A large government experiment has offered disappointing results. It was hoped a link could be found between Celebrex and Aleve and improved function in Alzheimer patients; however, the experiment indicates neither drug provides benefits on thinking skills or helps to slow Alzheimer’s or mental decline in the elderly. Also, earlier results from the same research showed the two drugs didn’t prevent Alzheimer’s, at least in the short term.
The experiment was halted several years early in 2004 when heart risks occurred in a separate study on Celebrex and researchers noticed increased heart attacks and strokes in those taking Aleve in the Alzheimer’s study. Scientists speculate that nonsteroidal anti-inflammatories (NSAIDs), such as Aleve and Celebrex, might help prevent Alzheimer’s by reducing brain inflammation. Although the study ended early, there was sufficient information to point to how the drugs act on thinking and memory.
Findings were posted online Monday and will appear in July’s Archives of Neurology. “These were not the results we were hoping for,” said co-author Barbara Martin of the Johns Hopkins Bloomberg School of Public Health. “We designed this study hoping we would see a protective effect of these drugs.” The halted study included over 2,000 people ages 70 and older with a family history of Alzheimer’s but no thinking problems themselves. People were randomly assigned to take standard daily doses of either Celebrex, Aleve—also known as naproxen, or a placebo. Patients were tested at the start and annually for up to three years via a battery of mental acuity tests. All three groups scored about the same at the start; however, over time, Aleve takers scored on average slightly lower than those on placebos. Celebrex takers scored slightly lower than placebo takers on most tests.
Previous, observational studies revealed that people who took the drugs experienced a lower risk of developing Alzheimer’s; however, since those studies merely observed behavior and health, it’s possible those taking the pills may have had other healthy habits that lowered their risk.
Researchers hope to continue monitoring participants to determine possible delayed benefit. “The drugs have several effects in the brain and the different effects could be important at different stages in the illness,” said study co-author Dr. John Breitner of the University of Washington in Seattle.
Meanwhile Celebrex maker Pfizer Inc. has begun to settle injury claims in the 7,000 cases filed by people who claim the defective painkiller caused heart attacks and strokes. Lawyers representing Pfizer have indicated the company is willing to pay as much as $500 million to resolve all outstanding cases. And, recently, the National Cancer Institute released an analysis of six Celebrex studies of 7,950 patients. According to The Wall Street Journal, analysis showed Celebrex was associated with an increased risk of cardiovascular death, heart attack, stroke, heart failure or thromboembolic event, or events related to blood clots, compared to patients not taking the drug. Researchers found patients receiving the highest dose of Celebrex of 400 milligrams twice daily had a nearly three times higher risk of heart attacks and strokes than patients not taking the drug. Patients taking a lower dose of Celebrex, 400 milligrams once daily, had a 10% higher risk of a cardiovascular event.
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