Bisphosphonate increases risk of gastroduodenal ulcer in rheumatoid arthritis patients on long-term nonsteroidal antiinflammatory drug therapy

Miyake, Kazumasa; Kusunoki, Masanori; Shinji, Yoko; Shindo, Tetsuya; Kawagoe, Tetsuro; Futagami, Seiji; Gudis, Katya; Tsukui, Taku; Nakajima, Atsushi; Sakamoto, Choitsu

doi:10.1007/s00535-008-2278-2

Cited by 17 publications

(9 citation statements)

References 44 publications

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“…Consistently with our findings, observational studies (OSs) did not found evidence of increased UGIC risk among BP users [15], [16], [19]. However, conversely to our results, BPs – NSAIDs co-therapy has been found to increase the UGIC risk [18], [19]. It should be noticed, that our findings were obtained by contrasting current and past use of BPs, rather than BPs use vs. placebo (or vs. no use) as in RCTs (or in OSs).…”

Section: Discussionsupporting

confidence: 91%

Risk of Severe Upper Gastrointestinal Complications among Oral Bisphosphonate Users

et al. 2013

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BackgroundOral bisphosphonates (BPs) are the primary agents for the treatment of osteoporosis. Although BPs are generally well tolerated, serious gastrointestinal adverse events have been observed.AimTo assess the risk of severe upper gastrointestinal complications (UGIC) among BP users by means of a large study based on a network of Italian healthcare utilization databases.MethodsA nested case-control study was carried out by including 110,220 patients aged 45 years or older who, from 2003 until 2005, were treated with oral BPs. Cases were the 862 patients who experienced the outcome (hospitalization for UGIC) until 2007. Up to 20 controls were randomly selected for each case. Conditional logistic regression model was used to estimate odds ratio (OR) associated with current use of BPs after adjusting for several covariates. A set of sensitivity analyses was performed in order to account for sources of systematic uncertainty.ResultsThe adjusted OR for current use of BPs with respect to past use was 0.94 (95% CI 0.81 to 1.08). There was no evidence that this risk changed either with BP type and regimen, or concurrent use of other drugs or previous hospitalizations.ConclusionsNo evidence was found that current use of BPs increases the risk of severe upper gastrointestinal complications compared to past use.

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Section: Discussionsupporting

confidence: 91%

Risk of Severe Upper Gastrointestinal Complications among Oral Bisphosphonate Users

et al. 2013

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“…A recent cross-sectional endoscopic analysis conducted in 2006 [29] has shown that 62.8% of the patients who regularly took NSAIDs had gastroduodenal injuries, even though loxoprofen was prescribed as the first choice of NSAID for long-term NSAID users. According to a recent report, the incidence of NSAID-associated gastroduodenal ulcers is higher than 20% in Japanese RA outpatients having taken NSAIDs for 3 or more months [30]. In the recent and first epidemiological study in Japan [31], the risks of upper GI bleeding have been shown to be about 6 and 11 times higher, respectively, in subjects taking loxoprofen and diclofenac than in subjects not taking NSAIDs.…”

Section: Safety Of Celecoxibmentioning

confidence: 99%

Efficacy and Safety of the Selective Cyclooxygenase-2 Inhibitor Celecoxib in the Treatment of Rheumatoid Arthritis and Osteoarthritis in Japan

Sakamoto

Soen

2010

Digestion

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Background/Aims: Gastrointestinal (GI) disorders are common adverse reactions of nonsteroidal anti-inflammatory drugs (NSAIDs). Loxoprofen is a representative NSAID widely used in East Asia. A selective cyclooxygenase-2 inhibitor, celecoxib, was introduced in Japan in 2007. In this study, we aimed to compare the efficacy and safety of celecoxib with those of loxoprofen in Japanese patients. Methods: We analyzed the data from 12 clinical studies conducted in Japan. These data of Japanese patients were compared with those of the patients in the West that had been published after 2000. Results: The efficacy of celecoxib as an analgesic was comparable to that of loxoprofen, whereas serious GI events, including symptomatic ulcers, were significantly less frequent with celecoxib than with loxoprofen in Japanese patients with rheumatoid arthritis (RA) and osteoarthritis (OA) (p = 0.039). These results were consistent with the findings of the studies conducted in the West. The incidence of serious cardiovascular events was 0.1% in 2,398 subjects on celecoxib, which was not statistically different from the incidence in subjects on loxoprofen (0.3%; p = 0.3404) and those on placebo (0.2%); this result was also consistent with the data of the studies conducted in the West. Conclusion: The analgesic activity of celecoxib, which was used for the treatment of RA, OA, and low back pain, was comparable to that of loxoprofen, and celecoxib was safer in terms of GI injury often caused by other nonselective NSAIDs.

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“…This patient was diagnosed as H. pylori positive and was concurrently using the bisphosphonate alendronate for the prevention of steroid-induced osteoporosis. Bisphosphonates are known to cause GI damage when administered alone [33], and it has been reported that co-administration of bisphosphonates increases the incidence rate of NSAID-induced ulcers [34,35].…”

Section: Discussionmentioning

confidence: 99%

Celecoxib, a cyclooxygenase-2 inhibitor, improved upper gastrointestinal lesions in rheumatoid arthritis patients as assessed by endoscopic evaluation

et al. 2011

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We prospectively evaluated the effects of celecoxib (CEL) on the gastrointestinal (GI) tract of rheumatoid arthritis (RA) patients with endoscopically identified GI mucosal injury after therapeutic switching from the long-term use of traditional nonsteroidal anti-inflammatory drugs (NSAIDs). Upper GI endoscopy was performed on RA patients who had been treated with NSAIDs for ≥3 months. GI mucosal injury was evaluated according to the modified LANZA score. Patients with mucosal injury without ulcers were switched from NSAIDs to CEL, while those with ulcers were switched to CEL with famotidine after ulcer healing. At week 16 of treatment, GI mucosal injury was endoscopically revaluated. An efficacy analysis was performed before therapeutic switching and at 8 and 16 weeks post-switching. Endoscopic analysis revealed GI mucosal injury, including six ulcers, in 45 of the 82 patients (54.9%). Sixteen weeks after switching to CEL, LANZA scores were significantly improved [2.1 ± 0.8 (pre-switching) vs. 1.6 ± 1.3, P = 0.0073] in patients with LANZA scores of 1, 2, or 3 (n = 35). The Disease Activity Score using 28 joint counts (DAS28) [erythrocyte sedimentation rate item score (ESR4) (P = 0.0257) and C-reactive protein item score (CRP4) (P = 0.0031)] was also significantly improved by week 16. Based on these results, we conclude that preexisting NSAID-induced upper GI injury is improved following therapeutic switching to CEL without any reduction in analgesic efficacy.

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Bisphosphonate increases risk of gastroduodenal ulcer in rheumatoid arthritis patients on long-term nonsteroidal antiinflammatory drug therapy

Abstract: Bisphosphonate co-therapy as well as advanced age and smoking was found to be a significant risk factor in PU, while co-therapies of standard-dose H2RA or PPI/PG proved effective in preventing PU in Japanese RA patients on long-term NSAID treatment.

Cited by 17 publications

References 44 publications

Risk of Severe Upper Gastrointestinal Complications among Oral Bisphosphonate Users

Risk of Severe Upper Gastrointestinal Complications among Oral Bisphosphonate Users

Efficacy and Safety of the Selective Cyclooxygenase-2 Inhibitor Celecoxib in the Treatment of Rheumatoid Arthritis and Osteoarthritis in Japan

Celecoxib, a cyclooxygenase-2 inhibitor, improved upper gastrointestinal lesions in rheumatoid arthritis patients as assessed by endoscopic evaluation

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