The burden of hypoglycemia on healthcare utilization, costs, and quality of life among type 2 diabetes mellitus patients.

OBJECTIVE: To assess the burden of hypoglycemia among type 2 diabetes patients on antidiabetic drugs with or without use of insulin. RESEARCH DESIGN AND METHODS: We used mail surveys, administrative claims data, and enrollment information from a sample of adult commercial health plan enrollees (n=813) with type 2 diabetes during a 12-month period. Patients' experience of hypoglycemia, its impact on patient perspectives and healthcare utilization were the outcomes evaluated. RESULTS: A greater percentage of patients in the antidiabetic with insulin cohort reported experiencing hypoglycemia compared with patients from sulfonylurea (SU) without insulin and non-SU without insulin cohorts (50% vs. 21% and 12%, respectively; p<0.01 for both comparisons). While 71% of the sample reported experiencing hypoglycemic symptoms with 28% confirmed by low blood glucose levels, only 10% of the patients had evidence of hypoglycemia event in the claims database. Patients with confirmed hypoglycemia had the highest Hypoglycemia Fear Survey behavior score (8) and worry subscale score (14). Significant differences were noted between the confirmed hypoglycemia and no hypoglycemia cohorts for the 12-item Short Form Health Survey's Mental Component Score (p<0.001) and Physical Component Score (p=0.002), and for the EQ-5D index (p<0.001). Diabetes-related annualized mean total healthcare costs were significantly higher for confirmed hypoglycemia vs. no hypoglycemia cohorts (p=0.004). CONCLUSIONS: Symptomatic hypoglycemia is a more significant burden among type 2 diabetes patients treated with antidiabetic drugs than is estimated by administrative claims data and needs to be considered when choosing therapy.

Azithromycin extended release vs amoxicillin/clavulanate: symptom resolution in acute sinusitis.

OBJECTIVE: The aim of the study was to compare early symptom resolution with a single 2-g dose of azithromycin extended release or 10 days of amoxicillin/clavulanate 875 mg/125 mg every 12 hours in patients with acute sinusitis. MATERIALS AND METHODS: This was a prospective, randomized, open-label, observational study to mimic "real-world" conditions, including patients with symptoms of acute bacterial sinusitis lasting between 7 and 30 days. Key symptoms were assessed twice daily by patient diary, and patients were interviewed by telephone at 12 and 28 days. The primary end point was symptom resolution at 5 days, defined as reporting "no problem" with at least 3 of 4 diary symptoms in 2 consecutive measures in the per-protocol population. Secondary end points included additional antibiotic use, sinusitis-related quality of life, and treatment satisfaction. RESULTS: Three hundred seventy-eight patients were randomized to a single dose of azithromycin extended release and 371 to 10 days of amoxicillin/clavulanate. In the per-protocol population at day 5, 70/236 patients (29.7%) in the azithromycin extended release arm and 45/238 patients (18.9%) in the amoxicillin/clavulanate arm had resolution of symptoms (difference = 10.8%; 95% confidence interval [CI], 3.1-18.4%). By day 28, 26/236 patients (11.0%) in the azithromycin extended release arm and 27/238 patients (11.3%) in the amoxicillin/clavulanate arm had used additional antibiotics (difference = -0.4%; 95% CI: -6.1% to 5.3%). Additional physician visits, quality of life, and overall satisfaction were similar between groups. CONCLUSIONS: More patients randomized to azithromycin extended release experienced symptom resolution at day 5 than those randomized to amoxicillin/clavulanate, without experiencing differences in second antibiotic use at 28 days.