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Fight World Hunger
Home Journal Excerpts COX-2 Selective NSAIDs
COX-2 Selective NSAIDs
toxicnsaidssmallAll NSAIDs, both COX-2 selective and nonselective, provide only a modest symptomatic benefit over placebo, and this benefit has been proven only in short-term trials. With long-term therapy, it is not known whether the benefits of this class of drugs exceed the harms. In fact, there is evidence to suggest that the opposite is true. Meta-analysis of FDA data from the CLASS and VIGOR trials shows, first, that COX-2 selective NSAIDs do not necessarily reduce the incidence of complicated ulcers. Second, the meta-analysis demonstrates that, rather than proving safer, COX-2 selective NSAIDs cause more morbidity (total SAEs) than nonselective NSAIDs.

Comment:

The original NSAIDs have been known for years to be killing thousands of people each year since their initial introduction. As reported in the American Journal of Medicine, over 100,000 people are hospitalized each year and at least 16,500 die each year from gastrointestinal (GI) bleeding. These figures are considered conservative and they are only figures for NSAIDs being used to treat arthritis. It also doesn't include the number of people who die of other complications of NSAID use such as congestive heart failure. A true analysis of the number of deaths world wide from NSAIDs would be overwhelming.

Celebrex and Vioxx were the pharmaceutical solutions to the devastating and deadly problems associated with the original less specific NSAIDs. Unfortunately, once again, a class of drugs were seriously marketed and promoted before the long-term effects of these drugs were studied and determined. Claims were made as to their safety and efficacy, which this research paper indicates not to be true. NSAIDs apparently "provide only a modest symptomatic benefit over placebo" and "this benefit has been proven only in short-term trials". We know that "NSAIDs inhibit inflammation and have the potential to interfere with this healing process. Impairment of joint healing can lead to joint deterioration in the various forms of arthritis." So by taking NSAIDs we may be getting a small short-term benefit at the expense of a worse long-term problem.

We know that not only can serious GI problems occur, but that they can be a contributing factor to congestive heart failure, thrombosis, and impaired fracture healing. In short, this class of medications is not a cause of "celebration" as promoted in one of these company's entertaining advertisements. This class of medication has been a disaster from its origin with smoke and mirrors hype to cover the pain and death. The public needs to understand that enormous profits were made at the expense of people. It's time for people to see through the propaganda and look towards safer and proven ways to deal with pain and the disease process. Nutrients that can be used to help arthritis include: Gammalinolenic Acid, S-adenosylmethionine (SAMe), boron, vitamin C, vitamin E, olive oil, and folic acid to name a very few. Many other ways can be used to help the body whole and healthy such as juicing, meditation, exercise, destressing, diet, and many more. When taken all together we have a solution that will give people the health and vitality that these drugs do not and never will.


The double-edged sword of COX-2 selective NSAIDs PDF Print E-mail
Tuesday, 12 November 2002 00:00
“Most new drug concepts are launched with fanfare, and it takes many years on the market for their appropriate role in practice to be established. An excellent example is the concept of cyclooxygenase-2 (COX-2) selective NSAIDs, which was launched in Canada in early 1999 with celecoxib (Celebrex). The launch of the COX-2 selective NSAIDs was based on 2 hypotheses. The first hypothesis is that the major adverse effects limiting the usefulness of nonselective NSAIDs are gastrointestinal symptoms, ulcers, ulcer complications and ulcer complications leading to death. The second hypothesis is that COX-2 selective NSAIDs are associated with less gastrointestinal toxicity than nonselective NSAIDs. At the time of the launch of COX-2 selective NSAIDs neither of these hypotheses had been proven and, as documented in this review, both remain uncertain. However, skilful marketing of these hypotheses without any published complete trial reports by the fall of 1999 resulted in celecoxib's achieving a record for the most sales in the shortest period of time. Worldwide sales of celecoxib exceeded $3.1 billion in 2001. In 2000, 2 large randomized controlled trials testing the second hypothesis were published. In the Celecoxib Long-term Arthritis Safety Study (CLASS) and the Vioxx Gastrointestinal Outcomes Research (VIGOR) study, celecoxib and rofecoxib respectively were compared with nonselective NSAIDs. These well-designed trials claimed to prove the safety of these agents, but the results became controversial when more complete data from the trials became available from the US Food and Drug Administration (FDA).”

“NSAIDs act by inhibiting cyclooxygenase, an enzyme involved in the formation of various prostanoids with a wide variety of pharmacologic actions. The COX-2 selective NSAIDs resulted from the discovery that cyclooxygenases represent at least 2 different isoenzymes, designated COX-1 and COX-2. COX-1 is mostly constitutive and is involved in such actions as platelet activation, gastrointestinal protection and kidney function. COX-2 is primarily produced in response to tissue damage and is involved in inflammatory responses to injury. The discovery of the different COX enzymes has allowed grading of the more than 20 available NSAIDs based on their ability to selectively inhibit the 2 COX enzymes. The best attempt to grade the available NSAIDs used standardized in vitro human assay systems. This demonstrated that ketorolac inhibits COX-1 300 times more than COX-2 at one extreme, and rofecoxib inhibits COX-2 80 times more than COX-1 at the other extreme. Four drugs marketed in Canada are claimed to be COX-2 selective. The selectivity of these drugs as well as of some nonselective NSAIDs is shown in Table 1.”
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