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Home: Drug Development: Drugs in Clinical Trials
Drugs In Clinical Trials

Important Notice: The Forum does not endorse any medical product or therapy. ALL medications and supplements should be taken ONLY under the supervision of a physician, due to the possibility of side-effects, drug interactions, etc.

Name: Naproxen
Other Names: Aleve™, Anaprox™, Naprosyn™
Therapy Types: pharmacological
Mechanisms: Anti-inflammatory
Development Status: investigational in U.S.
FDA Phase: Discontinued
Primary Medical Role: Approved by FDA in 1994 as an over the counter (OTC) nonsteroidal antiinflammatory drug (NSAIDs). It relieves pain and inflammation associated with rheumatoid arthritis (rheumatism), osteoarthritis, and juvenile (childhood) arthritis. Naproxen is also effective in treating other mild to moderate pain, including menstrual pain, premenstrual discomfort, and pain following surgery or childbirth.
Role in Alzheimer's Disease: May be useful in the treatment of the inflammatory process in Alzheimer's disease.
Pharmacological Role: A non-selective NSAIDs, inhibits prostaglandin production.
Contraindications: Patients with active peptic ulcers or active inflammatory diseases of the gastrointestinal tract. Aspirin allergy. 3rd trimester pregnancy.
Side Effects: Serious gastrointestinal toxicity such as perforation, ulceration, and bleeding can occur.
Evidence pro its efficacy: The evidence that nonsteroidal anti-inflammatory medications (NSAIDs) help Alzheimer's patients have been retrospective. In other words, certain flaws in the ointments exist. However, these studies suggest that the progression of Alzheimer's disease is delayed in those taking NSAIDs. Incidence in these patients is described as being cut as much as in half.
Evidence con its efficacy: No prospective, randomized, carefully-performed study that has been performed has shown any efficacy of NSAIDs in treating Alzheimer's disease.
Companies: Proctor & Gamble, Roche Pharmaceuticals, Syntex Roche Ireland
Notes: See ARF news published on 22 Dec 2004 regarding the decision by National Institute on Aging to halt the Alzheimer’s Disease Antiinflammatory Prevention Trial (ADAPT), in part because “Preliminary information from the study showed some evidence of increased risk of cardiovascular events, when compared to placebo, to patients taking naproxen”. See also news from the 2002 World Alzheimer Congress. See Medline Plus Drug Information: Naproxen [MedMaster] and Anti-inflammatory Drugs, Nonsteroidal (Systemic) [USP DI].

References

Imbimbo BP. The potential role of non-steroidal anti- inflammatory drugs in treating Alzheimer's disease. Expert Opin Investig Drugs. 2004 Nov ;13(11):1469-81. Abstract

Jacoby R. Rofecoxib or naproxen do not slow progression of mild to moderate Alzheimer's disease. Evid Based Ment Health. 2003 Nov ;6(4):110. Abstract

Aisen PS, Schafer KA, Grundman M, Pfeiffer E, Sano M, Davis KL, Farlow MR, Jin S, Thomas RG, Thal LJ, . Effects of rofecoxib or naproxen vs placebo on Alzheimer disease progression: a randomized controlled trial. JAMA. 2003 Jun 4;289(21):2819-26. Abstract

Flynn BL, Theesen KA. Pharmacologic management of Alzheimer disease part III: nonsteroidal antiinflammatory drugs-- emerging protective evidence? Ann Pharmacother. 1999 Jul- Aug;33(7-8):840-9. Abstract

Stewart WF, Kawas C, Corrada M, Metter EJ. Risk of Alzheimer's disease and duration of NSAID use. Neurology. 1997 Mar;48(3):626-32. Abstract

Fiebich BL, Lieb K, Hull M, Berger M, Bauer J. Effects of NSAIDs on IL-1 beta-induced IL-6 mRNA and protein synthesis in human astrocytoma cells. Neuroreport. 1996 Apr 26;7 (6):1209-13. Abstract

Rich JB, Rasmusson DX, Folstein MF, Carson KA, Kawas C, Brandt J. Nonsteroidal anti-inflammatory drugs in Alzheimer's disease. Neurology. 1995 Jan;45(1):51-5. Abstract


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