Improved persistence and adherence to diuretic fixed-dose combination therapy compared to diuretic monotherapy.

BACKGROUND: Diuretics are recommended as initial treatment for hypertension. Several studies have suggested suboptimal persistence and adherence to thiazide diuretic monotherapy; this study compared patient persistence and adherence with hydrochlorothiazide (HCTZ) monotherapy to fixed-dose combinations containing HCTZ. METHODS: Patients with at least one prescription claim during 2001 to 2003 for either HCTZ or one of the following fixed-dose combinations: angiotensin-receptor blockers/HCTZ (ARB/HCTZ), angiotensin-converting enzyme inhibitor/HCTZ (ACEI/HCTZ), or beta blockers/HCTZ (BB/HCTZ) were identified. Patients were required to be continuously benefit-eligible six months pre- and one year post-index date, and to have no prescription claims for any antihypertensive therapy six months prior to the index date. Patients were followed for one year to assess persistence, medication possession ratio (MPR), adherence (MPR >80%), and proportion of days covered (PDC) with initial antihypertensive therapy. Logistic regression was used to calculate adjusted odds ratios for persistence, adherence and PDC, adjusted for age, gender, business segment, RxRisk disease categories, average co-pay and concurrent cardiovascular-related medication utilization. RESULTS: The study cohort consisted of 48,212 patients; 72.5% used HCTZ, 13.2% ACEI/HCTZ, 9.3% ARB/HCTZ, and 5.0% BB/HCTZ. Mean age was 53.7 years and 66.5% were female. A significantly lower proportion of patients using HCTZ (29.9%) remained persistent with therapy at 12 months compared with ARB/HCTZ (52.6%; OR = 0.37, CI = 0.36, 0.38), ACEI/HCTZ (51.4%; OR = 0.38, CI = 0.37, 0.39), and BB/HCTZ (51.9%; OR = 0.38, 0.37, 0.40). Similarly, PDC was lower for HCTZ patients (32.5%) as compared to ARB/HCTZ (53.7%; OR = 0.39, CI = 0.37, 0.40), ACEI/HCTZ (50.9%; OR = 0.42, CI = 0.40, 0.43), and BB/HCTZ (51.3%; OR = 0.44, CI 0.42, 0.45). MPR was also significantly lower for HCTZ patients as compared to those using fixed-dose combination therapies. CONCLUSION: Initiating HCTZ fixed-dose combination therapy with an ACEI, ARB, or BB was associated with greater persistence and adherence as compared to HCTZ monotherapy. Further research is needed to determine the relationship between improved persistence and adherence with blood pressure control.

Adherence with single-pill amlodipine/atorvastatin vs a two-pill regimen.

While clinical trials demonstrate the benefits of blood pressure and cholesterol reduction, medication adherence in clinical practice is problematic. We hypothesized that a single-pill would be superior to a 2-pill regimen for achieving adherence. In this retrospective, cohort study based on pharmacy claims data, patients newly initiated on a calcium channel blocker (CCB) or statin simultaneously or within 30 days, regardless of sequence, were followed (N=4703). Adherence was measured over 6 months as proportion of days covered (PDC). At baseline, mean age was 63.0 years, 51.6% were female, and mean number of other medications was 7.8. Overall, 16.9% of patients were on single-pill amlodipine/atorvastatin, 15.6% amlodipine + atorvastatin, 24.7% amlodipine + other statin, 13.9% other CCB + atorvastatin, 28.9% other CCB + other statin. Percentages of patients achieving adherence (PDC >or= 80%) were: 67.7% amlodipine/atorvastatin; 49.9% amlodipine + atorvastatin; 40.4% amlodipine + other statin; 46.9% other CCB + atorvastatin; 37.4% other CCB +other statin. After adjusting for treatment selection and cohort differences, odds ratios for adherence with amlodipine/atorvastatin were 1.95 (95% confidence interval [CI], 1.80-2.13) vs amlodipine + atorvastatin, 3.10 (95% CI, 2.85-3.38) vs amlodipine + other statin, 2.06 (95% CI, 1.89-2.24) vs other CCB + atorvastatin, 2.85 (95% CI, 2.61-3.10) vs other CCB + other statin (all p<0.0001). Single-pill amlodipine/atorvastatin may provide clinical benefits through improving adherence, offering clinicians a practical solution for cardiovascular risk management.

Effects of initial antihypertensive drug class on patient persistence and compliance in a usual-care setting in the United States.

Antihypertensive treatment regimen persistence and compliance were measured using a retrospective cohort study of pharmacy claims data. Newly treated patients receiving monotherapy with angiotensin II receptor blockers (ARBs), angiotensin-converting enzyme inhibitors (ACEIs), calcium channel blockers (CCBs), beta-blockers (BBs), or diuretics were followed for 1 year (N=242,882). A higher proportion of ARB patients (51.9%) were persistent in taking prescribed medication compared with those in the ACEI (48.0%), BB (40.3%), CCB (38.3%), and diuretic groups (29.9%). Compared with patients receiving diuretics, those receiving ARBs (hazard ratio [HR], 0.593; P<.0001), ACEIs (HR, 0.640; P<.0001), CCBs (HR, 0.859; P<.0001), and BBs (HR, 0.819; P<.0001) were all less likely to discontinue therapy. Compliance was similar in ACEI and ARB patients, but patients receiving ARBs and ACEIs had better compliance than those receiving BBs, CCBs, or diuretics. The lesser degree of compliance and persistence observed in patients receiving diuretics compared with other antihypertensive medications may have public health as well as cost implications.

The effect of switching on compliance and persistence: the case of statin treatment.

OBJECTIVE: To determine the effect of switching drugs on the compliance and persistence of new statin users. STUDY DESIGN: Retrospective database analysis of pharmacy claims provided by a large pharmacy benefit manager. The study sample consisted of 38 866 new statin users 18 to 65 years old beginning treatment with atorvastatin calcium, fluvastatin sodium, lovastatin, pravastatin sodium, or simvastatin. METHODS: Compliance was measured by the "medication possession ratio," and persistence was measured by the time to discontinuation. Switching rates were derived from the proportions of patients filling a prescription other than the initial statin. RESULTS: Patients who switched statins were less compliant by 18.9% (odds ratio, 0.81; P < .001), as defined by the probability of having a medication possession ratio of 0.8 or higher, and were less persistent by 20.9% to 48.3% (P < .001) depending on the gap length used to define discontinuation. CONCLUSIONS: Switching statins substantially reduces the likelihood that patients will be compliant and remain on treatment long enough to obtain the full benefit of statin treatment. To ensure better compliance, special care should be given to patients who change drugs.

The impact of unrecognized bipolar disorders for patients treated for depression with antidepressants in the fee-for-services California Medicaid (Medi-Cal) program.

BACKGROUND: This study compares hospital use, suicide risk and health care costs of antidepressant patients with recognized bipolar disorders (recognized-BP) and unrecognized bipolar disorders (unrecognized-BP) with non-bipolar (non-BP) patients. METHODS: Data from the California Medicaid (Medi-Cal) program were used to identify 25,460 adults with a new episode of antidepressant therapy. Recognized-BP patients received either a bipolar (BP) diagnosis or a mood stabilizer (MS) on or before the initiation of antidepressant therapy. Unrecognized-BP patients received a BP diagnosis or MS therapy after antidepressant initiation. Non-BP patients had no BP diagnosis and no MS use. Multivariate models were used to estimate marginal risks and costs across groups. RESULTS: Recognized-BP and unrecognized-BP represented 14.9% and 6.2% of all antidepressant users, respectively. Less than half of recognized-BP patients used a MS medication in conjunction with their antidepressant. Unrecognized-BP patients were nearly four times more likely to attempt suicide and 50% more likely to be hospitalized than non-BP patients. Recognized-BP patients were at lower risk for attempted suicide and hospitalization relative to unrecognized-BP patients. Unrecognized-BP patients experienced higher 1-year total costs relative to non-BP patients (USD 995, p<0.01) and recognized-BP patients (USD 682, p<0.05). LIMITATIONS: Clinically relevant medical records data were not available making the classification of patients as unrecognized-BP, recognized-BP and non-BP imprecise. CONCLUSIONS: Unrecognized-BP is both common and costly. More than half of all recognized-BP patients do not use an MS at the time they initiated antidepressant therapy. More effort is needed to provide early and correct diagnosis and effectively treat both recognized-BP and unrecognized-BP patients.

Compliance with drug therapies for the treatment and prevention of osteoporosis.

OBJECTIVES: This study used paid claims data from real-world treatment settings to investigate the impact of hormone replacement therapy (HRT), bisphosphonate and raloxifene on patients with a recorded diagnosis of osteoporosis. METHODS: Data from a large health insurer were used to identify 58,109 osteoporosis patients who initiated drug therapy for osteoporosis. Multivariate statistical models were developed for duration of therapy, compliance at 1 year, time to discontinuation or a change in therapy, health care costs and risk of fracture over 1 year. RESULTS: One-year compliance rates were below 25% for all osteoporosis therapies. The mean unadjusted duration of continuous therapy was 221 days for raloxifene, 245 days for bisphosphonate, 262 for estrogen-only and 292 days for estrogen plus progestin. Raloxifene patients were consistently less compliant than estrogen-only patients after adjusting for differences in patient characteristics. Estrogen plus progestin patients were generally more compliant while bisphosphonate did not differentiate from estrogen-only. Compliance reduced the risk of hip fracture (o.r. = 0.382, P < 0.01) and vertebral fracture (o.r. = 0.601, P < 0.05). Compliant patients used fewer physicians services (-US dollars 56, P < 0.0001), hospital outpatient services (-US dollars 38, P < 0.05) and hospital care (-US dollars 155, P < 0.01). Bisphosphonate patients were twice as likely as estrogen-only patients to experience vertebral, Colles and other fractures and experienced higher health care costs (+US dollars 420, P < 0.01). The effectiveness of both raloxifene and bisphosphonate medications relative to estrogen-only improved significantly with the age of the patient. CONCLUSIONS: Compliance with drug therapies for osteoporosis over 1 year is poor leaving patients at risk for fractures and higher health care costs.

The demand for statin: the effect of copay on utilization and compliance.

Increasing drug costs in the US have prompted employers and insurers alike to turn to higher drug copays for cost containment. The effect of rising copays on compliance with statins (HMG-CoA reductase inhibitors) treatment has received surprisingly little attention in the applied literature. This paper uses pharmacy claims data from a commercially insured adult population to determine the effect of copay change on compliance at the individual level. Fixed effect logit and Poisson regressions estimate the effect of copays on monthly likelihood of high compliance and average monthly days of supply respectively. Higher copays reduce compliance among statin users, with less compliant patients responding more strongly to copay change than compliant patients. These results suggest that specific financial incentives given to less compliant patients could improve compliance with statin treatment at a relatively low cost.

Impact of disease management on utilization and adherence with drugs and tests: the case of diabetes treatment in the Florida: a Healthy State (FAHS) program.

OBJECTIVE: The purpose of this study was to evaluate the effect of telephonic care management within a diabetes disease management program on adherence to treatment with hypoglycemic agents, ACE inhibitors (ACEIs), angiotensin receptor blockers (ARBs), statins, and recommended laboratory tests in a Medicaid population. RESEARCH DESIGN AND METHODS: A total of 2,598 patients with diabetes enrolled for at least 2 years in Florida: A Healthy State (FAHS), a large Medicaid disease management program, who received individualized telephonic care management were selected if they were eligible for at least 12 months before and 12 months after beginning care management. Patients were matched one-to-one on all baseline characteristics to 2,598 control patients. The impact of care management on utilization and adherence rates for diabetes-related medications and tests was analyzed with the difference-in-difference estimator. RESULTS: Changes in utilization were evaluated separately for those who were characterized as adherent to treatment at baseline ("users") and those who were not ("nonusers"). Both groups achieved significant improvement in adherence between baseline and follow-up. Nonusers increased their overall hypoglycemic use by 0.7 script (P < 0.001), by 0.7 script for ACEIs and statins (both P < 0.001), by 0.8 test for A1C (P < 0.001), and by 0.7 test for lipids (P < 0.001). Users increased hypoglycemic use by 1.5 scripts (P < 0.001) and insulin use by 0.9 script (P < 0.001). CONCLUSIONS: The FAHS telephonic care management intervention effectively induced Medicaid patients with diabetes to begin treatment and improved adherence to oral hypoglycemic agents and recommended tests. It also substantially improved adherence among baseline insulin users.

Impact of rofecoxib withdrawal on cyclooxygenase-2 utilization among patients with and without cardiovascular risk.

OBJECTIVE: To compare how cyclooxygenase-2 (COX-2) users with and without cardiovascular (CV) risks responded to the withdrawal of rofecoxib on September 30, 2004. METHODS: The data, from a pharmacy claims database, consisted of patients who filled at least one prescription for a COX-2 agent in the 6 months before September 30, 2004 (n = 32,898) or September 30, 2003 for the control cohort (n = 37,930). Baseline drug utilization was used to determine comorbidities, and CV risk status was assessed with surrogate pharmacy markers. The first difference estimator was used to compare changes in utilization after September 30, 2004 with changes in utilization in a control cohort of patients who were treated with COX-2 over a similar time frame in 2003/2004. RESULTS: The reduction in COX-2 utilization depended on baseline CV risk status. Among celecoxib and valdecoxib users, patients without CV risks reduced their utilization of COX-2, as measured by days of supply, by between 16.2% and 22.7%. The reduction was 32% for patients with one CV risk marker and 55.8% for patients with three or more markers, a proxy for the severity of CV risk. The corresponding figures for rofecoxib users were 47.5% (no CV risk), 55.4% (one marker) and 64.8% (three or more markers). CONCLUSIONS: Our results suggest that patients and physicians used newly available information about COX-2 inhibitor agents and their side effects to reduce treatment. They also provide support for the notion that patients and providers were discriminating in their response to new information as a significant proportion of patients remained on treatment after extensive publicity concerning potential risks.