New Updates to the American Diabetes Association’s® 2019 Standards of Medical Care in Diabetes Incorporate Findings from the REDUCE-IT™ Cardiovascular Outcomes Study
The Standards of Care update references the drug, icosapent ethyl, studied in REDUCE-IT, which
Based on the results of REDUCE-IT™2, 3 in both primary and secondary prevention populations, the Living Standards of Care now include the recommendation that icosapent ethyl:
“…be considered for patients with diabetes and atherosclerotic cardiovascular disease (ASCVD) or other cardiac risk factors on a statin with controlled low-density cholesterol (LDL-C), but with elevated triglycerides (135-499) to reduce cardiovascular risk.”
The ADA added that this updated finding was:
“…based on the outcome of Reduction of Cardiovascular Events with Icosapent Ethyl–Intervention Trial (REDUCE-IT), which determined the addition of icosapent ethyl to statin therapy for patients with high triglyceride levels reduced cardiovascular events.”
The ADA standards also reiterate that:
“It should be noted that data are lacking with other omega-3 fatty acids, and results of the REDUCE-IT trial should not be extrapolated to other products.”
Cardiovascular disease is the leading cause of morbidity and mortality for individuals with diabetes, and cardiovascular disease is the cause of one in three deaths in the U.S. The ADA added that:
“Recently published research indicated an urgent need to update the 2019 Standards of Care to ensure optimal treatment recommendations for people with cardiovascular disease and diabetes.”
The findings were made with a level “A” grade of scientific evidence4, which under ADA standards, reflects that REDUCE-IT was considered to be a large well-designed clinical trial. Generally, according to ADA, A-level recommendations have the best chance of improving outcomes when applied to the population to which they are appropriate.
“As we have commenced transmission of data to the
The complete, annotated Standards of Care, which includes the recent updated findings, can be accessed online on Diabetes Care. The Abridged Standards of Medical Care in Diabetes have also been updated and can be accessed online on Clinical Diabetes.
REDUCE-IT3, an 8,179-patient cardiovascular outcomes study, was completed in 2018. REDUCE-IT was the first multinational cardiovascular outcomes study that evaluated the effect of prescription pure
More information on the REDUCE-IT study results can be found at www.amarincorp.com.
About Cardiovascular Disease
Worldwide, cardiovascular disease (CVD) remains the #1 killer of men and women. In
Multiple primary and secondary prevention trials have shown a significant reduction of 25% to 35% in the risk of cardiovascular events with statin therapy, leaving significant persistent residual risk despite the achievement of target LDL-C levels.8
Beyond the cardiovascular risk associated with LDL-C, genetic, epidemiologic, clinical and real-world data suggest that patients with elevated triglycerides (TG) (fats in the blood), and TG-rich lipoproteins, are at increased risk for cardiovascular disease. 9, 10, 11, 12
About Vascepa (icosapent ethyl) Capsules
Vascepa (icosapent ethyl) capsules are a single-molecule prescription product consisting of the omega-3 acid commonly known as
Indication and Usage Based on Current FDA-Approved Label (not including REDUCE-IT results)
- Vascepa (icosapent ethyl) is indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia.
- The effect of Vascepa on the risk for pancreatitis and cardiovascular mortality and morbidity in patients with severe hypertriglyceridemia has not been determined.
Important Safety Information for Vascepa Based on Current FDA-Approved Label (not including REDUCE-IT results) (Includes Data from Two 12-Week Studies (n=622) (MARINE and ANCHOR) of Patients with Triglycerides Values of 200 to 2000 mg/dL)
- Vascepa is contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to Vascepa or any of its components.
- In patients with hepatic impairment, monitor ALT and AST levels periodically during therapy.
- Use with caution in patients with known hypersensitivity to fish and/or shellfish.
- The most common reported adverse reaction (incidence >2% and greater than placebo) was arthralgia (2.3% for Vascepa, 1.0% for placebo). There was no reported adverse reaction >3% and greater than placebo.
- Adverse events and product complaints may be reported by calling 1-855-VASCEPA or the
FDAat 1-800- FDA-1088.
- Patients receiving treatment with Vascepa and other drugs affecting coagulation (e.g., anti-platelet agents) should be monitored periodically.
- Patients should be advised to swallow Vascepa capsules whole; not to break open, crush, dissolve, or chew Vascepa.
FULL VASCEPA PRESCRIBING INFORMATION CAN BE FOUND AT WWW.VASCEPA.COM.
Important Safety Information for Vascepa based on REDUCE-IT, as previously reported in
- Excluding the major adverse cardiovascular events (MACE) results described above, overall adverse event rates in REDUCE-IT were similar across the statin plus Vascepa and the statin plus placebo treatment groups.
- There were no significant differences between treatments in the overall rate of treatment emergent adverse events or serious adverse events leading to withdrawal of study drug.
- There was no serious adverse event (SAE) occurring at a frequency of >2% which occurred at a numerically higher rate in the statin plus Vascepa treatment group than in the statin plus placebo treatment group.
- Adverse events (AEs) occurring in 5% or greater of patients and more frequently with Vascepa than placebo were:
– peripheral edema (6.5% Vascepa patients versus 5.0% placebo patients), although there was no increase in the rate of heart failure in Vascepa patients
– constipation (5.4% Vascepa patients versus 3.6% placebo patients), although mineral oil, as used as placebo, is known to lower constipation, and
– atrial fibrillation (5.3% Vascepa patients versus 3.9% placebo patients), although there were reductions in rates of cardiac arrest, sudden death and myocardial infarctions observed in Vascepa patients
- There were numerically more SAEs related to bleeding in the statin plus Vascepa treatment group although overall rates were low with no fatal bleeding observed in either group and no significant difference in adjudicated hemorrhagic stroke or serious central nervous system or gastrointestinal bleeding events between treatments.
- In summary, Vascepa was well tolerated with a safety profile generally consistent with clinical experience associated with omega-3 fatty acids and current
FDA-approved labeling of such products.
Vascepa has been approved for use by the
Important Cautionary Information About These Data
Further REDUCE-IT data assessment and data release could yield additional useful information to inform greater understanding of the trial outcome. Further detailed data assessment by Amarin and regulatory authorities will continue and take several months to complete and record. The final evaluation of the totality of the efficacy and safety data from REDUCE-IT may include some or all of the following, as well as other considerations: new information affecting the degree of treatment benefit on studied endpoints; study conduct and data robustness, quality, integrity and consistency; additional safety data considerations and risk/benefit considerations; consideration of REDUCE-IT results in the context of other clinical studies.
Recurrent event analyses for the total primary endpoint events and for the total key secondary endpoint in REDUCE-IT as published in the
This press release contains forward-looking statements, including expectations regarding
Availability of Other Information About Amarin
Investors and others should note that
2 Bhatt DL, Steg PG, Miller M, et al. Effects of Icosapent Ethyl on Total Ischemic Events: From REDUCE-IT.J Am Coll Cardiol 2019. epub ahead of print.
3 Bhatt DL, Steg PG, Miller M, et al. Cardiovascular Risk Reduction with Icosapent Ethyl for Hypertriglyceridemia. N Engl J Med 2019;380:11-22.
5 Nichols G, Philip S, Granowitz CB, et al. Increased cardiovascular risk in patients with diabetes, statin-controlled LDL cholesterol, and residual hypertriglyceridemia [abstract]. Diabetes. 2018;67(suppl 1):1485P.
8 Ganda OP, Bhatt DL, Mason RP, et al. Unmet need for adjunctive dyslipidemia therapy in hypertriglyceridemia management. J Am Coll Cardiol. 2018;72(3):330-343.
9 Budoff M. Triglycerides and triglyceride-rich lipoproteins in the causal pathway of cardiovascular disease. Am J Cardiol. 2016;118:138-145.
10 Toth PP, Granowitz C, Hull M, et al. High triglycerides are associated with increased cardiovascular events, medical costs, and resource use: A real-world administrative claims analysis of statin-treated patients with high residual cardiovascular risk.
11 Nordestgaard BG. Triglyceride-rich lipoproteins and atherosclerotic cardiovascular disease - New insights from epidemiology, genetics, and biology. Circ Res. 2016;118:547-563.
12 Nordestgaard BG, Varbo A. Triglycerides and cardiovascular disease. Lancet. 2014;384:626–635.
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