A 25% reduction in cardiovascular events, including death, heart attack or stroke sounds like a big deal… and maybe it is. But this story about the results of a trial of a prescription drug derived from fish oil (brand name Vascepa) relies on a news release and company statements that don’t provide basic information about the precise number or type of cardiovascular events observed by researchers. Without absolute numbers, it is impossible to judge the importance of these results. It is also premature to claim that the results represent “heart-medicine history,” especially given that the findings haven’t been peer-reviewed and are at odds with numerous previous studies.
The story takes a cheerleading tone and fails to supply key context. For example, it highlights a dramatic quote from a researcher without noting that he was paid over $120,000 by the drug company, including payments for speeches and other appearances on its behalf, in 2017. The story headline and text do make clear that only patients with cardiovascular disease and high levels of triglycerides or diabetes were in the trial, so it should be clear to readers that this drug was not shown to prevent disease in healthy people. The story does not give any details about potential harms of the drug. It reports key details of the trial, but without access to the full trial report, it is impossible to judge the quality of the evidence or its real significance.
This story is based on the news release claim of a 25% reduction in the risk of major cardiovascular events. But what does that mean? It’s difficult to say, because that outcome consists of a combination of cardiovascular disease death, heart attack, stroke, coronary revascularization procedures (placing a stent in a blocked artery) and hospitalization for unstable angina (chest pain). Based on what little we know, it is possible that the 25% reduction was driven mainly by a lower rate of hospitalizations for chest pain — an outcome that’s less important and also more subject to bias on the part of investigators who decide which patients get hospitalized and which ones don’t. It’s possible there was little or no reduction in deaths, heart attacks or strokes. Until the full trial results are released, we simply don’t know.
The story reports that Vascepa costs about $2,400 per year. However, that price is much lower than indicated by online searches (here and here) that show prices around $3,400 per year at the 4 gram per day dose used in this study.
The story repeats the relative risk reduction of major cardiovascular events of 25% that the company provided. But it doesn’t grapple with the vital question: 25% of what? The true size of the benefit depends on the baseline risk of these participants, which is unknown and probably won’t be known until the results are presented at a conference in November. (Read our primer on absolute risk for more information on why this is important.)
The story does note that the company is withholding details about the study results for now, but readers should have been clearly alerted to the fact that without knowing how many events occurred or what they were, it is impossible to judge the importance of the results. The study outcome was a combination of cardiovascular disease death, heart attack, stroke, coronary revascularization procedures and hospitalization for unstable angina. The story would have been better if it had alerted readers that based on the sketchy information released by the company, it is impossible to say whether there was an important reduction in deaths, heart attacks or strokes. It could be that much or even all of the reduction was in the number of times patients were hospitalized for chest pain. (Read our primer Why you should be careful with composite outcomes in clinical trials for more information on why this is important.)
Although the story says the company reported a “side effect profile consistent with the drug’s currently approval label”, it did not tell readers what that means. The most important adverse event reported in other studies of Vascepa is joint pain, affecting up to about one in 25 patients. The story does not mention warnings about possible allergic reactions in people allergic to seafood or interactions with anti-clotting drugs, which many heart patients take.
It is difficult to rate the story on this criterion. The story reports key features of the REDUCE-IT trial, noting that it included 8,179 patients, compared Vascepa treatment to placebo, and followed patients for a median duration of almost five years. However, since the company is withholding key details of the trial, including critical information about the absolute numbers of cardiovascular events, adverse events and any limitations of the study, it is impossible to judge the quality of the evidence. The story does quote sources who say they are waiting to see detailed data before reaching a firm judgment about the results, but it doesn’t clarify what’s missing. And these faint notes of caution are buried under a mountain of premature praise about the study’s importance and significance.
The headline notes that this trial included only people with cardiovascular disease. The story reports that the patients were taking statins to reduce their cholesterol, but they still had high triglyceride levels or diabetes (which increases the risk of heart attacks and strokes).
The story includes comments from experts who were not involved in this trial and it identified others as being researchers for this trial or working for Amarin. However, when the first quote calls this drug “absolutely the most significant study in the field of cardiovascular risk reduction since the statins were introduced”, it is not enough to identify the source as “a Vascepa study investigator” when that researcher, Matthew Budoff, received over $120,000 in 2017 from Amarin, including payments of more than $4000 per appearance for speaking and teaching engagements on behalf of the company.
[Note: The text has been corrected to indicate that the quoted source’s name is Matthew Budoff, not Martin Budoff as it initially appeared.]
The story reports that another fish oil derivative, Lovaza, did not demonstrate benefits in trial results released in August. It also mentions another similar drug, Epanova, that is currently being studied.
The story compares the results of the trial of Vascepa to those from much costlier cholesterol drugs known as PCSK9 inhibitors, but it’s hard to know whether the comparison is useful given the unknowns about the what sort and how many cardiovascular events occurred in patients taking Vascepa.
The story reports that Vascepa is available by prescription to treat high triglyceride levels.
The story reports that this is the first trial to show a reduction in major cardiovascular events among patients taking this type of fish oil derivative.
The story relies on a news release from the company that produces Vascepa. Although some cautionary comments and quotes are included, this story is not really about the results of a trial of Vascepa (which the company has yet to fully release), but only about a news release and company statements that make claims about trial results. This case illustrates how it is impossible to do a good job reporting on a drug trial when the sponsors do not release critical details of the trial.