PACE-CME

Hello, everyone. It's my pleasure to present to you the summary of a paper, Demographic and Clinical Characteristics of Patients using Icosapent Ethyl in the Real World. These are my disclosures.

Back in 2020, there was the first publication of a subgroup of this big trial, REDUCE-IT trial, using icosapent ethyl. This is in the subgroup of patients with diabetes. As you can see here, patients with diabetes have a very high risk of cardiovascular events. Shown on the lower part of this graph, you can see the primary events that took place in patients with diabetes, with the hazard ratio of 0.77 with icosapent ethyl compared to placebo. That's a 23% reduction and absolute risk reduction of 7%. If you look at the total events over the course of several years, there was about 23% reduction in the cardiovascular events, with the absolute risk reduction of 12.7%, which means that it only takes about seven patients to prevent one cardiovascular event. Very, very favorable reduction by the icosapent ethyl. Just to give you a background of this particular abstract that's being presented.

Even though the results of the REDUCE-IT trial in the diabetic subgroup was quite impressive, little is known on whether the characteristic of patient using icosapent ethyl in the real work is consistent with this indication, particularly among high-risk patients with diabetes. The objective of this particular presentation is to describe the demographic and clinical characteristics of US patients with diabetes taking icosapent ethyl.

This is actually a complete summary of the patient that we studied. As of October 15th, there was a total of 22,000 patients with diabetes that were prescribed icosapent ethyl that were identified. You can see here, of the total patients, that there were about 12,000 patients who presented in this dataset with primary or secondary prevention criteria. Of these, as shown on the right, there were about 65% who fulfilled the criteria for secondary prevention. Shown on the left is about 35% of the patients, 4,000-plus, who fulfilled the criteria for primary prevention.

In the next slide, you see a much more detailed analysis of all the results. I will summarize them in the next slide to bring out the most important points.

First of all, the mean age of the subjects analyzed was 61.4 years, and 75% were White. The mean A1C of this group was 7.6%, and the mean glucose level was 152 milligram percent. In the three months before the IPE initiation in this real-world setting, the mean triglyceride level was 333.4 milligram per deciliter, and mean BMI was 32 as shown here. 92.5% of patients with triglyceride data had a level of more than 150 as approved by this current indication.

A total of 6,400 patients, say, 28.8%, were actually missing the triglyceride laboratory data. 86% of the patients with LDL results were actually in good range at LDL less than 100 milligram per deciliter, the criteria that was chosen originally in the REDUCE-IT trial inclusion criteria. Among patients with triglyceride data, 75.6% met the cardiovascular risk reduction indication for IPE, according to the approved label. 33% had severe hypertriglyceridemia, meaning, 500 milligram/dL or greater.

To conclude, in the real-world setting, the clinical characteristics were consistent with the indication for IPE. However, the mean triglyceride level of 333 was fairly high before starting the IPE in this population. This suggests that IPE may be underutilized among patients with diabetes with a moderately elevated triglyceride level at high risk for cardiovascular events.

What are the implications of this presentation for clinical practice? Number one, people with diabetes have high absolute risk and considerable residual risk remains for cardiovascular events, despite the LDL cholesterol goal achievement. Secondly, icosapent ethyl is the only approved drug in those with triglyceride greater than 150 after maximally tolerated statin and high risk of cardiovascular events in adults. Data presented here points to the underutilization of IPE, despite clear indication for its use to reduce cardiovascular events, including coronary heart disease and stroke. Finally, adherence to treatment and therapeutic inertia, I must say, remain very important concerns in general, and much more needs to be done in this regard to take the right patients, get the right drug at the right time, and staying with it for the long duration.

Thank you very much.