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Elizabeth Haag, MPA, RN, research nurse manager at St. Francis Hospital, The Heart Center, Roslyn, NY, was attending the American Heart Association's Scientific Sessions in New Orleans on Nov. 8-12, when she heard the buzz: JUPITER had achieved impressive results using rosuvastatin in apparently healthy individuals.
Originally planned as a 4-year trial, the JUPITER study was stopped in March 2008 when researchers learned people who took the cholesterol-lowering drug had half as many cardiovascular events as people on a placebo. (Ridker, 2008)
Unexpected Results
The Justification for Use of Statins in Primary Prevention: an Interventional Trial Evaluating Rosuvastatin (JUPITER) findings were particularly striking because the 18,000 men and women in the study had normal lipid levels, including LDL cholesterol levels below recommended thresholds for statin treatment. However, their levels of high sensitivity C-reactive protein (hs-CRP), a marker for inflammation, were above 2 mg/L.
When the trial was stopped after 2 years of statin treatment, those on the drug had lowered their LDL cholesterol by an average of 50 percent, and their hs-CRP by 37 percent.
The study was cut short when it became clear participants in the placebo arm of the trial had twice as many cardiovascular events. However, Haag believes the question of treating the population of low-risk patients with statins remains unanswered.
"The study was stopped early; therefore, we don't know the long-term effects of statin use in this population," she explained.
Chris Garvey, MPA, MSN, FNP, manager of pulmonary and cardiac rehabilitation at Seton Medical Center, Daly City, CA, shared a pragmatic view of the findings.
"I think everyone anticipated the results and were hopeful for something exciting from the JUPITER study," she said. "We were eagerly anticipating the panacea for everything, and instead it became a big hype."
Michael Chang, MD, medical director of cardiology at Mercy General Hospital, Sacramento, CA, pinpointed some of the hype. "The total number of patients [who benefited] is actually really small," he said. "[Of] the folks who didn't get a statin, the vast majority did fine, as well. That's where the rub is. These drugs do have side effects."
Risk vs. Benefit
Haag echoed Chang's perspective, noting, "The cost/benefit analysis of statin use for absolute risk reduction has not been demonstrated. Statin use is costly, and it is unclear whether it is necessary to start statin therapy for a low-risk population when the benefits for the population are small."
Maria Henderson, MS, ANP-C, CVN, a nurse practitioner at the Center of Advanced Clinical Practice at the Texas Heart Institute at St. Luke's Episcopal Hospital, Houston, described a middle-of-the-road approach.
"It's a matter of balance, of course, but the only two drawbacks I could think of with regard to statins are the cost and the potential side effects," she said. "Even some of the side effects are more of a sensitivity issue than a long-term problem; after patients have been on the drug for a while, the symptoms do subside.
"A small percentage of people have toxic effects of the statins, and that is why the continuous monitoring of liver enzymes is so important, contributing to the cost of the therapy," Henderson said.
Janeen Constantine, MS, ANP-C, ACNP, a nurse practitioner with Cardiology Associates at Washington Hospital Center, Washington, DC, emphasized the long-term nature of the decision to prescribe statins.
"If we start someone on a statin, we're talking about a lifelong commitment to a drug with not insignificant side effects," she said.
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