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GI Events (gi + event)
Selected AbstractsBenefits of conversion from mycophenolate mofetil to enteric-coated mycophenolate sodium in pediatric renal transplant patients with stable graft functionPEDIATRIC TRANSPLANTATION, Issue 2 2009Rejane 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] COX-2 inhibitors: complex association with lower risk of hospitalization for gastrointestinal events compared to traditional NSAIDs plus proton pump inhibitors,PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 10 2009Michiel W. van der Linden MDPhD Abstract Purpose To compare hospitalization rates for serious upper and lower gastrointestinal (GI) events between chronic and acute users of a traditional non-steroidal anti-inflammatory drugs (tNSAID),+,proton pump inhibitor (PPI) and users of a COX-2 selective inhibitor (Coxib). Methods The PHARMO Record Linkage System, including linked drug-dispensing and hospital records of approximately 3 million individuals in the Netherlands was used. We selected new Coxib or tNSAID users (01/01/2000,31/12/2004) with ,1,year history before the first NSAID dispensing and ,1,year follow-up ending at the first hospitalization for GI event (the outcome), last dispensing, or end of the study period. Chronic users were patients who used any NSAIDs for ,60,days during the first year (n,=,58,770); others were acute users (n,=,538,420). Multivariate analysis was performed by Poisson regression adjusted for gender, age, and duration of follow-up, tNSAID and Coxib dose, NSAID/PPI adherence, use of other gastroprotective agents, anticoagulants, acetaminophen, corticosteroids, and cardiovascular disease. Results The cohort included 23,999 new tNSAIDs,+,PPI users and 25,977 new Coxib users, with main characteristics: mean,±,SD age 58.1,±,15.5 vs. 56.7,±,17.5; female 55.3% vs. 62.2%; duration of treatment (days): 137,±,217 vs. 138,±,179, respectively. Among acute users, adjusted hazard ratios (95% Confidence Interval) were 0.21 (0.14,0.32) for upper and 0.26 (0.16,0.42) for lower GI events, for Coxib versus tNSAIDs,+,PPI users. Among chronic users, these were 0.35 (0.22,0.55) for upper GI and 0.43 (0.25,0.75) for lower GI events. Conclusions Coxib users had significantly lower rates of GI events. Further research should elucidate the possible impact of selection bias. Copyright © 2009 John Wiley & Sons, Ltd. [source] NSAID-related upper gastrointestinal bleeding: are risk factors considered during prophylaxis?INTERNATIONAL JOURNAL OF CLINICAL PRACTICE, Issue 5 2006D. Dincer Summary The purposes of this study were to evaluate the effect of nonsteroidal anti-inflammatory drugs (NSAIDs) on acute nonvaricose upper gastrointestinal bleeding (ANUGIB) and establish whether the NSAID-prescribing physicians take precautions to prevent or reduce GI ulcerations. Clinical characteristics, causes of bleeding and clinical outcomes of patients hospitalised in our gastroenterology clinic with ANUGIB were recorded prospectively over a 1.5-year period. NSAIDs, including aspirin, were used by 127 of 168 patients (73%). Among the NSAID users, 100 patients (78%) had at least one risk factor for serious adverse GI events related to NSAIDs. Only two patients were using proton pump inhibitors and one patient was using H2 receptor blocker of the high-risk group for GI side effects of NSAIDs. NSAIDs have an important effect on GI bleeding, and it seems that risk factors are underestimated by physicians. [source] Effect of Nonsteroidal Anti-Inflammatory Drug Use on the Rate of Gastrointestinal Hospitalizations Among People Living in Long-Term CareJOURNAL OF AMERICAN GERIATRICS SOCIETY, Issue 5 2001Kate L. Lapane PhD OBJECTIVES: Gastrointestinal (GI) complications are the most-common serious adverse reactions associated with nonsteroidal anti-inflammatory drugs (NSAIDs). We quantified the effect of specific NSAIDs on the rate of GI hospitalizations among older people living in long-term care. DESIGN: Retrospective cohort study. SETTING: All Medicare/Medicaid certified nursing homes in four states (Maine, Minnesota, New York, and South Dakota). PARTICIPANTS: We identified 125,516 newly admitted residents from a database of all residents (1992,1996) of all Medicare/Medicaid certified nursing homes in four states. Using the federally mandated Minimum Data Set, which includes information on all drugs received (prescription and over-the-counter), we identified patients who received at least one prescription for aspirin (n = 19,101) or NSAIDs (n = 9,777). The control population consisted of all institutionalized persons who did not receive these drugs. MEASUREMENTS: From Health Care Financing Administration inpatient claims, we identified the first hospitalization for GI perforation, ulcer, or hemorrhage that occurred during the year of follow up (ICD9-CM discharge codes: 531,534, 578). Cox proportional hazards models provided adjusted estimates of rate ratios. RESULTS: NSAID exposure increased the GI-event-related hospitalization rate in both men (rate ratios (RR) = 2.64; 95% confidence interval (CI) = 1.17,5.99) and women (RR = 3.23; 95% CI = 1.85,5.65). The rate of GI hospitalizations for both men and women taking sulindac, naproxen, or indomethacin was higher than for nonusers. The risk of GI-event-related hospitalizations was greatest among women exposed to diflunisal (RR = 6.08; 95% CI = 2.27,16.26) or oxaprozin (RR = 6.03; 95% CI = 2.49,14.58). CONCLUSIONS: Despite the high background rate of GI events, most NSAIDs increased the risk of GI hospitalization. Careful attention to choice of agent and dosing is needed in prescribing NSAIDs in this frail, older population. [source] Meta-analysis: incidence of endoscopic gastric and duodenal ulcers in placebo arms of randomized placebo-controlled NSAID trialsALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 3 2009Y.-H. YUAN Summary Background, The safety of NSAIDs is often evaluated by comparison with placebo in clinical trials. Aim, To investigate the incidence of gastric and duodenal ulcers (GDU) in placebo arms in NSAID trials over the last three decades. Methods, Randomized placebo-controlled trials of oral NSAIDs from 1975 to 2006 were systematically reviewed. The pooled incidence of GDU in placebo arms was calculated and compared. Meta-regression was used to identify risk factors related to the incidence of the placebo ulcer at the study level. Results, Thirty-six studies met inclusion criteria (duration of 6.5 days to 24 weeks). In total, 3.29% GDUs were reported in 36 placebo arms. The incidence of GDU in placebo arms was 0, 4.20% and 3.03% in the studies from 1975,1989, 1990,1999 and 2000,2006 respectively (P > 0.05). Eligible subjects with previous GI events and eligible subjects on co-therapy with low-lose aspirin/corticosteroids were associated with the increase in placebo ulcer incidence after adjusting for other factors. Conclusions, The incidence of GDU in placebo arms has not changed significantly over the last three decades, although has decreased in the past 10 years. Studies show that previous GI events and co-therapy with low-dose aspirin/corticosteroids were associated with increasing GDU in placebo arms. [source] COX-2 inhibitors: complex association with lower risk of hospitalization for gastrointestinal events compared to traditional NSAIDs plus proton pump inhibitors,PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 10 2009Michiel W. van der Linden MDPhD Abstract Purpose To compare hospitalization rates for serious upper and lower gastrointestinal (GI) events between chronic and acute users of a traditional non-steroidal anti-inflammatory drugs (tNSAID),+,proton pump inhibitor (PPI) and users of a COX-2 selective inhibitor (Coxib). Methods The PHARMO Record Linkage System, including linked drug-dispensing and hospital records of approximately 3 million individuals in the Netherlands was used. We selected new Coxib or tNSAID users (01/01/2000,31/12/2004) with ,1,year history before the first NSAID dispensing and ,1,year follow-up ending at the first hospitalization for GI event (the outcome), last dispensing, or end of the study period. Chronic users were patients who used any NSAIDs for ,60,days during the first year (n,=,58,770); others were acute users (n,=,538,420). Multivariate analysis was performed by Poisson regression adjusted for gender, age, and duration of follow-up, tNSAID and Coxib dose, NSAID/PPI adherence, use of other gastroprotective agents, anticoagulants, acetaminophen, corticosteroids, and cardiovascular disease. Results The cohort included 23,999 new tNSAIDs,+,PPI users and 25,977 new Coxib users, with main characteristics: mean,±,SD age 58.1,±,15.5 vs. 56.7,±,17.5; female 55.3% vs. 62.2%; duration of treatment (days): 137,±,217 vs. 138,±,179, respectively. Among acute users, adjusted hazard ratios (95% Confidence Interval) were 0.21 (0.14,0.32) for upper and 0.26 (0.16,0.42) for lower GI events, for Coxib versus tNSAIDs,+,PPI users. Among chronic users, these were 0.35 (0.22,0.55) for upper GI and 0.43 (0.25,0.75) for lower GI events. Conclusions Coxib users had significantly lower rates of GI events. Further research should elucidate the possible impact of selection bias. Copyright © 2009 John Wiley & Sons, Ltd. [source] Latest news and product developmentsPRESCRIBER, Issue 10 2008Article first published online: 3 JUN 200 Glitazones more than double fracture risk An analysis of the UK General Practice Research Database has found that both glitazones increase the risk of fracture more than two-fold (Arch Intern Med 2008;168:820-5). Compared with nonusers, the odds ratio for fracture (mostly hip and wrist) was 2.59 for pioglitazone and 2.38 for rosiglitazone. The risk increased with dose but was unrelated to age and sex. Reduce antipsychotics in dementia patients Antipsychotics should be prescribed for patients with dementia only as a last resort at times of severe distress or critical need, the All-Party Parliamentary Group on Dementia has concluded. Its inquiry (available at www.alzheimers.org.uk) found that antipsychotics are being prescribed for patients with mild behavioural symptoms and for prolonged periods despite the limited benefits they offer and the risk of serious adverse effects such as stroke. Contributory factors include lack of training for staff, inadequate leadership and exclusion of family and friends from decisions about treatment. High-dose atorvastatin in chronic kidney disease High-dose atorvastatin (Lipitor) reduces cardiovascular events in patients with chronic kidney disease (CKD) more than a low dose , despite similar reductions in LDL-C (J Am Coll Cardiol 2008;51:1448-54). A post hoc subgroup analysis of the Treating-to-New-Targets study involving 10 001 patients with CHD, with or without CKD, found that atorvastatin 10 and 80mg per day reduced LDLC and triglycerides to similar levels; there was no change in HDL-C. After a median follow-up of five years, the incidence of cardiovascular events in patients with CKD was 9.3 per cent at 80mg per day and 13.4 per cent at 10mg per day (number needed to treat to prevent one event, NNT, 24). In patients with no CKD, the corresponding figures were 7.9 vs 9.2 per cent (NNT 74). There was no difference in all-cause mortality; adverse events were more frequent at the higher dose. COX-2 NSAIDs not more cost-effective An economic analysis of COX-2 selective NSAIDs has concluded that they are not more cost effective than older agents plus a proton pump inhibitor (PPI) in the treatment of osteoarthritis and rheumatoid arthritis (Health Technology Assessment 2008;12:No. 11). The analysis concluded that selective and nonselective NSAIDs were similarly effective but selective agents were associated with a lower risk of upper GI events and a higher risk of cardiovascular events. However, the available evidence includes only low numbers of events and further studies are needed. Compared with ibuprofen or diclofenac plus a PPI, the COX-2 selective NSAIDs look ,generally unattractive from a cost effectiveness point of view', even in high-risk patients with a history of peptic ulcer. There were insufficient data to allow a reliable comparison within the COX-2s. Naftidrofuryl helps intermittent claudication Naftidrofuryl increases pain-free walking distance (PFWD) in patients with intermittent claudication, a new Cochrane review has shown (Cochrane Database of Systematic Reviews 2008, Issue 2. Art. No.: CD001368. DOI: 10.1002/ 14651858.CD001368.pub3; also see page 49 in this issue). The meta-analysis of six trials involving a total of 1083 patients found that, compared with placebo, naftidrofuryl increased PFWD by over a third with a proportion successfully treated of 20 per cent (NNT 4.5). Coversyl Arginine To clarify any confusion following our recent news item (Perindopril brand switch, 19 April issue, page 12), Servier has asked us to reiterate that the new formulations Coversyl Arginine 2.5, 5 and 10mg are equivalent to 2, 4 and 8mg of the discontinued Coversyl formulation. Coversyl Arginine contains perindopril arginine, a salt that offers greater stability and a longer shelf-life. Prescriptions for the Coversyl brand of perindopril must in future be written as Coversyl Arginine in its revised strengths. Coversyl Plus has also been replaced by Coversyl Arginine Plus and the same revised dosages apply. Generic formulations of perindopril remain unaffected. Copyright © 2008 Wiley Interface Ltd [source] Determinants and sequelae associated with utilization of acetaminophen versus traditional nonsteroidal antiinflammatory drugs in an elderly populationARTHRITIS & RHEUMATISM, Issue 11 2002Elham Rahme Objective Acetaminophen is recommended as initial therapy for patients with arthritis, particularly those at increased risk of nonsteroidal antiinflammatory drug (NSAID),induced gastrointestinal (GI) side effects. However, higher doses of acetaminophen inhibit prostaglandin synthesis and have been associated with GI events. This study was undertaken to compare the observed and adjusted rates of GI events (hospitalizations, ulcers, dyspepsia, GI prophylaxis) occurring with higher versus lower doses of acetaminophen. Methods This was a retrospective cohort study of subjects ages ,65 years who received a prescription for acetaminophen or NSAID between 1994 and 1996. Pharmaceutical and medical records were reviewed for 1 year of historical data prior to the index prescription of acetaminophen or non-aspirin NSAID. Risk factors for GI events were identified based on the historical data. To further control for bias, patients were categorized by propensity score (the likelihood of receiving acetaminophen, given defined risk factor values). Records were then reviewed for the duration of the index prescription or 30 days, whichever was less, to generate data on the occurrence of GI events. Determinants of acetaminophen utilization were identified using logistic regression, and rates of GI events for each therapy were examined using Poisson regression analyses, controlling for duration of exposure, individual risk factors, and propensity scores. Results The study included 26,978 patients in the NSAID cohort and 21,207 in the acetaminophen cohort. Determinants of acetaminophen utilization compared with NSAIDs (odds ratio [95% confidence interval]) included recent hospitalization (8.6 [7.7,9.5]), concomitant anticoagulation therapy (3.2 [2.7,3.8]), age >85 years (2.3 [2.1,2.4]), and history of prior GI events, especially those requiring hospitalization (14.6 [11.7,18.7]). Unadjusted rates of GI hospitalization, ulcer, and dyspepsia were higher for patients in the acetaminophen cohort than for those in the NSAID cohort. The occurrence of GI events in acetaminophen-treated patients was dose dependent, with rate ratios (compared with high-dose NSAIDs and adjusted for risk susceptibility) ranging from 0.6 (95% confidence interval 0.5,0.7) for ,650 mg/day to 1.0 (0.9,1.1) for >3,250 mg/day. Conclusion In this cohort, acetaminophen utilization is more common in patients at higher risk of GI events. After adjustment for risk susceptibility, patients receiving higher doses of acetaminophen have higher rates of GI events compared with those receiving lower doses. [source] | ||||||||||