Dapagliflozin in patients with type II diabetes mellitus, with and without elevated triglyceride and reduced high-density lipoprotein cholesterol levels.

BACKGROUND: Dapagliflozin is a selective sodium-glucose cotransporter 2 inhibitor that improves glycemic control in patients with type II diabetes mellitus (T2DM) by reducing renal glucose reabsorption. OBJECTIVE: The aim was to evaluate the lipid effects of dapagliflozin 10 mg or placebo in patients with T2DM with/without baseline elevated triglyceride and reduced high-density lipoprotein (HDL) cholesterol levels. METHODS: This was a post hoc analysis of 10 phase 3, placebo-controlled studies of dapagliflozin 10 mg (N = 2237) or placebo (N = 2164) administered for 24 weeks in patients with T2DM. Patients with elevated triglyceride (≥150 mg/dL [1.69 mmol/L]) and reduced HDL cholesterol levels (<40 mg/dL [1.04 mmol/L] in men; <50 mg/dL [1.29 mmol/L] in women) were included (group A). The reference group (group B) included patients who did not meet the defined lipid criteria. RESULTS: The effects of dapagliflozin on fasting lipid profiles were generally similar in the 2 lipid groups (ie, groups A and B) and, compared with placebo, were associated with minor increases in non-HDL cholesterol, low-density lipoprotein, and HDL cholesterol levels. The effects on triglyceride levels were inconsistent. The incidence of adverse events (AEs)/serious AEs, and AEs of genital infection, urinary tract infection, volume reduction, renal function, and hypoglycemia were similar in the 2 lipid groups. CONCLUSION: Patients with T2DM treated with dapagliflozin experienced minor changes in lipid levels; the changes were generally similar in the 2 lipid groups. The clinical significance of these changes in lipids is unclear, especially in view of the positive effects of dapagliflozin on other cardiovascular disease risk factors.

Optimized predictions of absolute and relative amounts of body fat from weight, height, other anthropometric predictors, and age 1.

BACKGROUND: Body mass index (BMI) is the dominating weight-for-height index, but its validity as a body fat (BF) index has not been properly examined. OBJECTIVES: Our aims were to establish and validate optimal weight-for-height indexes for predicting absolute and relative (percentage) amounts of BF, to examine whether other commonly available anthropometric variables or age could add to the predictive power, and to explore the upper limit for percentage BF. DESIGN: One thousand one hundred twelve randomly selected subjects, and an additional 149 obese subjects, were included in the study. The subjects were randomly allocated to either a primary study group or a validation group. BF was measured with dual-energy X-ray absorptiometry. The relations between weight/heightx (W/Hx) and BF (absolute or percentage) were examined for values of the exponent x that ranged from 0.0 to 3.0. The predictive power of equations that were based on optimal weight-for-height indexes was compared with equations based on weight, height, other anthropometric variables, and age. RESULTS: Absolute BF was optimally and linearly predicted by W/H1, whereas the percentage BF was optimally and nonlinearly predicted by W/H2. The percentage BF asymptotically approached 52% in women and 56% in men. The percentage BF increased only marginally from BMI (in kg/m2) values of >35 in women and >60 in men. Predictions of absolute BF were associated with smaller errors (8.5% for men and 5.7% for women) than were predictions of percentage BF (8.7% for men and 7.9% for women). The addition of other anthropometric measurements for both men and women, and the addition of age for women only, in the regression analyses moderately reduced these errors. CONCLUSION: Our data suggest that W/H may be a more optimal weight-for-height index than is BMI, particularly at high body weights.

Lifestyle, diabetes, and cardiovascular risk factors 10 years after bariatric surgery.

BACKGROUND: Weight loss is associated with short-term amelioration and prevention of metabolic and cardiovascular risk, but whether these benefits persist over time is unknown. METHODS: The prospective, controlled Swedish Obese Subjects Study involved obese subjects who underwent gastric surgery and contemporaneously matched, conventionally treated obese control subjects. We now report follow-up data for subjects (mean age, 48 years; mean body-mass index, 41) who had been enrolled for at least 2 years (4047 subjects) or 10 years (1703 subjects) before the analysis (January 1, 2004). The follow-up rate for laboratory examinations was 86.6 percent at 2 years and 74.5 percent at 10 years. RESULTS: After two years, the weight had increased by 0.1 percent in the control group and had decreased by 23.4 percent in the surgery group (P<0.001). After 10 years, the weight had increased by 1.6 percent and decreased by 16.1 percent, respectively (P<0.001). Energy intake was lower and the proportion of physically active subjects higher in the surgery group than in the control group throughout the observation period. Two- and 10-year rates of recovery from diabetes, hypertriglyceridemia, low levels of high-density lipoprotein cholesterol, hypertension, and hyperuricemia were more favorable in the surgery group than in the control group, whereas recovery from hypercholesterolemia did not differ between the groups. The surgery group had lower 2- and 10-year incidence rates of diabetes, hypertriglyceridemia, and hyperuricemia than the control group; differences between the groups in the incidence of hypercholesterolemia and hypertension were undetectable. CONCLUSIONS: As compared with conventional therapy, bariatric surgery appears to be a viable option for the treatment of severe obesity, resulting in long-term weight loss, improved lifestyle, and, except for hypercholesterolemia, amelioration in risk factors that were elevated at baseline.