Glycemic control and risk of cardiovascular disease hospitalization and all-cause mortality.

OBJECTIVES: This study sought to evaluate the relationship between glycemic control and cardiovascular disease (CVD) hospitalizations and all-cause mortality among patients with type 2 diabetes in a real-world setting. BACKGROUND: Clinical trials have not established that tight glycemic control reduces CVD events and may be associated with increased mortality. Observational studies of specific cohorts have reported increased risk of those outcomes at both high and low glycosylated hemoglobin (HbA1c) levels. METHODS: Using the mean of all HbA1c measures over a mean follow-up of 6 years, we created categories of HbA1c (<6.0%, 6.0% to 6.4%, 6.5% to 6.9%, 7.0% to 7.4%, 7.5% to 7.9%, 8.0% to 8.4%, 8.5% to 8.9%, and ≥ 9.0%) to estimate the risk of CVD hospitalization and all-cause mortality associated with glycemic control, adjusting for demographic and clinical characteristics among 26,673 members of Kaiser Permanente Northwest with type 2 diabetes. RESULTS: Compared with patients with mean HbA1c levels 7.0% to 7.4%, those with mean HbA1c levels <6.0% had a 68% increased risk of CVD hospitalization (hazard ratio [HR]: 1.68 [95% confidence interval (CI): 1.39 to 2.04], p < 0.001) after adjustment for demographic and clinical characteristics. Those with HbA1c levels 6.0% to 6.4% (HR: 1.18 [95% CI: 1.00 to 1.40], p = 0.048) and 6.5% to 6.9% (HR: 1.18 [95% CI: 1.02 to 1.37], p = 0.031) also had significantly higher risk relative to the reference group of 7.0% to 7.4%, as did patients with HbA1c levels 8.5% to 8.9% (HR: 1.55 [95% CI: 1.24 to 1.94], p < 0.001) and ≥ 9.0% (HR: 1.83 [95% CI: 1.50 to 2.22], p < 0.001). Risk of all-cause mortality was significantly greater than the reference group among HbA1c categories <6.0%, 6.0% to 6.4%, 6.5% to 6.9%, and ≥ 9.0%. CONCLUSIONS: The relationship between mean HbA1c and CVD hospitalizations and all-cause mortality was U-shaped, with greater risk at both higher and lower HbA1c levels.

Independent contribution of A1C, systolic blood pressure, and LDL cholesterol control to risk of cardiovascular disease hospitalizations in type 2 diabetes: an observational cohort study.

BACKGROUND: Cardiovascular disease (CVD) prevention in diabetes requires broad-based treatment of dyslipidemia, hypertension, and hyperglycemia. The independent contribution of all combinations of risk factor control to CVD risk has not been evaluated. OBJECTIVE: To estimate the independent association of control of glycosylated hemoglobin (A1C), systolic blood pressure (SBP), and low-density lipoprotein cholesterol (LDL-C) with risk of cardiovascular disease hospitalization. DESIGN: Non-concurrent longitudinal cohort study. PATIENTS: The study included 26,636 patients with type 2 diabetes who were members of an integrated group model HMO with multiple A1C, SBP, and LDL-C measurements. MAIN MEASURES: Patients were followed for a mean (SD) of 5.6 (2.5) years until they died or disenrolled, or until 31 December 2010. The outcome was a first-observed CVD hospitalization. Using the mean of all A1C, SBP, and LDL-C measures during follow-up, we created dichotomous categories of A1C control (< 7 %), SBP control (< 130 mmHg), and LDL-C control (< 100 mg/dL) to estimate the incidence rate of CVD hospitalization associated with all combinations of risk factor control adjusting for demographic and clinical characteristics. KEY RESULTS: Patients with no controlled risk factors (18.2/1,000 person-years, 95 % CI 16.5-20.2) or with only A1C in control (16.9, 15.0-19.0) had the highest rate of CVD hospitalization, whereas those with all three risk factors controlled (7.2, 6.2-8.4) or with SBP and LDL-C in control (6.1, 5.1-7.2) had the lowest rates. Those with only SBP or LDL-C in control, A1C and SBP controlled, or A1C and LDL-C controlled had statistically similar incidence between the highest and lowest rates. CONCLUSIONS: Maintaining SBP < 130 mmHg or LDL-C < 100 mg/dL was significantly associated with reduced CVD hospitalization risk, especially when both risk factors were well controlled. Maintaining A1C < 7 % was not independently associated with reduced CVD hospitalization risk.

Outpatient experience of patients with GERD in the United States: analysis of the 1998-2001 National Ambulatory Medical Care Survey.

This study documents the number of ambulatory visits associated with gastroesophageal reflux disease (GERD) in the United States. Sample data from nearly 80,000 patients captured by the National Ambulatory Medical Care Survey (NAMCS; 1998-2001) were analyzed. Basic demographics of patients with GERD and factors associated with each visit were assessed. Approximately 38.53 million of 2.653 billion adult outpatient visits made in the United States during the study period were GERD-related. GERD-related visits increased by 46.5% from 1998 to 2001. Most GERD-related visits were by women (54.7%) with an average age of 56.0 years, compared with patients without GERD, who were even more likely to be women (62.2%) and younger (52.6 years). Patients with GERD were more likely to have multiple reasons (50.5%) and multiple diagnoses (79.3%) per medical visit versus non-GERD patients (37.6% and 48.4%, respectively). Utilization of data from the NAMCS reveals that GERD-related visits increased annually during the study period. Patients with GERD are more likely to see a physician if they have concomitant medical conditions, making GERD a condition that is very likely untreated in a high percentage of individuals.

The economic impact of GERD and PUD: examination of direct and indirect costs using a large integrated employer claims database.

OBJECTIVE: The objective of this study was to examine the relationship of work loss associated with gastro- the relationship of work loss associated with gastro- the relationship of work loss associated with gastro-esophageal reflux disease (GERD) and peptic ulcer disease (GERD) and peptic ulcer disease (PUD) in a large population of employed individuals in the United States (US) and quantify the individuals in the United States (US) and quantify the economic impact of these diseases to the employer. METHODS: A proprietary database that contained work place absence, disability and workers' compensation data in addition to prescription drug and medical claims was used to answer the objectives. Employees with a medical claim with an ICD-9 code for GERD or PUD were identified from 1 January 1997 to 31 December 2000. A cohort of controls was identified for the same time period using the method of frequency matching on age, gender, industry type, occupational status, and employment status. Work absence rates and health care costs were compared between the groups after adjusting for demo graphic, and employment differences using analysis of covariance models. RESULTS: There were significantly lower (p < 0.05) prescription, and outpatient costs in the controls compared to the disease groups, although the eta-square values were very low. The mean work absence attributed to sick days was 2.8 (+/- 2.3) for controls, 3.4 (+/- 2.5) for GERD, 3.2 (+/- 2.6) for PUD, and 3.2 (+/- 2.3) days for GERD + PUD. For work loss, a significantly higher (p < 0.05) rate of adjusted all-cause absenteeism and sickness-related absenteeism were observed between the disease groups versus the controls. In particular, controls had an average of 1.2 to 1.6 days and 0.4 to 0.6 lower all-cause and sickness-related absenteeism compared to the disease groups. The incremental economic impact projected to a hypothetical employed population was estimated to be $3441 for GERD, $1374 for PUD, and $4803 for GERD + PUD per employee per year compared to employees without these diseases. CONCLUSIONS: Direct medical cost and work absence in employees with GERD, PUD and GERD + PUD represent a significant burden to employees and employers.

Validation of the treatment satisfaction questionnaire for Crohn's disease (TSQ-C).

Treatment satisfaction is used to capture the full impact of disease on patients' lives. Currently, no instruments exist to evaluate satisfaction with pharmacologic therapy in patients with Crohn's disease (CD). The purpose of this study was to evaluate the psychometric properties of a treatment satisfaction questionnaire for CD (TSQ-C). The 36-item questionnaire was completed by CD patients who reported taking 5-aminosalicylic acid derivatives to treat their CD. Measures used in the validation study were the Inflammatory Bowel Disease Questionnaire (IBDQ), Crohn's Work Activity Impairment Index (CWAII), and patient reports of clinical indicators (e.g., number of active flares and medications taken). Exploratory factor analysis was used to evaluate the items and subscale structure. Internal consistency reliability and concurrent and discriminant validity were assessed using Cronbach's alpha, Pearson correlation coefficients, and analysis of variance. A total of 813 CD patients participated, with the majority being Caucasian (95.9%), female (67.0%), and >34 years old (86.1%). Patient-rated severity of CD was mild (49.3%), moderate (41.7%), and severe (7.5%). The final TSQ-C consisted of 32 items, with six subscales (Symptoms, Satisfaction, Expectations, Physician Relationships, Bother, and Cost), with each subscale score ranging from 1 to 6. Cronbach's alpha values ranged from 0.63 (Cost) to 0.94 (Symptoms). Strong correlations were observed among the IBDQ, CWAII, and the Satisfaction and Symptoms subscales of the TSQ-C. TSQ-C subscales, particularly Symptoms and Satisfaction, significantly discriminated among levels of number of flares per year, patient-rated disease severity, and number of medication classes. The TSQ-C demonstrated excellent validity and reliability and appears to be a useful tool for evaluating satisfaction with pharmacologic therapy among patients with CD.

Health-related quality of life improves with treatment-related GERD symptom resolution after adjusting for baseline severity.

Severity and frequency of gastroesophageal reflux disease (GERD) related symptoms are associated with impaired health-related quality of life (HRQL). This study evaluated the association between baseline heartburn severity and endpoint HRQL of patients treated for heartburn and the relationship between complete resolution of heartburn symptoms and HRQL outcomes after controlling for baseline severity. We completed a secondary analysis of clinical symptom and HRQL data from three clinical trials in adult patients receiving either omeprazole or ranitidine treatment for GERD. HRQL was assessed using the Psychological General Well-Being Index (PGWB) in each of the three clinical trials, and two of the trials also included the Medical Outcomes Study Sleep disturbance scale. Gastrointestinal symptoms were evaluated using either the Gastrointestinal Symptom Rating Scale or a modified version of the scale. Baseline heartburn severity (none/minor, mild, moderate or severe) was defined based on patient-reported symptoms. Analysis of covariance (ANCOVA) models were used to compare mean HRQL scores by baseline level of heartburn symptom severity and whether or not patients experienced complete heartburn resolution. At baseline, PGWB scores were significantly worse (p < 0.05) for patients with more severe heartburn symptoms. There were no statistically significant baseline severity by symptom resolution interactions in any of the ANCOVA models. For all three trials and across all follow-up assessments, mean PGWB scores were statistically significantly higher for patients with completely resolved heartburn symptoms versus those whose symptoms were unresolved (all p-values < 0.05). Few significant effects were observed for sleep disturbance scores. While the severity of heartburn symptoms at the start of medical treatment for GERD is not associated with improvements in HRQL in subsequent weeks of treatment, complete resolution of symptoms is associated with improvements in psychological well-being.