Six-month length of stay associated with better recovery outcomes among residents of sober living houses.

Background: Sober living houses are designed for individuals in recovery to live with others in recovery, yet no guidelines exist for the time needed in a sober living house to significantly impact outcomes.Objectives: To examine how the length of stay in sober living houses is related to substance use and related outcomes, focusing on early discontinuation (length of stay less than six months) and stable residence (length of stay six months or longer).Methods: Baseline and 12-month data were collected from 455 sober living house residents (36% female). Longitudinal mixed models tested associations between early discontinuation vs. stable residence and abstinence, recovery capital, psychiatric, and legal outcomes. Final models were adjusted for resident demographics, treatment, 12-step attendance, use in social network, and psychiatric symptoms, with a random effect for house.Results: Both early discontinuers (n = 284) and stable residents (n = 171) improved significantly (Ps ≤ .05) between baseline and 12 months on all outcomes. Compared to early discontinuation, stable residence was related to 7.76% points more percent days abstinent (95% CI: 4.21, 11.31); 0.88 times fewer psychiatric symptoms (95% CI: 0.81, 0.94); 0.84 times fewer depression symptoms (95% CI: 0.76, 0.92); and lower odds of any DSM-SUD (OR = 0.65, 95% CI: 0.47, 0.89) and any legal problems (OR = 0.58, 95% CI: 0.40, 0.86).Conclusion: In this study of sober living houses in California, staying in a sober living house for at least six months was related to better outcomes than leaving before six months. Residents and providers should consider this in long-term recovery planning.

Measuring Architecture in Recovery Homes: Recovery Home Architecture Scale.

Background: The settings where we live shape our daily experiences and interactions. Social environment and physical setting characteristics may be particularly important in communal living services, such as recovery homes for alcohol and drug disorders. Objectives: This paper describes the measurement and mobilization of architectural characteristics in one type of recovery home, sober living houses (SLHs). The Recovery Home Architecture Scale (RHAS) is a 25-item measure comprised of six subscales designed to assess architecture in SLHs. Results: Using a sample of 528 individuals residing in 41 houses, we found the RHAS had good interrater reliability, factor structure, and internal consistency. The measure also showed modest construct validity. The RHAS was not associated with length of stay (LOS) but did interact with a measure of the social environment that predicted LOS, the Recovery Home Environment Scale (RHES). Conclusions: Future studies should include a more diverse sample of SLHs and assess how house management, recovery capital, and other factors work in concert with architecture.

Psychometric Properties of the Recovery Home Environment Scale.

BACKGROUND: Recovery homes for persons with alcohol and drug problems provide an abstinent living environment and social support for recovery. Research shows residents in these homes make significant, sustained improvements. However, descriptions of recovery environments within the homes have been limited. PURPOSE: The current study assessed psychometric properties for the Recovery Home Environment Scale (RHES), which assessed social environments within one type of recovery home, sober living houses (SLHs). METHODS: 373 residents were interviewed at entry into the house, 1-month follow-up, and 6-month follow-up. Measures included the RHES, other measures of the social environment, days of substance use, and length of stay. RESULTS: Principal components analysis suggested the RHES was largely unidimensional. Exploratory factor analysis suggested items could be grouped into recovery support (3 items) and recovery skills (5 items). Cronbach's alphas for the full scale and the recovery support and recovery skills subscales were 0.91, 0.89, and 0.87, respectively. As hypothesized, construct validity of the RHES was supported by correlations with other measures of the social environment and predictive validity was supported by associations with length of stay and substance use. CONCLUSIONS: SLHs have been described as "the setting is the service." However, the field has lacked a way to capture characteristics of the social environment. The RHES represents a new way to measure the recovery environment by focusing on social interactions among residents within SLHs and shared activities in the community.

Resident and house manager perceptions of social environments in sober living houses: Associations with length of stay.

AIMS: Studies have shown persons living in recovery homes for drug and alcohol problems make significant, sustained improvements. However, there is limited information about factors associated with outcomes. This study examined how perceptions of social environment of one type of recovery home, sober living houses (SLHs), were associated with length of stay (LOS). METHODS: SLH residents and their house managers (N = 416) completed the recovery home environment scale (RHES) that assessed social model recovery characteristics and the community-oriented program evaluation scale (CPES) that evaluated perceptions of the program environment. RESULTS: Scales completed by residents predicted LOS, but those completed by house managers did not. Larger discrepancies between the two groups were associated with shorter LOS. The RHES was shown to be a stronger predictor of LOS than the CPES. CONCLUSION: Results highlight the importance of the social environment in SLHs, particularly those most closely aligned with social model recovery principles.

House Manager Roles in Sober Living Houses.

BACKGROUND: Alcohol and drug treatment providers are increasingly emphasizing the role of long-term, community-based systems of care. A good example is Sober Living Houses (SLHs), which are peer operated alcohol- and drug-free living environments. Studies show residents of SLHs make significant improvements in multiple areas. However, little attention has been devoted to describing the critically important role of SLH managers who oversee these homes. METHODS: Thirty-five SLH managers completed interviews about the characteristics and operations of their houses, their activities as managers, and ways their own recovery was affected by their work. RESULTS: Managers reported widespread use of some but not all principles of social model recovery. Manager roles varied dramatically in terms of time spent managing houses, activities related to their roles, and training they received. Some reported extensive amounts of time proving support to residents, while others viewed their role as primarily administrative. CONCLUSIONS: Research is needed to understand reasons for manager differences, optimal manager functioning, and manager training needs. Research is also needed to assess whether different house characteristics require different manager roles.

Recovery Home Environment Characteristics Associated with Recovery Capital.

BACKGROUND: Recovery capital refers to internal and external resources that facilitate recovery from alcohol and drug disorders. Examples include support from friends and family, access to health and other services, stable housing and finances, and internal assets, such as self-esteem and motivation. Recovery capital is receiving increased emphasis as an integral component of addiction services. However, there are a limited number of studies assessing recovery capital in different settings. METHODS: The current study assessed recovery capital among 363 individuals entering sober living recovery homes (SLHs) and showed how recovery capital was associated with individual and social environment characteristics of the houses. Individual characteristics were assessed shortly after residents entered the house (mean=17 days, sd=9.0). Approximately one month later, individuals were interviewed about their perceptions of the social environment within the household. We hypothesized residents' perceptions of social model characteristics within the household would be associated with higher recovery capital. RESULTS: Study findings showed individual characteristics associated with recovery capital included motivation, support from friends and family, and 12-step involvement. Perceptions of the social environment assessed by four subscales on the Community Oriented Program Evaluation Scale and a measure of social model characteristics were correlated with recovery capital. Regression analyses controlling for individual characteristics showed modest, but consistent associations with recovery capital. CONCLUSION: Even after relatively short periods of time in SLHs, resident perceptions of the social environment show associations with recovery capital. Additional research is needed to understand causal dynamics of this relationship and associations with outcome.

Recovery in context: Sober living houses and the ecology of recovery.

Sober living houses (SLHs) are an increasingly common element of the recovery support services landscape, yet little is known about their neighborhood context. This study describes neighborhoods in which SLHs are located and examines differences by house characteristics. SLHs in Los Angeles County (N = 297) were geocoded and linked with U.S. Census, alcohol outlet, recovery resources, and accessibility data. Regression analyses tested differences by house characteristics. Co-ed houses were in neighborhoods that were less ethnically diverse and farther away from recovery resources. Larger house capacity was associated with increased density of off-premise alcohol outlets but also increased proximity to treatment. Higher fees were associated with lower neighborhood disadvantage and off-premise alcohol outlet density but the greater distance from treatment programs and other recovery resources. House characteristics are associated with neighborhood factors that both support recovery and place residents at risk.

Motivational Interviewing Case Management (MICM) for Persons on Probation or Parole Entering Sober Living Houses.

The failure of incarceration as a response to drug offenses has resulted in new policies supporting community-based alternatives. One challenge has been finding appropriate housing for persons on probation and parole. Sober living houses (SLHs) are alcohol- and drug-free living environments that are increasingly being used as housing options for these individuals. The current study examined 6- and 12-month outcomes for 330 persons on probation or parole who entered 49 SLHs. Residents in 22 houses (n = 149 individuals) were randomly assigned to receive a "Motivational Interviewing Case Management" (MICM) intervention and residents in the other 27 houses (n = 181 individuals) received SLH residency as usual. At 6-and 12-month follow-up, both study conditions showed significant improvement relative to baseline on substance abuse, criminal justice, HIV risk, and employment outcomes. For persons who attended at least one MICM session, there were better criminal justice outcomes compared to the SLH as usual group.

Quality of life after PCI with drug-eluting stents or coronary-artery bypass surgery.

BACKGROUND: Previous studies have shown that among patients undergoing multivessel revascularization, coronary-artery bypass grafting (CABG), as compared with percutaneous coronary intervention (PCI) either by means of balloon angioplasty or with the use of bare-metal stents, results in greater relief from angina and improved quality of life. The effect of PCI with the use of drug-eluting stents on these outcomes is unknown. METHODS: In a large, randomized trial, we assigned 1800 patients with three-vessel or left main coronary artery disease to undergo either CABG (897 patients) or PCI with paclitaxel-eluting stents (903 patients). Health-related quality of life was assessed at baseline and at 1, 6, and 12 months with the use of the Seattle Angina Questionnaire (SAQ) and the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36). The primary end point was the score on the angina-frequency subscale of the SAQ (on which scores range from 0 to 100, with higher scores indicating better health status). RESULTS: The scores on each of the SAQ and SF-36 subscales were significantly higher at 6 and 12 months than at baseline in both groups. The score on the angina-frequency subscale of the SAQ increased to a greater extent with CABG than with PCI at both 6 and 12 months (P=0.04 and P=0.03, respectively), but the between-group differences were small (mean treatment effect of 1.7 points at both time points). The proportion of patients who were free from angina was similar in the two groups at 1 month and 6 months and was higher in the CABG group than in the PCI group at 12 months (76.3% vs. 71.6%, P=0.05). Scores on all the other SAQ and SF-36 subscales were either higher in the PCI group (mainly at 1 month) or were similar in the two groups throughout the follow-up period. CONCLUSIONS: Among patients with three-vessel or left main coronary artery disease, there was greater relief from angina after CABG than after PCI at 6 and 12 months, although the extent of the benefit was small. (Funded by Boston Scientific; ClinicalTrials.gov number, NCT00114972.).

A pilot trial of injectable, extended-release naltrexone for the treatment of co-occurring cocaine and alcohol dependence.

BACKGROUND: There is a high co-occurrence of cocaine and alcohol use disorders, and patients with both of these problems are difficult to treat. There is a reasonable rationale and some empirical data to justify a pilot trial of an injectable, extended-release formulation of naltrexone for treating co-occurring cocaine and alcohol addiction. METHODS: Eighty cocaine (n = 80) and alcohol dependent, treatment-seeking subjects were randomly assigned to receive either two monthly extended-release injections of naltrexone or two matching placebo injections in an 8-week clinical trial, with weekly medical management plus cognitive behavioral therapy visits. RESULTS: No differences in reduction in cocaine or alcohol use were observed between the injectable naltrexone and placebo groups during the 8-week trial. CONCLUSIONS: Injectable extended-release naltrexone, while an ideal method for ensuring medication adherence in these traditionally hard-to-treat patients, did not result in any measurable reduction in cocaine or alcohol use over the course of 8 weeks of treatment.

Outcomes Among Sober Living House Residents Who Relapse: Role of Recovery Capital.

Studies show individuals living in residential recovery homes on average make significant improvements in multiple areas of functioning. Residents who achieve and maintain complete abstinence have particularly good outcomes. Residents who relapse after entering the houses have been studied minimally. The current study examined outcomes for 197 residents who relapsed within six months after entering sober living houses (SLHs), which is one type of residential recovery home that is common in California. Despite having relapsed, these residents made significant improvements between entry into the house and 6-month follow-up on measures of percent days abstinent from alcohol and drugs (PDA), psychiatric symptoms, severity of employment problems, and stable housing. Higher recovery capital predicted higher PDA (coefficient = 0.28, SE = 0.09, p = .001) and lower severity of employment problems (coefficient = -0.00, SE = 0.00, p = .007). Recovery capital showed a significant decrease between baseline and 6-month follow-up among persons who relapsed and were no longer living in the house. SLH providers can draw upon social model recovery principles to enhance recovery capital. However, residents should also seek other sources of recovery capital outside the SLH, which may be particularly important for individuals who leave the home.

Giving and Receiving Help among Persons Entering Sober Living Houses.

Giving and receiving help are integral to creating the social environments necessary to support recovery. However, studies assessing the effects of helping behaviors have focused primarily on the benefits derived from giving help to others in 12-step programs and treatment. The current study examined the frequency of giving and receiving help among 188 persons entering sober living houses (SLHs), a type of recovery home that is common in California. Helping was assessed in three contexts: the SLH, 12-step meetings they attended, and interactions with their family and friends. Residents who gave help to others in one of these contexts tended to also receive help in that context. Residents who reported giving or receiving help in one context tended to report giving and receiving help in other contexts. Study findings suggest helping in recovery occurs in a broader, more reciprocal manner than currently conceptualized. Studies should address how giving and receiving help in different contexts affects recovery outcomes. Research is also needed to describe the determinants of giving and receiving help. Considerations for facilitating help among SLH residents are described.

Multilevel Effects of Environmental and Neighborhood Factors on Sober Living House Resident 12-Month Outcomes.

OBJECTIVE: Sober living houses (SLHs) are abstinence-based environments designed for individuals in recovery to live with others in recovery. Research shows that SLHs help some individuals maintain recovery and that certain SLH-related factors may be particularly protective. Here we assess how SLH housing and neighborhood characteristics are related to abstinence and psychiatric symptoms over time. METHOD: Baseline, 6-month, and 12-month data were collected from 557 SLH residents. Multilevel mixed models tested associations between house and neighborhood characteristics and individual-level percent days abstinent (PDA) and the number of psychiatric symptoms (measured with the Psychiatric Diagnostic Screening Questionnaire [PDSQ]) as outcomes. Final models adjusted for sex, age, and race/ethnicity; ratings of house characteristics; and objective measurements of neighborhood-level exposures. RESULTS: Both PDA and PDSQ improved significantly (ps ≤ .05) over time in both unadjusted and adjusted models. More self-help groups and fewer alcohol outlets within one mile were significantly protective for PDA, whereas walkability was significantly related to worse PDA and PDSQ (ps ≤ .05). For house-level factors, better ratings of house maintenance were related to significantly fewer psychiatric symptoms, whereas higher scores on SLH's safety measures and personal or residence identity were related to more psychiatric symptoms (ps ≤ .05). No house-level factor was significantly related to PDA. CONCLUSIONS: Neighborhood-level factors such as increased availability of self-help groups and fewer nearby alcohol outlets may increase abstinence among individuals living in SLHs. House-level factors related to better maintenance may also facilitate improved mental health.

Do neighborhood characteristics of sober living houses impact recovery outcomes? A multilevel analysis of observational data from Los Angeles County.

OBJECTIVE: To identify neighborhood factors associated with recovery outcomes for sober living house (SLH) residents. METHODS: Six-month longitudinal data for new SLH residents (n = 557) was linked with census tract data, services available, alcohol outlets, and Walk Scores® (0-100 score indicating access to neighborhood resources) for 48 SLHs in 44 neighborhoods in Los Angeles County. RESULTS: Non-significant neighborhood characteristics in separate regressions for all outcomes were residents' ratings of perceived risk, percentage of residences with access to a car, percentage of homes over $500,000, percentage of renter-occupied units, percentage with income less than $25,000, percentage that were non-white, the density of substance inpatient within 10 miles, and transit scores from Walk Score®. Multilevel regressions found outpatient substance abuse treatment and density of AA groups were positively associated with more abstinent days. No neighborhood variables were associated with psychiatric symptoms. Higher perceived neighborhood cohesion, lower crime ratings, and better transportation ratings were associated with higher recovery capital. CONCLUSION: Greater neighborhood densities of substance abuse services and AA groups may help residents achieve more days abstinent. While residents may achieve better substance use outcomes even with negative perceptions of the neighborhood, positive perceptions of the neighborhoods may help them acquire more recovery capital.

Clinical and economic outcomes of liberal versus selective drug-eluting stent use: insights from temporal analysis of the multicenter Evaluation of Drug Eluting Stents and Ischemic Events (EVENT) registry.

BACKGROUND: Although the benefits of drug-eluting stents (DES) for reducing restenosis after percutaneous coronary intervention are well established, the impact of alternative rates of DES use on population-level outcomes is unknown. METHODS AND RESULTS: We used data from the Evaluation of Drug Eluting Stents and Ischemic Events (EVENT) registry to examine the clinical impact and cost-effectiveness of varying DES use rates in routine care. Between 2004 and 2007, 10,144 patients undergoing percutaneous coronary intervention were enrolled in the EVENT registry at 55 US centers. Clinical outcomes and cardiovascular-specific costs were assessed prospectively over 1 year of follow-up. Use of DES decreased from 92 in 2004 to 2006 (liberal use era; n=7587) to 68 in 2007 (selective use era; n=2557; P<0.001). One-year rates of death or myocardial infarction were similar in both eras. Over this time period, the incidence of target lesion revascularization increased from 4.1 to 5.1, an absolute increase of 1.0 (95 confidence interval, 0.1 to 1.9; P=0.03), whereas total cardiovascular costs per patient decreased by $401 (95 confidence interval, 131 to 671; P=0.004). The risk-adjusted incremental cost-effectiveness ratio for the liberal versus selective DES era was $16,000 per target lesion revascularization event avoided, $27,000 per repeat revascularization avoided, and $433 000 per quality-adjusted life-year gained. CONCLUSIONS: In this prospective registry, a temporal reduction in DES use was associated with a small increase in target lesion revascularization and a modest reduction in total cardiovascular costs. These findings suggest that although clinical outcomes are marginally better with unrestricted DES use, this approach represents a relatively inefficient use of healthcare resources relative to several common benchmarks for cost-effective care.

Cost-effectiveness of prasugrel versus clopidogrel in patients with acute coronary syndromes and planned percutaneous coronary intervention: results from the trial to assess improvement in therapeutic outcomes by optimizing platelet inhibition with Prasugrel-Thrombolysis in Myocardial Infarction TRITON-TIMI 38.

BACKGROUND: In patients with acute coronary syndromes and planned percutaneous coronary intervention, the Trial to Assess Improvement in Therapeutic Outcomes by Optimizing Platelet Inhibition With Prasugrel-Thrombolysis in Myocardial Infarction 38 (TRITON-TIMI 38) demonstrated that treatment with prasugrel versus clopidogrel was associated with reduced rates of cardiovascular death, MI, or stroke and an increased risk of major bleeding. We evaluated the cost-effectiveness of prasugrel versus clopidogrel from the perspective of the US healthcare system by using data from TRITON-TIMI 38. METHODS AND RESULTS: Detailed resource use data were prospectively collected for all patients recruited from 8 countries (United States, Australia, Canada, Germany, Italy, Spain, United Kingdom, and France; n=3373 prasugrel, n=3332 clopidogrel). Hospitalization costs were estimated on the basis of diagnosis-related group and in-hospital complications. Cardiovascular medication costs were estimated by using net wholesale prices (clopidogrel=$4.62/d; prasugrel=$5.45/d). Life expectancy was estimated from in-trial cardiovascular and bleeding events with the use of statistical models of long-term survival from a similar population from the Saskatchewan Health Database. Over a median follow-up of 14.7 months, average total costs (including study drug) were $221 per patient lower with prasugrel (95% confidence interval, -759 to 299), largely because of a lower rate of rehospitalization involving percutaneous coronary intervention. Prasugrel was associated with life expectancy gains of 0.102 years (95% confidence interval, 0.030 to 0.180), primarily because of the decreased rate of nonfatal MI. Thus, compared with clopidogrel, prasugrel was an economically dominant treatment strategy. If a hypothetical generic cost for clopidogrel of $1/d is used, the incremental net cost with prasugrel was $996 per patient, yielding an incremental cost-effectiveness ratio of $9727 per life-year gained. CONCLUSIONS: Among acute coronary syndrome patients with planned percutaneous coronary intervention, treatment with prasugrel versus clopidogrel for up to 15 months is an economically attractive treatment strategy. CLINICAL TRIAL REGISTRATION: clinicaltrials.gov. Unique identifier: NCT00097591.

Costs and cost-effectiveness of carotid stenting versus endarterectomy for patients at increased surgical risk: results from the SAPPHIRE trial.

OBJECTIVES: To evaluate the cost-effectiveness of carotid stenting vs. carotid endarterectomy using data from the SAPPHIRE trial. BACKGROUND: Carotid stenting with embolic protection has been introduced as an alternative to carotid endarterectomy for prevention of cerebrovascular and cardiovascular events among patients at increased surgical risk. METHODS: Between August 2000 and July 2002, 310 patients with an accepted indication for carotid endarterectomy but at high risk of complications were randomized to and subsequently underwent either carotid stenting (n = 159) or endarterectomy (n = 151). Clinical outcomes, resource use, costs, and quality of life were assessed prospectively for all patients over a 1-year period. Life expectancy, quality-adjusted life expectancy, and health care costs beyond the follow-up period were estimated for patients alive at 1 year, based on observed clinical events during the first year of follow-up. RESULTS: Although initial procedural costs were significantly higher for stenting than for endarterectomy (mean difference: $4,081/patient; 95% CI, $3,849-$4,355), mean post-procedure length of stay was shorter for stenting (1.9 vs. 2.9 days; P < 0.001) with significant associated cost offsets. As a result, initial hospital costs were just $559/patient higher with stenting (95% CI, $3,470 less to $2,289 more). Neither follow-up costs after discharge nor total 1-year costs differed significantly. The incremental cost-effectiveness ratio for stenting compared with endarterectomy was $6,555 per quality-adjusted life year (QALY) gained, with over 98 percent of bootstrap estimates < $50,000/QALY gained. CONCLUSIONS: Although carotid stenting with embolic protection is more costly than carotid endarterectomy, by commonly accepted standards, stenting is an economically attractive alternative to endarterectomy for patients at high surgical risk.

Understanding challenges for recovery homes during COVID-19.

Understanding the effects of COVID-19 mitigation for persons in group living environments is of critical importance to limiting the spread of the virus. In the U.S., residential recovery homes for persons with alcohol and drug disorders are good examples of high-risk environments where virus mitigation procedures are essential. The National Alliance for Recovery Residences (NARR) has taken recommendations developed by the Center for Disease Control (CDC) and applied them to recovery home settings. This paper describes how COVID-19 mitigation efforts in recovery homes may be influenced by two factors. First, while some houses are licensed by states with rigorous health and safety standards, others are not licensed and are subject to less oversight. These homes may be more inconsistent in adhering to mitigation standards. Second, to varying degrees, recovery homes use a social model approach to recovery that contrasts with mitigation procedures such as social distancing and stay-at-home orders. This paper provides examples of ways recovery homes have been forced to adjust to the competing demands of mitigation efforts and social model recovery. The paper also identifies multiple questions that could be addressed by provider-researcher coalitions to inform how social model recovery can navigate forward during the era of COVID-19. As we move forward during the era of COVID-19, providers are encouraged to remember that recovery homes have a history of resilience facing adversity and in fact have their origins in grassroots responses to the challenges of their times.

Cost effectiveness of eplerenone in patients with heart failure after acute myocardial infarction who were taking both ACE inhibitors and beta-blockers: subanalysis of the EPHESUS.

BACKGROUND: The EPHESUS (Eplerenone Post-Acute Myocardial Infarction Heart Failure and Survival Study) showed that the use of aldosterone blockade with eplerenone decreased mortality in patients with heart failure after acute myocardial infarction, and a subsequent analysis showed eplerenone to be highly cost effective in this population. OBJECTIVE: To assess the cost effectiveness of eplerenone in an EPHESUS subgroup population who were taking both ACE inhibitors and beta-blockers (beta-adrenoceptor antagonists) at baseline. In the EPHESUS, a total of 6632 patients were randomized to receive eplerenone 25-50 mg/day (n = 3319) or placebo (n = 3313) concurrently with standard therapy and were followed for up to 2.5 years. Of these, 4265 (64.3%) patients (eplerenone: n = 2113; placebo: n = 2152) were taking both ACE inhibitors and beta-blockers at baseline. METHODS AND MAIN OUTCOME MEASURES: Resource use after the initial hospitalization included additional hospitalizations, outpatient services, emergency room visits, and medications. Eplerenone was priced at an average wholesale price of $US3.60 per day (year 2004 value). Bootstrap methods were used to estimate the fraction of the joint distribution of the cost and effectiveness. A net-benefit regression model was used to derive the propensity score-adjusted cost-effectiveness curve. The incremental cost effectiveness of eplerenone in cost per life-year gained (LYG) and cost per quality-adjusted life-year (QALY) gained beyond the trial period was estimated using data from the Framingham Heart Study, the Saskatchewan Health database, and the Worcester Heart Attack Registry. Both costs and effectiveness were discounted at 3%. Although not all resource use could be accounted for, the overall perspective was societal. RESULTS: As in the overall EPHESUS population, the total direct treatment costs were higher in the eplerenone arm than the placebo arm for patients who were taking both ACE inhibitors and beta-blockers ($US14,563 vs $US12,850, difference = $US1713; 95% CI 721, 2684). The number of LYGs with eplerenone compared with placebo was 0.1665 based on the Framingham data, 0.0979 using the Saskatchewan data, and 0.2172 using the Worcester data. The incremental cost-effectiveness ratio (ICER) was $US10,288/LYG with the Framingham data, $US17,506/LYG with the Saskatchewan data, and $US7888/LYG with the Worcester data (99% <$US50,000/LYG for all three sources). The ICERs were systematically higher when calculated as the cost per QALY gained ($US14,926, $US25,447, and $US11,393, respectively) as the utilities were below 1 with no difference between the treatment arms. CONCLUSION: As for the overall EPHESUS population, aldosterone blockade with eplerenone is effective in reducing mortality and is cost effective in increasing years of life for the EPHESUS subgroup of patients who were taking both ACE inhibitors and beta-blockers.

Comparative determinants of 4-year cardiovascular event rates in stable outpatients at risk of or with atherothrombosis.

CONTEXT: Clinicians and trialists have difficulty with identifying which patients are highest risk for cardiovascular events. Prior ischemic events, polyvascular disease, and diabetes mellitus have all been identified as predictors of ischemic events, but their comparative contributions to future risk remain unclear. OBJECTIVE: To categorize the risk of cardiovascular events in stable outpatients with various initial manifestations of atherothrombosis using simple clinical descriptors. DESIGN, SETTING, AND PATIENTS: Outpatients with coronary artery disease, cerebrovascular disease, or peripheral arterial disease or with multiple risk factors for atherothrombosis were enrolled in the global Reduction of Atherothrombosis for Continued Health (REACH) Registry and were followed up for as long as 4 years. Patients from 3647 centers in 29 countries were enrolled between 2003 and 2004 and followed up until 2008. Final database lock was in April 2009. MAIN OUTCOME MEASURES: Rates of cardiovascular death, myocardial infarction, and stroke. RESULTS: A total of 45,227 patients with baseline data were included in this 4-year analysis. During the follow-up period, a total of 5481 patients experienced at least 1 event, including 2315 with cardiovascular death, 1228 with myocardial infarction, 1898 with stroke, and 40 with both a myocardial infarction and stroke on the same day. Among patients with atherothrombosis, those with a prior history of ischemic events at baseline (n = 21,890) had the highest rate of subsequent ischemic events (18.3%; 95% confidence interval [CI], 17.4%-19.1%); patients with stable coronary, cerebrovascular, or peripheral artery disease (n = 15,264) had a lower risk (12.2%; 95% CI, 11.4%-12.9%); and patients without established atherothrombosis but with risk factors only (n = 8073) had the lowest risk (9.1%; 95% CI, 8.3%-9.9%) (P < .001 for all comparisons). In addition, in multivariable modeling, the presence of diabetes (hazard ratio [HR], 1.44; 95% CI, 1.36-1.53; P < .001), an ischemic event in the previous year (HR, 1.71; 95% CI, 1.57-1.85; P < .001), and polyvascular disease (HR, 1.99; 95% CI, 1.78-2.24; P < .001) each were associated with a significantly higher risk of the primary end point. CONCLUSION: Clinical descriptors can assist clinicians in identifying high-risk patients within the broad range of risk for outpatients with atherothrombosis.