Carl V. Asche

A Review of Diabetes Treatment Adherence and the Association with Clinical and Economic Outcomes

BACKGROUNDnThe benefits of drug therapy to diabetic patients in terms of glycemic control, microvascular complications, cardiovascular event risk, mortality, and quality of life have been well established by clinical trial data. However, it has been a challenge to quantify the relationship between adherence and outcomes such as glycemic control, disease-related events, hospitalizations, cost, and quality of life.nnnOBJECTIVEnThis article provides a comprehensive summary of empirical studies that examine the associations between adherence and glycemic control, health care utilization, quality of life, and mortality in patients with diabetes. It is intended to provide a framework for researchers interested in conducting studies to improve their understanding of the value of medication adherence for patients with diabetes.nnnMETHODSnRelevant published articles were identified through searches of the National Center for Biotechnology PubMed database. Medical subject heading (MESH) terms diabetes mellitus, hypoglycemic agents, and insulin, were each combined with the MESH term medication adherence and with the subheadings economics, prevention and control, psychology, statistics and numerical data, therapy, adverse effects, therapeutic use, and administration and dosage, where available. Studies were included if they met the following criteria: (1) analyzed empirical data on some measure of patient adherence to diabetes pharmacotherapy; (2) described methods for measuring patient adherence; (3) evaluated economic, clinical, or humanistic outcomes related to diabetes; and (4) had as a goal of the research to evaluate the link between patient adherence and outcomes (as a primary or secondary objective). The data from the articles meeting these criteria were then abstracted, including mention of the specific interventions being compared, specific methods for measuring adherence, outcomes compared between adherent and nonadherent patients and how these outcomes were measured, and information on variables that were adjusted for in predictive and causal multivariable models.nnnRESULTSnA total of 37 articles that met all 4 criteria in this review underwent data extraction. Of these studies, 22 (59%) used objective measures to assess adherence, with 1 study using pill counts to assess adherence and 21 using either pharmacy claims or similar refill records to assess refill behavior. The remaining 15 (41%) studies used a wide variety of subjective patient-reported adherence assessments. The majority (13/23 [57%]) of the glycemic control studies reported that improved adherence was associated with better glycemic control. The ability to draw a distinction between adherence and glycemic control tended to occur more frequently [7/9 (78%)] among studies that characterized adherence in terms of prescription refills compared with studies that used various constructs for patient-reported adherence measures.nnnCONCLUSIONSnBased on the literature, better adherence was found to be associated with improved glycemic control and decreased health care resource utilization. There was no consistent association between improved adherence and decreased health care costs. Little data were available on the association between adherence and quality of life.

Prevalence and causes of dysphonia in a large treatment‐seeking population

To determine the prevalence and common causes of dysphonia as diagnosed by primary care physicians (PCPs) and otolaryngologists and to evaluate differences in etiologies offered by these providers.

Health economics and compliance of vials/syringes versus pen devices: a review of the evidence.

BACKGROUNDnThe goal of this review was to assess the state of the published literature on health economics and compliance of vials/syringes versus pen devices.nnnMETHODSnA literature search was performed using the Embase search engine for publications that linked drug terms (insulin and insulin lispro) to disease terms (insulin-dependent diabetes mellitus, non-insulin-dependent diabetes mellitus) and other terms (accuracy, article, clinical trial, controlled clinical trial, controlled study, cost benefit analysis, drug delivery system, drug dosage form, drug dosage form comparison, drug dose comparison, drug preference, equipment design, force, glycemic control, healthcare cost, human, insulin treatment, needle, patient attitude, patient compliance, patient safety, torque) along with author keywords (Diabetes, Dose accuracy, FlexPen [Novo Nordisk, Bagsvaerd, Denmark], Insulin, Next Generation FlexPen).nnnRESULTSnThe search yielded 39 articles, of which five articles met our study criteria. The focus of the critical outcomes was patient adherence to insulin pen devices versus insulin vials (syringes), hypoglycemic events, emergency department visits due to hypoglycemic events, and costs associated with diabetes and health care. The observation period, mean age of patients, and data sources differed across the studies. The studies indicated that there was an improved adherence with insulin pen devices as opposed to insulin vials (syringes) and that the associated healthcare resource utilization and costs associated with them were found to decrease with the use of pen devices, compared to vials.nnnCONCLUSIONSnThe use of pen devices improves the health economics benefits and adherence to insulin therapy.

Risk estimates of hysterectomy and selected conditions commonly treated with hysterectomy.

PURPOSEnThis study presents corrected rates and probability (risk) estimates of experiencing a hysterectomy and of selected conditions commonly treated with hysterectomy.nnnMETHODSnAnalyses are based on hysterectomy prevalence data from the Behavior Risk Factor Surveillance Survey (calendar years 2000-2006), hysterectomy incidence data from the National Hospital Discharge Survey (2001-2005), and population estimates from the U.S. Census Bureau (2001-2005). The correction involved removing those women without a uterus from the denominator in the rate calculation.nnnRESULTSnCorrected hysterectomy incidence rates per 1000 women were greater than the uncorrected rates for women ages 18-44 years (6.0 vs. 5.0), 45-64 years (10.4 vs. 7.1), and 65 years and older (4.9 vs. 2.6). Correcting the rates had a comparatively larger impact in the South. Incidence rates of selected conditions associated with the female reproductive system were greater after correction for hysterectomy prevalence. For example, corrected compared with uncorrected rates of uterine fibroids per 1000 women were 2.9 vs. 2.7 for ages 18-44 and 5.0 vs. 3.4 for ages 45-64. The uncorrected and corrected 10-year risk of being diagnosed with uterine fibroids among women aged 50 who have not previously had fibroids is 3.87 (1 in 26) and 4.54 (1 in 22), respectively.nnnCONCLUSIONSnThe correction method employed produces greater incidence and age-conditional-risk estimates of hysterectomy and of conditions commonly treated with hysterectomy. Corrected rates and age-conditional risk estimates may allow women with intact uteri to better assess their probability of undergoing a hysterectomy and certain other conditions of the reproductive system.

Adherence to current guidelines for chronic obstructive pulmonary disease (COPD) among patients treated with combination of long-acting bronchodilators or inhaled corticosteroids

Background To estimate the potential cost savings by following the current Global Initiative for Chronic Obstructive Lung Disease (GOLD) guideline recommendations in patients being treated for chronic obstructive pulmonary disease (COPD) with the combination of long-acting β2-agonist (LABA), long-acting muscarinic antagonist (LAMA) or inhaled corticosteroids (ICS). Methods The Geisinger Health System (GHS) database was utilized to identify subjects between January 1, 2004 to March 12, 2007. The index date was based on the first prescription of a LAMA plus LABA, LAMA plus LABA/ICS, or LABA plus ICS. Patients were included in the study if they: had a COPD diagnosis; had data representative of treatment 12 months prior to and 12 months post index date; were 40 years of age or over; had no prior diagnosis for asthma; and had pulmonary function test (PFT) data. We examined the baseline characteristics of these patients along with their healthcare resource utilization. Based on PFT data within 30 days of the index date, a subgroup was classified as adhering or non-adhering to GOLD guidelines. Results A total of 364 subjects could be classified as adhering or non-adherent to current GOLD guidelines based on their PFT results. The adherent subgroup received COPD medications consistent with current GOLD guidelines. Of the LAMA plus LABA cohort, 25 patients adhered and 39 patients were non-adherent to current GOLD guidelines. In the cohort of LABA plus ICS, 74 patients were adherent and 180 patients non-adherent to current GOLD guidelines. In the cohort of LAMA plus LABA/ICS, 21 patients were adherent and 25 patients non-adherent to current GOLD guidelines. GOLD adherence was associated with mean total cost of all services savings of

Rates of Hospitalizations and Emergency Department Visits in Patients with Asthma and Chronic Obstructive Pulmonary Disease Taking β-Blockers

5,889 for LAMA plus LABA,

Association between oral antidiabetic use, adverse events and outcomes in patients with type 2 diabetes

3,330 for LABA + ICS, and

Predictors of oral bisphosphonate prescriptions in post-menopausal women with osteoporosis in a real-world setting in the USA

10,217 for LAMA plus LABA/ICS cohorts. Conclusion Staging of COPD with a PFT and adherence to current GOLD guidelines was associated with lower costs in subjects with moderate to severe COPD. Appropriate use of LAMA plus LABA, LABA plus ICS, and LAMA plus LABA/ICS has economic as well as clinical benefits for patients and payers.

Presence of central nervous system, cardiovascular and overall co‐morbidity burden in patients with overactive bladder disorder in a real‐world setting

Study Objective. To determine the rates of hospitalizations and emergency department (ED) visits during cardioselective and nonselective β‐blocker therapy in patients with asthma and/or chronic obstructive pulmonary disease (COPD).

Good Research Practices for Measuring Drug Costs in Cost-Effectiveness Analyses: Medicare, Medicaid and Other US Government Payers Perspectives: The ISPOR Drug Cost Task Force Report—Part IV

Objective:u2002 To quantify adverse events (AEs) associated with the use of metformin (MET), sulphonylureas (SUs) and thiazolidinediones (TZDs) in a usual care setting, and to assess the relationship of AEs to treatment patterns and glycaemic response in patients with type 2 diabetes.