Incidence of Upper and Lower Gastrointestinal Bleeding in New Users of Low-Dose Aspirin

Background & Aims: There are few data on the incidence of upper and lower gastrointestinal bleeding (UGIB and LGIB) from observational studies of low-dose aspirin users. We aimed to estimate incidence rates of UGIB and LGIB in a large cohort of new users of low-dose aspirin in the United Kingdom, with subanalyses of hospitalization status and fatalities. Methods: We performed a population-based study of 199, 079 new users of low-dose aspirin (median age, 64.0 years) identified from the Health Improvement Network primary care database (2000–2012). Individuals were followed for a median 5.4 years (maximum, 14 years) to identify new cases of UGIB and LGIB. Following multistep validation, we calculated overall and age- and sex-specific incidence rates; we performed subanalyses for health care use and death within 30 days of GIB. We also estimated rates within a matched (1:1) cohort of nonusers of low-dose aspirin at the start of the follow-up period. Results: The low-dose aspirin users had 1115 UGIB events and 1936 LGIB events; most subjects with UGIB events (58.9%) were hospitalized, whereas most subjects with LGIB events were referred to secondary care (72.8%). Crude incidence rates of GIB per 1000 person-years were 0.97 for subjects with UGIB (95% CI, 0.91–1.02) and 1.68 for subjects with LGIB (95% CI, 1.60–1.75). Incidence rates per 1000 person-years for patients hospitalized for GIB were 0.57 for UGIB (95% CI, 0.53–0.61) and 0.45 for LGIB (95% CI, 0.42–0.49); for referred (but not hospitalized) cases, these values were 0.39 for UGIB (95% CI, 0.36–0.43) and 1.22 for LGIB (1.16–1.29). Incidence rates per 1000 person-years were 0.06 for fatal UGIB (95% CI, 0.04–0.07), 0.01 for fatal LGIB (95% CI, 0.01–0.02), 0.91 for nonfatal UGIB (95% CI, 0.86–0.97), and 1.66 for nonfatal LGIB (95% CI, 1.59–1.74). Among nonusers of low-dose aspirin, incidence rates per 1000 person-years were 0.67 (95% CI, 0.63–0.75) for UGIB and 0.76 (95% CI, 0.72–0.82) for LGIB. Conclusion: In a population-based study of low-dose aspirin users, the incidence of LGIB was higher than the incidence of UGIB. However, incidence rates of hospitalized GI bleeds and 30-day mortality rates were lower for LGIB than for UGIB. These estimates are valuable for benefit–risk assessments of low-dose aspirin for cardiovascular and colorectal cancer prevention

Moderate-intensity statin therapy seems ineffective in primary cardiovascular prevention in patients with type 2 diabetes complicated by nephropathy:a multicenter prospective 8 years follow up study

Background: Although numerous studies and metanalysis have shown the beneficial effect of statin therapy in CVD secondary prevention, there is still controversy such the use of statins for primary CVD prevention in patients with DM. The purpose of this study was to evaluate the occurrence of total major adverse cardio-vascular events (MACE) in a cohort of patients with type 2 diabetes complicated by nephropathy treated with statins, in order to verify real life effect of statin on CVD primary prevention. Methods: We conducted an observational prospective multicenter study on 564 patients with type 2 diabetic nephropathy free of cardiovascular disease attending 21 national outpatient diabetes clinics and followed them up for 8 years. 169 of them were treated with statins (group A) while 395 were not on statins (group B). Results: Notably, none of the patients was treated with a high-intensity statin therapy according to last ADA position statement. Total MACE occurred in 32 patients from group A and in 68 patients from group B. Fatal MACE occurred in 13 patients from group A and in 30 from group B; nonfatal MACE occurred in 19 patients from group A and in 38 patients from group B. The analysis of the Kaplan-Meier survival curves showed a not statistically significant difference in the incidence of total (p 0.758), fatal (p 0.474) and nonfatal (p 0.812) MACE between the two groups. HbA1c only showed a significant difference in the incidence of MACE between the two groups (HR 1.201, CI 1.041-1.387, p 0.012). Conclusions: These findings suggest that, in a real clinical setting, moderate-intensity statin treatment is ineffective in cardiovascular primary prevention for patients with diabetic nephropathy

Changes in HbA(1c) and frequency of measuring HbA(1c) and adjusting glucose-lowering medications in the 10 years following diagnosis of type 2 diabetes: a population-based study in the UK

Aim/hypothesis The aim of this work was to study levels of HbA(1c) and patterns of adjusting glucose-lowering drugs in patients with impaired glycaemic control over 10 years after diagnosis of type 2 diabetes. Methods We studied 4,529 individuals in The Health Improvement Network Database newly diagnosed with type 2 diabetes in the year 2000. Results From 6 months to 10 years after diagnosis, the HbA(1c) increased from 7.04% (53.4 mmol/mol) to 7.49% (58.3 mmol/mol) (average annual change: 0.047% [0.51 mmol/mol]). The greatest annual change occurred between 6 months and 2 years (0.21% [2.30 mmol/mol] increase per year, p < 0.001), followed by the 2-5 year time period (0.033% [0.36 mmol/mol] increase per year, p < 0.001). No significant increase in HbA(1c) occurred between 5 and 10 years (p = 0.20). In multivariable analyses, patients who were younger (p < 0.001), with higher BMI (p = 0.033) and who were current insulin users (p = 0.024) at diagnosis had greater increases in HbA(1c) between 6 months and 2 years. For individuals with HbA(1c) above 7.0% (53 mmol/mol) the mean time to next measurement of HbA(1c) was 0.53 years and increase in doses or changes to other glucose-lowering medications were performed in 26% of cases. Conclusions/interpretation HbA(1c) increases by approximately 0.5% (5 mmol/mol) over 10 years after diagnosis of type 2 diabetes, with the main increase appearing in the first years after diagnosis. More frequent monitoring of HbA(1c) and adjustments of glucose-lowering drugs may be essential to prevent the decline