A large observational study of cardiovascular outcomes associated with atorvastatin or simvastatin therapy in hypertensive patients without prior cardiovascular disease.

The objective of this study was to examine whether differences in effectiveness exist between statins in hypertensive patients seen in clinical practice. We assessed cardiovascular (CV) outcomes in hypertensive patients without cardiovascular disease who began therapy with atorvastatin (10 or 20 mg/d) or simvastatin (20 or 40 mg/d) between January 1, 2003, and September 30, 2005, using claims data from 92 US managed care plans in the PharMetrics database. A total of 98,471 hypertensive patients were identified, comprising 74,685 atorvastatin users (mean dose 13.6 mg/d) and 23,786 simvastatin users (mean dose 28.6 mg/d), and followed a median 1.5 years for the occurrence of a first CV event. The crude CV event rates were 2.81 and 3.92 per 100 person-years for atorvastatin and simvastatin, respectively [unadjusted hazard ratio (HR): 0.73; 95% confidence interval (CI): 0.68-0.78, P < 0.001]. After adjusting for clinical and demographic confounders, use of atorvastatin was associated with fewer CV events compared with simvastatin (HR: 0.91; 95% CI: 0.84-0.98, P = 0.009). However, the lipid-lowering efficacy of the 2 statins could not be assessed as patient lipid data were unavailable. In conclusion, hypertensive patients without cardiovascular disease who initiated atorvastatin (10 or 20 mg/d) had a significantly lower risk of subsequent CV events compared with those who initiated simvastatin at doses of similar potency (20 or 40 mg/d). As with all observational studies, the study is subject to certain limitations, and the findings should be regarded as hypothesis generating.

Predictors of discontinuing overactive bladder medications.

OBJECTIVE: To identify predictors of self-reported discontinuation of overactive bladder (OAB) medication using a three-phase survey. PATIENTS AND METHODS: In January 2005, a phase 1 survey was sent to 260 000 households in the USA to assess the prevalence of OAB symptom bother, treatment patterns and healthcare consulting behaviour. In July 2005, a detailed phase 2 follow-up survey was sent to 6577 phase 1 respondents who had used one or more OAB medications within the 12 months before phase 1; the phase 2 survey included questions about respondents' sociodemographic characteristics, general health status, OAB symptom bother, healthcare consulting behaviour, beliefs about OAB and treatment options, and medication usage. Six months later, a phase 3 survey was sent to 3387 phase-2 respondents who were persistent with OAB medication or had discontinued within <18 months of phase 2; the phase 3 survey measured the same variables as phase 2. Only phase 3 respondents who were persistent with OAB medication at phase 2 were included in the analyses reported here. Assessed were the proportions of respondents who were still persistent with OAB medication at phase 3 and who discontinued OAB medication between phases 2 and 3. The variables measured during the phase 2 survey were screened as potential predictors of discontinuation at phase 3 using univariate analysis and then assessed using multivariate logistic regression. RESULTS: Among 2838 respondents at phase 3 (84% response rate), 1194 had recently discontinued and 1644 were persistent with medication at phase 2. Among phase-3 respondents who were persistent at phase 2, 1040 (66%) continued to be persistent at phase 3, 280 (18%) had discontinued between phases 2 and 3, and 261 (17%) had switched medication between phases 2 and 3; 63 respondents had missing prescription information at phase 3. Predictors of discontinuing at phase 3 included smoking (odds ratio 1.80; 95% confidence interval 1.15-2.83; P = 0.010), not knowing whether treating bladder problems requires multiple daily doses of medication (1.71, 1.10-2.67; P = 0.018), believing (2.11, 1.34-3.33; P = 0.001) or not knowing (1.76, 1.23-2.52; P = 0.002) whether adverse effects of OAB medications are often severe, and being bothered 'quite a bit or more' by a sudden urge to urinate (1.54, 1.05-2.26; P = 0.028). Respondents taking two or more medications were less likely to discontinue (odds ratio 0.45-0.58; P < 0.05). CONCLUSION: Persistence with OAB medications might be improved by addressing predictors of discontinuation in the management of OAB, by proactively informing patients about the severity of antimuscarinic adverse effects, and dosing regimens. Bother associated with the key OAB symptom, urgency, is a predictor of discontinuation of treatment.

Patient-reported reasons for discontinuing overactive bladder medication.

OBJECTIVE: To evaluate patient-reported reasons for discontinuing antimuscarinic prescription medications for overactive bladder (OAB). PATIENTS AND METHODS: A phase 1 screening survey was sent to a representative sample of 260 000 households in the USA to identify patients using antimuscarinic agents for OAB. A detailed phase-2 follow-up survey was sent to 6577 respondents with one or more antimuscarinic prescriptions for OAB in the 12 months before the phase 1 survey. The follow-up survey included questions about demographics, clinical characteristics, antimuscarinic use, beliefs about OAB, treatment expectations, OAB symptom bother, and pre-coded reasons for discontinuation. Patients who reported discontinuing one or more OAB medication during the 12 months before phase 2 were grouped by reason, using latent class analysis (LCA); the Lo-Mendell-Rubin likelihood statistical test was used to determine the number of classes. Conditional probabilities of reasons for discontinuation were calculated for each class. Multivariable logistic regression was used to assess the influence of demographic and clinical characteristics on class assignment. RESULTS: In all, 162 906 (63%) and 5392 (82%) useable responses were returned in phases 1 and 2, respectively; the demographics were similar in respondents and nonrespondents in both phases. In all, 1322 phase 2 respondents (24.5%) reported discontinuing one or more antimuscarinic drugs during the 12 months before phase 2. LCA identified two classes (Lo-Mendell-Rubin statistic, P = 0.01) based on reasons for discontinuation. Most respondents (89%) reported discontinuing OAB medication primarily due to unmet treatment expectations and/or tolerability; many respondents in this class switched to a new antimuscarinic agent. A smaller group (11%) indicated a general aversion to taking medication. Age, sex, race, income, and history of incontinence were not predictive of class assignment. CONCLUSIONS: Expectations about treatment efficacy and side-effects are the most important considerations in discontinuing OAB medications for most patients. Interventions to promote realistic expectations about treatment efficacy and side-effects might enhance adherence.

Does a single-pill antihypertensive/lipid-lowering regimen improve adherence in US managed care enrolees? A non-randomized, observational, retrospective study.

BACKGROUND: A previous study in 4703 patients suggested that a single-pill combination of amlodipine and atorvastatin is associated with greater adherence to therapy than a two-pill calcium channel antagonist (calcium channel blocker [CCB]) and HMG-CoA reductase inhibitor (statin) regimen. However, the impact of prior medication use on the potential adherence benefits of single-pill amlodipine/atorvastatin has not been studied. OBJECTIVE: To compare adherence to single-pill amlodipine/atorvastatin versus two-pill CCB + statin regimens in a large managed care population, stratified according to prior CCB and statin use. METHODS: This retrospective study was conducted among managed care enrolees in the US. Patients included in the analysis had to have a pharmacy claim for single-pill amlodipine/atorvastatin or claims for both a CCB and a statin within any 30-day window between April 2004 and April 2005. Adherence was measured over 6 months following the index date (the date of the first single-pill amlodipine/atorvastatin claim or of the claim for the second medication class for any two-pill CCB + statin regimen) as the proportion of days covered (PDC) by both CCB and statin therapy; patients were considered 'adherent' if PDC was > or =80%. Patients were divided into four cohorts based on pre-index CCB and statin use: (i) naive (CCB)/naive (statin); (ii) experienced (CCB)/naive (statin); (iii) naive (CCB)/experienced (statin); and (iv) experienced (CCB)/experienced (statin). Within each cohort, adherence was compared for patients receiving single-pill amlodipine/atorvastatin versus two-pill amlodipine + atorvastatin or other two-pill CCB + statin regimens (including amlodipine or atorvastatin but not both) at index. Multivariable logistic regression with propensity score weighting was used to adjust for covariates, including age, sex and co-morbidities. RESULTS: In total, 35,430 patients were included in the analysis. At month 6 (after adjusting for covariates), patients in the experienced (CCB)/naive (statin) cohort receiving single-pill amlodipine/atorvastatin were more than twice as likely to be adherent as those receiving two-pill amlodipine + atorvastatin (odds ratio [OR] 2.20; p < 0.0001) or other two-pill CCB + statin regimens (OR 2.75; p < 0.0001). Similarly, patients in the naive (CCB)/experienced (statin) cohort receiving single-pill amlodipine/atorvastatin were more likely to be adherent than those receiving two-pill amlodipine + atorvastatin (OR 1.72; p < 0.0001) or other two-pill CCB + statin regimens (OR 2.81; p < 0.0001). In contrast, in the naive (CCB)/naive (statin) cohort there was no significant difference in adherence between patients receiving single-pill amlodipine/atorvastatin versus two-pill amlodipine + atorvastatin (OR 1.00), although patients receiving single-pill amlodipine/atorvastatin were slightly more likely to be adherent than those receiving other two-pill CCB + statin regimens (OR 1.29; p < 0.01). In the experienced (CCB)/experienced (statin) cohort there was also no significant difference between patients receiving single-pill amlodipine/atorvastatin versus two-pill amlodipine + atorvastatin (OR 1.08), and only a slightly greater likelihood of achieving adherence to single-pill amlodipine/atorvastatin versus other two-pill CCB + statin regimens (OR 1.19; p < 0.01). CONCLUSIONS: This large retrospective study confirms previous observations that single-pill amlodipine/atorvastatin can help improve adherence versus two-pill CCB + statin regimens. However, greater improvements in adherence are likely to be observed in patients with prior experience of either CCB or statin therapy than in those either naive to, or experienced with, both therapies.

Bother related to bladder control and health care seeking behavior in adults in the United States.

PURPOSE: We measured patient reported bother due to overactive bladder syndrome, patterns of physician consultation and prescription medication use for overactive bladder symptoms in adults in the United States. MATERIALS AND METHODS: A survey sample was derived from a consumer panel of 600,000 American households developed to match the United States Census of 260,000 adults. The survey included the Overactive Bladder-Validated 8 awareness tool, which includes 8 questions that measure the degree of bother due to specific bladder symptoms. A score of 8 or greater denotes probable overactive bladder. Additional questions probed treatment patterns, health care consultation, overactive bladder diagnosis, treatment type and prescription treatment used. A nonrespondent telephone survey in 1,004 participants was done to evaluate differences between mail survey respondents and nonrespondents. RESULTS: The response rate was 63% (162,906 respondents). Women represented 55.1% of the sample and 21.8% of respondents were 65 years old or older. Symptom bother, as determined by an Overactive Bladder-Validated 8 score of 8 or greater, was reported by 26.6% of the total sample, including 23.7% of men and 28.9% of women. The percent of men and women reporting bother increased with age. Of respondents with probable overactive bladder only 45.7% had discussed the symptoms with a medical provider, 22.5% had previously used prescription medication for overactive bladder, 13.5% had used overactive bladder medication in the last 12 months and 8.1% were currently on treatment. CONCLUSIONS: A substantial proportion of adults in the United States reported some degree of bother due to overactive bladder symptoms. The degree of bother was associated with age and gender. Overall less than half of patients with probable overactive bladder discussed the symptoms with a health care provider. A small proportion was prescribed medication and an even smaller proportion was currently on treatment.

Transition probabilities and predictors of adherence in a California Medicaid population using antihypertensive and lipid-lowering medications.

OBJECTIVES: To determine adherence rates, transition probabilities, and factors associated with transition from higher to lower adherence in antihypertensive (AH) and lipid-lowering (LL) medications. METHODS: California Medicaid data (1995-2003) were used to identify hypertensive patients with prescriptions for both AH and LL medications. Proportion of days covered (PDC) was used to define three adherence classifications: fully adherent (FA, PDC >or= 0.8), partially adherent (PA, 0.2

The clinical and economic burden of nonadherence with antihypertensive and lipid-lowering therapy in hypertensive patients.

OBJECTIVE: We sought to determine lifetime costs, morbidity, and mortality associated with varying adherence to antihypertensive and 3-hydroxy-3-methylglutaryl-coenzyme A reductase inhibitors (statin) therapy in a hypertensive population. METHODS: A model was constructed to compare costs and outcomes under three adherence scenarios: no treatment, ideal adherence, and real-world adherence. Simulated patients' characteristics matched those of participants in the Anglo-Scandinavian Cardiac Outcomes Trial-Lipid-Lowering Arm and event probabilities were calculated with Framingham Heart Study risk equations. The real-world adherence scenario employed adherence data from an observational study of a US population; risk reductions at each level of adherence were based on linear extrapolations from clinical trials. Outputs included life expectancy, frequencies of primary and secondary coronary heart disease and stroke, and direct medical costs in 2006 US$. The incremental cost per life-year gained and incremental cost per event avoided were calculated comparing the three adherence scenarios. RESULTS: Mean life expectancy was 14.73 years (no-treatment scenario), 15.07 (real-world adherence), and 15.49 (ideal adherence). The average number of cardiovascular events per patients was 0.738 (no treatment), 0.610 (real-world adherence), and 0.441 (ideal adherence). The incremental cost of real-world adherence versus no treatment is $30,585 per life-year gained, and ideal adherence versus real-world adherence is $22,121 per life-year gained. CONCLUSIONS: Hypertensive patients taking antihypertensive and statin therapy at real-world adherence levels can be expected to receive approximately 50% of the potential benefit seen in clinical trials. Depending on its cost, the incremental benefits of an effective adherence intervention program could make it an attractive value.

Are high-risk hypertensive patients being prescribed concomitant statin therapy?: a retrospective cohort study.

BACKGROUND: Treatment guidelines for dyslipidemic patients have focused on lipid levels and risk assessments. However, normolipidemic patients who have multiple risk factors for cardiovascular disease may also benefit from HMG-CoA reductase inhibitor (statin) therapy. OBJECTIVE: We examined the frequency of statin prescriptions in patients initiating antihypertensive drug treatment in a US managed-care setting. STUDY DESIGN AND PATIENT: This retrospective cohort study used the PharMetrics' Patient-Centric Database to identify enrollees initiating antihypertensive treatment (September 2001 to February 2004). Patients newly treated with antihypertensives and with various levels of coronary heart disease (CHD) risk (including dyslipidemia, established CHD, type 2 diabetes mellitus, and no CHD but three or more cardiovascular risk factors) were included in the study. MAIN OUTCOME MEASURE: Cumulative probability of receiving statin therapy each month after antihypertensive initiation. Multivariable logistic regression was used to identify factors associated with receiving concomitant statin therapy. RESULTS: Of 142 389 patients (mean age 51.7 years) newly treated with antihypertensives, 32 056 (22.5%) were prescribed statins within 1 year. The cumulative probability of being prescribed a statin increased with increasing numbers of CHD risk factors, irrespective of dyslipidemia status. After adjusting for age, sex, and other potential predictors, patients were more likely to receive statin therapy if they had a history of dyslipidemia (adjusted odds ratio [AOR] 5.68 [95% CI 5.52, 5.85]), established CHD/congestive heart failure (AOR 3.39 [95% CI 3.16, 3.63]), or three or more additional cardiovascular risk factors but no CHD (AOR 3.01 [95% CI 2.74, 3.30]). CONCLUSION: Among patients beginning antihypertensive treatment, those with established CHD or CHD risk factors were more likely to receive statins, but a substantial fraction did not fill any statin prescription. The increased use of statin therapy could benefit many hypertensive patients with additional CHD risk factors.

Comparing adherence and persistence across 6 chronic medication classes.

BACKGROUND: The National Quality Forum recently endorsed the proportion of days covered (PDC)-a measure of medication adherence-as an indicator of quality in drug therapy management. OBJECTIVE: To inform initial efforts to improve the quality of drug therapy management, we compared PDC and persistence among new users of 6 commonly used chronic medication categories. METHODS: A retrospective analysis of pharmacy claims in a database of more than 64 million members enrolled in 100 health plans assessed persistence and adherence to drug therapy in 6 chronic conditions. Patients were included in the analysis if they initiated a prescription drug of interest in any of 6 drug classes-prostaglandin analogs, statins, bisphosphonates, oral antidiabetics, angiotensin II receptor blockers (ARBs), and overactive bladder (OAB) medications-between January 1 and December 31, 2005. The first claim for a drug of interest during this period was considered a patient's index date. Patients were required to have a minimum of 12 months of continuous enrollment both preceding and following their index date. New users of a treatment were identified by excluding patients who filled a prescription for any drug in the same class during the previous 12 months and were followed for a minimum of 12 months. Nonpersistence was defined as discontinuation of the therapy class following an allowed gap between refills-30-, 60-, and 90-day refill gaps were used. Adherence was defined as a continuous measure of the proportion of days covered (PDC) during the 12-month post-index period. Logistic regression analyses predicted (a) nonpersistence during the 12-month post-index period and (b) adherence (PDC) of at least 80%, with drug class as the predictor variable of interest, controlling for demographic variables, insurance and plan type, history of hospitalization, Charlson comorbidity score, copayment for index medication, and number of medications at index. RESULTS: A total of 167,907 patients were identified across 6 cohorts. Using the 60-day gap, 6-month persistence rates were prostaglandin analogs 47%, statins 56%, bisphosphonates 56%, oral antidiabetics 66%, ARBs 63%, and OAB medications 28%. After the first 90 days of therapy, relative persistence was stable across cohorts, and rates declined consistently from 6 months post-index to study end. Logistic regression models showed that oral antidiabetic users had a 59%, 36%, 37%, and 79% decreased risk of nonpersistence in a 12-month follow-up period compared with patients taking prostaglandin analogs, statins, bisphosphonates, or OAB medications, respectively. Risk of nonpersistence decreased with increasing age. Mean (SD) 12-month adherence rates were: prostaglandin analogs 37% (26%), statins 61% (33%), bisphosphonates 60% (34%), oral antidiabetics 72% (32%), ARBs 66% (32%), and OAB medications 35% (32%). Logistic regression indicated that oral antidiabetic use was a significant predictor of adherence (PDC) of at least 80% compared with other therapy classes. Adjusted odds ratios for oral antidiabetics were 17.60 (95% confidence interval [CI] = 15.38-20.14) versus prostaglandin analogs, 2.06 (95% CI = 1.99-2.12) versus statins, 1.92 (95% CI = 1.83-2.02) versus bisphosphonates, 1.29 (95% CI = 1.24-1.34) versus ARBs, and 5.77 (95% CI = 5.38-6.19) versus OAB medications. CONCLUSION: This analysis of adherence (PDC) and persistence across a sample of 6 chronic therapies found variable but uniformly suboptimal medication use. Adherence to prostaglandin eye drops and OAB medications was lower than to cardiovascular, oral antidiabetic, and oral osteoporosis therapies. These findings provide useful baseline information for the development of initiatives to improve the quality of drug therapy management.

Predictors of adherence to concomitant antihypertensive and lipid-lowering medications in older adults: a retrospective, cohort study.

BACKGROUND: Many older individuals have concomitant hypertension and dyslipidaemia--two conditions that, together with age, increase the risk of adverse cardiovascular events. Adherence to antihypertensive (AH) and lipid-lowering (LL) therapy is therefore particularly important in older patients with concomitant hypertension and dyslipidaemia. OBJECTIVE: To determine patterns and predictors of adherence to concomitant AH and LL therapy among an older Medicare-eligible population. METHODS: Enrolees (n=4052) aged>or=65 years who initiated treatment with both AH and LL therapy within a 90-day period were studied in this retrospective cohort study conducted in a US managed care organization. Adherence to AH and LL medications was measured as the proportion of days covered by any AH and/or LL medication in each 3-month interval, from the start of concomitant therapy for up to 36 months (mean follow-up 19.5 months). In each interval, patients were considered 'adherent' to AH and LL therapy if they had filled prescriptions sufficient to cover>or=80% of days with both medication classes. A multivariable regression model evaluated potential predictors of adherence to concomitant therapy, including patient demographics, clinical characteristics and health services use patterns at baseline. RESULTS: The percentage of patients adherent to both AH and LL therapy declined rapidly, before stabilizing, with 40.5%, 32.7% and 32.9% adherent at 3, 6 and 12 months, respectively. At each timepoint, an additional 27.8-35.0% of patients were adherent to either AH or LL therapy, but not both. Adherence was on average greater to AH than LL therapy. After adjusting for age, sex and other potential predictors, patients were more likely to be adherent if AH/LL therapies were initiated closer together in time (adjusted odds ratio [AOR] 1.13 for 0-30 days vs 61-90 days, p=0.0563), had a history of cardiovascular disease (AOR 1.27, p=0.0004), took fewer additional medications (AOR 0.43 for six or more medications vs zero or one medication, p<0.0001) or had more outpatient physician visits in the prior year (AOR 1.26 for four to six visits vs zero to one visit, p<0.0027). CONCLUSION: Adherence to concomitant AH and LL therapy among older adults is poor. Modifiable factors that may improve adherence in Medicare-eligible patients include initiating therapy concurrently and reducing patients' overall pill burden.

Rationale, design, and methods for the risk evaluation and communication health outcomes and utilization trial (REACH OUT).

OBJECTIVE: To test the primary study hypothesis that a physician-delivered coronary heart disease risk evaluation and communication program can lower patients' predicted 10-year risk of myocardial infarction or death due to coronary heart disease by 10% within 6 months compared to usual care. DESIGN: Prospective, parallel group, open-label, controlled, cluster-randomized multinational trial; the study site is the unit of randomization. SETTING: Patients were recruited from 106 general practices located in nine European countries. PATIENTS: Men and women aged 45 to 64 (N=1500) with a documented history of hypertension (treated or untreated), systolic blood pressure > or =140 mmHg (or > or =130 mmHg in the presence of renal or kidney disease), no history of cardiovascular disease, and a predicted 10-year risk of myocardial infarction or death due to coronary heart disease > or =10%. INTERVENTION: Sites were randomized to deliver a physician-directed coronary heart disease risk communication and education program or usual care. The intervention program included informing patients of their 10-year risk of myocardial infarction or death due to coronary heart disease, educating patients about modifiable risk factors and their control, and three follow-up phone calls by a physician or study nurse. MAIN OUTCOME MEASURE: Predicted 10-year risk of myocardial infarction or death due to coronary heart disease at 6 months. CONCLUSIONS: REACH OUT will evaluate a novel, patient-focused, physician-implemented application of coronary heart disease risk equations. Results of the study will be of practical relevance to physicians, health care organizations, and those who issue clinical guidelines for the reduction of cardiovascular risk.

Assessing health state utilities in elderly patients at cardiovascular risk.

BACKGROUND: Health state preferences can be a crucial component of cost-effectiveness analyses, but off-the-shelf health state utilities specifically for older people are not available. OBJECTIVES: Among participants in PROSPER, a trial of pravastatin in patients>70 years, the authors assessed utilities for the health states that were relevant for the trial's cost-utility analysis. SUBJECTS AND METHODS: The authors cross-sectionally administered the Health Utilities Index, Mark 3 (HUI) to all PROSPER participants to assess each patient's health state at the time of interview; they then used the scale's multiattribute utility function to estimate the resulting utilities. The population was then stratified into 3 health states, and the mean utility function for each was calculated: recent myocardial infarction (MI, within 3 months), previous MI (>3 months), or no prior MI. Linear and logistic regression were used to control for potential demographic and clinical characteristics. RESULTS: Of the 5804 patients enrolled in the trial, 4677 were administered the HUI instrument. The likelihood of having a complete HUI response set decreased with higher age (P<0.001) but not with the other variables studied. A complete utility score could be calculated for 3390 participants. Of these, 2755 (81.3%) had no history of MI, 546 (16.1%) had an MI>3 months previously, and 89 (2.6%) had an MI within 3 months. The mean (median) utilities were virtually identical for these states: 0.75 (0.84), 0.74 (0.84), and 0.74 (0.84), respectively. From multivariate analyses, utilities decreased with higher age and the presence of several other comorbidities (diabetes, stroke, peripheral vascular disease); women had lower utilities than men (all P<0.01). CONCLUSIONS: In this large implementation of the HUI in elderly patients, the instrument did not detect any differences in estimated utilities related to having a MI. Potential causes of nondiscrimination for MI include the possibility that competing comorbidities may reduce the impact of MI on quality of life in this age group, as well as the possibility that a standard instrument derived from and validated in younger populations may not perform as well in elderly people.

Predictors of adherence with antihypertensive and lipid-lowering therapy.

BACKGROUND: Patients with comorbid hypertension and dyslipidemia are at high risk for cardiovascular disease, which can be considerably mitigated by treatment. Adherence with prescribed drug therapy is, therefore, especially important in these patients. This study was undertaken to describe the patterns and predictors of adherence with concomitant antihypertensive (AH) and lipid-lowering (LL) therapy. METHODS: This retrospective cohort study examined 8406 enrollees in a US managed care plan who initiated treatment with AH and LL therapy within a 90-day period. Adherence was measured as the proportion of days covered in each 3-month interval following initiation of concomitant therapy (mean follow-up, 12.9 months). Patients were considered adherent if they had filled prescriptions sufficient to cover at least 80% of days with both classes of medications. A multivariate regression model evaluated potential predictors of adherence. RESULTS: The percentage of patients adherent with both AH and LL therapy declined sharply following treatment initiation, with 44.7%, 35.9%, and 35.8% of patients adherent at 3, 6, and 12 months, respectively. After adjustment for age, sex, and other potential predictors, patients were more likely to be adherent if they initiated AH and LL therapy together, had a history of coronary heart disease or congestive heart failure, or took fewer other medications. CONCLUSIONS: Adherence with concomitant AH and LL therapy is poor, with only 1 in 3 patients adherent with both medications at 6 months. Physicians may be able to significantly improve adherence by initiating AH and LL therapy concomitantly and by reducing pill burden.

Gauging the treatment gap in dyslipidemia: findings from the 1999-2000 National Health and Nutrition Examination Survey.

BACKGROUND: Despite published guidelines and availability of many effective lipid-altering therapies, dyslipidemia in the United States remains largely underdiagnosed and undertreated. METHODS: This study used data from the 1999-2000 National Health and Nutrition Examination Survey to assess the current state of dyslipidemia management in the US adult population compared with guidelines issued by the Third Adult Treatment Panel of the National Cholesterol Education Program. Percentages were weighted to reflect population estimates, computed using SUDAAN (Research Triangle Institution, Cary, NC). RESULTS: Among 1,425 respondents aged > or = 20 years with complete data, 29.5% were eligible for therapeutic lifestyle changes (TLCs, 16.0%) or lipid-lowering drug therapy (LDT, 13.4%). Among high-risk adults, 79.3% were eligible for either TLC (35.7%) or LDT (43.6%). Only 43.7% of treatment-eligible adults reported ever being diagnosed with dyslipidemia. Of those diagnosed, 77.4% reported being told to undertake TLC, and 34.2% reported being told to take LDT. Of adults eligible for drug therapy, the average percentage reduction in low-density lipoprotein cholesterol (LDL-C) required to reach goal was 28.0% (standard error [SE] 1.1), and 41.9% required a reduction of > 30% in LDL-C to reach goal. Of high-risk adults eligible for drug therapy, the average required reduction was 36.9% (SE 1.4), and 76.3% required a reduction of > 30% in LDL-C. CONCLUSIONS: Despite advances in dyslipidemia therapy and changes in guidelines over the last decade, LDL-C continues to be inadequately managed among US adults. Of particular concern is the undertreatment of high-risk patients and failure of many treated patients to achieve LDL-C goal.

Association between short-term effectiveness of statins and long-term adherence to lipid-lowering therapy.

PURPOSE: The relationship between low-density lipoprotein (LDL) cholesterol reduction in the first 3 months of statin therapy and medication adherence during a 33-month follow-up period was studied. METHODS: A retrospective cohort study was conducted among enrollees in a Southeastern managed care plan who started therapy with atorvastatin, fluvastatin, lovastatin, pravastatin, or simvastatin between October 1999 and August 2001, were enrolled for > or =12 months before and > or =6 months after treatment initiation, and had at least one LDL cholesterol measurement in the year before and 4-12 weeks after the start of therapy. Patients were followed up via electronic pharmacy and medical records for up to 33 more months. The follow-up period was divided into 3-month intervals; patients were considered adherent if statin therapy was available > or =80% of the time. A generalized linear model for repeated measures quantified the association between change in LDL cholesterol at 4-12 weeks and medication adherence in subsequent intervals, adjusting for demographic, clinical, and health-service-use variables. RESULTS: The final sample consisted of 9510 patients. Medication adherence decreased significantly over time: 59%, 40%, 34%, and 21% of patients were adherent at 3, 6, 12, and 36 months, respectively. Mean +/- S.D. LDL cholesterol reduction at 12 weeks was 28.9% +/- 19.9%. The relative LDL cholesterol reduction at 12 weeks was significantly and independently associated with subsequent medication adherence: Compared with subjects in the first quartile of LDL cholesterol reduction, those in quartiles 2, 3, and 4 were more likely to be adherent in any subsequent interval (adjusted odds ratio [95% confidence interval], 1.26 [1.12-1.42], 1.25 [1.11-1.40], and 1.15 [1.02-1.29], respectively). Other independent predictors of adherence in months 4-36 included adherence during the initial three months of therapy, age, and recent history of coronary revascularization. CONCLUSION: Greater reduction in LDL cholesterol levels during the first three months of statin therapy was associated with greater adherence to lipid-lowering drug therapy.

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

INTRODUCTION AND OBJECTIVE: The National Cholesterol Education Program recommends regular physician follow-up and lipid testing to promote adherence with lipid-lowering 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 > or = 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 follow-up 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.