BOXED WARNING
Cardiovascular Risk
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NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk (See WARNINGS).
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Etodolac is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS).
Gastrointestinal Risk
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NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events (See WARNINGS).
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ETODOLAC SUMMARY
Etodolac is a pyranocarboxylic acid chemically designated as (±) 1, 8-diethyl-1,3,4,9-tetrahydropyrano-[3,4-b]indole-1-acetic acid.
Etodolac is indicated for acute and long-term use in the management of signs and symptoms of osteoarthritis. Etodolac is also indicated for the management of pain.
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NEWS HIGHLIGHTS
Published Studies Related to Etodolac
Evaluation of adverse effects of long-term oral administration of carprofen, etodolac, flunixin meglumine, ketoprofen, and meloxicam in dogs. [2007.03] OBJECTIVE: To evaluate adverse effects of long-term oral administration of carprofen, etodolac, flunixin meglumine, ketoprofen, and meloxicam in dogs... Monitoring for adverse effects should be considered when nonsteroidal anti-inflammatory drugs are used to treat dogs with chronic pain.
Etodolac versus dexamethasone effect in reduction of postoperative symptoms following surgical endodontic treatment: a double-blind study. [2006.06] OBJECTIVE: The purpose of this prospective study was to analyze the effect of etodolac versus dexamethasone in reducing postoperative pain in patients who had surgical endodontic treatment using a strict protocol... CONCLUSION: Postoperative pain following endodontic surgical treatment is not uncommon. Etodolac as well as dexamethasone might serve as a pain relief measure for postoperative pain in these patients.
Clinical Trials Related to Etodolac
Safety and Efficacy of SDX-101 (R-Etodolac) in Patients With Relapsed or Refractory Multiple Myeloma (MM) [Terminated]
An Open Label, Multi-Center, Phase II Study to Investigate the Safety and Efficacy of SDX-101
(R-Etodolac) in Patients with Relapsed or Refractory Multiple Myeloma (MM)
Safety and Efficacy of SDX-101 (R-Etodolac) in Combination With Chlorambucil, and That of Chlorambucil Alone, in Patients With Chronic Lymphocytic Leukemia (CLL) [Terminated]
This is a Phase 2, multi-center, open label, randomized clinical study to evaluate the safety
and efficiency of SDX-101 in combination with chlorambucil (CLB) and chlorambucil alone in
Chronic Lymphocytic Leukaemia (CLL) patients. The study treatment period will be
approximately 24-26 weeks with a follow-up period of approximately 8 weeks. Following the end
of treatment, patients with a confirmed complete response, partial response or stable disease
will be followed for up to 2 years to assess time to disease progression. Approximately 80
patients with documented diagnosis of B-cell CLL by standard clinical and immunophenotyping
criteria will be enrolled into the SDX-101-03 study. This study is being conducted in the
following European countries: France, Germany, Poland, Sweden and the United Kingdom.
β-Adrenergic Blocker and a COX2 Inhibitor for Prevention of Colorectal Cancer Recurrence [Not yet recruiting]
Colon and rectal cancer is the second most prevalent malignant disease in the western world,
causing significant morbidity, mortality, and healthcare sources use. Treating colon and
rectal cancer with curative intent generally includes resection of the primary tumor.
Despite its crucial role, surgery by itself induce physiological changes resulting in
significant immune depression and other physiological perturbations, which may in turn play
a significant role in the initiation of new metastases and the progression of pre-existing
dormant metastases. The aim of this study is to assess the use of perioperative medical
intervention using a combination of a β-adrenergic blocker (Propranolol) and a COX2
inhibitor (Etodolac), in order to attenuate the surgically induced immunosuppression and
other physiological perturbations, aiming to reduce the rate of tumor recurrence and distant
metastatic disease.
Evaluation of Stepped Care for Chronic Pain in Iraq and Afghanistan Veterans
The purpose of this study is to determine if a stepped-care intervention makes pain symptoms
better and reduces activity limitations because of pain. Our two primary hypotheses are that
in OIF/OEF veterans with chronic pain:
1. Stepped care is more effective than usual care in reducing pain-related disability
2. Stepped care is more effective than usual care in reducing psychological distress
Perioperative Administration of COX 2 Inhibitors and Beta Blockers to Women Undergoing Breast Cancer Surgery: an Intervention to Decrease Immune Suppression, Metastatic Potential and Cancer Recurrence [Not yet recruiting]
Surgery for breast cancer has a major role in enhancing long term survival and cure, but
several physiological aspects associated with surgery are implicated as enhancing tumor
spread and formation of distant metastases. These include: an increase in pro-angiogenic
factors, direct spread of tumor cells, accumulation of grown factors, immune suppression and
direct effects of anesthetics and opiate pain relievers on cancer cells. Some of these
pro-metastatic mechanism may be blocked by the interventions proposed in this study, namely
by administration of β-adrenergic blockers and COX2 inhibitors around the time of surgery.
Studies have shown that surgery increases levels of catecholamines and prostaglandins, which
in turn may promote the release of pro-angiogenic factors such as VEGF, and enhance
vascularization of micro metastases.
Opiates given for pain relief during and after surgery have been reported to enhance tumor
cell division and cause immune suppression.
The immune system is significantly suppressed during surgery. This suppression has been
shown to affect the systemic resistance to infection as well as neoplastic metastatic
processes.
Several studies have shown that increased levels of catecholamines and prostaglandins add to
the immune suppression.
Studies in rats found that peri-operative administration of the beta β-blocker propranolol
together with the COX2 inhibitor etodolac significantly reduced the suppression of NK cell
activity as well as the risk for distant metastases.
A recent retrospective clinical study found that among breast cancer patients treated with a
combination of regional anesthesia and a COX inhibitor the recurrence rated were
significantly less than among patients undergoing surgery without these two interventions.
The purpose of the proposed prospective trial is to examine if peri-operative administration
of the combination of a β-blocker together with a COX2 inhibitor will prevent suppression of
cellular immunity, decrease VEGF levels, and decrease cancer recurrence rates.
In the proposed study breast cancer patients will be treated with a combination of a
β-blocker and COX2 inhibitor (or placebo) before, during and after surgery. (A control group
of healthy women will serve as untreated controls). The variables which will be examined
are: number and activity of NK cells, levels of Th1 and Th2 cytokines, serum stress hormones
and angiogenic factors, and the ability of leukocytes to produce Th1 and Th2 cytokines as a
result of in vitro stimulation.
In addition to these immediate parameters, long term follow up will be conducted in order to
determine the effect of the intervention on long term cancer recurrence over five years.
Statistical analysis will be done using t-tests, ANOVA, and multivariate regressions, with
regard to the known risk factors for recurrence such as tumor grade, lymph node involvement
etc. Sample size for immunological parameters will be 40 patients in each group and 20
healthy women. Sample size for estimates of cancer recurrence at five years of follow up
wiil be 460 women (230 in each group). This sample size provides a power of 80% to detect a
50% reduction in cancer recurrence at an α of 0. 05.
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 1 ratings/reviews, Etodolac has an overall score of 9. The effectiveness score is 8 and the side effect score is 8. The scores are on ten point scale: 10 - best, 1 - worst.
| | Etodolac review by 51 year old female patient | | | Rating |
| Overall rating: | |           |
| Effectiveness: | | Considerably Effective |
| Side effects: | | Mild Side Effects | | | Treatment Info |
| Condition / reason: | | Osteo-arthritis |
| Dosage & duration: | | 400mg taken twice a day for the period of 3 yrs. |
| Other conditions: | | Asthma, Hashimoto's Thyroiditis, Vitiligo, Hypertension, Anxiety |
| Other drugs taken: | | Lisinopril, Lexapro, Levothroid, Asmanex, Albuterol | | | Reported Results |
| Benefits: | | It is moderately effective in reducing the pain, and very effective in reducing the inflammation, swelling and heat in the joints. I had not realized just how effective it is, until I ran out recently, and was without it for a few days. I guess I had forgotten how debilitating OA can be. Without it, I walk with a cane- with it, I don't need a cane, and can even walk for a mile or so for exercize, without 'paying for it' the next day. |
| Side effects: | | At first it made me pretty drowsy. After about three weeks, my body adjusted to it, and the drowsiness went away. I have to be sure to take Etodolac after eating a meal, or it causes rather pronounced nausea. I've found that it has to be an actual meal, too. Just a nibble of something isn't enough to prevent the upset stomach. |
| Comments: | | I am severely allergic to Aspirin and Naproxyn, so cannot take these for the pain and inflammation of osteoarthritis. I developed OA in both knees after injuring the cartilage and the arthroscopic surgery to try to repair the damage. My left knee still has a little cartilage, but the right knee has bone on bone. I had been taking Vioxx, which worked very well, but then it was pulled off the market. Mobic did not work very well, so we went on to Etodolac. Once a year, I have to go in and get bloodwork done, to make sure I have not developed any liver damage. |
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Page last updated: 2007-05-03
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