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Aims To investigate the long-term efficacy and safety of empagliflozin as add-on to metformin in people with Type 2 diabetes. Methods Of 637 participants treated with empagliflozin 10 mg, empagliflozin 25 mg, or placebo once daily for 24 weeks, 463 (72.7%) were treated in a double-blind extension trial for ≥ 52 weeks. Prespecified exploratory endpoints included changes from baseline in HbA1c, weight and blood pressure at week 76. Results Compared with placebo, adjusted mean changes from baseline in HbA1c (overall baseline mean ± sd 63 ± 9 mmol/mol [7.9 ± 0.9%]) were â'7 mmol/mol [(â'0.6%) 95% CI â'8, â'5 mmol/mol (â'0.8, â'0.5%); P < 0.001] and â'8 mmol/mol [(â'0.7%) 95% CI â'10, â'6 mmol/mol (â'0.9, â'0.6%); P < 0.001], for empagliflozin 10 mg and 25 mg, respectively. Compared with placebo, adjusted mean changes from baseline in weight were â'1.9 kg (95% CI â'2.5, â'1.3; P < 0.001) and â'2.2 kg (95% CI â'2.8, â'1.6; P < 0.001) for empagliflozin 10 mg and 25 mg, respectively. Empagliflozin led to sustained reductions in systolic blood pressure vs. placebo. Adverse events were reported in 77.7, 80.2 and 72.0% of participants on placebo, empagliflozin 10 mg and empagliflozin 25 mg, respectively. Confirmed hypoglycaemic adverse events (glucose ≥ 3.9 mmol/l and/or event requiring assistance) were reported in 3.4, 4.1 and 4.2% of participants in these groups, respectively. Conclusions In people with Type 2 diabetes, empagliflozin 10 mg and 25 mg given as add-on to metformin for 76 weeks were well tolerated and led to sustained reductions in HbA1c, weight and systolic blood pressure. [ABSTRACT FROM AUTHOR]

Aims To estimate the immediate and long-term inpatient and non-inpatient costs for Type 2 diabetes-related complications. Methods The costs of all consultations, visits, admissions and procedures associated with diabetes-related complications during UK Prospective Diabetes Study post-trial monitoring in the period 1997-2007 were estimated using hospitalization records for 2791 patients in England and resource use questionnaires that were administered to 3589 patients across the UK. Results The estimated (95% CI) inpatient care costs (in 2012 pounds sterling) in the event year for the example of a 60-year-old man were: non-fatal ischaemic heart disease £9767 (£7038-£12 696); amputation £9546 (£6416-£13 463); non-fatal stroke £6805 (£3856-£10 278); non-fatal myocardial infarction £6379 (£4290-£8339); fatal stroke £3954 (£2012-£6428); fatal ischaemic heart disease £3766 (£746-£5512); heart failure £3191 (£1678-4903); fatal myocardial infarction £1521 (£647-£2670); and blindness in one eye £1355 (£415-£2655). In subsequent years, estimated (95% CI) costs ranged from £1792 (£1060-£2943) for amputations to £453 (£315-£691) for blindness in one eye. Costs of non-inpatient healthcare in the event year were: amputation £2699 (£1409-£4126); blindness in one eye £1790 (£878-£3056); non-fatal stroke £1019 (£770-£1499); nonfatal myocardial infarction £1963 (£794-£1157); heart failure £979 (£708-£1344); non-fatal ischaemic heart disease £864 (£718-£1014); and cataract extraction £700 (£619-£780). In each subsequent year, non-inpatient costs ranged from £1611 (£1193-£2116) for amputations to £654 (£572-£799) for ischaemic heart disease. Conclusions Diabetic complications are associated with substantial immediate and long-term healthcare costs. Our comprehensive new estimates of these costs, derived from detailed recent UK Prospective Diabetes Study post-trial data, should aid researchers and health policy analyses. [ABSTRACT FROM AUTHOR]

Aim To investigate, with extended follow-up, cause-specific mortality among low-income Black and White Americans with Type 2 diabetes who have similar socio-economic status. Methods Black and White Americans aged 40-79 years with Type 2 diabetes ( n = 12 498) were recruited from community health centres as part of the Southern Community Cohort Study. Multivariable Cox analysis was used to estimate mortality hazard ratios and 95% CIs for subsequent cause-specific mortality, based on both underlying and contributing causes of death. Results During the follow-up (median 5.9 years), 13.3% of the study population died. The leading causes of death in each race were ischaemic heart disease, respiratory disorders, cancer, renal failure and heart failure; however, Blacks were at a lower risk of dying from ischaemic heart disease (hazard ratio 0.70, 95% CI 0.54-0.91) or respiratory disorders (hazard ratio 0.70, 0.53-0.92) than Whites but had higher or similar mortality attributable to renal failure (hazard ratio 1.57, 95% CI 1.02-2.40), heart failure (hazard ratio 1.47, 95% CI 0.98-2.19) and cancer (hazard ratio 0.87, 95% CI 0.62-1.22). Risk factors for each cause of death were generally similar in each race. Conclusions These findings suggest that the leading causes of death and their risk factors are largely similar among Black and White Americans with diabetes. For the two leading causes of death in each race, however, ischaemic heart disease and respiratory disorders, the magnitude of risk is lower among Black Americans and contributes to their higher survival rates. [ABSTRACT FROM AUTHOR]