Last week the National Institutes of Health (NIH) took the unusual step of announcing the early conclusion of a “landmark” study on managing hypertension.
What makes it unusual is that when the NIH made the bold announcement that intensive intervention with a combo of three drugs to reach a new target systolic blood pressure of under 120 mm Hg reduced the rate of heart attacks, heart failure and stroke by 30% and cardiovascular deaths by 25%, the agency didn’t release any of the evidence, statistics, or even which kind of drugs were used in the trial. Those are to be delivered in a few months’ time when the study is published in as-yet-to-be-named journal. Kevin Lomangino summarized here why many physicians and journalists feel the NIH jumped the gun on the trial, referred to as SPRINT (Systolic Blood Pressure Intervention Trial).
The lack of data is especially concerning since the SPRINT announcement contradicts findings from previous reviews and recommendations, some of which have a different conclusion about intensive treatment with drugs for mild hypertension. If the NIH trial findings are such an advancement that they will lead to new practice parameters, as the news release and media briefing suggest, physicians and patients should be informed now so that they can incorporate the results into their decision-making, argued Harlan M. Krumholz and Eric J. Topol in a New York Times op-ed.
The current, and also controversial, hypertension treatment guidelines (JNC 8, published in JAMA in December 2013) state that drug treatment should be initiated in healthy people over age 60 when blood pressure is 150/90 or higher. If under 60 years old, medications should be introduced in adults with blood pressure readings of 140/90 or higher. But the conclusion of researchers involved with the SPRINT study is that the top blood pressure reading should be below 120 for adults 50 and older who are at risk of developing heart or kidney disease.
Both the JNC 8 recommendations and the SPRINT report, which would conceivably introduce millions of new patients to anti-hypertension medications, are coming under some criticism for having too heavy of a reliance on medications and next to little attention given to lifestyle changes, or the harms and costs of medications.
“It’s frustrating because they [SPRINT report] make huge, huge claims and supply no data,” said David Cundiff, MD, an internal medicine physician and author of “Money Driven Medicine Test and Treatments That Don’t Work.” Cundiff was part of the Cochrane Hypertension Group that published a systematic review of randomized controlled trials devoted to “Pharmacotherapy for mild hypertension” in 2012. The Cochrane group found no evidence that drugs benefit patients with mild hypertension (defined as systolic BP of 140 to 159) while about 9% discontinue treatment due to severe side effects.
Cundiff said it’s “hard to fathom” the NIH’s claims that “three blood pressure lowering medications versus two blood pressure lowering medications are responsible for reducing heart attacks by one-third and deaths by one-quarter.”
“I can’t say it’s wrong because they don’t present any of the data and specifics,” he added. He’s also concerned about the costs (already estimated at $32 billion annually for treating mild hypertension, according to the American Heart Association) and harms from introducing more people to blood pressure drugs, citing falls and black-outs among people taking the meds.
Today, faced with a report with no evidence shared, it seems prescient that an article in the BMJ last year called it a “leap of faith” to argue that lowering threshold blood pressures will lead to increased diagnosis and treatment, and decreased mortality.
In an article in Slate following the release of the Cochrane Hypertension Group’s review, veteran medical journalist and editor Jeanne Lenzer suggested the trend for earlier and broader treatment for mild hypertension might fall under the term “disease creep,” used to describe the trend to treat patients at risk or with milder cases the same as patients with severe cases. “Most patients with mild disease would do well in any case, so it’s easy for drug side effects to overwhelm any benefit,” she noted.
If it’s true that patients with mild hypertension are being over-treated now, that could change – for the worse – under new guidelines if they’re based on the SPRINT study and don’t adequately account for side effects.
None of this will be totally clear until the NIH publishes the peer-reviewed SPRINT data and other experts have a chance to dissect it.
Kathlyn Stone is an associate editor and regular blog contributor for HealthNewsReview.org.