Cardiovascular Risk
- NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction (MI), 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 and CLINICAL TRIALS.)
- Lodine is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery. (See WARNINGS.)
Gastrointestinal Risk
- 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 (GI) events. (See WARNINGS.)
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LODINE SUMMARY
Lodine®
(etodolac capsules 200 and 300 mg, and etodolac tablets 400 and 500 mg)
Lodine® (etodolac) is a member of the pyranocarboxylic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). Each tablet and capsule contains etodolac for oral administration. Etodolac is a racemic mixture of [+]S and [-]R-enantiomers. Etodolac is a white crystalline compound, insoluble in water but soluble in alcohols, chloroform, dimethyl sulfoxide, and aqueous polyethylene glycol.
Carefully consider the potential benefits and risks of Lodine and other treatment options before deciding to use Lodine. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
Lodine (etodolac capsules and tablets) is indicated:
- For acute and long-term use in the management of signs and symptoms of the following:
- Rheumatoid arthritis
For the management of acute pain
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NEWS HIGHLIGHTS
Published Studies Related to Lodine (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.
Preventive effects of etodolac, a selective cyclooxygenase-2 inhibitor, on cancer development in extensive metaplastic gastritis, a Helicobacter pylori-negative precancerous lesion. [2009.08.26]
The present study investigated the preventive effects of etodolac, a selective cyclo-oxygenase (COX)-2 inhibitor, on metachronous cancer development after endoscopic resection of early gastric cancer. Among 267 early gastric cancer patients who underwent endoscopic resection, 47 patients with extensive metaplastic gastritis were selected based on endoscopic findings and our previously described criteria of serum pepsinogen (PG) test-positive and Helicobacter pylori antibody-negative conditions...
Single dose oral etodolac for acute postoperative pain in adults. [2009.07.08]
CONCLUSIONS: Etodolac 200 mg may be a useful analgesic in postoperative pain, with efficacy similar to paracetamol 1000 mg and celecoxib 200 mg. Higher doses may provide analgesia equivalent to more commonly used drugs, such as ibuprofen 400 mg, naproxen 500 mg and diclofenac 50 mg.
Paradoxical effects of a selective cyclooxygenase-2 inhibitor, etodolac, on proliferative changes of forestomach in alloxan-induced diabetic rats. [2009.07]
A single intravenous injection of alloxan, a non-genotoxic diabetogenic chemical, induces proliferative changes in forestomach mucosa of rats, and some lesions progress to squamous cell carcinoma accompanied with inflammatory change. The present study was conducted to examine the effects of a selective cyclooxygenase-2 (COX-2) inhibitor, etodolac, on the proliferative changes of forestomach mucosa in alloxan-induced diabetic rats...
Clinical Trials Related to Lodine (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.
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
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.
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, Lodine has an overall score of 1. The effectiveness score is 4 and the side effect score is 4. The scores are on ten point scale: 10 - best, 1 - worst.
| | Lodine review by 54 year old female patient | | | Rating |
| Overall rating: | |   |
| Effectiveness: | | Marginally Effective |
| Side effects: | | Severe Side Effects | | |
Treatment Info |
| Condition / reason: | | pain |
| Dosage & duration: | | 400mg taken twice a day for the period of 10 days |
| Other conditions: | | extreme diarrhea, upset stomach |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | mild pain reduction in arm/wrist |
| Side effects: | | extreme diarrhea, upset stomach, nausua |
| Comments: | | My DO prescirbed this pain med to reduce pain in my right arm/wrist from a car accident.
I had tried 3 massage visits with a medical massage therapist that only temporarily relieved the pain. So after trying the massage thearpy, my doctor precribed this pain medication. |
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Page last updated: 2009-10-20
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