Hm Campbell

GI Risk Factors and Use of GI Protective Agents Among Patients Receiving Nonsteroidal Antiinflammatory Drugs

Background: Patient characteristics increase the risk of gastrointestinal (GI) complications associated with nonsteroidal antiinflammatory drugs (NSAIDs). Patients at risk may not be prescribed protective therapies that might mitigate their risk of NSAID-associated GI complications. Objective: To assess GI risk among Veterans Affairs (VA) patients on NSAID therapy, determine whether therapy conformed to VA guidelines for lessening the risk of GI complications, and identify patient risk factors associated with conformance. Methods: Using databases from 3 VA medical centers, we retrospectively identified patients receiving NSAIDs and obtained data regarding age, history of GI bleed over 8 years, GI adverse effects associated with NSAIDs, diagnoses, and medication history over one year. We inferred health status from age-adjusted Charlson comorbidity index values. Each patients risk of developing GI complications over one year was calculated using these data. Among patients at significant or substantial risk, we assessed conformance to VA guidelines. We used logistic regression to identify risk factors associated with conformance and determine adjusted ORs (AORs) with 95% CIs for each risk factor. Results: There were 19122 patients receiving NSAIDs. Of 4589 patients at significant risk and 1246 at substantial risk, 1161 (25.3%) and 356 (28.6%), respectively, were prescribed guideline-conformant therapy. Risk factors associated with conformance (p s 0.001) among patients at significant risk were rheumatoid arthritis (AOR 1.34; 95% CI 1.13 to 1.58) and GI adverse effects (AOR 1.53; 95% CI 1.42 to 1.64). For substantial risk patients, risk factors associated with conformance (p s 0.031) were rheumatoid arthritis (AOR 1.65; 95% CI 1.37 to 1.98), concomitant corticosteroids (AOR 1.21; 95% CI 1.02 to 1.43), GI hospitalization (AOR 2.01; 95% CI 1.57 to 2.59), and GI adverse effects (AOR 1.79; 95% CI 1.47 to 2.18). Conclusions: Many patients at risk for GI adverse events do not receive guideline-conformant therapy. Educational interventions to improve conformance could focus on specific risk factors for GI complications.

Relationship between diet, exercise habits, and health status among patients with diabetes.

BACKGROUND The American Diabetes Association recommends that people with diabetes should engage in physical activity and healthy eating. Similarly, diets rich in fruits or vegetables (5-13 servings) have been found to lower the risk of stroke, cardiovascular conditions, cancer, and diabetes. OBJECTIVES To examine the associations between eating fruits and vegetables and exercising on physical/mental health among diabetes patients. A secondary objective was to describe the relationship between socioeconomic status and physical/mental health. Finally, we used the Health Belief Model (HBM) to help providers understand how they can work best with their patients to implement healthy lifestyle. METHODS The 2005 Centers for Disease Controls Behavioral Risk Factor Surveillance System was used to determine the relationship between eating fruits/vegetables and exercise on physical and mental health. The sample was restricted to individuals who self-reported being diagnosed with diabetes (N=33,320) in 2005. Eating fruits and vegetables was categorized by the number of fruit and vegetable servings consumed daily (0, 1-2, 3-4, and ≥5). Poisson regression was used to assess these associations. RESULTS Only 26% of individuals ate 5 or more servings of fruits and vegetables, whereas only 33% met exercise recommendations. Individuals who ate 5 or more servings of fruits and vegetables reported better mental health but poor physical health. Compared with meeting exercise recommendations, no exercise was associated with more days of poor physical/mental health. CONCLUSIONS Reinforcement of daily exercise is helpful to patients with diabetes (PWDS); meeting exercise recommendations was associated with better outcomes of physical and mental health. Pharmacists and other public health providers should focus on interventions that incorporate the promotion of healthy lifestyles. The HBM can be used to improve health behavior among PWDS. Pharmacists are in a unique position to advocate change with consistent access to care.

Pharmacoeconomic Analysis of Angiotensin-Converting Enzyme Inhibitors in Type 2 Diabetes: A Markov Model

Background: Prevention of cardiovascular disease (CVD) events by initiating an angiotensin-converting enzyme (ACE) inhibitor on diagnosis of type 2 diabetes may increase survival and decrease costs. Objective: To determine the incremental cost-effectiveness ratios of ACE inhibitor initiation in normoaIbuminuric, microalbuminuruc, and macroaIbuminuric patients with newly diagnosed type 2 diabetes. Methods: A cohort of patients with newly diagnosed type 2 diabetes was followed for 8 years in a Markov model. Clinical outcomes included CVD events, dialysis, all-cause mortality, and the composite endpoints of the 3 events. Probabilities and costs were obtained from the literature. One-way and two-way sensitivity analyses were conducted to test the robustness of the model. Results: Implementation of ACE inhibitor therapy on diagnosis of type 2 diabetes in normoalbuminuric and microalbuminuric patients is a dominant strategy (ie, more effective and less costly) across all outcomes. In macro-albuminuric patients, an additional

Medication adherence assessment in a clinical trial with centralized follow-up and direct-to-patient drug shipments

4,10 and

Angiotensin-converting enzyme inhibitors versus angiotensin receptor blockers for end-stage renal disease/mortality in type 2 diabetes §

4.58 saves one life and avoids one composite endpoint, respectively; however, in these patients, not giving an ACE inhibitor is dominant for prevention of CVD events and dialysis. This is due to a 28.62% higher mortality rate in patients not receiving an ACE inhibitor. Thus, analysts of the composite endpoint shows that not giving an ACE inhibitor does not remain dominant. A limitation of our study is the inability to determine causality. Conclusions: If every newly diagnosed patient with type 2 diabetes in the US was prescribed an ACE inhibitor, our model shows that 68 314 CVD events would be averted, 46410 lives would be saved, and 48 people would be prevented from needing dialysis over 8 years. These findings suggest that ACE inhibitors prevent numerous events in patients with type 2 diabetes who are normoalbuminuric at diagnosis, in addition to those already identified as being at risk for CVD events.

Pharmacoeconomic analysis of therapies for pediatric patients

Background Assessment of adherence to study medications is a common challenge in clinical research. Counting unused study medication is the predominant method by which adherence is assessed in outpatient clinical trials but it has limitations that include questionable validity and burdens on research personnel. Purpose To compare capsule counts, patient questionnaire responses, and plasma drug levels as methods of determining adherence in a clinical trial that had 2056 participants and used centralized drug distribution and patient follow-up. Methods Capsule counts from study medication bottles returned by participants and responses to questions regarding adherence during quarterly telephone interviews were averaged and compared. Both measures were compared to plasma drug levels obtained at the 3-month study visit of patients in the treatment group. Counts and questionnaire responses were converted to adherence rates (doses taken divided by days elapsed) and were categorized by stringent (≥85.7%) and liberal (≥71.4%) definitions. We calculated the prevalence-adjusted bias-adjusted kappa to assess agreement between the two measures. Results Using a pre-paid mailer, participants returned 76.0% of study medication bottles to the central pharmacy. Both capsule counts and questionnaire responses were available for 65.8% of participants and were used to assess adherence. Capsule counts identified more patients who were under-adherent (18.8% by the stringent definition and 7.5% by the liberal definition) than self-reports did (10.4% by the stringent definition and 2.1% by the liberal definition). The prevalence-adjusted bias-adjusted kappa was 0.58 (stringent) and 0.83 (liberal), indicating fair and very good agreement, respectively. Both measures were also in agreement with plasma drug levels determined at the 3-month visit (capsule counts: p = 0.005 for the stringent and p = 0.003 for the liberal definition; questionnaire: p = 0.002 for both adherence definitions). Limitations Inconsistent bottle returns and incomplete notations of medication start and stop dates resulted in missing data but exploratory missing data analyses showed no reason to believe that the missing data resulted in systematic bias. Conclusions Depending upon the definition of adherence, there was fair to very good agreement between questionnaire results and capsule counts among returned study bottles, confirmed by plasma drug levels. We conclude that a self-report of medication adherence is potentially comparable to capsule counts as a method of assessing adherence in a clinical trial, if a relatively low adherence threshold is acceptable, but adherence should be confirmed by other measures if a high adherence threshold is required.

PHC5 COST-EFFECTIVENESS ANALYSIS OF THROMBOPROPHYLACTIC STRATEGIES OVER ONEYEAR AFTERTOTAL KNEE REPLACEMENT IN VETERAN PATIENTS

AIMS To compare angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) for end-stage renal disease (ESRD) development and all-cause mortality in veterans with macroalbuminuria and with newly documented type 2 diabetes. METHODS A retrospective cohort study utilizing data from the national Department of Veterans Affairs (VA) databases. The study followed 5166 subjects without a history of use of ACEIs or ARBs. To control for differences in baseline characteristics between groups, comparisons of subjects ACEIs and ARBs were made by incorporating propensity scores analysis into multivariate logistic regression. This resulted in adjusted odds ratios and 95% confidence intervals for ESRD development and all-cause mortality. RESULTS The sample was followed up to five years with a mean follow-up of three years. Subjects taking ACEIs has lower odds of ESRD development (OR, 0.33 [95% CI, 0.13-0.82]) and all-cause mortality (OR, 0.10 [95% CI, 0.04-0.21]) than ARBs. CONCLUSIONS This study shows that ACEIs are associated with lower ESRD development and all-cause mortality than ARBs. This may have implications for guidelines which currently suggest that these two therapeutic classes provide similar benefits in people with newly diagnosed type 2 diabetes and macroalbuminuria.

PDB9 PHARMACOECONOMIC ANALYSIS OF ANGIOTENSIN-CONVERTING ENZYME INHIBITORS IN TYPE II DIABETICS

© Future Drugs Ltd. All rights reserved. ISSN 1473-7167 483 Dennis W Raisch†, PhD (Pictured) Mark T Holdsworth, PharmD, BCOP Patricia L Marshik, PharmD Heather M Campbell, PharmD †Author for correspondence Veterans Affairs Co-operative Studies Program, Clinical Research Pharmacy, 2401 Centre, SE Albuquerque, NM 87111, USA Tel.: +1 505 248 3201 Fax: +1 505 248 3202 dennis.raisch@csp.research.med.va.gov Pharmacoeconomic analysis of therapies for pediatric patients

PMH3 QUALITY-ADJUSTED LIFE YEARS GAINED WITH BUPRENORPHINE TREATMENT FOR OPIATE ADDICTION

Cost Report. Regression modeling with log transformation was employed to compare differences in fixed hospital costs (those insensitive to volume), variable costs (those sensitive to volume), and post-operative LOS. Control variables included age, gender, All Patient Refined-Diagnosis Related Group severity codes, region, hospital teaching status, bed size, population served (urban or rural), and primary payer. RESULTS: A total of 82,788 discharges were included. The models demonstrated that patients who received Gelfoam + thrombin had higher fixed and variable costs (+6.1% and +7.3%, respectively, p < 0.01) and Surgicel + thrombin patients had higher fixed and variable costs (+18% and +10%, p < 0.01, respectively) compared to FloSeal only. In terms of fixed costs, the predicted increase was

A Comparison of Veteran and Nonveteran Motivations and Reasons for Participating in Clinical Trials

15,956 for Gelfoam + thrombin and