Vascepa

Diabetes, Cardiovascular Events, Diet + 4 more
Treatment
8 FDA approvals
20 Active Studies for Vascepa

What is Vascepa

Icosapent ethylThe Generic name of this drug
Treatment SummaryIcosapent Ethyl is a synthetic form of omega-3 fatty acid eicosapentaenoic acid (EPA). It is used to treat high levels of triglycerides in the blood (above 500 mg/dL), when other treatments have failed. The FDA approved Icosapent Ethyl in 2012.
Vascepais the brand name
image of different drug pills on a surface
Vascepa Overview & Background
Brand Name
Generic Name
First FDA Approval
How many FDA approvals?
Vascepa
Icosapent ethyl
2012
14

Approved as Treatment by the FDA

Icosapent ethyl, otherwise known as Vascepa, is approved by the FDA for 8 uses such as Diabetes Mellitus and elevation of serum triglyceride levels .
Diabetes Mellitus
elevation of serum triglyceride levels
Diabetes
Cardiovascular Events
Hospitalizations
Cardiovascular Disease
Hypertriglyceridemia
Cardiovascular Diseases

Effectiveness

How Vascepa works in the bodyStudies suggest that EPA reduces triglycerides in the liver and increases the rate of triglyceride breakdown in the body. This is likely due to increased fat burning, decreased fat creation, and increased breakdown of fat in the bloodstream.

When to interrupt dosage

The suggested amount of Vascepa hinges on the determined condition. The dosage also depends on the mode of administration outlined in the table below.
Condition
Dosage
Administration
Diabetes
, 1000.0 mg, 500.0 mg, 0.625 mg, 998.0 mg
, Oral, Capsule, Capsule - Oral, Tablet, coated - Oral, Tablet, coated
Cardiovascular Events
, 1000.0 mg, 500.0 mg, 0.625 mg, 998.0 mg
, Oral, Capsule, Capsule - Oral, Tablet, coated - Oral, Tablet, coated
Cardiovascular Disease
, 1000.0 mg, 500.0 mg, 0.625 mg, 998.0 mg
, Oral, Capsule, Capsule - Oral, Tablet, coated - Oral, Tablet, coated
Hypertriglyceridemia
, 1000.0 mg, 500.0 mg, 0.625 mg, 998.0 mg
, Oral, Capsule, Capsule - Oral, Tablet, coated - Oral, Tablet, coated
Cardiovascular Diseases
, 1000.0 mg, 500.0 mg, 0.625 mg, 998.0 mg
, Oral, Capsule, Capsule - Oral, Tablet, coated - Oral, Tablet, coated
Diet
, 1000.0 mg, 500.0 mg, 0.625 mg, 998.0 mg
, Oral, Capsule, Capsule - Oral, Tablet, coated - Oral, Tablet, coated
Hospitalizations
, 1000.0 mg, 500.0 mg, 0.625 mg, 998.0 mg
, Oral, Capsule, Capsule - Oral, Tablet, coated - Oral, Tablet, coated

Warnings

Vascepa Contraindications
Condition
Risk Level
Notes
Severe Hypersensitivity Reactions
Do Not Combine
Icosapent Ethyl may interact with Pulse Frequency
There are 20 known major drug interactions with Vascepa.
Common Vascepa Drug Interactions
Drug Name
Risk Level
Description
Abrocitinib
Major
The risk or severity of bleeding and thrombocytopenia can be increased when Icosapent ethyl is combined with Abrocitinib.
Aldesleukin
Minor
The risk or severity of bleeding can be increased when Icosapent ethyl is combined with Aldesleukin.
Alemtuzumab
Minor
The risk or severity of bleeding can be increased when Icosapent ethyl is combined with Alemtuzumab.
Altretamine
Minor
The risk or severity of bleeding can be increased when Icosapent ethyl is combined with Altretamine.
Amsacrine
Minor
The risk or severity of bleeding can be increased when Icosapent ethyl is combined with Amsacrine.
Vascepa Toxicity & Overdose RiskIcosapent ethyl is generally safe to use and unlikely to cause any adverse reactions.
image of a doctor in a lab doing drug, clinical research

Vascepa Novel Uses: Which Conditions Have a Clinical Trial Featuring Vascepa?

Four active clinical trials are presently underway to assess the efficacy of Vascepa in managing Hypertriglyceridemia.
Condition
Clinical Trials
Trial Phases
Diabetes
74 Actively Recruiting
Phase 1, Not Applicable, Phase 4, Phase 2, Phase 3
Hospitalizations
1 Actively Recruiting
Not Applicable
Cardiovascular Events
4 Actively Recruiting
Not Applicable
Diet
5 Actively Recruiting
Not Applicable, Phase 1
Hypertriglyceridemia
0 Actively Recruiting
Cardiovascular Diseases
0 Actively Recruiting
Cardiovascular Disease
27 Actively Recruiting
Not Applicable, Early Phase 1, Phase 3, Phase 2

Vascepa Reviews: What are patients saying about Vascepa?

5Patient Review
1/24/2020
Vascepa for Primary Prevention of Heart Attack
I started this treatment in March 2018 with no problems whatsoever. My bloodwork has actually shown improvement, and I feel great about my heart health in general. Sign up for the coupon at vasecpa savings plan--it's worth it! Also, ignore the bad reviews; they're probably from a competitor. This product is a game changer!
5Patient Review
6/8/2019
Vascepa for High Amount of Triglyceride in the Blood
I'm so happy that this drug has been able to help me in so many ways. Not only have my lipids improved, but I've also experienced less brain fog and overall inflammation. I haven't had any negative side effects, which is amazing.
5Patient Review
12/19/2019
Vascepa for High Amount of Triglyceride in the Blood
I had no issues whatsoever with this drug, and it worked great! I don't know what people are talking about when they say they've experienced side effects.
4.3Patient Review
3/3/2020
Vascepa for High Amount of Triglyceride in the Blood
I switched to Vascepa from the generic EPA, and it worked well for me. The cost is a bit high, though.
3.3Patient Review
7/27/2022
Vascepa for Treatment to Prevent a Heart Attack
Although this treatment didn't have the intended effect of decreasing my cholesterol (as shown by bloodwork), it also didn't come with any negative side effects.
2.3Patient Review
4/2/2019
Vascepa for High Amount of Triglyceride in the Blood
I unfortunately had some pretty severe allergic reactions to this treatment. Namely, hives on my stomach and a rash that looked like poison ivy developed on both of my forearms.
2.3Patient Review
9/29/2022
Vascepa for High Amount of Triglyceride in the Blood
I didn't feel great while taking this medicine, and it seemed to interact negatively with some of my other medications. My doctor took me off of it, and now I'm just trying to detox from it.
2.3Patient Review
12/26/2018
Vascepa for High Amount of Triglyceride in the Blood
I've only been taking this medication for a few weeks, but I've already developed joint pain and severe diarrhea. I'll be stopping use of the drug.
2Patient Review
1/15/2020
Vascepa for High Amount of Triglyceride in the Blood
My doctor recommended this to me, but it didn't work. My triglycerides actually went up after taking it for six weeks! I use Fenofibric Besylate now and have been for 15 years - it's much more effective.
2Patient Review
2/23/2022
Vascepa for High Amount of Triglyceride in the Blood
I've been on this medication for two months now and I'm experiencing joint pain in my elbow and shoulder like never before. Additionally, the heaviness and pain in my legs has made it impossible to walk even short distances. I came off the medication yesterday and have a follow-up appointment next week. In my opinion, the negatives of this treatment outweigh the positives.
2Patient Review
11/10/2021
Vascepa for High Amount of Triglyceride in the Blood
I took this medication for weeks, but experienced extreme diarrhea the whole time. I stopped taking it, but even after a few weeks I was still passing pills in my stool. I've had tests done and it seems like the pills are just stored in my intestines, causing me a lot of distress.
1.7Patient Review
12/20/2021
Vascepa for Stroke Prevention
I took Vascepa for a week and stopped because of adverse effects. I have been off of it for three weeks and I am still having terrible pain in my feet and hands. I can't sleep because of the pain. Terrible! Hope the side effects will go away soon.
1.7Patient Review
8/29/2021
Vascepa for Changes Involving Fatty Deposits in the Blood Vessels
Vascepa caused me a lot of pain. My muscles and joints became progressively worse to the point where I could hardly walk.
1Patient Review
3/29/2022
Vascepa for Stroke Prevention
I had a stroke after receiving a booster for Covid. My doctor put me on Vascepa, but the side effects were so severe that I stopped taking it after just three days. The pain in my hands and feet was unbearable, to the point where I couldn't use them at all. I ended up hospitalized for a week as a result. It's been three months now, and I still don't think I'm anywhere close to recovered. That stuff ruined my life.
1Patient Review
8/11/2020
Vascepa for High Amount of Triglyceride in the Blood
Do not bother with this medicine. It made me so dizzy that I couldn't function and constantly felt nauseous.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about vascepa

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is Vascepa the same thing as fish oil?

"Vascepa is an omega-3 fatty acid supplement that contains only EPA, while most fish oil supplements contain EPA and DHA."

Answered by AI

What are the side effects of Vascepa?

"Muscle and joint pain, constipation, swelling in extremities, gout, and chest pressure are all possible side effects of the medication."

Answered by AI

What is the medical Vascepa used for?

"Vascepa has been FDA-approved to lower blood triglyceride levels in adults with severe hypertriglyceridemia."

Answered by AI

Does Vascepa cause weight loss?

"As of February 17th, 2022, there are no documented reports which state that Vascepa is an effective way to lose weight."

Answered by AI

Clinical Trials for Vascepa

Image of UConn Health in Farmington, United States.

Digital Exercise Prescription Tool for Cardiovascular Disease

18 - 64
All Sexes
Farmington, CT
The investigators will conduct a feasibility and pilot efficacy randomized controlled trial to test the usability and user satisfaction of an evidence-based digital health tool the investigators developed for physicians to use to Prioritize Personalize Prescribe EXercise (P3-EX) to patients with cardiovascular disease (CVD) risk factors. The investigators will recruit 24 physicians from two local hospitals in CT, USA. Physicians will recruit two patients each (N=48) having CVD risk factors. Physicians will deliver a P3-EX exercise prescription (ExRx) to one of their patients (n=24) and the American College of Sports Medicine Physical Activity Vital Sign (ACSM-PAVS) ExRx to the other (n=24) in a random sequence crossover design. Physicians and patients will rate the feasibility and acceptability of each method using validated questionnaires. Patients will perform their prescribed ExRx for 12 weeks and complete a self-report exercise diary to monitor exercise adherence with virtual oversight from University of Connecticut (UConn) Graduate Research Assistants. Before and after the exercise intervention, the investigators will measure patient CVD risk factors and physical activity (PA) levels via accelerometry. The primary aim is to evaluate the feasibility and acceptability of P3-EX for physicians to use to prescribe exercise to patients with CVD risk factors, and the secondary aim is to explore the preliminary efficacy of P3-EX to improve patient CVD risk factors, PA levels, and exercise adherence. The investigators hypothesize P3-EX will be feasible for physicians to use to prescribe customized exercise routines for patients with CVD risk factors, and physicians and patients will be satisfied with P3-EX.
Waitlist Available
Has No Placebo
UConn Health (+2 Sites)Linda S Pescatello, PhD
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Exendin-9 + Dexamethasone for Insulin Resistance

18 - 60
All Sexes
Durham, NC
Glucagon secretion from α-cells has long been viewed as primarily a counterregulatory mechanism - e.g. an agent with a role to prevent blood sugar from decreasing to levels that compromise function. Our group, along with other researchers, have begun to identify a much more complex role for α-cells, raising questions about when and how glucagon may influence blood glucose levels. This proposal looks to detail proglucagon peptide secretion from α-cells and the impact this has on β-cell function and glucose tolerance, in preclinical studies of human islets and translational studies in human subjects. This protocol registration describes Aim 2 from this NIH grant which involves 2 study populations and separate protocols but addresses a common question. Aim 3 in the grant is focused on a separate hypothesis and will be conducted and published separately from Aim 2.
Phase 1
Waitlist Available
Duke Center for LivingDavid D'Alessio, MD
Image of Baltimore VA Medical Center in Baltimore, United States.

Continuous Glucose Monitors for Diabetes

18 - 90
All Sexes
Baltimore, MD
Among the diffident groups of patients, those with chronic and severe medical conditions are more likely to be readmitted to the hospital. It is not surprising therefore that patients with diabetes have high readmission rates. Patients with diabetes have 40% higher re-hospitalization rates compared with those patients without diabetes, with 30-day readmission rates reported to range between 14% and 26%. It should be noted that almost 30% of the patients with diabetes are experiencing two or more hospital admissions per year, accounting for more than 50% of total hospitalizations and hospital health care costs. This research application will evaluate whether the initiation of Continuous Glucose Monitor (CGM) devices at the time of hospital discharge will lead to better glucose control and health outcomes compared to the use of "finger sticks" Point of Care (POC) following hospital discharge among patients with diabetes. This study will be a two arm (Real Time CGM vs POC) single center RCT at the Baltimore VA Medical Center. One hundred and twenty individuals will be recruited and randomly assigned (1:1) to either Real Time CGM or to POC following hospital discharge. All subjects will be followed from for 3 months post hospital discharge.
Waitlist Available
Has No Placebo
Baltimore VA Medical CenterIlias Spanakis, MDDexCom, Inc.
Have you considered Vascepa clinical trials? We made a collection of clinical trials featuring Vascepa, we think they might fit your search criteria.Go to Trials
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Arginine Hydrochloride for Diabetic Ketoacidosis

18+
All Sexes
Detroit, MI
Diabetic ketoacidosis (DKA) is increasingly recognized in adults with "ketone-prone" type 2 diabetes. In many of these patients, the pancreas can still make insulin but becomes temporarily "stunned" during severe, prolonged high blood sugar. Arginine is a naturally occurring amino acid that can trigger the pancreas to release its own insulin when glucose is high. It is FDA-approved for other uses and has been given intravenously for decades with a strong safety record. Whether a single arginine infusion given early during DKA can safely boost the body's insulin and speed recovery has not been tested. This randomized, double-blind, placebo-controlled, phase 1/2 trial will enroll 60 adults who present to one of four Detroit-area emergency departments with DKA consistent with ketone-prone type 2 diabetes (high glucose and significant ketones). Participants will receive standard DKA care ordered by their clinicians. In addition, under blinded conditions they will receive either arginine hydrochloride 30 grams (in 300 mL) or placebo (normal saline), infused intravenously over 30 minutes as early as feasible after DKA is recognized. The main question is whether arginine increases endogenous (self-made) insulin soon after infusion. We will measure C-peptide (a marker released in equal amounts with insulin) and glucose at 10, 30, and 90 minutes after the start of the infusion and calculate the C-peptide/glucose ratio. Secondary measures include the rate of ketone (β-hydroxybutyrate) clearance and the total insulin dose required in the first 24 hours. Additional blood tests will examine arginine and related amino acids, and a small sample of platelets will be used to explore mitochondrial function. Safety will be closely monitored during and after the infusion, and participants will be contacted at 90 days to assess for any delayed problems. Potential risks include temporary flushing, nausea, or headache; the infusion can be stopped at any time if needed. Potential benefits include faster resolution of ketosis and reduced insulin needs, but benefits cannot be guaranteed for individual participants.
Phase 1 & 2
Waitlist Available
Detroit Medical Center
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Mobile Exercise App for Cardiovascular Health During Pregnancy

18 - 45
Female
Norfolk, VA
The goal of this study is to determine the effectiveness of a mobile exercise app in improving cardiovascular health and motivation to exercise in pregnant women who are healthy, in their 2nd trimester, between 18-45 years age, and do not do exercise currently. The aims of this study are determine i) the effect of a mobile app (BumptUp) to increase motivation to exercise as assessed by questionnaire, and ii) the changes may occur in cardiovascular health outcomes such as increased percent Flow-Mediated Dilation (FMD), Heart Rate Variability (HRV), and decreased Pulse Wave Velocity (PWV) over an 8-week period of intervention. Researchers will compare this to pregnant women who are healthy, in their 2nd trimester, between 18-45 years age, and who will not be using the mobile app (BumptUp) for exercise. Participants who are in the experimental group will be given access to the mobile app (BumptUp) for 8 weeks. Both the control and experimental group will visit the lab for their baseline measurements (study visit 1), followed by two visits at 4 weeks (study visit 2) and 8 weeks (study visit 3) to have their heart rate variability, arterial stiffness (PWV), and vascular function (FMD) assessed. At each study visit, blood pressure, heart rate, height, and weight will also be measured. Additionally, at all three study visits, participants will fill out a questionnaire to determine motivation to exercise.
Recruiting
Has No Placebo
Old Dominion University
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Continuous Glucose Monitor + Nutrition Counseling for Type 2 Diabetes

18+
All Sexes
Chapel Hill, NC
This study is designed to test the feasibility and preliminary efficacy of a continuous glucose monitor (CGM)-augmented food is medicine (FIM) intervention for adults with type 2 diabetes and nutrition or food insecurity. This study will learn if a FIM intervention ("intervention") that includes access to real-time CGM and nutrition counseling can increase engagement, improve glycemic management, and support healthy eating in this population, compared to the FIM intervention alone ("comparator"). At the study baseline, participants will be randomized to either the intervention or the comparator arm for 16 weeks. The intervention will occur during the first 12 weeks (phase 1: intervention phase) and will be compared to a standard FIM approach without CGM or counseling. Phase 2 (extension phase) will last 4 weeks and will consist of all participants in the intervention and comparator arm receiving both FIM and CGM for self-directed use. The study will also explore participant experiences through a series of semi-structured interviews with a subset of randomly selected participants to identify opportunities for scaling the intervention to a broader population.
Recruiting
Has No Placebo
University of North Carolina at Chapel HillAnna Kahkoska, MD, PhD
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Physical Activity Program for Cardiovascular Risk

Any Age
All Sexes
State College, PA
This pilot study evaluates the feasibility, acceptability, and preliminary effectiveness of Lion Hearts, a community-based, family-centered physical activity intervention designed to improve cardiovascular health among mother-child dyads. Developed through community co-design, the 12-week intervention is delivered in local CrossFit affiliates and includes twice-weekly fitness sessions incorporating functional movement, goal setting, teamwork, and health education. The study aims to assess changes in physical activity, fitness, and cardiovascular health markers, as well as family dynamics and motivation for physical activity. Participants complete baseline, mid-, post-, and 3-month follow-up assessments, including surveys, fitness testing, accelerometry, and optional lab work. Findings will inform the refinement of the intervention for future large-scale trials.
Waitlist Available
Has No Placebo
Penn State University
Have you considered Vascepa clinical trials? We made a collection of clinical trials featuring Vascepa, we think they might fit your search criteria.Go to Trials
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Life's Essential 8 for Cardiovascular Health

18+
All Sexes
New York, NY
The goal of this early-stage study is to support the heart health of home health aides, a workforce that provides care for adults at home but whose own health has been historically poor. To do this, the study will use Life's Essential 8 (LE8), a program developed by the American Heart Association (AHA) that promotes cardiovascular wellness through education and lifestyle changes. The program has been adapted specifically for home health aides and will be delivered by trained "peer coaches," who are fellow home health aides who will help guide participants through the program. The main questions the study aims to answer are: * Will the LE8 intervention, which provides cardiovascular health education and support with positive thinking, be used by home health aides and do they like it? * Does the LE8 intervention actually improve home health aides' cardiovascular health after the intervention's conclusion compared to baseline? Participants will be paired with a trained peer coach and take part in the 10-week program over the course of 6 months. The program includes support for healthy behaviors and positive thinking, with the goal of making lasting improvements in cardiovascular health.
Recruiting
Has No Placebo
1199 SEIU Home Care Industry Education Fund (+1 Sites)Madeline Sterling, MD, MPH, MS
Image of Grady Health System in Atlanta, United States.

Continuous Glucose Monitoring for Heart Failure

18 - 90
All Sexes
Atlanta, GA
Heart failure (HF) is a major cause of hospital admissions in the US, with over 6 million hospital days annually. More than 40% of hospitalized patients with HF have diabetes mellitus (DM), which increases the risk of recurrent hospitalizations for HF with reduced and preserved ejection fraction by more than two-fold. Current methods for assessing glycemic control do not consider fluctuations in blood glucose levels, known as glycemic variability. High glycemic variability is a poor prognostic marker for HF re-hospitalizations. Given the significant prevalence and impact of DM in individuals with HF, it is crucial to examine whether improving glycemic control and avoiding hypoglycemia could lead to a decrease in HF readmissions. Real-time continuous glucose monitoring (rt-CGM), which provides glucose measurements as frequently as every 5 minutes, has improved glycemic control in insulin-treated adults with DM compared to the standard of care, capillary point-of-care blood glucose testing (POC). Researchers will monitor participants during their hospital stay and 3 months after discharge.
Waitlist Available
Has No Placebo
Grady Health SystemKasra Moazzami, MD, MPHAbbott Diabetes Care
Have you considered Vascepa clinical trials? We made a collection of clinical trials featuring Vascepa, we think they might fit your search criteria.Go to Trials
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