Study predicted cardiovascular risk of Cox-2 inhibitors

Amid the recent controversy and confusion over serious side effects from pain medications, a new UCLA and Veterans Affairs Greater Los Angeles Healthcare System study demonstrates that for arthritis sufferers at high risk for gastrointestinal problems who traditionally may have used a drug like Vioxx, the most cost-effective and safest treatment is actually a common painkiller combined with an acid-reducing drug.

Published in the April 15 issue of Arthritis Care and Research, the clinical journal of the American College of Rheumatology, the study used a sophisticated economic model to develop patient scenarios and compare costs of the following three therapies often used for treating pain from chronic arthritis: 1) a nonsteroidal anti-inflammatory drug alone, such as Naproxen or Ibuprofen; 2) a nonsteroidal anti-inflammatory drug combined with an acid-reducing drug (proton pump inhibitor) such as Prevacid or Nexium; and 3) a Cox-2 inhibitor (cyclooxygenase 2-selective inhibitor) alone, such as Vioxx or Celebrex.

The study marks the first time researchers have looked at the cost-effectiveness of a popular combination of two drugs and also included other factors that may affect therapy, such as aspirin use and the risk of complications such as heart attack.

According to researchers, the study also looked at the health economic consequences of heart attacks related to Cox-2 inhibitors like Vioxx. The study, completed a year before Vioxx was removed from the market, not only predicted the cardiovascular complications, but also demonstrated that a combination therapy of two other drugs may prove more cost-effective and safer than Cox-2s.

"The study is one of the first to assess the most relevant therapies for high-risk arthritis patients," said Dr. Brennan M.R. Spiegel, study author and co-director, Center for the Study of Digestive Healthcare Quality and Outcomes and assistant professor of medicine, David Geffen School of Medicine at UCLA and VA Greater Los Angeles Healthcare System. "We found that for high-risk patients, the combination of a common anti-inflammatory drug taken with an acid-lowering drug was not only less expensive, but also safer and more effective. Cox-2 inhibitors were not a health economic bargain at all -- especially given the added costs of more heart attacks."

More than 15 million Americans suffer from chronic arthritis, including osteoarthritis and rheumatoid arthritis. According to researchers, non-steroidal anti-inflammatory drugs are the most commonly used medications for chronic arthritis, but can cause gastrointestinal complications such as ulcers and hemorrhages in high-risk patients.

The UCLA study found that for high-risk patients, it is more cost-effective and safer to use a non-steroidal anti-inflammatory drug combined with a proton pump inhibitor, which is an acid-lowering drug, compared to using a Cox-2 inhibitor drug alone, which guidelines had traditionally recommended as a first-line therapy for this patient group. According to the study, for patients at low risk of gastrointestinal problems, a non-steroidal anti-inflammatory drug alone proved the most cost-effective.

Over a one-year timeframe, researchers tracked a hypothetical group of 60-year-old patients with chronic arthritis who require long-term non-steroidal anti-inflammatory drug therapy for moderate to severe arthritis pain. Since this is an older group, it was assumed that some patients were taking a daily aspirin for cardiovascular benefits.

"With an aging population that will have higher risk factors for gastrointestinal and other health events, it's critical to assess arthritis therapies using additional factors that can impact treatment such as taking aspirin," Spiegel said.

The model reflected probabilities of various adverse events that could occur, including heart attack, ulcer perforation, ulcer bleeds and stomachaches. Medical and hospital costs for these events were factored into the cost analysis. Researchers used a standard measure that assesses the outcome of health care procedures or services called the quality-adjusted life-year. The measurement is designed to take into account health-related quality of life as well as the duration of survival.

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