food and Drug Administration (FDA) to help sponsors create acromegaly treatments for patients who are either in poor health or have not responded to surgery.

Furthermore, in August 2022 TGA Approved a new generic medicine with the active ingredient Lanreotide Acetate to Amdipharm Mercury Australia Pty Ltd for the treatment of Acromegaly.

Clinical Trial Assessment

The DiseaseLandscape Insights consultancy firm provides valuable support in future market trends on the development of new pharmaceutical products. This support helps to streamline the planning and execution of clinical trials of novel medications and treatments, implement effective patient recruitment strategies, ensure regulatory compliance, and increase the likelihood of successful trial outcomes.

The below table gives information about some currently ongoing clinical trials, including their study titles and respective stages:

Conclusion

Disease Landscape Insights (DLI) provides key players in the production of medicinal goods with vital information and experience. With the help of Disease Landscape Insights, market participants more easily plan and execute clinical trials for novel drugs and pharmaceuticals, patient recruitment strategies, and regulatory compliance.

This enables market leaders to conduct focused research and development, find suppliers of raw materials, research contract manufacturing companies, and ensure legal compliance for the company. DiseaseLandscape Insights (DLI) helps all players in the market establish a more robust presence in the healthcare industry.