Safety and efficacy of long-term esomeprazole 20 mg in Japanese patients with a history of peptic ulcer receiving daily non-steroidal anti-inflammatory drugs

Abstract

BackgroundNon-steroidal anti-inflammatory drugs (NSAIDs) are an effective and common treatment for chronic pain disorders, but long-term use is associated with risk of potentially life-threatening gastrointestinal adverse events (AEs). The proton pump inhibitor esomeprazole has been found to be effective for gastroprotection in NSAID users, but few long-term studies have been conducted in Japan.MethodsThis was an open-label, multicentre, single-arm, prospective 1-year study of treatment with esomeprazole (20 mg once daily) in Japanese patients (aged ≥20 years) with endoscopic evidence of previous peptic ulcer and receiving daily oral NSAID therapy (at a stable dose) for a chronic condition. Eligibility was not dictated by type of oral NSAID. The primary objective was to determine long-term safety and tolerability of esomeprazole. Efficacy for prevention of peptic ulcers was also determined (Kaplan-Meier method). All statistical analyses were descriptive.ResultsA total of 130 patients (73.1% women, mean age 62.1 years, 43.8% Helicobacter pylori-positive) received treatment with esomeprazole in addition to long-term NSAID therapy (most commonly for rheumatoid arthritis [n=42] and osteoarthritis [n=34]). Loxoprofen, meloxicam and diclofenac were the most commonly used NSAIDs; cyclo-oxygenase (COX)-2 selective agents were used by 16.2% of patients (n=21). Long-term compliance with esomeprazole (capsule counts) was >75% for the majority of patients. Although 16.9% of patients (n=22) experienced AEs judged to be possibly related to treatment with esomeprazole, they were mostly mild and transient. The most commonly reported possibly treatment-related AEs were abnormal hepatic function, headache, increased γ-glutamyltransferase levels and muscle spasms (2 patients each). Overall, 95.9% (95% confidence interval: 92.3, 99.4) of patients remained ulcer free at 1 year.ConclusionLong-term treatment with esomeprazole (20 mg once daily) is well tolerated and efficacious for preventing ulcer recurrence in Japanese NSAID users with a history of peptic ulcer.Trial registrationClinicalTrials.gov identifier NCT00595517.

Pharmacokinetic Drug–Drug Interactions Between Vonoprazan and Low-Dose Aspirin or Nonsteroidal Anti-inflammatory Drugs: A Phase 2, Open-Label, Study in Healthy Japanese Men

“…Hence, it was important to assess whether vonoprazan was associated with drug–drug interactions with LDA or commonly prescribed NSAIDs. Loxoprofen sodium, diclofenac sodium, and meloxicam are the most commonly prescribed NSAIDs in Japan for the management of pain in patients with osteoarthritis or rheumatoid arthritis [22]. The results of this study support the lack of drug–drug interactions between vonoprazan and LDA or these NSAIDs.…”

Potent Potassium-competitive Acid Blockers: A New Era for the Treatment of Acid-related Diseases

“…These results were consistent with previous studies that investigated the effect of PPIs in NSAID-associated secondary ulcer prevention. 103,108,109 No unexpected adverse events were identified during at least a 1-year period of exposure to vonoprazan. After these data were introduced, the Japanese government approved 10 mg vonoprazan for the prevention of recurrent upper GI ulcers during long-term NSAID therapy.…”

Non-steroidal anti-inflammatory drug (NSAID) therapy in patients with hypertension, cardiovascular, renal or gastrointestinal comorbidities: joint APAGE/APLAR/APSDE/APSH/APSN/PoA recommendations

“…In another case–control study, PPI therapy was associated with a significant reduction in the risk of upper GI bleeding 188 201. Esomeprazole is effective in preventing ulcer recurrence in both H. pylori -positive and -negative NSAID users,199 and long-term esomeprazole treatment is well tolerated and efficacious for preventing ulcer recurrence in NSAID users 197 202. Most studies used omeprazole or esomeprazole for ulcer prophylaxis,45 46 102 160–162 164 171 176 but other PPIs are likely to be similarly effective 124 180 203.…”