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Biomedical subjects

James D Lewis

Publications and source records attributed to James D Lewis.

At least 19 recordsLinked to original sources
PubMed2007

Relationship between 6-mercaptopurine dose and 6-thioguanine nucleotide levels in patients with inflammatory bowel disease.

BACKGROUND: 6-Thioguanine nucleotides (6-TGN) are active metabolites of azathioprine (AZA) and 6-mercaptopurine (6MP). Higher remission rates have been observed in patients with higher 6-TGN levels. However, many physicians prescribe AZA/6MP using milligrams per kilogram (mg/kg) dosing regimens without measuring 6-TGN levels. The aim of this study was to examine the association between 6MP dose and 6-TGN levels. METHODS: We conducted a cross-sectional study of patients treated for inflammatory bowel disease (IBD) with AZA or 6MP, whose 6-TGN levels were measured. Patients with low or intermediate thiopurine methyl transferase (TPMT) activity were excluded. AZA dose was converted to 6MP equivalents. The relationship between dose and 6-TGN levels was assessed with the Spearman correlation coefficient. We used logistic regression to assess the relationship between dose and 6-TGN levels of >230 pmol/8 x 10(8). RESULTS: In this study, 155 patients met our inclusion criteria (median dose, 1.01 +/- 0.40; range, 0.61-1.41 mg/kg). There was a weak correlation between 6-TGN levels and the absolute dose (rho = 0.18, P = 0.04) and the dose in mg/kg (rho = 0.19, P = 0.03). The correlation between mg/kg dosage and 6-TGN levels was slightly stronger in those using concomitant 5-aminosalicylate (5-ASA) medications (rho = 0.24, P = 0.02). Compared with <1.0 mg/kg per day, doses of > or =1.5 mg/kg per day were strongly associated with 6-TGN levels of >230 pmol/8 x 10(8) RBC (adjusted odds ratio [OR] = 3.7, 95% confidence interval [CI] = 1.1-11.8). However, only 37% of patients receiving > or =1.0 mg/kg per day had 6-TGN levels of >230 pmol/8 x 10(8) RBC. CONCLUSIONS: 6MP dose is weakly associated with 6-TGN levels. The use of standard mg/kg dosing regimens will result in low 6-TGN levels in most patients.

Adult↗
PubMed2007

Validation studies of the health improvement network (THIN) database for pharmacoepidemiology research.

BACKGROUND: The Health Improvement Network (THIN) is a new medical records database that contains records from general practices some of which have or continue to participate in the General Practice Research Database (GPRD) and others that never participated in GPRD. We sought to replicate in THIN well-established associations from the medical literature and to compare results from the GPRD practices to the non-GPRD practices within THIN. METHODS: Using THIN data from 1986-2003, we conducted case-control studies of associations between diseases (e.g., hypertension and stroke) and between diseases and drugs (e.g., aspirin and colon cancer). Conditional logistic regression was used to calculate odds ratios adjusted for potential confounders. Differences between GPRD and non-GPRD practices were assessed by testing for a statistical interaction by practice type in each outcome-exposure association. RESULTS: We observed the expected positive associations (p < 0.05) of stroke with hypertension and diabetes mellitus; of myocardial infarction with hypertension, hypercholesterolemia, obesity, and smoking; and of peptic ulcer disease with aspirin, NSAIDs, and potassium. We observed the expected negative associations (p < 0.05) of colorectal cancer with aspirin, NSAIDs, and cox-2 inhibitors. The expected protective effect of aspirin use for myocardial infarction was not observed. In all cases, the results obtained from the GPRD practices were similar to the results obtained from the non-GPRD practices, only being statistically different for the associations of myocardial infarction with diabetes and aspirin use. CONCLUSIONS: THIN data that are collected outside of the GPRD appear as valid as the data collected as part of the GPRD.

Anti-Inflammatory Agents, Non-Steroidal↗
PubMed2006

Long-term proton pump inhibitor therapy and risk of hip fracture.

CONTEXT: Proton pump inhibitors (PPIs) may interfere with calcium absorption through induction of hypochlorhydria but they also may reduce bone resorption through inhibition of osteoclastic vacuolar proton pumps. OBJECTIVE: To determine the association between PPI therapy and risk of hip fracture. DESIGN, SETTING, AND PATIENTS: A nested case-control study was conducted using the General Practice Research Database (1987-2003), which contains information on patients in the United Kingdom. The study cohort consisted of users of PPI therapy and nonusers of acid suppression drugs who were older than 50 years. Cases included all patients with an incident hip fracture. Controls were selected using incidence density sampling, matched for sex, index date, year of birth, and both calendar period and duration of up-to-standard follow-up before the index date. For comparison purposes, a similar nested case-control analysis for histamine 2 receptor antagonists was performed. MAIN OUTCOME MEASURE: The risk of hip fractures associated with PPI use. RESULTS: There were 13,556 hip fracture cases and 135,386 controls. The adjusted odds ratio (AOR) for hip fracture associated with more than 1 year of PPI therapy was 1.44 (95% confidence interval [CI], 1.30-1.59). The risk of hip fracture was significantly increased among patients prescribed long-term high-dose PPIs (AOR, 2.65; 95% CI, 1.80-3.90; P<.001). The strength of the association increased with increasing duration of PPI therapy (AOR for 1 year, 1.22 [95% CI, 1.15-1.30]; 2 years, 1.41 [95% CI, 1.28-1.56]; 3 years, 1.54 [95% CI, 1.37-1.73]; and 4 years, 1.59 [95% CI, 1.39-1.80]; P<.001 for all comparisons). CONCLUSION: Long-term PPI therapy, particularly at high doses, is associated with an increased risk of hip fracture.

Aged↗
PubMed2006

Predictors of recall of over-the-counter and prescription non-steroidal anti-inflammatory drug exposure.

PURPOSE: Because of the difficulty in establishing a gold standard, data on accuracy of recall of over-the-counter (OTC) medication use are sparse. METHODS: We studied a cohort of 1889 persons living in the Philadelphia area to assess recall of non-aspirin non-steroidal anti-inflammatory drug (NANSAID) use during the preceding 8 weeks. Our analyses were based on the assumption that among the group of subjects, on average, the reported usage of NANSAIDs should not vary over the previous 8 weeks. To model the effect of time on reported usage while allowing for the inherent correlation of responses within subjects over time, we employed alternating logistic regression. RESULTS: We documented a significant decline in reported use of OTC NANSAIDs but not prescription NANSAIDs during the 8-week study period (p = 0.3 for frequent prescription NANSAIDs, p = 0.2 for infrequent prescription NANSAIDs, p < 0.001 for frequent OTC NANSAIDs, and p < 0.001 for infrequent OTC NANSAIDs). Reported rates of frequent and infrequent OTC NANSAID consumption declined from 6.3 to 4.6% and from 17.1 to 12.8% between the most recent week and eight weeks prior, respectively. CONCLUSIONS: Interviews focusing on medications used on an as needed basis should be performed as close as possible to the index date. Likewise, data on frequent use of OTC NANSAIDs may be more reliable than that on infrequent use, particularly when subjects are asked to recall more than a few weeks back in time.

Adult↗
PubMed2006

Quality of manufacturer provided information on safety and efficacy claims for dietary supplements for colonic health.

PURPOSE: Food and Drug Administration (FDA) approval of dietary supplements is not required. However, manufacturers must ensure that data exist to support safety and efficacy claims of their product. This study was designed to evaluate accessibility and quality of such data from manufacturers of dietary supplements for 'colonic health.' METHODS: Supplements promoting 'colonic health' were identified at area stores. A physician contacted the manufacturers by mail and telephone requesting data to substantiate claims of efficacy and safety. MEDLINE was searched to identify reports of adverse events or medication interactions. RESULTS: Twelve manufacturers of 23 products were surveyed. Eight manufacturers responded, of whom four provided no clinical data to substantiate claims of efficacy or safety. No manufacturer provided data that directly evaluated their product. Our literature review identified a wide range of potential adverse events and drug-supplement interactions, albeit mostly as case reports, animal studies, or in vitro experiments. CONCLUSIONS: There is a need to increase availability of supplement safety data to physicians and the general public. Consideration should be given to various responses, including legislative actions that address this issue.

Colonic Diseases↗
PubMed2006

The impact of increased body mass index on the clinical course of Crohn's disease.

BACKGROUND & AIMS: Tumor necrosis factor-alpha production in adipose tissue is well documented. Crohn's disease (CD) patients with increased adipose tissue may have more severe disease. This study evaluated overweight patients with CD to determine if their clinical course differs from those with a normal or low body mass index (BMI). METHODS: Patients at the Hospital of the University of Pennsylvania from 1997 to 2002 were included. Data were collected from outpatient records and standardized interviews. Overweight was defined as a BMI of 25 kg/m2 or higher. The primary outcome was time to first surgery. Secondary outcomes included age at diagnosis, number of surgeries, and escalation of therapy. Patients with a BMI of 25 kg/m2 or higher at diagnosis were compared with patients with a BMI of less than 25 kg/m2 using statistical analyses. Survival analysis compared time to first surgery. RESULTS: A total of 148 patients were included. Forty-eight (32.4%) had a BMI of 25 kg/m2 or higher at diagnosis. Patients with a BMI of 25 kg/m2 or higher were older at diagnosis; 35 years vs 22.5 years for patients with a BMI of less than 25 kg/m2 (P = .0001). The number of surgeries, escalation of therapy, and disease distribution did not differ between the 2 groups. A significant difference was found for time to first surgery, 252 months vs 24 months for patients with a BMI of less than 18.5 kg/m2 vs patients with a BMI of 25 kg/m2 or higher, respectively (P = .043). CONCLUSIONS: CD patients with a BMI of 25 kg/m2 or higher at diagnosis were older at diagnosis and had a shorter time to first surgery than those with a BMI of less than 18.5 kg/m2. This suggests that overweight CD patients require earlier surgical intervention and perhaps more aggressive medical therapy.

Adult↗
PubMed2006

Incidence and risk factors for herpes zoster among patients with inflammatory bowel disease.

BACKGROUND & AIMS: An increased risk of herpes zoster in patients with inflammatory bowel disease (IBD) is hypothesized based on altered immune function, especially among patients receiving immunosuppressive medications. METHODS: We performed a retrospective cohort study and a retrospective nested case-control study using 1988-1997 data from the General Practice Research Database. In the cohort study, 7823 Crohn's disease (CD) and 11,930 ulcerative colitis (UC) patients were matched on age, sex, and primary care practice to 79,563 randomly selected controls without CD or UC. In the nested case-control study, 185 CD patients with zoster and 266 UC patients with zoster were matched on sex and year of birth to 1787 IBD patients without zoster. RESULTS: In the cohort study, the incidence of zoster was higher in patients with CD and UC compared with their matched controls (UC incidence rate ratio, 1.21; 95% confidence interval [CI], 1.05-1.40; CD incidence rate ratio, 1.61; 95% CI, 1.35-1.92). In the nested case-control study, receipt of a prescription for corticosteroids (adjusted odds ratio, 1.5; 95% CI, 1.1-2.2) or azathioprine/6-mercaptopurine (adjusted odds ratio, 3.1; 95% CI, 1.7-5.6) were both associated with zoster. CONCLUSIONS: Patients with IBD, especially those on immunosuppressive medications, are at higher risk for herpes zoster compared with the general population. Future studies should clarify the relative risk associated with anti-tumor necrosis factor alpha therapies and determine the use of the new zoster vaccine for patients with IBD.

Adolescent↗
PubMed2006

Association of 6-thioguanine nucleotide levels and inflammatory bowel disease activity: a meta-analysis.

BACKGROUND & AIMS: 6-Thioguanine nucleotide (6-TGN) levels have been proposed to correlate with inflammatory bowel disease (IBD) activity among patients treated with azathioprine or 6-mercaptopurine (6-MP). Previous studies, most with small sample sizes, yielded conflicting conclusions. Our aim was to pool the available data to provide a more precise estimate of the association between 6-TGN levels and IBD activity. METHODS: We searched Medline and PubMed (from 1966 to November 2004) and reviewed the reference lists of selected articles. Fixed and random-effects models were used to test whether mean/median 6-TGN levels differed among patients with active disease vs remission and whether 6-TGN levels above a threshold of 230-260 pmol/8 x 10(8) red blood cells were associated with clinical remission. When studies reported multiple 6-TGN threshold values, we used the data for the lower value. RESULTS: We identified 55 articles, 12 of which contained data sufficient for inclusion. The mean/median 6-TGN levels were higher among patients in remission than in those with active IBD (pooled difference, 66 pmol/8 x 10(8) red blood cells; 95% confidence interval, 18-113; P = .006), but with significant heterogeneity. Excluding the 1 outlier study eliminated this heterogeneity. Patients with 6-TGN levels above the threshold value were more likely to be in remission (62%) than those below the threshold value (36%) (pooled odds ratio, 3.3; 95% confidence interval, 1.7-6.3; P < .001), but with significant heterogeneity. Again, excluding the 1 outlier study eliminated this heterogeneity. CONCLUSIONS: Although prior studies yielded inconsistent conclusions, this analysis strongly supports that higher 6-TGN levels are associated with clinical remission.

Guanine Nucleotides↗
PubMed2006

The impact of bariatric surgery on menstrual patterns.

BACKGROUND: Obesity and anovulation are common medical problems in the United States. Anovulation in obese patients primarily manifests with irregular, sporadic or absent menstrual bleeding. Weight loss of at least 5% has been shown to reverse obesity-related anovulation. The aim of this study was to assess the impact of bariatric surgery on infertility in morbidly obese women and to identify factors associated with return of normal menses following bariatric surgery. METHODS: A survey of patients was collected from the bariatric surgery data-base at the Hospital of the University of Pennsylvania. 410 women under the age of 40 were sent questionnaires. 195 patients completed the questionnaire, and 29 patients had incorrect addresses without a forwarding address, resulting in a 51.2% response rate. Patients who reported menstrual cycle lengths >35 days were considered abnormal. 92 of the 195 responders were considered anovulatory preoperatively, based on menstrual history. RESULTS: There was no significant difference in postoperative BMI, BMI decrease or age at surgery between the survey responders and non-responders. There was a significant difference between these 2 groups in time since surgery (P=.01). Both groups had a decrease in BMI of >18 kg/m(2). The mean menstrual cycle length preoperatively among those categorized as ovulatory and anovulatory was 27.3 and 127.5 days, respectively. Of the 98 patients who were anovulatory preoperatively, 70 patients (71.4%) regained normal menstrual cycles after surgery. Those patients who regained ovulation had greater weight loss than those who remained anovulatory (61.4 kg vs 49.9 kg, P=0.02). CONCLUSIONS: Anovulation resulting in abnormal menses is a common problem in morbidly obese premenopausal women. The menstrual cycle disorders may completely resolve after bariatric surgery. Thus, infertility due to anovulation among morbidly obese women could potentially be viewed as an additional indication for bariatric surgery.

Adult↗
PubMed2005

Renal function after orthotopic liver transplantation is predicted by duration of pretransplantation creatinine elevation.

In patients with recent onset renal insufficiency, the decision to perform combined kidney/liver transplantation (CKLT) vs. orthotopic liver transplantation alone (OLTa) can be difficult. We hypothesized that duration of renal dysfunction may correlate with creatinine elevation after liver transplantation. We retrospectively identified 69 liver transplantation patients with pretransplantation creatinine > or =1.5 mg/dL (53 OLTa, 13 CKLT). Variables analyzed were presence of hepatorenal syndrome, creatinine, Model for End-Stage Liver Disease score, albumin, age, race, gender, cause of liver disease, diabetes mellitus, hypertension, and history of ascites, spontaneous bacterial peritonitis, variceal bleeding, hepatic encephalopathy, renal replacement therapy (RRT), and transjugular intrahepatic portosystemic shunting. Duration of pretransplantation renal dysfunction was predictive of 6- and 12-month creatinine post-OLTa. Area under the receiver operating characteristic (ROC) curve for prediction of 12-month renal insufficiency by renal dysfunction duration was 0.71; optimal duration cutoff was 3.6 weeks. We applied a multivariable model, derived from OLTa patients, to CKLT subjects with definite or possible hepatorenal syndrome. Predicted 12-month creatinine without renal transplantation was >2.0 mg/dL for each patient. CKLT patients as opposed to OLTa patients had longer duration of renal dysfunction (median, 18.1 vs. 2.7 weeks, P < 0.001), higher creatinine (median 4.0 versus 1.7 mg/dL, P < 0.001), and higher rate of pretransplantation RRT (62% vs. 7%, P < 0.001). Adjusting for baseline characteristics, CKLT patients had lower creatinine than OLTa patients at 6 months (P =0.15) and 12 months (P =0.01) after transplantation. In conclusion, duration, but not cause, of renal dysfunction predicts renal outcome in OLTa recipients. Prospective studies may use duration of renal dysfunction to help identify CKLT candidates.

Cohort Studies↗
PubMed2005

The relationship between time since registration and measured incidence rates in the General Practice Research Database.

BACKGROUND: The General Practice Research Database (GPRD) is widely used to study incidence rates. This study examines whether incidence rates are overestimated during the first year after registration, how long one needs to wait to obtain accurate incidence rates, and whether the time period of overestimation differs among disease types. METHODS: We measured incidence rates of nine acute, eight chronic, and eight neoplastic outcomes in 3-month intervals through month 36 after enrollment in GPRD. The incidence rates in months 13-36 were used to estimate baseline incidence rates for each diagnosis. RESULTS: For patients registering with practices that were already UTS, incidence rates were highest in the first 3 months after registration. In eight of nine acute diagnoses, the incidence rate was within 20% of baseline by months 4-6; and in seven of eight cancers, the incidence rate was within 20% of baseline by months 7-9. For chronic conditions, the incidence rate in months 10-12 differed from baseline by more than 20% for five of the eight outcomes, respectively. For patients registering prior to UTS, incidence rates during the first quarter were within 20% of baseline for all acute and cancer diagnoses and six of eight chronic diagnoses. CONCLUSIONS: Reported incidence rates are highest in the first 3 months after registration with an UTS practice and decline to baseline over the first year, more quickly for acute conditions than chronic conditions. For patients who registered prior to UTS, incidence rates are near the baseline level at the start of follow-up.

Cohort Studies↗
PubMed2005

Potential limitations of electronic database studies of prescription non-aspirin non-steroidal anti-inflammatory drugs (NANSAIDs) and risk of myocardial infarction (MI).

PURPOSE: To determine whether specific limitations in electronic database studies may lead to biased estimates of the association between prescription, non-selective non-aspirin non-steroidal anti-inflammatory drugs (NANSAIDs) and myocardial infarction (MI) METHODS: Using our case-control study of NANSAIDs and first, non-fatal MI, we determined the odds ratio (OR) for prescription NANSAIDs and MI. In the 'Replicating Electronic Database Analysis,' we considered non-prescription NANSAID users to be 'non-users,' did not stratify by aspirin use, and did not adjust for confounders typically unavailable or incomplete in existing databases. In the 'Misclassification Assessment Analysis,' we removed non-prescription NANSAIDs from the 'non-user' category. In the 'Confounding Assessment Analysis #1,' we additionally adjusted for smoking, family history, and years of education. In the 'Confounding Assessment Analysis #2,' we also adjusted for body mass index (BMI) and physical activity. In the 'Interaction Assessment Analysis,' we stratified on aspirin use and repeated the latter analysis. RESULTS: The prevalence of current NANSAID and aspirin use was higher in our controls than in electronic database studies, consistent with the fact that non-prescription NANSAIDs accounted for 81% of all NANSAID use. Education, physical activity, and BMI also were associated with prescription NANSAID use. When each potential source of bias was removed, the OR for NANSAIDs moved further from 1.0 (i.e., toward a protective association with MI): 'Replicating Electronic Database' analysis (OR 1.00, 95% confidence interval [CI]: 0.78--1.28); 'Misclassification Assessment Analysis' (OR 0.89, 95%CI: 0.70--1.14); 'Confounding Assessment Analysis #1' (OR 0.85, 95%CI: 0.66--1.10); 'Confounding Assessment Analysis #2' (OR 0.78, 95%CI: 0.60--1.01); 'Interaction Assessment Analysis' (OR 0.69, 95%CI: 0.51--0.95). CONCLUSIONS: Limitations in electronic databases may be responsible for the lack of association of NANSAIDs on lower MI risk noted in these studies. Further studies-preferably randomized trials-are needed to address the risk-benefit ratio of NANSAID use.

Adult↗
PubMed2005

Antibiotic use and the risk of flare of inflammatory bowel disease.

BACKGROUND & AIMS: Intestinal microbial flora participate in the pathogenesis of inflammatory bowel disease. Because antibiotic therapy alters intestinal microbial flora, we hypothesized that use of antibiotics might decrease the risk of flare. METHODS: We conducted a case-crossover study by using the General Practice Research Database from 1989-1997. Flares of disease were identified by receipt of a new prescription for either corticosteroids or mesalamine medications after an interval of at least 4 months without prescriptions for either class of medication. The primary exposure was receipt of any antibiotics in the 60 days preceding the index date. RESULTS: Among 1205 patients with Crohn's disease, exposure to antibiotics was associated with a reduced risk of flare (adjusted odds ratio [OR], 0.78; 95% confidence interval [CI], 0.64-0.96; P = .019). The effect was strongest with more recent exposure (test for trend, P < .05). Among 2230 patients with ulcerative colitis, use of any antibiotics within 60 days was not associated with flare of disease (adjusted OR, 0.96; 95% CI, 0.82-1.12; P = .581), although a potentially protective effect was observed in those patients with very recent exposure (exposure within 15 days: OR, 0.66; 95% CI, 0.51-0.85). CONCLUSIONS: Antibiotic use within 60 days was associated with a lower risk of flare of Crohn's disease, but not ulcerative colitis. The strength of the protective effect of antibiotics in Crohn's disease wanes over time.

Adrenal Cortex Hormones↗
PubMed2005

Type 2 diabetes mellitus and the risk of colorectal cancer.

BACKGROUND & AIMS: Type 2 diabetes mellitus might increase the risk of colorectal cancer on the basis of chronic hyperinsulinemia and hyperglycemia. However, epidemiologic evidence for this association is inconclusive. We conducted a population-based study to clarify this association. METHODS: We conducted a case-control study in the United Kingdom General Practice Research Database. Cases included all patients with incident colorectal cancer diagnoses (n = 10,447). Up to 10 control subjects were selected for each case, matching on year of birth, enrollment date, and duration of database follow-up. The exposure of interest was type 2 diabetes mellitus. Odds ratios (ORs) were calculated by using conditional logistic regression. RESULTS: A prior diagnosis of type 2 diabetes mellitus was associated with a modestly increased risk of colorectal cancer (OR, 1.42; 95% confidence interval [CI], 1.25-1.62). The association between type 2 diabetes mellitus and colorectal cancer was observed in both men (OR, 1.36; 95% CI, 1.16-1.61) and women (OR, 1.38; 95% CI, 1.14-1.67). The risk increase was observed in both colon (OR, 1.45; 95% CI, 1.25-1.70) and rectal (OR, 1.34; 95% CI, 1.08-1.68) cancers. CONCLUSIONS: Type 2 diabetes mellitus is associated with an increased risk of colorectal cancer. The risk increase is present in both sexes, as well as in both colonic and rectal cancers.

Colorectal Neoplasms↗
PubMed2005

Increased risk for demyelinating diseases in patients with inflammatory bowel disease.

BACKGROUND & AIMS: Reports of multiple sclerosis (MS), demyelination, and optic neuritis (ON) associated with anti-tumor necrosis factor alpha therapy resulted in warnings on prescribing instructions for infliximab, etanercept, and adalimumab. However, the underlying relationship between IBD and these neurologic conditions has not been established. METHODS: We performed a retrospective cohort study and a retrospective cross-sectional study using 1988 to 1997 data from the General Practice Research Database. A total of 7988 Crohn's disease and 12,185 ulcerative colitis patients were matched for age, sex, and primary care practice to 80,666 randomly selected controls. In the cohort study, incident cases of MS, demyelination, and/or ON (MS/D/ON) had to occur at least 1 year after registration with the physician and after the diagnosis of IBD. In the cross-sectional study, the diagnosis of MS/D/ON could either precede or follow the IBD diagnosis. RESULTS: In the cohort study, the incidence of MS/D/ON was higher in patients with Crohn's disease and ulcerative colitis compared with their matched controls, reaching statistical significance for ulcerative colitis (ulcerative colitis incidence rate ratio [IRR], 2.63; 95% confidence interval, 1.29-5.15; Crohn's disease IRR, 2.12; 95% confidence interval, .94-4.50). In the cross-sectional study, MS/D/ON was more prevalent in patients with Crohn's disease and ulcerative colitis compared with their matched controls (Crohn's disease odds ratio, 1.54; 95% confidence interval, 1.03-2.32; ulcerative colitis odds ratio, 1.75; 95% confidence interval, 1.28-2.39). CONCLUSIONS: Demyelinating diseases occur more commonly among patients with IBD than among non-IBD patients. Future studies should clarify whether treatment with tumor necrosis factor alpha blockers results in further increased incidence of MS/D/ON among IBD patients.

Adult↗
PubMed2005

Risk of serious upper gastrointestinal toxicity with over-the-counter nonaspirin nonsteroidal anti-inflammatory drugs.

BACKGROUND & AIMS: Use of prescription nonaspirin nonsteroidal anti-inflammatory drugs (NANSAIDs) increases the risk of serious upper gastrointestinal toxicity. Less is known about over-the-counter (OTC) NANSAIDs, which are typically used at lower doses and for shorter durations. This study assessed the risk of toxicity with OTC NANSAIDs. METHODS: A total of 359 case subjects hospitalized for upper gastrointestinal bleeding, perforation, or benign gastric outlet obstruction were recruited from 28 hospitals. A total of 1889 control subjects were recruited by random digit dialing from the same region. Data on medication use were collected via structured telephone interview. RESULTS: Use of OTC NANSAIDs on > or = 4 days during the most recent week had an adjusted odds ratio (OR) of 1.83 (95% confidence interval [CI], 1.14-2.95). Use of high-dose OTC NANSAIDs during the index week had an adjusted OR of 5.21 (95% CI, 2.32-11.69). In contrast, use of OTC NANSAIDs <4 times during the index week (adjusted OR, 0.67; 95% CI, 0.43-1.06) and use of very low doses of prescription or OTC NANSAIDs during the index week (adjusted OR, 0.74; 95% CI, 0.49-1.12) were not significantly associated with an increased risk of serious gastrointestinal toxicity. We did not observe a significant difference between the risk of toxicity with OTC naproxen versus OTC ibuprofen (adjusted OR, 0.84; 95% CI, 0.26-2.70). CONCLUSIONS: Use of OTC NANSAIDs at recommended doses has a relatively good safety profile compared with prescription NANSAIDs. However, use of high-dose OTC NANSAIDs (comparable to a prescription dose) is associated with serious gastrointestinal toxicity.

Adult↗