"Edema (say: eh-dee-mah) is swelling or puffiness of parts of the body. It is caused by water that gets trapped in the tissues of your body. Edema usually happens in the feet, ankles and legs. It also can affect the face and hands. Pregnant women and older adults often get edema, but it can happen to anyone.
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What causes edema?
Many things can cause edema. Sometimes gravity pulls water down into your legs and feet. Sitting in one place for too long can cause edema of the legs. Eating food with too much salt can make the problem worse.
Congestive heart failure and liver, kidney and thyroid diseases can cause edema. You cannot catch edema from other people. It does not run in families."
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2006-12-09 11:42:56
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answer #1
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answered by Sancira 7
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CELEBREX® AND VIOXX® COMPARATIVE STUDIES:
STUDIES 149 and 181
Fact Sheet
OBJECTIVES OF STUDIES
Study 149 and study 181 are head-to-head safety studies of the COX-2 specific inhibitors CELEBREX (celecoxib capsules) and Vioxx [insert register mark information] (rofecoxib) that were designed to compare the incidence of clinically significant edemda and clinically significant hypertension, such as important increases in systolic blood pressure (SBP), in elderly patients suffering from both osteoarthritis and hypertension.
Study 181 was specifically designed to replicate and confirm the findings of study 149.
STUDY 149/181 METHODOLOGIES
Both studies were 6-week, double-blind, randomized, 2 arm, parallel group studies that enrolled approximately 810 and 1092 elderly patients respectively, all of whom were being actively treated for hypertension.
These studies compared the safety and tolerability of CELEBREX 200 mg daily versus Vioxx (rofecoxib) 25 daily, with the study drug taken each morning with breakfast. Participants may have used COX-2 inhibitors in the past, but not within 30 days of starting the study.
All study participants were age 65 or older. More than 60% of people studied were 65-75, and more than 38% were older than 75. The mean age of all patients studied was 73. More than 60% of patients studied were women.
Mean duration of hypertension in all patients studied was over 13 years. Mean duration of osteoarthritis in all patients studied was 11 years.
The 181 study intended to closely parallel the design of study 149. Sample size for study 181 was determined on results of study 149.
In both studies, blood pressure, edema and renal chemistry readings were taken at baseline, at the completion of weeks 1 and 2, and at the conclusion of the study at week 6.
In both studies, safety and tolerability were assessed by comparing differences between the treatment groups in the following areas:
Treatment-related renal side effects, such as edema as evidenced by an increase in grade (scale 1+ to 4+) and weight gain of 3% or more
Treatment-related increases in blood pressure (SBP: >20mmHg and >140mmHg; DBP: >15mmHg and >90mmHg)
KEY FINDINGS
Study 149 Key Findings
Compared to CELEBREX 200 mg QD, Vioxx (rofecoxib) 25 mg QD is associated with a significant increase in clinical meaningful increase in systolic blood pressure. Note: 16.5 percent of Vioxx-treated patients experienced increases in SBP (SBP: >20mmHg and >140mmHg; DBP: >15mmHg and >90mmHg) compared to 10.9 percent of CELEBREX patients.
Compared to CELEBREX 200 mg QD, Vioxx (rofecoxib) 25 mg QD is associated with a significant increase in peripheral edema. Note: 9.5 percent of Vioxx-treated patients experienced a clinically significant increase in edema, compared to 4.9 percent increase in the CELEBREX group (p=0.035).
Among patients who take aspirin for cardioprotection, study 181 demonstrates nearly 6 times the incidence of UGI distress among Vioxx-treated patients, as compared to CELEBREX-treated patients.
There were no differences between treatment groups in diastolic blood pressure.
Study 181 Key Findings
Compared to CELEBREX 200 mg QD, Vioxx (rofecoxib) 25 mg QD is associated with a significant increase in clinically meaningful increase in systolic blood pressure. Note: 14.9 percent of Vioxx-treated patients experienced increases in SBP (SBP: >20mmHg and >140mmHg; DBP: >15mmHg and >90mmHg) compared to 6.9 percent of CELEBREX patients.
Compared to CELEBREX 200 mg QD Vioxx (rofecoxib) 25 mg QD is associated with a significant increase in peripheral edema. Note: 7.7 percent of Vioxx-treated patients experienced a clinically significant increase in edema, compared to 4.6 percent increase in the CELEBREX group (p=0.035).
Among patients who take aspirin for cardioprotection, study 181 demonstrates nearly 6 times the incidence of UGI distress among Vioxx-treated patients, as compared to CELEBREX-treated patients.
There were no differences between treatment groups in diastolic blood pressure.
BACKGROUND
Cardiovascular Disease and Arthritis:
For 43 million Americans – nearly one in six – who suffer from arthritis, finding safe and effective treatment options is extremely important.
Fifty million Americans (1 in 4 adults) have hypertension and up to 1 in 3 of these people also suffer from arthritis (approximately 18 million people)[1].
Hypertension is a serious condition that can result in heart disease, the leading cause of death among men and women.
The Cardiorenal System and How it Works
Although the heart and kidney are two separate organs, their interaction is vital to one's health. If the intimate functioning between the two organs is altered the effect could be extremely detrimental.
Experts use the term "cardiorenal" to describe the complex physiologic interactions between the organs. In simplest terms, the heart pumps blood through the vascular system and the kidney manages important aspects of body chemistry by filtering out unwanted elements of wastes and helping to control blood pressure.
OTHER IMPORTANT INFORMATION
Patients who have a known allergic reaction to CELEBREX, certain sulfa drugs called sulfonamides, aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) should not use Celebrex.
CELEBREX should not be taken by women in their third trimester of pregnancy.
As with all NSAIDs, serious gastrointestinal (GI) tract ulcerations can occur without warning symptoms. Physicians and patients should remain alert to the signs and symptoms of GI bleeding.
Concomitant administration of aspirin with CELEBREX may result in an increased risk of gastrointestinal ulceration or other complications, compared to CELEBREX alone.
CELEBREX does not affect platelet function and therefore should not be used for cardiovascular prophylaxis.
There have been infrequent post-marketing reports of increases in prothrombin time, sometimes associated with bleeding events, predominantly in the elderly. Anticoagulant activity should be monitored when therapy with CELEBREX is initiated or changed in patients taking warfarin, particularly in the first few days.
As with all NSAIDs, CELEBREX should be used with caution in patients with fluid retention, hypertension, or heart failure.
In studies, the most common side effects of CELEBREX were dyspepsia, diarrhea and abdominal pain, which were generally mild to moderate.
CELEBREX is co-marketed by Pharmacia Corporation and Pfizer Inc. Pharmacia Corporation (NYSE:PHA) is a top-tier global pharmaceutical company with a leading agricultural subsidiary. Pharmacia's innovative medicines and other products save lives and enhance health and wellness. Pharmacia's 59,000 people work together with many diverse stakeholders to bring these benefits to people around the world, and to create new health solutions for the future.
Pfizer Inc discovers, develops, manufactures and markets leading prescription medicines, for humans and animals, and many of the world's best-known consumer products. Pfizer had global revenues of $29.6 billion in 2000. Pfizer plans to make a research and development investment of about $5 billion in 2001.
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For complete prescribing information on Celebrex, access www.celebrex.com or call toll-free 1-888-735-3214.
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2006-12-09 10:55:12
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answer #2
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answered by Brittany 4
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