Michael F. Bullano

Follow-up lipid tests and physician visits are associated with improved adherence to statin therapy

AbstractIntroduction and Objective: The National Cholesterol Education Program recommends regular physician follow-up and lipid testing to promote adherence with lipidlowering medications. The objective of this study was to determine whether lipid tests and physician visits after treatment initiation are indeed associated with adherence to statin therapy. Subjects and Methods: A retrospective cohort study was conducted among 19 422 enrolees in a US managed care plan who initiated treatment with a statin between October 1999 and August 2001. Computerised pharmacy, medical and laboratory records were used to study the patterns and predictors of adherence with lipid-lowering therapy for up to 3 years. Adherence was assessed in 3-month intervals with patients considered ‘adherent’ if ≥80% of days were covered by lipid-lowering therapy. Results: In the first 3 months, 40% of patients had follow-up lipid tests and only 21% had dyslipidaemia visits (14% had both). Those receiving such care were substantially more likely to be adherent in subsequent intervals. Compared with those without follow-up, the relative odds of adherence were 1.42 and 1.27 for patients with one or more lipid test and one or more dyslipidaemia visit, respectively (95% confidence intervals [CI] 1.33, 1.50 and 1.16, 1.39). Patients who received a followup visit and lipid test were 45% more likely to be adherent (95% CI 1.34, 1.55). Similar associations were observed when lipid tests and dyslipidaemia visits occurred later in therapy. Conclusion: Early and frequent follow-up by physicians — especially lipid testing — was associated with improved adherence to lipid-lowering therapy. A randomised prospective study is needed to determine whether this relationship is causal.

Effect of Rosuvastatin Compared with Other Statins on Lipid Levels and National Cholesterol Education Program Goal Attainment for Low-Density Lipoprotein Cholesterol in a Usual Care Setting

Study Objective. To compare, in a usual care setting, the effects of rosuvastatin and other 3‐hydroxy‐3‐methylglutaryl coenzyme A inhibitors (statins) on lipid levels and on goal attainment of low‐density lipoprotein cholesterol (LDL) levels from the National Cholesterol Education Program (NCEP) third report of the Adult Treatment Panel (ATP III).

Analysis of healthcare utilization patterns and adherence in patients receiving typical and atypical antipsychotic medications

SUMMARY Objective: To examine the effects of typical and atypical antipsychotics on medication adherence and healthcare resource utilization. Research design and methods: This was a retrospective observational cohort analysis of pharmacy and medical health insurance reimbursement data of patients from a southeastern United States health plan. Pharmacy data of subjects between 6 and 65 years of age were identified. Inclusion criteria included initiation of a single antipsychotic agent between July 1, 1999 and September 30, 2000; no antipsychotic medication usage 6 months prior to the index prescription date; and continuous health plan enrollment for the 18-month study period. Multivariable methods were utilized to analyze healthcare resource utilizations between groups. Outcome measures: Primary outcome measures included: (1) adherence and persistence with antipsychotic therapy; (2) healthcare utilization for outpatient office and hospital visits, inpatient hospital visits, and emergency room visits; and (3) therapy modifications and concomitant medications. Results: A total of 469 patients met initial study criteria. Atypical and typical antipsychotics were prescribed to 384 and 85 patients, respectively. Length of therapy (days) for the atypical cohort was significantly longer (136 vs 80; p < 0.001). As defined using medication possession ratio (MPR), the atypical cohort was significantly more adherent to therapy than the typical cohort (mean MPR, 0.53 vs 0.24; p < 0.001). After adjusting for differences in demographics, baseline utilization, MPR, and length of therapy (n = 377), the atypical cohort experienced significantly fewer office visits (2,635 vs 4,249 per 1000 patients per month [P1000PPM]; p = 0.005), fewer inpatient admissions (197 vs 511 P1000PPM; p = 0.032), and fewer emergency room visits (125vs354 P1000PPM; p = 0.002). Conclusions: Atypical antipsychotic users were significantly more adherent to therapy, and had lower rates of office, hospital and emergency room utilization. Within the context of inherent limitations associated with health insurance claims databases, this study suggests that a relationship exists across cohorts between medication adherence and use of healthcare resources.

Agreement between administrative claims and the medical record in identifying patients with a diagnosis of hypertension.

Objective:This study evaluated the accuracy of 2 administrative claims-based selection rules to identify patients with hypertension (HTN) using medical records as the gold standard. Research Design:The claims database consisted of inpatient, outpatient, pharmacy, and eligibility claims for members of a single insurance company from January 2000 through March 2003. Medical records were abstracted for 258 matched patient pairs selected by Rule A (at least 1 HTN-related International Classification of Diseases, 9th Revision [ICD-9] claim) and 138 pairs selected by Rule B (at least 1 HTN-related ICD-9 and at least 1 HTN prescription claim) from 31 provider sites. Sensitivity and specificity of the 2 selection rules were computed using medical chart review as the gold standard for a diagnosis of HTN. Subjects:Of patients selected by Rule A, chart review identified 281 patients with and 235 patients without HTN. Of patients selected by Rule B, chart review identified 172 patients with and 104 patients without HTN. Results:The sensitivity and specificity was 70.8% and 74.9% for Rule A and 76.2% and 93.3% for Rule B. The kappa score was 0.45 for Rule A and 0.65 for Rule B. Conclusion:To identify patients with HTN, a selection rule using both a diagnosis and prescription claim has greater sensitivity and specificity than a rule using a diagnosis claim only.

Monitoring anticoagulation in atrial fibrillation

AbstractBackground: Randomized control trials and observational studies show high-quality warfarin therapy leads to safe and effective stroke prophylaxis. In usual community practice, patient, physician and health care system factors are barriers to optimal anticoagulation. We examined the predictive relationship between inpatient and outpatient INR values in chronic non-valvular atrial fibrillation (AF) patients hospitalized for ischemic stroke (S), bleed (B) and control events (C) in usual community practice. Methods: This nested case-control analysis identified AF patients hospitalized for S, B and C using medical and pharmacy claims spanning 4.5 years (‘98–‘03) and validating diagnosis with chart abstraction. AF was defined as 2 medical claims for AF ≥ 42 days apart with a related prescription claim for warfarin. INRs from both outpatient and inpatient settings were used to yield a continuous history of coagulation status. Time-in-therapeutic-range (TTR) was calculated by Rosendaal’s linear interpolation method. Correlation of inpatient and prognostic utility of last outpatient INRs was tested with S or B hospitalizations using univariate and multivariate logistic regression. Results: Overall, 614 hospitalizations (means: age 73.9, CHADS2 = 3.24; 52% male) included S (n = 98), B (n = 101) and C (n = 415) events. Average TTR was 28.6% (49.4% at INR <2.0, 21.9% at INR >3.0). First INR on admission (INR <2.0 or >3.0) was associated with S and B hospitalizations (OR-adjusted [95%CI], 1.68 [1.04–2.73] and 1.72 [1.02–2.90]), respectively. Last outpatient INR <2.0 was not associated with S (OR-adjusted [95%CI], 1.12 [0.77–1.81]), and INR >3.0 was not associated with B (OR-adjusted [95%CI], 1.25 [0.67–2.32]). Last outpatient INR measurement occurred at 28, 22 and 24 days (median; S, B & C, respectively) before hospitalization. Conclusion: Patients were observed within therapeutic range less than 30% of their time on warfarin. While inpatient INRs were clearly associated with both ischemic stroke and bleed events, last outpatient INR before event was not predictive.

Therapy modifications and low-density lipoprotein cholesterol goal attainment rates associated with the initiation of generic simvastatin

Abstract Objective: The availability of generic simvastatin has changed the relative cost structure within the statin marketplace and has been associated with third-party payer changes to formularies and statin utilization policies. The current study examines simvastatin therapy modification patterns and associated low-density lipoprotein cholesterol (LDL-C) goal attainment rates. Methods: This retrospective, observational study utilized administrative claims linked to laboratory result data from a national health plan. Patients newly initiated on generic simvastatin from January 2007 to March 2008 were identified. National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) risk categories and goal LDL-C targets were assigned. Simvastatin dose titrations and switches to other statins were described, as were changes in LDL-C values and NCEP ATP III goal attainment rates both before and after therapy modifications. Results: Of the 1654 patients newly initiated on simvastatin, 84% had no simvastatin therapy modification in the >1-year follow-up period. For patients with no therapy modification, 54.4% did not achieve their LDL-C NCEP ATP III goal at their first lipid panel and goal attainment was strongly associated with the level of cardiovascular risk (goal attainment rate = 75.1%, 51.7%, and 28.6% for low-, moderate- and high-risk categories, respectively). Of patients not achieving NCEP ATP III LDL-C goals (n = 885), 85.4% had no therapy modification. Goal was achieved after therapy modification in 36% (dose titration) and 42% (switchers); high-risk patients goal attainment rates were 23% and 38%, respectively. Limitations: Limitations of the study include the observational design, use of an administrative claims database to assess cardiovascular risk, relatively short follow-up time (slightly more than 1 year) and the lack of assessment of adherence to therapy. Conclusions: This study found that the majority of patients initiated on generic simvastatin stayed on their initial starting dose regardless of NCEP ATP III goal attainment status. The findings of low rates of therapy modification irrespective of baseline CV risk and associated low rates of goal attainment, especially in high risk patients treated with simvastatin, indicate an opportunity to encourage clinical decision making based on the needs of the individual patient.

Atherosclerosis profile and incidence of cardiovascular events: a population-based survey

BackgroundAtherosclerosis is a chronic progressive disease often presenting as clinical cardiovascular disease (CVD) events. This study evaluated the characteristics of individuals with a diagnosis of atherosclerosis and estimated the incidence of CVD events to assist in the early identification of high-risk individuals.MethodsRespondents to the US SHIELD baseline survey were followed for 2 years to observe incident self-reported CVD. Respondents had subclinical atherosclerosis if they reported a diagnosis of narrow or blocked arteries/carotid artery disease without a past clinical CVD event (heart attack, stroke or revascularization). Characteristics of those with atherosclerosis and incident CVD were compared with those who did not report atherosclerosis at baseline but had CVD in the following 2 years using chi-square tests. Logistic regression model identified characteristics associated with atherosclerosis and incident events.ResultsOf 17,640 respondents, 488 (2.8%) reported having subclinical atherosclerosis at baseline. Subclinical atherosclerosis was associated with age, male gender, dyslipidemia, circulation problems, hypertension, past smoker, and a cholesterol test in past year (OR = 2.2) [all p < 0.05]. Incident CVD was twice as high in respondents with subclinical atherosclerosis (25.8%) as in those without atherosclerosis or clinical CVD (12.2%). In individuals with subclinical atherosclerosis, men (RR = 1.77, p = 0.050) and individuals with circulation problems (RR = 2.36, p = 0.003) were at greatest risk of experiencing CVD events in the next 2 years.ConclusionSelf-report of subclinical atherosclerosis identified an extremely high-risk group with a >25% risk of a CVD event in the next 2 years. These characteristics may be useful for identifying individuals for more aggressive diagnostic and therapeutic efforts.

Effectiveness of rosuvastatin versus atorvastatin in reducing lipid levels and achieving low-density-lipoprotein cholesterol goals in a usual care setting

PURPOSE The effectiveness of rosuvastatin versus atorvastatin in reducing lipid levels and achieving low-density-lipoprotein (LDL) cholesterol goals in patients treated in a usual care setting was studied. METHODS Electronic medical and pharmacy administrative claims from a western U.S. health plan with approximately 8 million covered members were extracted and used in this retrospective, longitudinal cohort study. Patients age 18 years or older who were newly initiated on rosuvastatin or atorvastatin between August 1, 2003, and June 30, 2004, were included. Propensity-score matching on baseline characteristics was used to minimize selection bias between groups. Administrative claims and medical records were used to assign patients a cardiovascular risk status and corresponding LDL cholesterol goal using guidelines from the National Cholesterol Education Program (NCEP). Changes in lipid levels and attainment rates of goal LDL cholesterol levels were estimated after accounting for baseline covariates using regression techniques. RESULTS A total of 453 patients met the study criteria. The mean dose of rosuvastatin was 11 mg compared with 15 mg for atorvastatin. After adjusting for baseline differences between groups, patients receiving rosuvastatin had significantly greater mean percent reductions in LDL cholesterol, total cholesterol, and non-high-density-lipoprotein (non-HDL) cholesterol than did patients receiving atorvastatin (p < 0.001 for all comparisons). No significant differences were found in HDL cholesterol and triglyceride levels between groups. Attainment rates for NCEP LDL cholesterol goals were significantly higher in patients receiving rosuvastatin. CONCLUSION Patients treated in a usual care setting with rosuvastatin had significantly greater reductions in LDL cholesterol, non-HDL cholesterol, and total cholesterol levels compared with those receiving atorvastatin. Patients receiving rosuvastatin were more likely to attain NCEP LDL cholesterol goals compared with patients treated with atorvastatin.

Adherence to single-pill combination versus multiple-pill combination lipid-modifying therapy among patients with mixed dyslipidemia in a managed care population

Abstract Background: Suboptimal adherence to lipid-lowering therapies is associated with and potentially contributes to increased cardiovascular morbidity and mortality. Single-pill combination (SPC) lipid-modifying therapies may improve patient adherence due to decreased pill burden and increased convenience for the patient. Objective: To compare adherence to SPC versus multi-pill combination (MPC) lipid-modifying medications. Methods: This retrospective study used pharmacy and medical claims and laboratory result data from a national managed care dataset to evaluate patients who were newly prescribed simvastatin plus ezetimibe, simvastatin plus niacin, and lovastatin plus niacin either as SPC or MPC. Patients were considered adherent to therapy if they had a proportion of days covered (PDC) ≥0.80. Results: The mean PDC was 0.76 and 0.70 in the first 3 months of therapy, 0.54 and 0.45 in the second 3 months, and 0.50 and 0.41 for the remaining 30 months of follow-up for the SPC and MPC groups, respectively. SPC patients were 32% (OR = 1.32; 95% CI: 1.27–1.36; P < 0.01) more likely to be adherent to treatment than MPC patients. Conclusion: Adherence was significantly higher among patients receiving SPC than MPC. Although only associations and not temporality were assessed due to the observational design of this study, the use of SPC may be a successful method for improving adherence in a real-world setting.

The impact of initial statin treatment decisions on cardiovascular outcomes in clinical care settings: estimates using the Archimedes Model

Purpose Many patients treated for dyslipidemia do not achieve recommended cholesterol goals despite the widespread availability of effective statins. Pharmaceutical claims show a strong tendency for patients to remain on their initially assigned treatment. With computer simulations, the impact of initial statin treatment decisions on medium- and long-term cardiovascular outcomes were examined. Patients and methods Using the Archimedes Model, three treatment scenarios were simulated. Patients initiated treatment with simvastatin (20, 40, or 80 mg), atorvastatin (10, 20, 40, or 80 mg), or rosuvastatin (10, 20, or 40 mg), and periodically intensified treatment. The simulated population consisted of 50,025 patients, aged 45–70 years, with low-density lipoprotein cholesterol exceeding goal. The proportion of patients initiating each dose was calibrated to United States pharmacy claims. Patients not reaching goal intensified the dose of their current statin or switched to an appropriate dose of rosuvastatin at rates matching pharmacy claims. Biomarkers and major adverse cardiovascular events (MACE) were tracked for 10 years and several high-risk subpopulations were analyzed. Statin models used biomarker effects from the STELLAR (Statin Therapies for Elevated Lipid Levels Compared Across Doses to Rosuvastatin) trial and outcomes data from various trials. Results Initiating therapy with rosuvastatin reduced MACE more than simvastatin or atorvastatin. The 5- year relative risk of MACE was 0.906 (95% confidence interval: 0.888–0.923; P < 0.001) for initial treatment with atorvastatin rather than simvastatin, 0.831 (0.812–0.850; P < 0.001) for rosuvastatin rather than simvastatin, and 0.918 (0.898–0.938; P < 0.001) for rosuvastatin rather than atorvastatin. Subgroups with higher MACE incidence experienced greater absolute benefit. Conclusion Considering observed rates of treatment intensification, initial treatment choices appear to significantly impact medium- and long-term cardiovascular risk. Patients at high cardiovascular risk are good candidates for aggressive initial therapy.