Persistence with migraine prophylactic treatment and acute migraine medication utilization in the managed care setting.

OBJECTIVE: The aim of this study was to describe persistence with migraine prophylactic treatment and acute migraine medication utilization in patients prescribed migraine prophylaxis. METHODS: For this retrospective cohort study, the Health Core Integrated Research Database provided pharmacy/medical claims data from 5 commercial health insurance plans (ie, excluding Medicare and Medicaid) on adult patients with migraine. Eligible patients had >or=1 pharmacy claim for a migraine prophylactic medication between July 1, 2000, and May 31, 2005, and >or=12 U of any combination of acute treatment (serotonin receptor agonist [triptan], ergotamine, or ergotamine combination) dispensed during the 180-day period preceding a first pharmacy claim for a prophylactic medication (index date). The prophylactic medication identified at index date was used for categorizing patients into 1 of 4 cohorts: amitriptyline, propranolol/timolol, divalproex sodium, or topiramate (reference). Kaplan-Meier curves were used for evaluating unadjusted risk for discontinuation over time, and a multivariate Cox proportional hazards model was developed to analyze factors associated with discontinuation of prophylactic medication. RESULTS: A total of 12,783 patients met the inclusion criteria and were included in the analysis (amitriptyline, 3749; propranolol/timolol, 2718; divalproex sodium, 1644; and topiramate, 4672). The mean (SD) ages were not significantly different across cohorts (43.9 [11.3], 42.0 [11.1], 43.1 [11.3], and 43.9 [10.6] years, respectively). The mean duration of treatment was significantly longer (131 [184] days) with topiramate compared with amitriptyline (94 [152] days), propranolol/ timolol (119 [180] days), and divalproex sodium (109 [158] days) (P < 0.001, P = 0.005, and P<0.001,respectively). The risks for discontinuing prophylactic treatment were 23%, 6%, and 11% higher with amitriptyline, propranolol/timolol, and divalproex sodium, respectively, compared with topiramate (P<0.001, P = 0.024, and P <0.001). Patients prescribed topiramate had a higher mean consumption rate of triptans preindex; postindex, decreases in triptan use were observed in all cohorts, although the magnitude of the decrease was greatest in patients prescribed topiramate compared with the other cohorts. CONCLUSIONS: In this study, prescription of topiramate was associated with greater persistence with prophylactic treatment than the other prophylactic drugs. Furthermore, greater reductions in acute treatment utilization, particularly triptans, were observed among patients prescribed topiramate compared with the other prophylactic cohorts.

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.

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). DESIGN: Retrospective, longitudinal, cohort study. DATA SOURCE: Managed care medical and pharmacy claims and laboratory database. PATIENTS: A total of 8251 patients starting treatment with rosuvastatin, atorvastatin, simvastatin, pravastatin, lovastatin, or fluvastatin from August 1, 2003-September 30, 2004, excluding those who received dyslipidemic therapy in the previous 12 months. MEASUREMENTS AND MAIN RESULTS: Patients with at least one pretreatment and posttreatment lipid level were followed until their initial statin was changed or they reached the end of benefit eligibility or the study period. Percent changes in lipid levels were calculated, and adjusted changes in LDL and goal attainment were evaluated by regression techniques. Absolute and percent reductions in LDL, triglyceride, and total cholesterol levels were significantly greater with rosuvastatin than with other statins (all p<0.05 except for triglyceride reduction vs atorvastatin). After adjustment for age, sex, and baseline LDL, percent LDL reductions still were significantly greater with rosuvastatin than with other statins (p<0.05). Changes in high-density lipoprotein cholesterol were not significant. Goal attainment was higher with rosuvastatin than with other statins after adjustment for age, sex, baseline LDL, risk status, dose, and duration of therapy (p<0.05). Dose-stratified analysis showed that LDL goal attainment was significantly higher with rosuvastatin 10 mg than with atorvastatin 10 or 20 mg. CONCLUSION: Rosuvastatin was more effective than other statins in reducing LDL, triglyceride (except vs atorvastatin), and total cholesterol levels. Significantly more patients taking rosuvastatin than patients taking other statins attained their LDL goals.

Cardiovascular event rates in atorvastatin patients versus patients switching from atorvastatin to simvastatin.

OBJECTIVE: Statin dose, adherence, and cardiovascular (CV) outcomes are important factors when considering switching statin therapies. The objective of the study was to compare CV event rates and risk in managed care patients receiving atorvastatin versus those switched to simvastatin from atorvastatin. METHODS: Patients 18-64 years, with ≥3 continuous pharmacy claims for atorvastatin between 1/1/05-11/30/07 and ≥12 months pre- and ≥3 months post-index continuous eligibility were identified using HealthCore Integrated Research Database (HIRD). Patients were stratified into two cohorts: one continued atorvastatin without interruption and the other switched to simvastatin. Patients were matched 1:10 (continue atorvastatin/switch simvastatin) on five variables, excluding lipid parameters due to limited data availability. Descriptive statistics were reported for sample characteristics. A multivariate Cox proportional hazards model was developed to evaluate adjusted CV risk. RESULTS: In total 73,960 atorvastatin patients and 7396 simvastatin-switch patients were analyzed. The mean age was 54 ± 7 years (both cohorts). Mean follow-up was 440 days for atorvastatin patients and 237 days for simvastatin-switch patients. Mean dose and therapy duration for atorvastatin was 20 mg and 321 days compared with 33 mg and 195 days for simvastatin-switch, respectively. Of the simvastatin-switch patients, 32% were switched to a less potent simvastatin dose (<2× prior atorvastatin dose). After adjusting for demographic/clinical characteristics, no significant differences were found in CV risk between cohorts. LIMITATIONS: Limitations include use of administrative claims data without lipid level laboratory results data and the length of follow-up which may not have been sufficient to demonstrate significant differences in event rates between groups. CONCLUSION: In this managed care population, no significant differences were found in risk of CV events among patients switching to simvastatin compared to patients continuing atorvastatin. Switched patients may differ from controls for reasons not captured in the database.

Treatment pattern changes in high-risk patients newly initiated on statin monotherapy in a managed care setting.

BACKGROUND: For high-risk patients who do not achieve guideline-recommended LDL-C levels, more intensive treatment including statin-uptitration to higher doses or potency, as well as combination therapy may be considered. A better understanding of statin treatment patterns in real-world clinical practice may contribute to improved lipid-lowering management in these patients. OBJECTIVE: We determined treatment pattern changes among patients with high risk of cardiovascular disease who were not at low-density lipoprotein cholesterol (LDL-C) goal on statin monotherapy. METHODS: Treatment pattern changes were evaluated among patients newly initiated on statins between January 1, 2006, and August 31, 2009, in the HealthCore Integrated Research Database. Rates and mean time to first and second treatment changes were examined in patients with claims for coronary heart disease (CHD), atherosclerotic vascular disease (AVD), and diabetes mellitus during 12 months before index, who were not at LDL-C <70 mg/dL at their first-eligible LDL-C test (≥ 4 weeks after index). Therapy change was assessed for 12 months after the LDL-C result. RESULTS: Of 11,473 eligible subjects, 61.3% had diabetes, 26.6% had CHD and AVD, and 12.1% had CHD and AVD and diabetes. At index, patients were prescribed medium-potency levels of statins, including simvastatin (44.7%), atorvastatin (31.5%), and other statins (23.8%). Mean ± SD LDL-C before statin initiation was 138 ± 34 mg/dL, and at the first-eligible LDL-C result after index, it was 101 ± 25 mg/dL. During follow-up, 7444 subjects (64.9%) experienced a first treatment change, with mean time to change of 93.8 ± 92 days, whereas 4029 (36.1%) had no treatment change. Discontinuation of index therapy occurred in 46.9% of subjects and medication switches or titration in 18.0% (index statin titration, switch to other statins, other lipid-lowering therapies [LLT], including ezetimibe). Of the discontinuers, 27.4% restarted LLT. Of subjects with a first treatment change who did not discontinue, 48.9% experienced a second therapy change. Results were similar between the 3 high-risk groups. CONCLUSIONS: In this managed-care setting, among patients with high risk of cardiovascular disease who were not at LDL-C goal, statins were usually started at medium-potency doses without being titrated up, whereas nearly one-half had a discontinuation of LLT within 12 months. These treatment patterns indicate the need for better patient and provider education as well as other system-wide modifications to improve medication adherence.

Economic impact of tobramycin in patients with cystic fibrosis in a managed care population.

OBJECTIVE: Guidelines recommend chronic use of tobramycin solution for inhalation (TSI) for cystic fibrosis (CF) patients with moderate-to-severe lung disease and persistent airway Pseudomonas aeruginosa. This study evaluated the economic impact of TSI in managed care CF patients. METHODS: Patients (0-64 years) with ≥2 CF medical claims between 01/01/04-03/31/09 were identified. For TSI users, the index date was the first TSI claim in the period; for non-users, a pseudo-index date was determined and randomly assigned by simulating the distribution of index dates of TSI users. Maximum sample size was obtained for patients with ≥3 months pre- and ≥12 months post-index eligibility. Users were categorized by number of TSI prescriptions filled during 12-month post-index period as low (1 fill), medium (2-3 fills) and high adherence (≥4 fills). Differences in per member per month (PMPM) costs pre-index to post-index were analyzed using paired t-tests. RESULTS: A total of 388 TSI users (mean age 19 years, 48% female) and 444 non-users (mean age 30 years, 54% female) met study criteria. In users, total and CF-related PMPM costs decreased $959 (17%) and $113 (3%), respectively, after starting TSI. Among TSI users, CF-related inpatient PMPM costs decreased by $1171 (49%; p=0.01), while CF-related prescription PMPM costs increased by $992 (p<0.01). CF-related inpatient PMPM costs decreased by $381 (38%; p=0.16) for low and $1425 (50%; p=0.21) for medium users and decreased by $1829 (51%; p=0.02) for high users. LIMITATIONS: Limitations include use of administrative claims data, small sample size due to disease rarity, random assignment of pseudo-index date to non-users and differences in baseline characteristics between TSI users and non-users. CONCLUSION: All-cause and CF-related PMPM medical costs significantly decreased after TSI initiation. Among TSI users, total healthcare costs decreased, although not significantly, due to PMPM increases in prescription costs. A trend towards greater decrease in inpatient PMPM costs was observed with increasing TSI adherence.

Impact of asthma control on sleep, attendance at work, normal activities, and disease burden.

BACKGROUND: The 2007 Expert Panel Report 3 asthma treatment guidelines place substantial emphasis on understanding the effectiveness of treatment strategies on outcomes such as disease control. OBJECTIVE: To assess the impact of asthma control on patient-reported outcomes and disease burden in a real-world setting. METHODS: Patients aged 18 to 64 years with moderate to severe asthma defined by medical and pharmaceutical use were asked to participate in a cross-sectional survey of asthma care, control, and burden. Patients were included if they had an International Classification of Diseases, Ninth Revision, Clinical Modification code for asthma, a prescription for an Expert Panel Report 3-defined controller medication (or combinations), and 24-month pre-index continuous eligibility. Patients with chronic obstructive pulmonary disease were excluded. Survey respondent data were linked to commercial health claims information to create the research database. The Asthma Therapy Assessment Questionnaire (ATAQ) was used as the measure of control. The ATAQ scores range from 0 to 4, with 0 indicating no asthma control problems. RESULTS: A total of 1,199 patients (73% women) completed the survey and had their claims data linked for analysis. Age, sex, and comorbidity index measures did not differ between respondents and nonrespondents. Only 12.2% of respondents scored 0 on the ATAQ, 77.0% scored 1 or 2, and 10.8% scored 3 or 4. The ATAQ scores were moderately correlated with patient-rated severity. Decreasing levels of asthma control were associated with greater prevalences of sleep problems, depression, functional impairment, and effect on work and regular activities. CONCLUSIONS: Approximately 88% of patients with moderate to severe asthma were not fully controlled despite anti-inflammatory drug treatment. Lack of asthma control is associated with substantial patient burden.

Risk of cardiovascular events and all-cause mortality in patients treated with thiazolidinediones in a managed-care population.

BACKGROUND: This study directly compares risk of acute myocardial infarction (AMI), acute heart failure (AHF), or all-cause death among pioglitazone- and rosiglitazone-treated patients in a managed-care population. METHODS AND RESULTS: Patients ≥18 years of age, newly initiated on rosiglitazone or pioglitazone between January 1, 2001, and December 12, 2005, were included. The date of the first pharmacy claim for rosiglitazone or pioglitazone was defined as index date. Patients were excluded if they had <1 year continuous eligibility preindex or a preindex insulin claim. Primary outcome measure was time to composite event of AMI, AHF or death among pioglitazone- and rosiglitazone-treated patients. The National Death Index database was accessed to obtain date of death for patients who died during the study period. Propensity score matching was used to control for potential confounders. The Cox proportional hazards model was used to evaluate effects of exposure to rosiglitazone and pioglitazone on time to event. A total of 36 628 patients (58% male; mean age, 54 years) were identified. Of the rosiglitazone-treated patients, 602 (4.16%) had an AMI, AHF, or death compared with 599 (4.14%) propensity score-matched pioglitazone-treated patients. No significant difference was observed between matched groups for risk of composite event (hazard ratio, 1.03; 95% confidence interval, 0.91 to 1.15; P=0.666) when patients were followed from index date until end of study period, termination of enrollment status, or diagnosis of AMI/AHF/death. CONCLUSIONS: In this retrospective cohort study directly comparing rosiglitazone and pioglitazone with a propensity score-matched population that includes mortality data, no significant differences were found in the risk of AMI, AHF or death.

Resource utilization impact of topiramate for migraine prevention in the managed-care setting.

OBJECTIVE: To determine the pattern of headache-related resource utilization and costs before and after initiation of preventive migraine treatment with topiramate in a sample of a large managed-care population. METHODS: This study was a retrospective, longitudinal, cohort study analysis of medical and pharmacy claims using The HealthCore Integrated Research Network Database. Patients were required to have had at least one pharmacy claim for topiramate between 7/1/00 and 11/30/04, and at least 12 dosage units dispensed of any combination of acute migraine treatments (triptan, ergotamine, or ergotamine combination) during the 6-month period preceding the first pharmacy claim for topiramate (the index date). Headache-related inpatient and outpatient resource utilizations were compared pre-index vs. post-index period 1 (months 1-6) and pre-index vs. post-index period 2 (months 7-12). Statistical analyses included McNemar tests for categorical variables and paired t-tests for continuous variables. RESULTS: A total of 3246 patients met the inclusion criteria. The mean (+/- SD) age was 44 +/- 10 years and 88% were female. From pre- to post-index period 2, outpatient visits significantly decreased by 30% (p < 0.0001), diagnostic procedures decreased by 74% (p = 0.0013), emergency room (ER) visits decreased by 27% (p < 0.0001), and abortive prescriptions decreased by 25% (p < 0.0001). No significant differences were found in mean number of hospitalization days. Total headache-related inpatient costs and outpatient costs decreased (p < 0.01) during post-index period 2 (43 and 46%, respectively). Headache-related pharmacy costs increased from pre- to post-index period 2. CONCLUSION: Topiramate treatment for migraine prevention was associated with significantly lower healthcare resource use (ER visits, diagnostics, acute treatment) in the first 6 months of treatment, with continuing decreases, including physician office visits, during the second 6 months of treatment. LIMITATIONS: Since this study is a claims-based analysis there is the potential introduction of non-claims identifiable factors that might influence resource use such as lifestyle modifications and over-the-counter medications. In addition, adherence to topiramate treatment was not accounted for in this study. Nonetheless, this study provides important insights into the benefit of preventive migraine treatment in actual clinical practice.

Comparison of cardiovascular event rates in patients without cardiovascular disease in whom atorvastatin or simvastatin was newly initiated.

OBJECTIVE: To compare cardiovascular (CV) event rates and risk in patients without previous CV disease in whom atorvastatin or simvastatin was newly initiated in a managed care setting. PATIENTS AND METHODS: Patients aged 18 to 64 years in whom atorvastatin or simvastatin was newly initiated between January 1, 2003, and December 31, 2006, and who had no history of CV disease and at least 12 months of preindex and 3 months of postindex continuous eligibility in a managed care health plan, were identified using administrative claims from the HealthCore Integrated Research Database. Descriptive statistics were reported for sample characteristics. Unadjusted CV event rates were compared between treatment groups. A multivariate Cox proportional hazards model was developed to evaluate adjusted CV risk in all patients, as well as in a subset of patients with diabetes mellitus. RESULTS: A total of 168,096 patients in the atorvastatin group and 51,333 patients in the simvastatin group were analyzed. Mean+/-SD age was 50.2+/-9.0 years for patients using atorvastatin and 50.6+/-9.0 years for patients using simvastatin. Mean+/-SD follow-up time was 664.2+/-386.2 days for the atorvastatin group and 511.4+/-359.8 days for the simvastatin group. Mean+/-SD dose and mean+/-SD therapy duration for patients taking simvastatin were 29.1+/-15.1 mg and 188.6+/-236.3 days, respectively, compared with 16.8+/-11.1 mg and 241.8+/-292.0 days, respectively, for patients taking atorvastatin. Unadjusted CV event rates were lower with use of atorvastatin than with simvastatin (hazard ratio, 0.80; 95% confidence interval, 0.75-0.84; P<.001). Adjusting for demographic/clinical characteristics, patients taking atorvastatin experienced a 13% risk reduction in total CV events during the entire follow-up period compared with those who were taking simvastatin (hazard ratio, 0.87; 95% confidence interval, 0.82-0.92; P<.001). No significant differences in CV events were found between patients taking atorvastatin or simvastatin in the diabetes mellitus subset (n=36,969). CONCLUSION: In a managed care population with no history of CV disease, risk of CV events was lower among patients taking atorvastatin compared with patients taking simvastatin, after adjusting for known baseline differences.