Some of the views expressed in the following notes on newly approved products should be regarded as preliminary, as there may have been limited published data at the time of publication, and little experience in Australia of their safety or efficacy. However, the Editorial Executive Committee believes that comments made in good faith at an early stage may still be of value. Before new drugs are prescribed, the Committee believes it is important that more detailed information is obtained from the manufacturer's approved product information, a drug information centre or some other appropriate source.

Prexige (Novartis)
400 mg tablets
Approved indication: analgesia
Australian Medicines Handbook section 15.1

Lumiracoxib is a non-steroidal anti-inflammatory drug which selectively inhibits the COX-2 isoenzyme. Like celecoxib, lumiracoxib may have fewer gastrointestinal adverse effects than similar drugs which inhibit the COX-1 and COX-2 isoenzyme (see COX-2 inhibitors, Aust Prescr 2000;23:30-2).

A small study randomised 65 men to take lumiracoxib, naproxen or a placebo for eight days. While none of the volunteers who took lumiracoxib developed gastroduodenal erosions, 13 of those taking naproxen developed duodenal erosions and one man developed a gastric ulcer.1

A larger trial compared lumiracoxib with naproxen and ibuprofen in 18 325 people over 50 years old with osteoarthritis.2 Although 39% of the patients did not complete the one-year trial, there was a significant difference in the incidence of gastrointestinal adverse effects. Complications occurred in 29 of the 9117 people (0.32%) in the lumiracoxib group compared with 83 of the 9127 people (0.91%) who took another non-steroidal anti-inflammatory drug.

At the time lumiracoxib was approved in Australia much of the information about its efficacy was only publicly available as conference abstracts. Several papers were presented at the 2003 congress of the European League against Rheumatism.3

One of the conference abstracts describes a comparison of lumiracoxib, celecoxib and placebo in 1600 patients with osteoarthritis of the knee. After 13 weeks the effect of lumiracoxib on pain and function was greater than with placebo and similar to the effect of celecoxib. There was no significant difference in the efficacy of once-daily lumiracoxib 200 mg and lumiracoxib 400 mg.3

An extension of another study found celecoxib and lumiracoxib had similar efficacy after nine months of treatment.3

In addition to osteoarthritis, lumiracoxib has also been approved for the treatment of acute pain. Few of the studies of primary dysmenorrhoea, postoperative dental pain and postoperative surgical pain have been published in full.

Lumiracoxib can cause the same problems as other non-steroidal anti-inflammatory drugs. It can affect hepatic and renal function and should be used with caution in patients with hypertension or heart failure as it can cause fluid retention. Lumiracoxib is contraindicated in patients with ischaemic heart disease, cerebrovascular disease and peripheral arterial disease.

In the comparison with naproxen and ibuprofen the incidence of cardiovascular events was higher in patients taking lumiracoxib, but the difference was not significant.4 If the patients were taking low-dose aspirin lumiracoxib lost its significant gastrointestinal advantage over the other drugs.2

Most of a dose is metabolised, primarily by cytochrome P450 2C9. Although lumiracoxib therefore has several potential interactions it is not clear which will be clinically significant.

Although there is now published information about using lumiracoxib for osteoarthritis it should probably not be prescribed for other conditions until more data are available.

manufacturer had no objection to providing data but did not actually provide it

The Transparency Score () is explained in New drugs: transparency', Vol 37 No 1, Aust Prescr 2014;37:27.