Autoimmune Hyperlipidaemia Disease

Published Date : Nov 2023
Category : Autoimmune Diseases
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Autoimmune Hyperlipidaemia – High Cholesterol Level

A Complete Overview of Etiology, Symptoms, Diagnosis, and Treatment Market Players

Hyperlipidaemia is a term that includes various genetic and acquired disorders that include elevated lipid levels in the body. Worldwide, but particularly in the western hemisphere, hyperlipidaemia is a very frequent condition. A more objective definition of hyperlipidemia would be defined as having low-density lipoprotein (LDL), total cholesterol, triglyceride, or Lipoprotein metabolism levels that are higher than the 90th percentile relative to the general population or having High-density lipoprotein (HDL) levels that are lower than the 10th percentile. Cholesterol levels, lipoproteins, chylomicrons, very low-density lipoprotein (VLDL), LDL, apolipoproteins, and HDL are examples of lipids. The amount of hyperlipidemia is highest in patients with premature coronary artery disease (CAD), defined as CAD arising in males before age 55 to 60 years and females before age 65 years.

According to NCBI, the incidence of hyperlipidaemia is around 75-85%, contrasting to roughly 40 to 48% in the control population of comparable age, but without the incidence of premature coronary artery disease. Over 50% of adult Americans are estimated to have raised low-density lipoprotein (LDL) levels. Of those individuals, it is hypothesized that less than 35% effectively manage their higher LDL levels, indicating an illness that is not receiving enough Hyperlipidaemia treatment. It makes sense that, when compared to rates in Europe and the US, nations with lower general obesity and saturated fat consumption rates would also have lower prevalence of hyperlipidaemia and, consequently, coronary artery disease.

There are two main Hyperlipidemia types: primary hyperlipidemia, which is inherited, and secondary hyperlipidemia, which is acquired. While secondary hyperlipidemia usually results from an alternative underlying etiology, such as an unhealthy diet, medications (Amiodarone, Glucocorticoids), hypothyroidism, uncontrolled diabetes, and a poor lifestyle regimen, primary hyperlipidemia is caused by a variety of genetic disorders that a patient inherit from birth.

Various hyperlipidemia causes are smoking, drinking a lot of alcohol, eating foods that have a lot of saturated fats or trans fats, sitting too much instead of being active, being stressed, and being overweight.

Early on, high cholesterol doesn’t give Autoimmune hyperlipidemia symptoms. However, after a while, plaque buildup (made of cholesterol and fats) slows down or stops blood flow to the heart or brain. The symptoms of coronary artery disease include chest pain with exertion, jaw pain, and shortness of breath. When a plaque of cholesterol breaks and a clot covers it, it closes off an entire artery. This is a heart attack, and the symptoms include severe chest pain, flushing, nausea, and difficulty breathing which is a medical emergency.

Diagnostic Analysis

A "lipid profile" that measures triglyceride disorders and cholesterol disorder levels is one of the guidelines for lipid panel screening that have been developed by several specialists. There are different guidelines about the age at which primary care physicians should begin screening for hyperlipidemia and the frequency of such screenings. Routine lipid screening is generally suggested to happen when a male patient reaches the age of 25 to 35 Additionally, if there are no other cardiovascular risk factors present, routine lipid screening in females should begin at age 45. If the patient has other cardiovascular risk factors, the recommended age range is 30 to 35 years old. Lipid screening should be done every five years for those who are at lower risk.

As previously stated, measuring the fasting lipid profile which typically includes LDL, HDL, high triglycerides, and total cholesterol is the most beneficial laboratory test. For a comprehensive test, a v-LDL, total cholesterol: HDL, and LDL: HDL ratio.

The National Heart, Lung, and Blood Institute advises that hyperlipidemia in children have one cholesterol screening test between the ages of nine and eleven, and then that the test be repeated every five years thereafter. Doctors advise more frequent or earlier cholesterol testing if the child has a personal or family history of obesity, diabetes, or early-onset heart disease.

DiseaseLandscape Insights assists key players by providing knowledge about diagnostic kits, the use of new technology for improving the existing as well as new diagnostic tools, and the data of current industry players and their innovative products for a better understanding of the market dynamics. Stakeholders should determine their plan of action and strategies for their business and ways for expanding the market by using DLI data.

Diagnostic Market Players


Test Kit

Cell Biolabs Inc

HDL and LDL/VLDL Cholesterol Assay Kit

Boditech Technology


Block Scientific Inc

Diazyme LDL




HDL kit

Meril Diagnostics Pvt. Ltd.

CHOFSR-01 Cholesterol Kit


ERBA Hdl Cholesterol Test Kit

Panacea Diagnostic

Erba Cholesterol Kit


Hdl Cholesterol




Treatment Analysis

Changes in lifestyle lower cholesterol which include a healthy diet, weight loss, and exercise for hyperlipidemia. If a person has a high body weight or obesity, losing weight helps lower total cholesterol levels. When lifestyle changes aren’t enough to treat hyperlipidemia, doctors prescribe medication.

Statins are the first-line medication for hyperlipidemia. If a person cannot tolerate statins or if do not reduce elevated LDL cholesterol enough, mRNA and monoclonal antibody drugs have been developed recently.

Common cholesterol- and triglyceride-lowering medications include statins, bile-acid-binding resins, and cholesterol absorption inhibitors, such as Ezetimibe. Injectable alternatives to statins, such as Alirocumab or Evolocumab. Fibrates, like Fenofibrate or Gemfibrozil. Niacin, omega-3 fatty acid supplements, and other Autoimmune hyperlipidemia cholesterol-lowering drugs supplements.

Inclisiran is a new drug using mRNA technology. It is approved in Europe but not yet in the United States. In 2020, the two drugs Nexlitol and Nexlizet, approved by the FDA, are the first new non-statin cholesterol drugs approved by the FDA since 2002. As an add-on treatment for familial hypercholesterolemia Praluent (alirocumab) was approved by the FDA in 2021. This is a genetic condition that causes severely Elevated cholesterol.

Industry players should use the research and consulting services of DiseaseLandscape Insights to enhance and evolve in the treatment sector of Autoimmune Hyperlipidaemia. DLI offers data about the autoimmune hyperlipidemia treatment options market players, their strategies, their innovative products, and market analysis to keep our clients updated and ahead of the competition. DLI also provides knowledge about current clinical trials of new drug development to promote the client for performing concentrated research and establishing a stable business.

The table below demonstrates the industry leaders who are revolutionizing the landscape and driving innovation in the search for better health outcomes, as well as the names of their products for the treatment of Autoimmune Hyperlipidaemia:

Treatment Market Player





Lescol XL

Covis Pharmaceutical




Teva USA






Upsher-Smith Laboratories, LLC.




Amneal - Honeybee Health




Regeneron and Sanofi




Mylan Pharmaceuticals



Regulatory Framework

On 18 February 2019 Pharmacor Ezetimibe Simvastatin, Akm-Ezetimibe Simvastatin was approved by TGA and Sponsored by Pharmacor Pty Ltd, where the active ingredient is Simvastatin and Ezetimibe.

Pharmacor Ezetimibe Simvastatin, Akm-Ezetimibe Simvastatin (tablets) is indicated in adults (aged above18 years) for:

Prevention of Cardiovascular Disease

In patients with coronary heart disease (CHD) and a history of acute coronary syndrome (ACS) taking their extremely tolerated dose of simvastatin and in need of extra lowering of LDL-C in the expectation of a further decrease in the risk of cardiovascular events following at least one year of therapy.

Primary Hypercholesterolemia – As an adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolemia or mixed hyperlipidemia where the use of a combination product is appropriate: Patients not properly controlled with a statin or ezetimibe alone and patients are already treated with a statin and ezetimibe. In patients with Homozygous Familial Hypercholesterolemia (HoFH). Receive adjunctive treatments like LDL apheresis. Pharmacor Ezetimibe Simvastatin, Akm-Ezetimibe Simvastatin (tablets) is also indicated in Children and Adolescents.

Clinical Trial Assessment

The advancement in technology research and government initiatives has increased the scope for clinical trials. One of the main objectives of healthcare reform is realized by industry participants thoroughly assessing medical therapy using clinical data.

DiseaseLandscape Insights helps in the design and management of clinical trials for novel Autoimmune hyperlipidemia medications and therapies, patient recruiting plans, regulatory compliance, and the protection of successful trial outcomes, etc.

The below table enlists study titles of clinical trials currently in development according to the phases they are being conducted:

Phase 1

Phase 2

Phase 3

Phase 4

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability and Efficacy, as Well as Immunogenecity, Pharmacokineticks and Pharmacodynamics of Multiple Doses of JS002 on Stable Statin Therapy in Patients with Hyperlipidemia.

A Randomised, Parallel, Double-Blind, Placebo-Controlled Phase 2b Study to Assess the Safety, Tolerability and Efficacy of AZD8233 Treatment in Participants with Hyperlipidaemia

Ezetimibe Together with Any Statin Cholesterol Enhancement

Does Adding Red Yeast Rice to Statin Can Improve Lipid Profile or Vascular Inflammation? A Randomized Clinical Trial

A Phase 1, Randomized, Double Blind, Dose-escalation, Placebo Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Subcutaneous Injection of SHR-1918 Injection in Healthy Subjects

Viscosity Rather Than Quality of Dietary Fibre Predicts Cholesterol-lowering Effect in Healthy Individuals

A Randomized, Double-blind, Placebo-controlled Phase III Clinical Study Evaluating the Efficacy and Safety of JS002 Prefilled Syringes (PFS) and Prefilled Autosyringes(AI) in Patients With Primary Hypercholesterolemia and Mixed Hyperlipidemia

Lipid Management in Renal Transplant Recipients: A Pilot Study Evaluating the Use of PCSK-9 Inhibitor, Evolocumab.

A Randomized, Open, Single-dose, 2x2x4 Replicate Crossover-design Clinical Trial to Evaluate the Safety and Pharmacokinetic Characteristics After Co-administration of UIC201806 and UIC201602 or Administration of UI018 in Healthy Volunteers

A 4-Weeks Treatment, Randomised, Double-Blind, Parallel-Group Study Evaluating the Efficacy and Safety of JTT-705 300 to 900mg in Comparison with Placebo in Patients with Type II Hyperlipidaemia

A Phase III, Randomized, Double-blind, Placebo-controlled Clinical Study Evaluating the Efficacy and Safety of JS002 in Patients with Primary Hypercholesterolemia and Mixed Hyperlipidemia in China

Effects of Ezetimibe in Association with Statins on Postprandial Lipemia in Type 2 Diabetic Patients

A Parallel, Open-Label, Single-Dose Administration, Phase 1 Clinical Study to Assess the Safety and Pharmacokinetics of AD-104-A in Healthy Adult Volunteers and Patients with Renal Impairment

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability and Efficacy, as Well as Immunogenecity, Pharmacokineticks and Pharmacodynamics of Multiple Doses of JS002 on Stable Statin Therapy in Patients with Hyperlipidemia.

A Worldwide, Multicenter, Double-Blind, Randomized, Parallel, Placebo-Controlled Study to Evaluate the Lipid-Altering Efficacy, Safety and Tolerability of MK0524A in Patients with Primary Hypercholesterolemia or Mixed Hyperlipidemia

A Randomized, 12-Week, Open Labeled Study to Evaluate the Efficacy And Safety Of Once Daily Atorvastatin In Diabetes Mellitus Type 2 With Hyperlipidemia

An Open-label, Randomized, Single-dose, 2-sequence, 2-period, Crossover, Phase 1 Study to Evaluate the Safety and Pharmacokinetics of AD-221 Compared to Coadministration of AD-221A and AD-221B in Healty Adult Volunteers

An Open-label, Single-arm Study Evaluated the Efficacy and Safety of JS002 in Patients with Homozygous Familial Hypercholesterolemia

A Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Effects of Sitagliptin on Postprandial Plasma Lipoprotein Concentrations in Men with Type 2 Diabetes

Investigate Effect on Mean IMT of Probucol And/or CilosTazol in Patients with Coronary Heart dIsease Taking HMGCoA Reductase Inhibitor Therapy: A Randomized, Multicenter, Multinational Study


Conclusion –

There are different market scenarios concerning Autoimmune Hyperlipidaemia-specific diagnostics and therapies. Governments have reported various investment and centre developments in the field of Autoimmune Hyperlipidaemia diagnosis and treatment. The impact of Autoimmune Hyperlipidaemia, as well as difficulties related to economic viability regarding treating Autoimmune Hyperlipidaemia.

DLI helps with target market identification, marketing strategy development, and informing industry participants about new trends. Healthcare organizations gain a competitive advantage, improve patient outcomes, and make a positive impact on global healthcare standards by leveraging DLI expertise.

This incentivizes multinational corporations to conduct research in the areas of Autoimmune Hyperlipidaemia diagnosis and treatment, as well as legal compliance among manufacturers. Overall, Disease Landscape Insights aids in the establishment of a stronger foothold for all market participants.

Vishal SawantBusiness Development

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