what they said (Hover the mouse cursor over underlined words for more info)
Lumiracoxib launch expands options for osteoarthritis Rx; post-marketing study a condition of approval
TORONTO | With the approval earlier this month of lumiracoxib (Prexige), Canadian physicians have a new COX-2-selective inhibitor at their disposal for the first time since safety concerns led to the withdrawal of two previous medications in this class.
Lumiracoxib will be available in pharmacies across the country by the end of November, according to manufacturer Novartis, and will be indicated for acute and chronic treatment of osteoarthritis (OA) of the knee in adults, in a once-daily 100 mg tablet....
The original article can found in the Media Doctor archives.
what we said (Hover the mouse cursor over underlined words for more info)
Since it was written for a physician audience, it has a somewhat more sophisticated approach than articles written for the general public, and side effects are well documented. However, I am surprised that there is no mention of effectiveness of the new drug relative to presently available agents.
While the article describes the difference between the drug and its comparator using relative numbers, it uses absolute numbers to describe the benefit for each cohort "Among patients not taking ASA, the cumulative one-year incidence of ulcer complications was 1.09% in the traditional NSAID group and 0.25% in patients on lumiracoxib-a 79% reduction."
One might say that the data derived from this study is really of limited use. Despite being described as the "largest trial in history to evaluate the safety of an anti-inflammatory drug before it was launched," we learn that the study excluded most people with any form of cardiovascular conditions, such as a history of myocardial infarction, stroke, bypass surgery or angioplasty. This would surely limit the generalizability of the findings.
The most serious failing in this study is not getting any critical comment from anyone not involved in the study or from anyone who is not enthusiastic about a new coxib.