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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: Rofecoxib
Other Names: Vioxx™
Therapy Types: pharmacological
Mechanisms: anti-inflammatory
Development Status: investigational in U.S.
FDA Phase: Inactive
Primary Medical Role: Approved by FDA in 1999 for relief of the signs and symptoms of osteoarthritis. Also used for the management of acute pain and for the treatment of primary dysmenorrhea.
Role in Alzheimer's Disease: May slow the rate of cognitive deterioration by decreasing inflammation in the brain.
Pharmacological Role: A selective nonsteroidal anti-inflammatory drug that exhibits anti-inflammatory, analgesic, and antipyretic activities in animal models. The mechanism of action of rofecoxib is believed to be due to inhibition of prostaglandin synthesis, via inhibition of cyclooxygenase- 2 (COX-2). At therapeutic concentrations in humans, Rofecoxib does not inhibit the cyclooxygenase-1 (COX-1) isoenzyme.
Contraindications: VIOXX is contraindicated in patients with known hypersensitivity to rofecoxib or any other component of VIOXX. VIOXX should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients.
Side Effects: Liver damage, upper respiratory tract infection, diarrhea, nausea, heartburn, swelling of the lower legs or feet, high blood pressure, and others.
Companies: Merck & Co., Inc.
Notes: See latest news from the 2002 World Alzheimer Congress. See Medline Plus Drug Information: Rofecoxib [MedMaster] and Rofecoxib (Systemic) [USP DI]. Testing of Rofecoxib for Alzheimer Disease has been discontinued. This record was updated Dec 19, 2008.

References

Reines SA, Block GA, Morris JC, Liu G, Nessly ML, Lines CR, Norman BA, Baranak CC, . Rofecoxib: no effect on Alzheimer's disease in a 1-year, randomized, blinded, controlled study. Neurology. 2004 Jan 13;62(1):66-71. 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

Ahuja N, Singh A, Singh B. Rofecoxib: an update on physicochemical, pharmaceutical, pharmacodynamic and pharmacokinetic aspects. J Pharm Pharmacol. 2003 Jul ;55 (7):859-94. 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

Scali C, Giovannini MG, Prosperi C, Bellucci A, Pepeu G, Casamenti F. The selective cyclooxygenase-2 inhibitor rofecoxib suppresses brain inflammation and protects cholinergic neurons from excitotoxic degeneration in vivo. Neuroscience. 2003 ;117(4):909-19. Abstract

Konstam MA, Weir MR, Reicin A, Shapiro D, Sperling RS, Barr E, Gertz BJ. Cardiovascular thrombotic events in controlled, clinical trials of rofecoxib. Circulation. 2001 Nov 6;104(19):2280-8. Abstract

Bennett A. Anti-inflammatory drugs, cyclooxygenases and other factors. Expert Opin Pharmacother. 2001 Jan;2(1):1-2. Abstract

Ferencik M, Novak M, Rovensky J, Rybar I. Alzheimer's disease, inflammation and non-steroidal anti-inflammatory drugs. Bratisl Lek Listy. 2001;102(3):123-32. Abstract

Blain H, Jouzeau JY, Netter P, Jeandel C. [Non-steroidal anti-inflammatory agents with selective inhibitory activity on cyclooxygenase-2. Interest and future prospects] Rev Med Interne. 2000 Nov;21(11):978-88 Abstract

Blain H, Jouzeau JY, Blain A, Terlain B, Trechot P, Touchon J, Netter P, Jeandel C. [Non-steroidal anti- inflammatory drugs with selectivity for cyclooxygenase-2 in Alzheimer's disease. Rationale and perspectives] Presse Med. 2000 Feb 12;29(5):267-73. Abstract


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