Epidemiology, Disease Course, and Clinical Outcomes of Perianal Fistulas and Fissures Crohn's Disease: A Nationwide Population-Based Study in Taiwan.

Background: Population-based data on the course of perianal disease in East Asian populations with Crohn's disease (CD) are limited. This study examined the prevalence, clinical course, and compared the outcomes of CD patients with perianal CD (pCD) versus without pCD in Taiwan. Methods: A nationwide population-based study was implemented from 2000 to 2017 by using the Taiwan National Health Insurance Research Database. Results: Of 2424 patients with CD, 358 (14.8%) patients with pCD were identified. Most patients with CD and pCD were men (79.3%). The mean age at CD diagnosis was lower in patients with pCD (33.7 years) than in those without pCD (44.9 years). Approximately half the patients with pCD received the pCD diagnosis at least 6 months before receiving a CD diagnosis. Approximately one-third (121/358) of patients with pCD had recurrent fistula; the median recurrence interval was 239 days. Compared with patients without pCD, patients with pCD had higher mean incidences of hospitalization (7.0 vs 3.8, P < .01), outpatient visits (13 vs 2.9, P < .01), and emergency room visits (10.3 vs 4.4, P < .01) over a 15-year period. Although patients with pCD had higher rates of healthcare utilization, their 15-year mortality rate was lower than that of those without pCD (6.1% vs 17.3%, P < .01). Conclusions: The period prevalence of pCD in Taiwanese patients with CD was 14.8%. Although patients with pCD required more intensive care and had greater healthcare utilization, they did not have inferior survival outcomes compared with those without pCD.

Acute reactions after a homologous primary COVID-19 vaccination series: Analysis of Taiwan V-Watch data.

INTRODUCTION: The ChAdOx1 nCoV-19 (ChAd), mRNA-1273 (m1273), MVC-COV1901 (MVC), and BNT162b2 (BNT) COVID-19 vaccines received authorization for emergency use in Taiwan beginning in February 2021. We investigated acute reactions to homologous primary COVID-19 vaccination series in adults aged ≥ 18 years. METHODS: In this prospective observational study based on smartphone data (Taiwan V-Watch), we calculated the frequencies of self-reported local and systemic acute reactions within 7 days of a COVID-19 vaccination, and the health effects up to 3 weeks after each dose. Those who reported adverse reactions after both doses were assessed by the McNemar test. RESULTS: During 22 March 2021-13 December 2021, 77,468 adults were enrolled; 59.0 % were female and 77.8 % were aged 18-49 years. For both doses of all four vaccines, the local and systemic reactions were minor in severity and highest on days 1 and 2 after vaccination, and declined markedly until day 7. For 65,367 participants who provided data after the first and second doses, systemic reactions were more frequent after dose 2 of the BNT and m1273 vaccines (McNemar tests: both p < 0.001), while local reactions were more frequent after dose 2 of the m1273 and MVC vaccines (both p < 0.001), compared with dose 1 of the homologous vaccine. Among the participants aged 18-49 years, the percentage who missed work on the day after vaccination was slightly higher among women (9.3 %) than among men (7.0 %). CONCLUSIONS: Acute reactogenicity and impact of work absenteeism for the four COVID vaccines in the V-Watch survey were mild and of short duration.

Safety surveillance of varicella vaccine using tree-temporal scan analysis.

IMPORTANCE: Passive surveillance systems are susceptible to the under-reporting of adverse events (AE) and a lack of information pertaining to vaccinated populations. Conventional active surveillance focuses on predefined AEs. Advanced data mining tools could be used to identify unusual clusters of potential AEs after vaccination. OBJECTIVE: To assess the feasibility of a novel tree-based statistical approach to the identification of AE clustering following the implementation of a varicella vaccination program among one-year-olds. SETTING AND PARTICIPANTS: This nationwide safety surveillance was based on data from the Taiwan National Health Insurance database and National Immunization Information System for the period 2004 through 2014. The study population was children aged 12-35 months who received the varicella vaccine. EXPOSURE: First-dose varicella vaccine. OUTCOMES AND MEASURES: All incident ICD-9-CM diagnoses (emergency or inpatient departments) occurring 1-56 days after the varicella vaccination were classified within a hierarchical system of diagnosis categories using Multi-Level Clinical Classifications Software. A self-controlled tree-temporal data mining tool was then used to explore the incidence of AE clustering with a variety of potential risk intervals. The comparison interval consisted of days in the 56-day follow-up period that fell outside the risk interval. RESULTS: Among 1,194,189 varicella vaccinees with no other same-day vaccinations, nine diagnoses with clustering features were categorized into four safety signals: fever on days 1-6 (attributable risk [AR] 38.5 per 100,000, p < 0.001), gastritis and duodenitis on days 1-2 (AR 5.9 per 100,000, p < 0.001), acute upper respiratory infection on days 1-5 (AR 11.0 per 100,000, p = 0.006), and varicella infection on days 1-9 (AR 2.7 per 100,000, p < 0.001). These safety profiles and their corresponding risk intervals have been identified in previous safety surveillance studies. CONCLUSIONS: Unexpected clusters of AEs were not detected after the mass administration of childhood varicella vaccines in Taiwan. The tree-temporal statistical method is a feasible approach to the safety surveillance of vaccines in populations of young children.

Class effect of beta-blockers in survivors of ST-elevation myocardial infarction: A nationwide cohort study using an insurance claims database.

Beta-blockers can help reduce mortality following acute myocardial infarction (MI); however, whether beta-blockers exert a class effect remains controversial. This study identified all patients with first ST-elevation MI for the period of 2003 to 2010 from the National Health Insurance claims database, Taiwan. We compared patients prescribed carvedilol, bisoprolol, and propranolol. Study outcomes included all-cause death, cardiovascular death, and recurrence of MI. The propensity scores were constructed using multinomial logistic regression to model the receipt of different beta-blockers. Treating carvedilol group as a reference, we employed a simultaneous three-group comparison approach using the Cox regression model with adjustment for the propensity scores to compare the relative risks of various outcomes. Among the 16836 patients, 7591 were prescribed carvedilol, 5934 bisoprolol, and 3311 propranolol. Mean follow-up time was one year. After accounting for baseline differences, patients treated with bisoprolol (HR 0.87, 95% CI 0.72-1.05, p = 0.14) or propranolol (HR 1.07, 95% CI 0.84-1.36, p = 0.58) had a similar risk of all-cause death in comparison with carvedilol. No significant differences were observed among three beta-blocker groups with regard to the risks of cardiovascular death and recurrence of MI. Our results suggest that beta-blockers exert a possible class effect in the treatment of acute MI.

Use of a claims-based active drug safety surveillance system to assess the risk of acute pancreatitis with exenatide or sitagliptin compared to metformin or glyburide.

OBJECTIVE: To estimate risk and relative risk (RR) of acute pancreatitis among patients using incretin-based diabetes therapies (exenatide or sitagliptin) compared to patients treated with agents with established safety profiles (metformin or glyburide). RESEARCH DESIGN AND METHODS: The study population was derived from a large US commercial health insurance transaction database using an active drug safety surveillance system (i3 Aperio). This analysis is based on data from June 2005 through June 2008. Cohorts of exenatide and sitagliptin initiators were each matched to an equal number of metformin or glyburide (met/gly) initiators using propensity scores to reduce confounding in the comparison of outcomes during follow-up. Patients with claims suggesting pancreatic disease in the 6 months prior to cohort entry were excluded. MAIN OUTCOME MEASURE: Claims for hospitalizations associated with a primary diagnosis of acute pancreatitis (ICD-9 577.0). RESULTS: There were 27 996 exenatide initiators and 16 276 sitagliptin initiators and approximately equal numbers of matched comparators. During follow-up of up to 1 year, acute pancreatitis occurred among 0.13% of patients treated with exenatide and 0.12% of patients treated with sitagliptin. The risk of acute pancreatitis was comparable for initiators of exenatide (RR 1.0; 95% confidence interval (CI) 0.6-1.7) and sitagliptin (RR 1.0; 95% CI 0.5-2.0) relative to the comparison cohorts. CONCLUSIONS: These data do not provide evidence for an association of acute pancreatitis among initiators of exenatide or sitagliptin compared to met/gly initiators. These results are limited by the data available in an administrative, healthcare database.

The thiazolidinediones rosiglitazone and pioglitazone and the risk of coronary heart disease: a retrospective cohort study using a US health insurance database.

BACKGROUND: The thiazolidinediones (TZDs), including rosiglitazone maleate and pioglitazone hydrochloride, are commonly prescribed in patients with type 2 diabetes mellitus. Although recent meta-analyses suggest there is an increased risk of myocardial infarction (MI) among rosiglitazone users, these findings were not supported by data from other studies. OBJECTIVE: The goal of this research was to compare the risk of MI, coronary revascularization (CR), and sudden death in patients who began rosiglitazone therapy versus those who began pioglitazone therapy. METHODS: This was a retrospective cohort study using information from a large health care database (with data available on approximately 14 million individuals). All initiators of rosiglitazone or pioglitazone from July 1, 2000, through March 31, 2007, for whom the first dispensing followed >or=6 months of health plan membership and the member's 18th birthday were identified. The propensity score method was used to create matched cohorts of patients in 3 treatment groups: TZD monotherapy, dual therapy (a TZD plus another antidiabetic agent), and TZD therapy with concomitant insulin. Follow-up continued to a change in treatment regimen, defined as regimen switch (ie, the addition of any antidiabetic agent to an existing regimen) or regimen stop (ie, the discontinuation of any component of the therapeutic regimen). Three outcomes that represent coronary heart disease were assessed for this analysis: MI, CR, and sudden death. The proportional hazards model, stratified by therapeutic regimen, was used to estimate hazard ratios (HRs) and 95% CIs of coronary heart disease risk associated with use of rosiglitazone relative to pioglitazone. RESULTS: Among 47,501 matched pairs of rosiglitazone and pioglitazone users, 72,104 (75.9%) were receiving TZD monotherapy, 17,822 (18.8%) were receiving dual therapy, and 5076 (5.3%) were receiving TZD therapy with insulin. Mean follow-up was 9.6 months with regimen switch as the censoring event and 8.4 months with regimen stop as the censoring event. For MI, the HR was 1.35 (95% CI, 1.12-1.62) through regimen switch and 1.41 (95% CI, 1.13-1.75) through regimen stop. For the composite outcome of MI, CR, and/or sudden death, the HR was 1.09 (95% CI, 0.97-1.22) through regimen switch and 1.12 (95% CI, 0.98-1.27) through regimen stop. CONCLUSIONS: In this retrospective cohort analysis, MI was more common in users of rosiglitazone than in users of pioglitazone. The incidence of a combined end point of MI, CR, and/or sudden death in patients receiving rosiglitazone was not significantly different from that in patients receiving pioglitazone.

Chronic disease score as a predictor of hospitalization.

BACKGROUND: The Chronic Disease Score is a risk-adjustment metric based on age, gender, and history of dispensed drugs. We compared four versions of the score for their ability to predict hospitalization among members of eight health maintenance organizations nationwide. METHODS: The study included 29,247 women age 45 years and older. Logistic regression models were constructed using rank quintile and rank decile indicators for each of four scores as predictors of hospitalization during the year after 1 October 1995. Discrimination and model fit were compared using several model properties including the C statistic and the odds ratio comparing highest with lowest quantiles. RESULTS: All Chronic Disease Score versions performed similarly, with the version that predicts total healthcare cost, proposed by Clark et al. (Med Care 1995;33:783-795), performing somewhat better than the other three. The overall risk of hospitalization was 12%. Individuals with higher quantile ranks had a higher risk of hospitalization. Among the Chronic Disease Score versions, the risk of hospitalization ranged from 4% for the lowest decile to 27-29% for the highest decile. Odds ratios comparing the highest with the lowest deciles ranged from 8.9 to 10.2. CONCLUSIONS: The Chronic Disease Score predicts hospitalization and therefore may be a useful indicator of baseline comorbidity for control of confounding.