Brand Name Drug: Mobic
Active Ingredient Drug: meloxicam
Indication: Treatment of osteoarthritis
Company Name: Boehringer Ingelheim Pharmaceuticals, Inc. and Abbott Laboratories
Availability: Approved by the FDA on April 14, 2000
As the population ages, the need for effective pain relief from osteoarthritis – which currently affects 80% of Americans over age 65 — is expected to increase. Millions of people are still searching for an effective treatment they can tolerate. Often arthritis patients try several medications and find they are not effective or cause side effects that make tolerating the medication difficult. Some patients keep searching, while others simply give up.
Mobic (meloxicam) tablets provide a new alternative for patients – when beginning therapy or when other treatments are discontinued. The FDA approved the use of Mobic for the once-daily treatment of osteoarthritis on April 14, 2000. The drug will be co-marketed by Boehringer Ingelheim Pharmaceuticals, Inc. and Abbott Laboratories. Mobic is a member of the family of COX-2 inhibitors. The recommended starting dose is 7.5 mg/day, increasing the dosage to a maximum of 15 mg/day in patients who require it.
How It Works
Mobic is an NSAID that exhibits anti-inflammatory, analgesic, and antipyretic activities in animal models. The mechanism of action of meloxicam may be related to prostaglandin synthetase (cyclooxygenase-2) inhibition.
Mobic (meloxicam): Clinical Study Results
Mobic was evaluated for the treatment of osteoarthritis of the knee and hip in a double-blind controlled trial in the US of 464 patients treated for 12 weeks. Mobic (3.75 mg, 7.5 mg, and 15 mg) was compared with placebo. Patients who received Mobic 7.5 mg/day and 15 mg/day showed significant improvement in investigator’s and patient’s global assessments, patient pain assessment, and total WOMAC score (which addresses pain, function, and stiffness).
The use of Mobic for managing the signs and symptoms of osteoarthritis was also assessed in six double-blind active controlled trials outside the US involving 9,589 patients treated for 4 weeks to 6 months. Mobic (meloxicam) 7.5 mg/day and 15 mg/day showed efficacy comparable to piroxicam 20 mg/day and diclofenac SR 100 mg/day and consistent with the efficacy demonstrated in the US trial.
However, Mobic was found to be better tolerated than both drugs. In one study, the incidence of adverse events was significantly lower in the Mobic group (22.5%) compared with the piroxicam group (27.9%), mainly due to the significantly lower incidence of adverse gastrointestinal events in the Mobic group than in the piroxicam group (10.3% vs. 15.4%). Individual GI events occurred significantly less often with Mobic than piroxicam, including dyspepsia (3.4% vs. 5.8%), nausea/vomiting (2.5% vs. 3.4%), and abdominal pain (2.1% vs. 3.6%). There were 16 patients with perforations, ulcerations, or bleeding of the upper GI tract in the piroxicam group compared with seven in the Mobic group.
In another study, significantly fewer adverse events were reported by patients receiving Mobic compared to diclofenac. This was attributable to fewer GI adverse events (13%) compared to diclofenac (19%). Of the most common GI adverse events, there was significantly less dyspepsia, nausea and vomiting, abdominal pain, and diarrhea with Mobic (meloxicam) compared to diclofenac. Five patients on Mobic experienced a perforation, ulcer or bleed vs. seven on diclofenac. No endoscopically verified ulcer complication was detected in the Mobic group, compared to four with diclofenac.
What the Patient Should Know
Patients who have a known allergy to meloxicam, aspirin, or other traditional NSAIDs should not use Mobic tablets, nor should women who are, or may be, pregnant. As with all NSAIDs, Mobic has the potential to cause gastrointestinal bleeding, particularly in patients with bleeding disorders and those taking anticoagulants such as warfarin. Therefore, patients should be educated about the signs and symptoms of such bleeding and advised to seek medical attention promptly should it occur.
The most common side effects associated with Mobic are diarrhea, abdominal pain, and dyspepsia. Patients should also report any skin rash, unexplained weight gain, or edema to their physicians.
Mobic (meloxicam) should be used with caution in patients with hepatic or renal impairment, and in those with fluid retention, hypertension, or heart failure (since some patients taking Mobic have experienced fluid retention and edema). Mobic may interact with ACE inhibitors, furosemide, and lithium. Patients taking these drugs should inform their physicians.