Gastroprotective strategies in chronic NSAID users: a cost-effectiveness analysis comparing single-tablet formulations with individual components.

OBJECTIVES: To evaluate the cost-effectiveness of competing gastroprotective strategies, including single-tablet formulations, in the prevention of gastrointestinal (GI) complications in patients with chronic arthritis taking nonsteroidal anti-inflammatory drugs (NSAIDs). METHODS: We performed a cost-utility analysis to compare eight gastroprotective strategies including NSAIDs, cyclooxygenase-2 inhibitors, proton pump inhibitors (PPIs), histamine-2 receptor antagonists, misoprostol, and single-tablet formulations. We derived estimates for outcomes and costs from medical literature. The primary outcome was incremental cost per quality-adjusted life-year gained. We performed sensitivity analyses to assess the effect of GI complications, compliance rates, and drug costs. RESULTS: For average-risk patients, NSAID + PPI cotherapy was most cost-effective. The NSAID/PPI single-tablet formulation became cost-effective only when its price decreased from €0.78 to €0.56 per tablet, or when PPI compliance fell below 51% in the NSAID + PPI strategy. All other strategies were more costly and less effective. The model was highly sensitive to the GI complication risk, costs of PPI and NSAID/PPI single-tablet formulation, and compliance to PPI. In patients with a threefold higher risk of GI complications, both NSAID + PPI cotherapy and single-tablet formulation were cost-effective. CONCLUSIONS: NSAID + PPI cotherapy is the most cost-effective strategy in all patients with chronic arthritis irrespective of their risk for GI complications. For patients with increased GI risk, the NSAID/PPI single-tablet formulation is also cost-effective.

Gastroprotection in low-dose aspirin users for primary and secondary prevention of ACS: results of a cost-effectiveness analysis including compliance.

PURPOSE: Low-dose aspirin (ASA) increases the risk of upper gastrointestinal (GI) complications. Proton pump inhibitors (PPIs) reduce these upper GI side effects, yet patient compliance to PPIs is low. We determined the cost-effectiveness of gastroprotective strategies in low-dose ASA users considering ASA and PPI compliance. METHODS: Using a Markov model we compared four strategies: no medication, ASA monotherapy, ASA+PPI co-therapy and a fixed combination of ASA and PPI for primary and secondary prevention of ACS. The risk of acute coronary syndrome (ACS), upper GI bleeding and dyspepsia was modeled as a function of compliance and the relative risk of developing these events while using medication. Costs, quality adjusted life years and number of ACS events were evaluated, applying a variable risk of upper GI bleeding. Probabilistic sensitivity analyses were performed. RESULTS: For our base case patients using ASA for primary prevention of ACS no medication was superior to ASA monotherapy. PPI co-therapy was cost-effective (incremental cost-effectiveness ratio [ICER] €10,314) compared to no medication. In secondary prevention, PPI co-therapy was cost-effective (ICER €563) while the fixed combination yielded an ICER < €20,000 only in a population with elevated risk for upper GI bleeding or moderate PPI compliance. PPI co-therapy had the highest probability to be cost-effective in all scenarios. PPI use lowered the overall number of ACS. CONCLUSIONS: Considering compliance, PPI co-therapy is likely to be cost-effective in patients taking low dose ASA for primary and secondary prevention of ACS, given low PPI prices. In secondary prevention, a fixed combination seems cost-effective in patients with elevated risk for upper GI bleeding or in those with moderate PPI compliance. Both strategies reduced the number of ACS compared to ASA monotherapy.

Admission time is associated with outcome of upper gastrointestinal bleeding: results of a multicentre prospective cohort study.

BACKGROUND: It has been suggested that patients presenting with upper gastrointestinal bleeding (UGIB) during the weekend have a worse outcome compared with weekdays, with an increased risk of recurrent bleeding and mortality. AIM: To investigate the association between timing of admission and adverse outcome after UGIB. METHODS: We prospectively collected data from patients presenting with symptoms suggestive of UGIB to the emergency room of eight participating hospitals. Using standard descriptive statistics and logistic regression analyses, differences in 30-day mortality, rebleeding rate, and need for angiography and surgical intervention were assessed for week- and weekend admissions and time of admission. Moreover, patient- and procedure-related factors were identified that could influence outcome. RESULTS: In total, 571 patients were included with suspected UGIB. Patient admitted during the weekend had a higher mortality rate than patients admitted during the week [9% vs.3%; adjusted odds ratio 2.68 (95%CI 1.07-6.72)]. Weekend admissions were not associated with other adverse outcomes. Patients admitted during the weekend presented more often with bleeding and had a significantly lower systolic and diastolic blood pressure. No differences were found in procedure-related factors. Time of admission was not associated with an adverse outcome, although patients admitted during the evening had a significantly longer time to endoscopy (15, 22 and 16 h for day, evening and night admissions respectively, P < 0.01). CONCLUSION: Although quality of care did not appear to differ between week/weekend admissions, patients with suspected upper gastrointestinal bleeding admitted during the weekend were at higher risk of an adverse outcome. This might be due to the fact that these patients have more severe haemorrhage.

Prediction scores in gastrointestinal bleeding: a systematic review and quantitative appraisal.

BACKGROUND AND STUDY AIMS: Several algorithms predicting outcomes in acute gastrointestinal bleeding have been developed over the past three decades. These algorithms differ substantially and therefore the aim of the current study was to conduct a systematic review to compare their predictive performance and methodological quality in gastrointestinal bleeding. METHODS: A PubMed literature search was performed up to 1 July 2011. All studies reporting prediction scores in gastrointestinal bleeding were included. Studies were analyzed for predictive performance, and a quality appraisal of these rules was performed for which a score range of 0 (lowest) to 29 (highest) was used. RESULTS: A total of 372 studies were identified, of which 16 were eligible for inclusion. The studies evaluated different outcomes: mortality (n = 5), rebleeding (n = 2), intervention required (n = 2), or a combination (n = 7). The predictive performance of the identified prediction scores varied between an area under the curve of 0.71 - 0.92 (if given). The mean overall quality rating was 17 (SD 4.0, range 9 - 25). Major methodological shortcomings were the absence of validation and absence of impact analyses. Eight of 16 scores (50 %) were determined "easy to use," and five scores (31 %) reported some type of action based on the results. CONCLUSION: Substantial heterogeneity in outcomes and results was seen in the 16 identified prediction scores. Moreover, the methodological quality was suboptimal in most studies. However, we suggest that clinicians should use the "best available" scores according to performance and quality, which are the Blatchford score to assess the need for intervention, and the scores of Villanueva et al. for poor outcome, Guglielmi et al. for rebleeding, and Chiu et al. for mortality risk.

Systematic review: the effects of conservative and surgical treatment for obesity on gastro-oesophageal reflux disease.

BACKGROUND: Incidence rates of both obesity and gastro-oesophageal reflux disease (GERD) are increasing, particularly in the Western world. It has been suggested that GERD symptoms may be improved by weight reduction. AIM: To review the literature on the effect of various weight reducing modalities on manifestations of GERD in obese patients. METHODS: A literature search was performed using PubMed, EMBASE and the Cochrane Library, combining the words obesity and gastro-oesophageal reflux with bariatric surgery, diet, lifestyle intervention and weight loss. RESULTS: With regard to diet/lifestyle intervention (conservative), four of seven studies reported an improvement of GERD. For Roux-en-Y gastric bypass, a positive effect on GERD was found in all studies, although this was mainly evaluated by questionnaires. In contrast, for vertical banded gastroplasty, no change or even an increase of GERD was noted, whereas the results for laparoscopic adjustable gastric banding were conflicting. CONCLUSIONS: Dietary and lifestyle intervention may improve GERD in obese patients; however, the most favourable effect is likely to be found after bariatric surgery, especially after Roux-en-Y gastric bypass. Future studies need to elucidate for which GERD patients laparoscopic adjustable gastric banding might have a beneficial effect and how they can be identified preoperatively.