Anti-inflammatories don't slow cognitive decline in Alzheimer's

Question Can treatment with selective COX-2 inhibitors or traditional non-steroidal anti-inflammatory drugs slow cognitive decline in patients with mild to moderate Alzheimer's disease?

Synopsis Observational studies suggest that anti-inflammatory drugs have a protective effect in reducing the incidence of Alzheimer disease. To evaluate this more reliably with a prospective trial, a total of 351 participants with mild to moderate Alzheimer's were randomised (concealed allocation assignment; double blinded) to rofecoxib (Vioxx; 25 mg/day), naproxen (220 mg twice a day), or placebo. The primary outcome measure was a change of score at one year on the cognitive subscale of the Alzheimer disease assessment scale. Outcomes were assessed by individuals blinded to treatment group assignment. Complete data were available for only 76% of the original subjects at one year. With intention to treat analysis, neither active treatment had any significantly beneficial effect on reducing cognitive decline compared with placebo. Side effects such as fatigue, dizziness, and hypertension were more commonly reported in the active treatment groups. Serious adverse events such as gastrointestinal bleeds, strokes, and subdural haematomas were also more common in the active treatment groups.

Bottom line Rofecoxib and naproxen are not effective in slowing the cognitive decline of patients with mild to moderate Alzheimer's disease. Because of their likelihood of causing important adverse events, they should not be recommended for this indication. Add another to the list of observational study results that were contradicted by more reliable data from prospective randomised controlled trials.

Level of evidence 2b (see www.infopoems.com/resources/levels.html); cohort study or low quality randomised controlled studies (less than 80% follow up).