After months of waiting, the final and complete results from a study about the Meridia diet pill are now available in The New England Journal of Medicine and the findings are as bad as what was suggested by the preliminary data released last November. The SCOUT study, which was financed by Abbott Labs (ABT), the company that sells the pill, shows Meridia raised heart attack and stroke risk in patients with pre-existing heart disease (read the abstract).
The study examined nearly 10,000 people 55 and older with pre-existing cardiovascular disease, type 2 diabetes or both, who were given Meridia or a placebo. They also participated in a diet and exercise program. On average, Meridia was taken for more than three years and the risk of a heart attack or stroke was 16 percent higher. Those taking the diet pill, which has been on the US market since 1997, were not more likely to die of cardiovascular disease, although it’s worth noting the drug is known to increase blood pressure and heart rates.
When preliminary results were released, European regulators quickly told docs to stop prescribing Meridia, because the risks outweigh the benefits, and decided Abbott’s license to market the pill should be suspended. By contrast, the FDA added new warnings highlighting increased risks for patients with heart problems, but reserved further action until full results were released and an advisory committee meeting is held this month.
An editorial in the New England Journal, however, points out some shortcomings with the FDA approach. The Meridia label, for instance, includes a warning that the drug should not be used in patients with preexisting cardiovascular disease, but does not state that the pill is contraindicated in patients with cardiovascular disease. Moreover, the editorial also notes that 13 years have passed before a large clinical trial was completed to offer “an accurate assessment of cardiovascular risk.”
They also underscored that, in exchange for a net weight loss of about 8 pounds, there was a 1 in 70 chance of having a myocardial infarction or stroke (and a 1 in 52 chance for those with cardiovascular disease). Given that diet pills are presumed to be taken for a long period of time by those who are struggling to keep off weight - and heavier people are likely to have an increased risk of cardiovascular problems - those odds do not look so good.
And so the editorialists, who included New England Journal editor Jeff Drazen, conclude Meridia should go. “Given that (Meridia) has minimal efficacy for weight loss, no apparent benefit for clinical outcomes, a worrisome cardiovascular risk profile, and a plausible mechanism to explain the cardiovascular risk, it is difficult to discern a credible rationale for keeping this medication on the market,” they write. Meridia is actually not widely used in this country, but is likely viewed as helpful by some docs and patients. And for its part, the FDA can argue that issuing sterner warnings while waiting for complete results is prudent. Then again, months have passed while an untold number of people were at risk, unlike in Europe.
