Name: Hoh Chun Onn Roll No: EPC/26/007/10 EPCE Group 2 Assignment of Power Tools: Report Structure People suffering from the joint pain, stiffness and inflammation associated with arthritis are typically interested in available drugs to relieve this unpleasant side effect of the disease. Arthritis sufferers – whether they have osteoarthritis (OA), rheumatoid arthritis (RA), lupus or one of the other 100 plus forms of the disease – are afflicted to some degree with joint pain and stiffness caused by the condition. One class of drugs used by physicians to treat arthritis joint pain and inflammation is called NSAIDS (non-steroidal anti-inflammatory drugs), and within this class is a sub-class known as COX-2 Inhibitors. Currently, only two drugs are available within the COX-2 inhibitor sub-class, Celebrex and Vioxx. This report is limited to these two COX-2 inhibitor drugs. Celebrex and Vioxx work in similar ways, but each has its unique characteristics as well. These drugs will be evaluated based on cost, recommended dosage, and frequency of ulcers in patients. Development Background "Despite all of the new options for treating arthritis in recent years, NSAIDS are still by far the most prescribed and most widely used medications for arthritis," according to Mary Anne Dunkin with Arthritis Today [1:42]. All NSAIDS work by blocking the production of body chemicals known as prostaglandins. By doing this, NSAIDS reduce inflammation and relieve joint pain and stiffness. According to Arthritis Today, "Unfortunately, blocking prostaglandins also has some adverse effects in some people, including stomach ulcers and increased bleeding" [1:42]. Two enzymes called COX-1 and COX-2 are present in the human body. COX-1 helps regulate normal cell function in the stomach. COX-2 "plays a role in causing arthritis pain and inflammation" . COX-2 inhibitors were created to provide the same level of relief for joint pain and inflammation as other NSAIDS. However, these drugs work without affecting the way the body naturally protects the stomach. COX-2 inhibitors attack only the inflammationcausing prostaglandins (COX-2 enzymes) without damaging the stomach-protecting prostaglandins (COX-1 enzymes). Consequently, prescriptions for this class of drugs have increased significantly in the past few years. Note: At least two new COX-2 inhibitors are currently in clinical testing for RA and OA. These drugs should have greater inflammation-reducing abilities with even fewer side effects on the stomach than the drugs reviewed in this recommendation report [1:44]. Requirements for evaluation Currently, only two drugs are classified as COX-2 inhibitors, Celebrex and Vioxx. Both of these drugs provide relief for arthritis pain, inflammation and stiffness helping patients with their daily activities, like walking, standing or climbing stairs. These drugs also provide relief while an arthritis sufferer is sitting or lying in bed. Although many drugs can be classified as NSAIDS, both prescription and non-prescription, only Celebrex and Vioxx are COX-2 inhibitors. This recommendation report will focus exclusively on COX-2 inhibitor drugs since these drugs are the only ones currently available that provide protection for an arthritis patient's stomach while also relieving joint pain, stiffness and inflammation. The following points of comparison will be made for Celebrex and Vioxx: Cost for a 30-day supply Manufacturer's dosage recommendations Frequency of ulcers in patients during clinical trials Comparison of Celebrex and Vioxx The three areas of comparison for these two COX-2 inhibitor drugs will be (1) cost, (2) recommended dosage and (3) ulcer frequency. Cost. Since many prescription-drug insurance plans cover the cost of a month's supply, price comparisons are based on a 30-day supply. Costs can vary somewhat from one pharmacy to another, and patients can reduce their drug cost by using mail-order suppliers or other such methods of purchasing prescriptions. However, for this comparison only one pharmacy was selected to illustrate how the cost of Celebrex and Vioxx compare. Also, note that these two drugs are produced in different size doses. Celebrex comes in 100-400 milligram (mg) tablets and Vioxx comes in 25-50 milligram (mg) tablets as well as a liquid form. For this cost comparison, 200 mg Celebrex and 25-mg Vioxx tablets were selected, because these dosages are comparable in effectiveness for treating OA or RA pain [1:44]. The cost of a 30-day supply of Vioxx is $88.95 and the cost of Celebrex is $161.90. Vioxx is the most costeffective COX-2 inhibitor drug available today. One important reason for its costeffectiveness is that Vioxx is taken only once daily. In addition, the manufacturer of Vioxx does not increase the price regardless of the milligram level of the tablet, 25 mg cost the same as 50 mg. Since the manufacturer of Celebrex recommends using its drug twice daily, this greatly affects the cost of the treatment. Recommended dosage frequency. Since Celebrex and Vioxx have two different chemical structures, the dosage frequency recommended by the manufacturer of the drug varies. Celebrex should be taken twice daily and Vioxx is taken once daily. Therefore, the convenience to the patient is affected by these dosage recommendations. Vioxx is a more convenient drug because it is taken by the patient only once a day. Celebrex, because of its chemical structure, is not capable of providing extended relief and, therefore it must be taken twice daily for arthritis pain and inflammation relief. Frequency of ulcers. During a three-month clinical trial using patients who did not show any evidence of ulcers before beginning the study, the percentage of patients who developed ulcers while taking either Celebrex or Vioxx were very similar. The incidence of ulcers for those taking one of the COX-2 inhibitor drugs was significantly less than for patients using aspirin or ibuprofen. The occurrence of ulcers was slightly less frequent for patients on Vioxx than for those using Celebrex, 7.3% versus 7.5%, respectively. Therefore, Vioxx is the recommended choice for a COX-2 inhibitor drug. Since the difference between these two drugs in this category is relatively insignificant, the variance should not be used as the sole determining factor for selection. Conclusions 1. The cost of these two COX-2 inhibitor drugs are similar per dose, however because Celebrex is taken twice daily its 30-day supply cost is above Vioxx for a month's supply. 2. The recommended dosage frequency for OA, osteoarthritis, and RA, rheumatoid arthritis, sufferers is once daily for Vioxx and twice daily for Celebrex. Consequently, Vioxx is a more convenient drug to the patient than Celebrex. 3. In a 3-month clinical trial, Vioxx patients had a slightly less frequent incidence of ulcers than Celebrex users. Therefore, Vioxx has a superior rating in this category. 4. Since there is no significant difference between the two drugs, ulcer frequency should not be used as the sole determining factor in drug selection. The following table summarizes the ranking for each COX-2 inhibitor drug in each category (a lower score indicates a better ranking): Category Vioxx Celebrex Cost 1 2 Recommended dosage 1 2 Ulcer frequency 1 2 Totals 3 6 Recommendations Of the two currently available COX-2 inhibitor drugs, Vioxx is preferable. You should base your drug selection solely on this report; always consult your physician who knows your medical history and potential drug interactions. In addition, if you have any sensitivity to aspirin or other NSAIDS, you should not take either of these drugs. If you show sensitivity to either Celebrex or Vioxx, you should not use either of these COX-2 inhibitor drugs. Note. There is no evidence to show that Celebrex or Vioxx will provide the same protection against heart attack or stroke as aspirin. Use of Celebrex with a low dose of aspirin is permitted but may increase ulcer risk [1:45]. Sources 1. Dunkin, Mary Anne. "2001 Drug Guide." Arthritis Today (January-February, 2001), 40-45. 2. Pharmacia, Pfizer. "Discover Celebrex – The #1 Selling Brand of Prescription Arthritis Pain Medicine." Pharmacia and Pfizer Inc. 2001. http://www.celebrex.com/celebrex/index/htm. (27 April 2001). 3. Merck & Co. Inc. "Learn more about Vioxx." Merck & Co. Inc. 2000. http://www.merck.com/product/usa/vioxx/cns/about_vioxx/imagine.jsp. (26 April 2001). 4. Jones, Erica. Publix Pharmacy. Atlanta, GA (30 April 2001).