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GI Complications (gi + complications)

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Selected Abstracts

Cost-utility analysis of proton pump inhibitors and other gastro-protective agents for prevention of gastrointestinal complications in elderly patients taking nonselective nonsteroidal anti-inflammatory agents

ALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 12 2010
C. CAMERON
Aliment Pharmacol Ther,31, 1354,1364 Summary Background The use of proton pump inhibitors (PPIs) among elderly patients using nonselective nonsteroidal anti-inflammatory drugs (nsNSAIDs) has increased; the price of PPIs is higher than that of majority of alternative treatment strategies. Aim To evaluate the cost-effectiveness of nsNSAIDS + PPIs relative to alternative gastroprotective regimens in the prevention of GI complications among elderly patients (aged ,65 years). Methods An incremental cost-utility analysis, comparing PPIs with alternative gastroprotective regimens was conducted using a decision analytical model. Clinical outcomes, costs and utilities were derived from recently published studies. Probabilistic and deterministic sensitivity analyses were performed to test the robustness of the results to variation in model inputs and assumptions. Results The incremental cost-utility ratio (ICUR) of PPIs, relative to nsNSAID alone, was $206 315 per QALY gained or were more costly and less effective. Other co-prescribed treatment options had higher costs per QALY gained. In patients with a history of a complicated or uncomplicated ulcer, PPIs had ICURs of $24 277 and $40 876, respectively. Conclusions Use of PPIs in all elderly patients taking nsNSAIDs is unlikely to represent an efficient use of finite healthcare resources. Co-prescribing PPIs, however, to elderly patients taking nsNSAIDs who have a history of complicated or uncomplicated ulcers appears to be economically attractive. [source]

Benefits of conversion from mycophenolate mofetil to enteric-coated mycophenolate sodium in pediatric renal transplant patients with stable graft function

PEDIATRIC TRANSPLANTATION, Issue 2 2009
Rejane De Paula Meneses
Abstract:, Conversion from MMF to EC-MPS may reduce GI complications and permit increased MPA dosing with a concomitant reduction in CNI dose. In a prospective trial, paediatric renal transplant patients with stable graft function were converted from MMF to EC-MPS and followed-up for 12 months. Data from 28 patients (mean age 13.9 ± 3.1 yr) were available for analysis. Mean EC-MPS dose increased significantly from conversion to month 12 (668 ± 81 mg/m2/day vs. 747 ± 98 mg/m2/day, p < 0.001). CsA-ME dose (n = 23) decreased from 5.3 ± 1.7 mg/kg/day at conversion to 4.6 ± 1.4 mg/kg/day at month 12 (p = 0.010). cGFR increased from 69.5 ± 23.3 mL/min/1.73 m2 at the time of conversion to 80.7 ± 30.7 mL/min/1.73 m2 at month 12 (p = 0.007). The number of patients reporting at least one GI event during six months prior to conversion was 15/28 (53.6%), declining to 8/28 (28.6%) at month 6 post-conversion and 5/28 (17.8%) at month 12. This single-arm study suggests that conversion of paediatric renal transplant patients from MMF to EC-MPS does not compromise efficacy and leads to improved GI tolerability. MPA dose increased and CsA-ME dose decreased significantly, with an associated improvement in calculated GFR. A large-scale controlled trial is required to confirm these promising findings. [source]

NSAID switching and short-term gastrointestinal outcome rates after the withdrawal of rofecoxib

PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 12 2009
Sebastian Schneeweiss MD
Abstract Objective The consequences of the rofecoxib withdrawal on upper GI toxicity are largely unknown. We sought to estimate the effect of switching from selective Cox-2 inhibitors to non-selective non-steroidal anti-inflammatory drugs (nsNSAIDs) on the incidence of upper GI adverse events following the withdrawal of rofecoxib on 30 September 2004. Methods We identified a cohort of 33,045 patients with arthritis and chronic use of any selective Cox-2 inhibitor during the 6 months before the withdrawal of rofecoxib in claims data from several US health plans. We calculated monthly rates of hospitalization for upper GI adverse events or upper GI endoscopy for the 6 months before and 3 months after the switching and compared the time trends in outcomes. Results In the subgroup of 15,916 patients using rofecoxib immediately before its withdrawal, 2626 (17%) switched to nsNSAIDs without co-prescribing of a gastroprotective drug, 146 (1%) with a gastroprotective drug, and 5246 (33%) switched to either celecoxib or valdecoxib. Among those switching to nsNSAID without gastroprotection, time trends of upper GI hospitalization rates and endoscopies did not significantly increase compared with those switching to celecoxib or valdecoxib (+0.3 per 1000 per month; 95%CI ,3.0 to 3.5). The visit rate for peptic ulcer disease (PUD) increased more in the group switching to nsNSAIDs without gastroprotection (+5.2 visits per 1000 per month; 1.2,9.2) compared with the group switching to another coxib. Conclusions Short-term follow-up data suggest that the sudden shift from rofecoxib to nsNSAIDs without gastroprotection did not increase the rate of hospitalization for GI complications but increased outpatient visits for PUD. Copyright © 2009 John Wiley & Sons, Ltd. [source]

Application of a propensity score to adjust for channelling bias with NSAIDs,

PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 6 2004
S. V. Morant
Abstract Purpose To compare the relative risks of upper GI haemorrhage (UGIH) in users of Newer versus Older, non-specific NSAIDs when adjusted for channelling bias by regression on individual covariates, a propensity score and both. Methods Cohort study of patients prescribed NSAIDs between June 1987 and January 2000. Exposure to Newer and Older non-specific NSAIDs was identified, and risk factors evaluated for each patient. Results of multiple covariate analyses and the propensity scoring technique to assess potential channelling bias in comparisons between Newer and Older non-specific NSAIDs were compared. Results This study included 7.1 thousand patient years (tpy) exposure to meloxicam, 1.6,tpy exposure to coxibs, and 628,tpy exposure to Older non-specific NSAIDs. Patients receiving Newer NSAIDs were older, more likely to have a history of GI symptoms, and at higher risk for GI complications. Adjusting for these risk factors reduced the relative risks of UGIH on meloxicam and coxibs versus Older non-specific NSAIDs to 0.84 (95%CI 0.60, 1.17) and 0.36 (0.14, 0.97) respectively. Conclusions Channelling towards high GI risk patients occurred in the prescribing of Newer NSAIDs. Propensity scores highlighted the markedly different risk profiles of users of Newer and Older non-specific NSAID. Correcting for channelling bias, coxib exposure, but not meloxicam exposure, was associated with less UGIH than Older non-specific NSAID exposure. In the present study, corrections made by regression on a propensity score and on individual covariates were similar. Copyright © 2004 John Wiley & Sons, Ltd. [source]