Early symptom improvement and discontinuation of 5-α-reductase inhibitor (5ARI) therapy in patients with benign prostatic hyperplasia (BPH).

BACKGROUND: Pharmacological treatment options for benign prostatic hyperplasia (BPH) commonly include α-blocker (AB) and 5-α-reductase inhibitor (5ARI) agents, which have separate but important attributes that carry clinical implications in terms of improvement of lower-urinary tract symptoms (LUTS) and clinical disease progression. OBJECTIVES: This study hypothesized that administering AB therapy concomitantly with newly started 5ARI treatment would reduce the likelihood of 5ARI discontinuation through early symptom improvement. METHODS: This retrospective analysis of the PharMetrics Integrated Medical and Pharmaceutical Database included men aged ≥50 years with ≥1 medical claim of BPH diagnosis and ≥1 prescription claim of a 5ARI with or without an AB. Patients initiating 5ARI monotherapy were propensity score matched with patients initiating combination AB + 5ARI therapy (1:1), with 5ARI time to discontinuation (30-day gap in treatment) compared between groups utilizing survival analysis techniques. The percentage of patients adherent to 5ARI therapy based on medication possession ratio (MPR) was assessed. RESULTS: After 180 days of follow-up, 61.7% of the combination therapy arm versus 59.2% of the monotherapy arm remained on therapy. Combination therapy patients were 10% less likely to discontinue 5ARI treatment (hazard ratio = 0.904; P = .006) and were more likely to be adherent when adherence was defined as MPR ≥70% and ≥75%. CONCLUSIONS: Based on an assessment of claims data, initiating AB with 5ARI therapy is associated with a lower rate of 5ARI discontinuation compared with 5ARI monotherapy. Early symptom relief from AB therapy may contribute to a lower discontinuation rate for concomitant 5ARI therapy.

Clinical and economic impact of early versus delayed 5-alpha reductase inhibitor therapy in men taking alpha blockers for symptomatic benign prostatic hyperplasia.

BACKGROUND AND OBJECTIVE: Recent clinical trials indicate that combining an alpha blocker for rapid symptom improvement and a 5-alpha reductase inhibitor (5-ARI) to reduce the risk of clinical progression of benign prostatic hyperplasia (BPH) may be an optimal approach to management; however, few studies have evaluated the effect of combination therapy on clinical progression in a real-world setting. The purpose of our study was to assess the clinical and economic impact of early versus delayed 5-ARI therapy in patients treated with an alpha blocker for BPH. MATERIALS AND METHODS: A retrospective database analysis included men 50 years of age and older who were treated for BPH between 2003 and 2007. Clinical outcomes were evaluated for patients using 5-ARIs early (within 30 days of starting an alpha blocker) compared with those using delayed 5-ARI therapy (between 30 and 180 days after starting an alpha blocker). We assessed the likelihood of clinical progression (defined as the occurrence of acute urinary retention or prostate surgery) for each group over a one-year period following the start of alpha-blocker therapy. DATA SOURCE: The MarketScan Database, which was used to identify patients, contains medical and pharmacy claims data obtained directly from Medicare and commercial health plans and employers, representing 18 to 20 million lives annually. RESULTS: Of 8,617 men included in the analysis, 64.5% began 5-ARI therapy within 30 days of alpha-blocker therapy (the early cohort). These patients were less likely than those receiving delayed 5-ARI treatment to have clinical progression (12.8% vs. 17.4% respectively; P < 0.0001), acute urinary retention (10.2% vs. 13.8%, P < 0.0001), and prostate surgery (5% vs. 7%, P = 0.0002). The early group also incurred lower BPH-related medical costs ($572 vs. $730, P < 0.0001). Even though BPH-related pharmacy costs were significantly higher ($1,137 vs. $1,263, P = 0.0313), their total BPH-related costs were lower ($1,834 vs. $1,867, P = 0.0068). CONCLUSION: These results suggest that early 5-ARI therapy for men with symptomatic BPH who receive an alpha blocker may significantly reduce the risk of clinical progression (i.e., acute urinary retention or prostate surgery) over the next 12 months as well as lower BPH-related medical costs and BPH-related total costs.

An assessment of the diagnosed prevalence of diseases in men 50 years of age or older.

OBJECTIVE: A lack of focus on certain men's health problems has led to significant morbidity and mortality in aging men. Managed care must begin to focus on the conditions that are most prevalent in this fast-growing population in an effort to improve the quality of care. To assist in achieving this goal, a naturalistic retrospective study assessing the prevalence of the 10 leading disorders in men older than the age of 50 was conducted, with an additional focus on men eligible for Medicare. METHODS: Claims data were obtained from the Integrated Health Care Information Solutions National Managed Care Benchmark database (Waltham, Mass), that includes data from 30 health plans covering more than 25 million lives, and from the Centers for Medicare & Medicaid Services, representing men from a 5% random sample of Medicare-eligible patients. Men older than 50 years of age were included in the study. The prevalence of all diseases was determined in the 2003 calendar year for each population. Prevalence was calculated by dividing the number of diagnosed cases of a disease by the total person-time observations within the 2003 period. RESULTS: The results indicate that cardiovascular (ie, coronary artery disease [CAD], hypertension, and arrhythmias), urological (ie, enlarged prostate and prostate cancer), and musculoskeletal disorders (ie, osteoarthritis and bursitis) comprise 70% of the 10 leading diseases. CAD and hypertension ranked first and second across all age categories, whereas enlarged prostate ranked fourth. In men older than 50, diabetes ranked third, whereas cataracts ranked third in Medicare-eligible men. CONCLUSION: The diseases identified in this study have the potential to cause significant clinical and economic implications when poorly treated or undertreated. Therefore, there is a need to institute early treatment for these conditions before they progress and require more extensive and costly interventions.

Anxiety disorders in the 21st century: status, challenges, opportunities, and comorbidity with depression.

Anxiety disorders are highly prevalent in adults and often coexist with depression. Patients with anxiety commonly present to their primary care doctors, or in other medical settings, reflecting a high utilization of medical services. Furthermore, some patients initially complain of only somatic symptoms before they are ultimately diagnosed with a primary anxiety disorder. Approaches to management include both nondrug and drug treatments, and pharmacotherapy has substantial evidence-based support for efficacy. Of the drugs available for use, an antidepressant, and in particular a selective serotonin reuptake inhibitor, is the preferred initial treatment for most patients. This choice is based on the drug's proven efficacy, favorable adverse event profile, relative safety in overdose, and better management of comorbid depression. The treatment of anxiety disorders has multiple potential benefits in systems of managed care. These include the ability to maintain remission or prevent relapse, a decrease in comorbid depression, promotion of adherence with improvement in quality of life, and reduction in claims for medical care. This overview of the anxiety disorders sets the stage for subsequent discussions of managed care datasets highlighting the opportunities for making informed decisions about access to care and treatment that can lead to economic benefits, especially in light of the Medicare Modernization Act.

Cost-minimization analysis of darbepoetin alfa versus epoetin alfa in the hospital setting.

PURPOSE: The cost of darbepoetin alfa versus that of epoetin alfa in a hospital setting was studied. METHODS: The study was an observational, retrospective review of the hospitalwide use of darbepoetin and epoetin during hospital admissions beginning in the period from January 2003 through April 2003. After the identification from daily charge reports of patients who used at least one of the study drugs during an admission, charts were requested for review. Drug product costs were determined from hospital purchasing information. Material and labor costs were combined to estimate drug administration costs. Total costs were calculated as the sum of drug product costs and administration costs. RESULTS: A total of 429 epoetin records and 80 darbepoetin records were included. The two cohorts were similar with respect to demographic characteristics. With respect to costs, the only significant difference between cohorts was in daily administration costs, which were lower for patients receiving darbepoetin. Sensitivity analysis found lower costs for darbepoetin only after the dose-conversion ratio (DCR) was increased to above 256.74 units:1 microg. The overall DCR based on the median daily dose of each drug was 244.90 units:1 microg. CONCLUSION: A cost-minimization study in a hospital showed no cost difference between treatment with epoetin and darbepoetin.

Evaluation of recent trends in treatment patterns among men with benign prostatic hyperplasia.

Although there is an abundance of evidence regarding clinical efficacy and safety of benign prostatic hyperplasia (BPH) treatment, real-world evidence is lacking for pharmacotherapy utilization and trends. It is unclear how evidence demonstrating the efficacy of combination 5-alpha reductase inhibitors and alpha blockers for improving symptoms and reducing risk of disease progression translates into real-world practice for the treatment of BPH. A retrospective study of a database was conducted to describe pharmacotherapy utilization/trends in the treatment of BPH among patients in the managed care setting. After inclusion and exclusion criteria were applied, the final sample size was 107,038. The proportion of patients with BPH receiving 5-alpha reductase inhibitors therapy increased (21.1% in 2003 to 30.5% in 2007), as did the proportion receiving combination therapy (10.7% and 16.1%, respectively). We observed an almost 50% increase in 5-alpha reductase inhibitors use over 5 years and a 60% increase in the use of combination 5-alpha reductase inhibitors/alpha blockers therapy.

The economic impact of delaying 5-alpha reductase inhibitor therapy in men receiving treatment for symptomatic benign prostatic hyperplasia.

BACKGROUND: Pharmacologic treatment of lower urinary tract symptoms associated with benign prostatic hyperplasia often includes alpha-blockers and 5-alpha reductase inhibitors. Many clinicians use alpha-blockers for rapid symptom control, later adding 5-alpha reductase inhibitors to modify long-term disease progression. Delaying the addition of these medications has been shown to result in reduced clinical outcomes. The economic impact of this practice has not been widely studied or reported to date. OBJECTIVE: The objective of this study was to assess the economic impact of delaying initiation of concomitant 5-alpha reductase inhibitor therapy (≥30 days) in patients receiving alpha-blockers for lower urinary tract symptoms. METHODS: Using 2 nationally representative databases (Integrated Health Care Information Solutions and PharMetrics), 2 retrospective analyses were conducted involving 2636 and 4260 men, respectively, aged ≥50 years treated for benign prostatic hyperplasia between 2000 and 2007. Economic outcomes (ie, the cost of therapy and the use of healthcare resources) were compared for adding 5-alpha reductase inhibitor therapy early (within <30 days of initiating an alpha-blocker) versus delaying these medications (≥30 days after initiating an alpha-blocker). RESULTS: In the Integrated Health Care Information Solutions analysis, patients in the early add-on therapy group (n = 1572) had lower benign prostatic hyperplasia-related medical costs in the posttreatment period than those in the delayed-therapy group (n = 1064), $349 versus $618 (P <.0001). Similar trends were seen in the PharMetrics analysis-the medical costs in the early add-on therapy group (n = 2604) and delayed group (n = 1656) were $344 versus $449, respectively (P <.001). Pharmacy costs were $1068 for the early-treatment cohort and $989 for the delayed-treatment cohort for the Integrated Health Care Information Solutions database, yielding total costs of $1417 and $1606, respectively, for a $189 savings per patient over the initial year of treatment (P <.0001). In the PharMetrics analysis, pharmacy costs were $1391 for the early-treatment cohort and $1237 for the delayed-treatment cohort, resulting in total cost of $1735 and $1686, respectively, yielding $59 in additional costs per patient annually for those treated early (P = .8645). CONCLUSION: These results suggest that patients receiving 5-alpha reductase inhibitor therapy within 30 days after initiating alpha-blocker treatment have lower benign prostatic hyperplasia-related medical costs than those who start combination treatment later. The increase in pharmacy costs associated with early initiation of 5-alpha reductase inhibitor therapy resulted in total costs that were similar or significantly lower than those of delayed combination users.

Impact of delaying 5-alpha reductase inhibitor therapy in men on alpha-blocker therapy to treat BPH: assessment of acute urinary retention and prostate-related surgery.

OBJECTIVE: Pharmacologic treatment of lower urinary tract symptoms from benign prostatic hyperplasia (BPH) commonly includes alpha-blockers (ABs) and 5alpha-reductase inhibitors (5ARIs). Many clinicians use ABs for rapid symptom control and 5ARIs to modify long-term disease progression. The purpose of this study was to assess the clinical impact of delayed 5ARI therapy in patients treated with AB for lower urinary tract symptoms. RESEARCH DESIGN AND METHODS: Using two nationally representative databases, two retrospective analyses were conducted including patients aged > or =50 years treated for BPH between 2000 and 2007. Clinical outcomes for those using add-on 5ARI therapy early (within 30 days of initiating AB) and late (>30 days after initiating AB) were compared. Likelihood of clinical progression, defined as the presence of acute urinary retention (AUR) and prostate surgery, was assessed over 1 year after AB initiation, and modeled as a function of the treatment cohorts and the following baseline covariates: AUR, BPH stage, Charlson Comorbidity Index, age, and number of unique diagnosis codes, unique non-BPH-related classes of prescriptions filled, and specialty care. RESULTS: Of 6896 men included in the analyses, approximately 60% initiated 5ARI therapy within 30 days of AB therapy (the early cohort). Patients in the early cohort were less likely to have clinical progression. Each 30-day delay in starting 5ARIs resulted in an increased likelihood of overall clinical progression (average 21.1%), AUR (average 18.6%), and prostate-related surgery (average 26.7%). CONCLUSIONS: These results suggest that delaying 5ARI therapy in men with BPH increases the risk of AUR and prostate surgery. LIMITATIONS: Confounding factors, such as symptom severity and prostate volume, may have influenced the findings of the study.

Cost comparison of finasteride and dutasteride for enlarged prostate in a managed care setting among Medicare-aged men.

OBJECTIVE: To assess cost differences between dutasteride and finasteride use within the first year of initiating treatment for enlarged prostate (EP) among men aged > or =65 years in a managed care setting. METHODS: For this retrospective analysis, medical/pharmacy claims data from July 1, 2003, to June 30, 2006, were analyzed for EP patients aged > or =65 years who were treated with dutasteride or finasteride. Analysis of average monthly costs over each patient's 1-year follow-up period incorporated total charges for EP-related medical care, including physician, inpatient and outpatient hospital care, emergency department, and other ancillary services. RESULTS: A total of 4498 patients met selection criteria, with comparable demographics between treatment cohorts. Patients taking dutasteride incurred $51 less per month in medical expenses than finasteride-treated patients ($122 vs $173; P <.001), attributable to lower monthly inpatient hospitalization costs ($55.84 vs $70.34), outpatient costs ($22.07 vs $44.25), and physician office visit costs ($40.69 vs $51.10). CONCLUSION: Medicare-aged patients treated with dutasteride incurred $51 less per month in medical costs than those treated with generic finasteride, suggesting that the higher price of dutasteride may be offset by decreased medical resource consumption.