Characteristics of Latinas in Puerto Rico and the US mainland receiving teriparatide in the DANCE observational study.

OBJECTIVE: The Direct Assessment of Nonvertebral Fractures in Community Experience (DANCE) study investigated the use of teriparatide in men and women with osteoporosis in the United States (US) and Puerto Rico (PR). In a sub-analysis, we evaluated whether the baseline characteristics of Latinas differed from those of white women in the study population and whether any patient attributes affected physicians' decisions to prescribe teriparatide. METHODS: We assessed 3 patient cohorts treated with teriparatide 20 microg once daily for up to 24 months: 1) PR Latinas, 2) US Latinas, and 3) white women on the US mainland (white women). We analyzed differences related to ethnicity (Latina vs. white) and geography (PR vs. US mainland). RESULTS: Overall, 302 of the 3243 women (9%) enrolled in DANCE were Latina (205 of these 302 Latinas resided in PR). Significant differences were observed in 7 of 11 baseline characteristics. White women had more prior fragility fractures and family history of hip fracture than Latinas, while PR Latinas were generally older than US Latinas and had more comorbid conditions. A similar proportion of subjects in each cohort had received prior osteoporosis therapy. Physicians prescribed teriparatide more often for Latinas based on multiple risk factors for fracture and intolerance to previous osteoporosis therapy and to white women based on inadequate response to previous therapy or new (incident) fractures. Overall, Latinas were less persistent with teriparatide therapy than white women. CONCLUSION: We observed significant differences related to ethnicity and geography in the baseline demographics of Latinas enrolled in the DANCE study, criteria cited by physicians for initiating teriparatide therapy, and treatment persistence.

The Puerto Rico Cardiovascular Risk-Estimation Study (PRCaRES): an exploratory assessment of new patients in physicians' offices.

OBJECTIVE: To determine the risk of developing coronary heart disease (CHD) in a cross-sectional sample of Puerto Rico residents through an analysis of the 10-year Framingham risk score. METHODS: An exploratory, retrospective, cross-sectional study of the medical records of patients 35 years or older who each visited the office of 1 of the 4 participating physicians on or after July 1, 2007. RESULTS: Data for 453 patients were extracted from the medical records, but 96 cases were excluded because of incomplete data or the patients' not fulfilling the inclusion criteria, thus yielding a total sample of 357 patients. The average patient age was 58 years old (+/- 11.8); the majority (58%) was female. Eight of 10 patients were either overweight or obese. Eighty-five percent reported having at least 1 cardio-metabolic condition. Of these, 72.3% self-reported having hypertension; 38.4%, dyslipidemia; and 37.8%, diabetes. Many patients were not at goal for blood pressure or for lipid and glucose parameters nor were these patients taking any medication for these conditions. Nearly one-third of the participants had a 10% or greater 10-year risk of developing CHD. Compared with women, men were 3.3 times more likely to have a 10-year CHD risk of 10% or greater and 4.2 times more likely to have a risk of 20% or greater. CONCLUSION: A substantial number of patients had risk factors for developing CHD and were not at goal for specific parameters. Larger scale epidemiological studies should be conducted to assess CHD risk in Puerto Rico so that public health initiatives to reduce this risk might be proposed.

Efficacy and safety of AIR inhaled insulin compared to insulin lispro in patients with type 1 diabetes mellitus in a 6-month, randomized, noninferiority trial.

BACKGROUND: Patients with type 1 diabetes may prefer features of AIR inhaled insulin (developed by Alkermes, Inc. [Cambridge, MA] and Eli Lilly and Company [Indianapolis, IN]; AIR is a registered trademark of Alkermes, Inc.) over insulin injection, but the two methods need to be compared for efficacy and safety. METHODS: This multicenter, 6-month, parallel-group, noninferiority trial had 500 patients with type 1 diabetes randomized to morning doses of basal insulin glargine plus either preprandial injectable insulin lispro or preprandial AIR insulin. We hypothesized that AIR insulin is noninferior (upper bound of the 95% confidence interval < or = 0.4%) to insulin lispro for change-from-baseline hemoglobin A1C (A1C). RESULTS: Baseline A1C was 7.95 +/- 0.08% for both groups. At end point, A1C was lower with insulin lispro than with AIR insulin by 0.27% (95% confidence interval 0.11, 0.43; P< 0.001). Noninferiority of AIR insulin to insulin lispro was not demonstrated, but similar percentages of patients in each group achieved A1C <7.0% (P = 0.448). Overall daily blood glucose was similar between groups at baseline (P = 0.879) and end point (P = 0.161). Two-hour postprandial blood glucose change from baseline was significantly (P < 0.001) higher with AIR insulin (20.77 +/- 4.33 mg/dL at 3 months and 15.85 +/- 3.08 mg/dL at end point) than with insulin lispro (3.29 +/- 4.14 mg/dL at 3 months and 1.67 +/- 2.91 mg/dL at end point). Overall hypoglycemia was similar between treatment groups (P = 0.355). The AIR insulin group had greater decrease in diffusing capacity of the lung for carbon monoxide at end point (P = 0.020) and greater incidence of cough (P = 0.024) and dyspnea (P = 0.030). Body weight decreased in the AIR insulin group and increased in the insulin lispro group. CONCLUSIONS: Insulin lispro provided lower A1C than AIR insulin, but the difference may not be clinically relevant.