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Effect of risk factors on complicated and uncomplicated ulcers in the TARGET lumiracoxib outcomes study
Christopher J Hawkey1, Wilfred M Weinstein, Walter Smalley
1Wolfson Digestive Diseases Centre, University Hospital, Nottingham, United Kingdom. cj.hawkey@nottingham.ac.uk <cj.hawkey@nottingham.ac.uk>
Background & Aims:
Selective cyclooxygenase-2 inhibitors were developed to reduce the gastrointestinal risk associated with nonsteroidal anti-inflammatory drugs (NSAIDs). The Therapeutic Arthritis Research and Gastrointestinal Event Trial was the largest study to evaluate primarily the gastrointestinal safety outcomes of selective cyclooxygenase-2 inhibitors. Data from the Therapeutic Arthritis Research and Gastrointestinal Event Trial were used to identify risk factors and investigate the safety of lumiracoxib in subgroups.
Methods:
Patients with osteoarthritis (age, >or=50 y) were randomized to receive lumiracoxib 400 mg once daily, naproxen 500 mg twice daily, or ibuprofen 800 mg 3 times daily for 12 months. Events were categorized by a blinded adjudication committee. The primary end point was all definite or probable ulcer complications.
Results:
For patients taking NSAIDs, factors associated with an increased risk of ulcer complications were age 65 years or older (hazard ratio [HR], 2.30; 95% confidence interval [CI], 1.48-3.59), previous history of gastrointestinal bleed or ulcer (HR, 3.61; 95% CI, 1.86-7.00), non-Caucasian racial origin (HR, 2.10; 95% CI, 1.35-3.27), and male sex (HR, 1.70; 95% CI, 1.08-2.68). With lumiracoxib, significant risk factors were age 65 years or older (HR, 3.18; 95% CI, 1.40-7.20), male sex (HR, 2.60; 95% CI, 1.25-5.40), non-Caucasian racial origin (HR, 2.16; 95% CI, 1.02-4.59), and concomitant aspirin use (HR, 2.89; 95% CI, 1.40-5.97). Increased risks in patients age 65 years and older were increased further if other risk factors were present. Lumiracoxib maintained an advantage over NSAIDs across all subgroups except aspirin use.
Conclusions:
Lumiracoxib was associated with a reduced risk of ulcer complications compared with NSAIDs in all significant subgroups except aspirin users.
Insights
Selective cyclooxygenase-2 inhibitors like lumiracoxib reduce ulcer complications compared to traditional nonsteroidal anti-inflammatory drugs (NSAIDs). However, this benefit was not observed in aspirin users, highlighting specific risk factors for gastrointestinal events.
Area of Science:
- Pharmacology and Therapeutics
- Gastroenterology
- Clinical Trial Research
Background:
- Development of selective cyclooxygenase-2 inhibitors aimed to mitigate gastrointestinal risks associated with nonsteroidal anti-inflammatory drugs (NSAIDs).
- The Therapeutic Arthritis Research and Gastrointestinal Event Trial (TAREGT) was a pivotal study assessing the gastrointestinal safety of selective cyclooxygenase-2 inhibitors.
- Analysis of TAREGT data focused on identifying risk factors and evaluating the safety profile of lumiracoxib within specific patient subgroups.
Purpose of the Study:
- To evaluate the gastrointestinal safety outcomes of selective cyclooxygenase-2 inhibitors, specifically lumiracoxib.
- To identify risk factors associated with ulcer complications in patients treated with lumiracoxib and traditional NSAIDs.
- To investigate the comparative safety of lumiracoxib versus naproxen and ibuprofen in subgroups defined by demographic and clinical characteristics.
Main Methods:
- A randomized controlled trial involving patients aged 50 years and older with osteoarthritis.
- Participants were assigned to receive lumiracoxib (400 mg daily), naproxen (500 mg twice daily), or ibuprofen (800 mg three times daily) for 12 months.
- Ulcer complications were adjudicated by a blinded committee, with the primary endpoint being all definite or probable ulcer complications.
Main Results:
- For NSAID users, increased risk of ulcer complications was linked to age (≥65 years), prior gastrointestinal bleed/ulcer, non-Caucasian race, and male sex.
- In lumiracoxib users, risk factors included age (≥65 years), male sex, non-Caucasian race, and concomitant aspirin use.
- Lumiracoxib demonstrated a gastrointestinal safety advantage over NSAIDs across most subgroups, with the exception of patients concurrently using aspirin.
Conclusions:
- Lumiracoxib was associated with a reduced risk of ulcer complications compared to traditional NSAIDs.
- This gastrointestinal benefit of lumiracoxib was consistent across various patient subgroups.
- The exception to lumiracoxib's improved safety profile was observed in patients using concomitant aspirin therapy.
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