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Collectively, coronary artery disease (CAD) and peripheral artery disease (PAD) are highly prevalent and are associated with increased risk of major adverse cardiovascular events (MACE) and major adverse limb events (MALE). Improved ability to identify those at highest risk of these events may help optimize secondary prevention efforts in this population.Using the Optum Integrated Database, a healthcare claims database linked to electronic medical records (EMR), we identified patients with CAD and/or PAD between January 1, 2009, and September 30, 2016. Index date was the earliest date on which chronic and stable disease was established. Follow-up ran from index date until earliest of patient death, plan disenrollment, or end of study. We developed multivariate Cox proportional hazards models to identify predictors of MACE and/or MALE, limited to measures presumed available to clinicians during patient encounters (e.g., age, presence of selected comorbidities).A total of 20,932 patients met all selection criteria; 86.9% had CAD and 26.1% had PAD; 13% (n = 2753) experienced MACE and/or MALE during a mean follow-up of 2.3 years, for a rate of 7.1 events per 100 person-years (PYs). We identified 11 predictors of MACE and/or MALE. Most (95.1%) patients had ≥ 1 predictors; 34.0% and 6.9% had ≥ 4 and ≥ 6, respectively. Incidence of MACE and/or MALE was strongly correlated with number of predictors (rReadily identifiable predictors can be used to identify subgroups with chronic CAD and/or PAD at elevated risk of MACE and/or MALE. Further research is required to understand the degree to which these subgroups may benefit from early identification and treatment with secondary prevention therapies.Janssen Pharmaceuticals.

Chronic coronary artery disease (CAD) and peripheral artery disease (PAD) are both associated with elevated risks of major adverse cardiovascular events (MACE) and major adverse limb events (MALE). The frequency of these events in patients with CAD or PAD, and their corresponding costs, are not well understood. Accordingly, we describe the incidence and cost of both MACE and MALE in patients with CAD or PAD. Using a database that included healthcare claims linked to electronic medical records, we identified patients with evidence of chronic CAD and PAD, respectively, between January 1, 2009, and September 30, 2016. We assessed the occurrence of MACE (defined as myocardial infarction, stroke, or cardiovascular-related death) and MALE (critical limb ischemia, amputation, or peripheral artery disease-related revascularization). A total of 99,730 patients met all selection criteria: 86.0% had CAD, 25.8% had PAD, and 11.8% had both. Mean (±standard deviation) age was 67.7 (±11.5) years and 59.8% were male. During follow-up (mean: 1.8 years), 13.6% experienced MACE or MALE (6.3 per 100 person-years [PYs]), predominantly MACE (9.6% [4.3 per 100 PYs]). Adjusted 1-year healthcare costs were $44,495 greater in patients who experienced MACE or MALE (mean [95% confidence interval]: $64,099 [$33,254 to $123,557] vs $19,604 [$10,175 to $37,771]; p 0.001). In conclusion, approximately 1 in 7 patients with chronic CAD or PAD experiences additional MACE or MALE within approximately 2 years of follow-up; the relatively high risk and cost of these events highlight the need for new secondary prevention therapies that may improve outcomes in these patients.

Author(s): Michelson, Edward A.; Huff, J. Stephen; Loparo, Mae; Naunheim, Rosanne S.; Perron, Andrew; Rahm, Martha; Smith, David W.; Stone, Joseph A; Berger, Ariel | Abstract: Introduction: Mild traumatic brain injury (mTBI) is a common cause for visits to the emergency department (ED). The actual time required for an ED workup of a patient with mTBI in the United States is not well known. National emergency medicine organizations have recommended reducing unnecessary testing, including head computed tomography (CT) for these patients.10Methods: To examine this issue, we developed a care map that included each step of evaluation of mTBI (Glasgow Coma Scale Score 13-15) – from initial presentation to the ED to discharge. Time spent at each step was estimated by a panel of United States emergency physicians and nurses. We subsequently validated time estimates using retrospectively collected, real-time data at two EDs. Length of stay (LOS) time differences between admission and discharged patients were calculated for patients being evaluated for mTBI.Results: Evaluation for mTBI was estimated at 401 minutes (6.6 hours) in EDs. Time related to head CT comprised about one-half of the total LOS. Real-time data from two sites corroborated the estimate of median time difference between ED admission and discharge, at 6.3 hours for mTBI.Conclusion: Limiting use of head CT as part of the workup of mTBI to more serious cases may reduce time spent in the ED and potentially improve overall ED throughput.

Background To examine the clinical and economic burdens associated with delayed receipt of appropriate therapy among patients with Gram-negative bacteria (GNB) infections, stratified by antibiotic resistance status. Materials and Methods Retrospective analysis using the Premier Hospital Database. Adult admissions (July 2011-September 2014) with evidence of complicated urinary tract infection, complicated intra-abdominal infection, hospital-associated pneumonia, or bloodstream infection, length of stay (LOS) ≥1 days and a positive GNB culture from a site consistent with infection type (culture draw date = index date) were identified and stratified by antibiotic susceptibility to index pathogens. Delayed appropriate therapy was defined as no receipt of antibiotic(s) with relevant microbiological activity on or within 2 days of index date. Inverse probability weighting and multivariate regression analyses were used to estimate the association between delayed appropriate therapy and outcomes. Generalized linear models were used to evaluate postindex duration of antibiotic therapy, LOS and total in-hospital costs. Logistic models were used to evaluate discharge destination and in-hospital mortality/discharge to hospice. Results A total of 56,357 patients with GNB infections were identified (resistant, n = 6,055; susceptible, n = 50,302). Delayed appropriate therapy was received by 2,800 (46.2%) patients with resistant and 16,585 (33.0%) patients with susceptible infections. Using multivariate analysis, delayed appropriate therapy was associated with worse outcomes including ∼70% increase in LOS, ∼65% increase in total in-hospital costs and ∼20% increase in the risk of in-hospital mortality/discharge to hospice, regardless of susceptibility status. Conclusions Our results suggest that outcomes in patients with GNB infections, regardless of resistance status, significantly improve if timely appropriate therapy can be provided.

Prostacyclins play an important role in the management of pulmonary arterial hypertension (PAH). Intravenous prostacyclin was the first disease-specific treatment for patients with PAH. Subcutaneous and nonparenteral (oral or inhaled) formulations have subsequently become available. However, data are lacking on how these different prostacyclin formulations are being used in clinical practice.To (a) conduct retrospective analyses of a large U.S. health care claims database to describe the characteristics of patients with PAH initiating prostacyclin therapy, and (b) evaluate their treatment patterns, health care resource use, and associated costs.Truven Commercial and Medicare databases were used to define annual cohorts of adults with PAH between January 1, 2010, and October 31, 2015. These patients were identified based on claims with ICD-9-CM diagnoses indicative of PAH (codes 416.0 or 416.8) and claims for PAH-specific medications and PAH-related procedures. Patients with evidence of receiving a prostacyclin were identified, and prostacyclin use was categorized as parenteral versus nonparenteral. Health care costs were assessed alternatively employing an all-cause and PAH-related perspective.Of 13,633 adults with identified PAH, 3,006 (22.0%) received a prostacyclin during at least 1 year of the study period, and annual prevalence of prostacyclin use ranged from 19.9% to 22.6%. Across calendar years, the median age of prostacyclin users ranged from 56 to 58 years, and 71.9%-75.8% were female. Among prostacyclin users, parenteral prostacyclin use declined from 63.2% in 2010 to 46.5% in 2015, while use of nonparenteral prostacyclins increased from 39.7% to 56.2% over the same period (both P0.001). Few patients (2.7%-4.1%) received both parenteral and nonparenteral formulations in a given calendar year. Among patients using prostacyclins, receipt of other PAH-specific medications increased from 62.1% in 2010 to 79.2% in 2015. Comparing the 6 months preceding the first prostacyclin prescription (any formulation) to the 6 months subsequent, mean overall health care costs rose from $61,243 to $119,283, and PAH-related health care costs increased from $58,815 to $116,661, driven mainly by PAH-specific medications, spending on which increased from $15,053 to $73,705 (all P0.001).While overall use of prostacyclins was relatively constant from 2010 to 2015, our findings revealed a shift from parenteral to nonparenteral formulations, coupled with increased prescribing of PAH-related medications from other drug classes. Further research is needed to better understand how these changes in patterns of prostacyclin use affect levels of health care resource utilization and costs and patients' overall quality of life.This research was funded by Actelion Pharmaceuticals US, a Janssen pharmaceutical company of JohnsonJohnson. Burger has received grant funding from Actelion, Gilead Sciences, and United Therapeutics; personal fees from Actelion and Gilead Sciences; and nonfinancial support from Actelion. Pruett, Lickert, and Drake are employees of Actelion. Pruett and Lickert own shares in Actelion. Berger and Murphy are employees of Evidera, a consultancy that received payment from Actelion to conduct this research. Pruett, Lickert, Berger, and Drake contributed to study conception and participated with Burger in study design. Lickert and Murphy performed the data analyses. Burger, Pruett, Lickert, Murphy, and Drake interpreted the data. All authors participated in manuscript drafting and/or critical revision, approved the final manuscript, and agree to be accountable for all aspects of the work.

To conduct a cost-effectiveness assessment of lenalidomide plus dexamethasone (Rd) vs bortezomib plus melphalan and prednisone (VMP) as initial treatment for transplant-ineligible patients with newly-diagnosed multiple myeloma (MM), from a U.S. payer perspective.A partitioned survival model was developed to estimate expected life-years (LYs), quality-adjusted LYs (QALYs), direct costs and incremental costs per QALY and LY gained associated with use of Rd vs VMP over a patient's lifetime. Information on the efficacy and safety of Rd and VMP was based on data from multinational phase III clinical trials and a network meta-analysis. Pre-progression direct costs included the costs of Rd and VMP, treatment of adverse events (including prophylaxis) and routine care and monitoring associated with MM. Post-progression direct costs included costs of subsequent treatment(s) and routine care and monitoring for progressive disease, all obtained from published literature and estimated from a U.S. payer perspective. Utilities were obtained from the aforementioned trials. Costs and outcomes were discounted at 3% annually.Relative to VMP, use of Rd was expected to result in an additional 2.22 LYs and 1.47 QALYs (discounted). Patients initiated with Rd were expected to incur an additional $78,977 in mean lifetime direct costs (discounted) vs those initiated with VMP. The incremental costs per QALY and per LY gained with Rd vs VMP were $53,826 and $35,552, respectively. In sensitivity analyses, results were found to be most sensitive to differences in survival associated with Rd vs VMP, the cost of lenalidomide and the discount rate applied to effectiveness outcomes.Rd was expected to result in greater LYs and QALYs compared with VMP, with similar overall costs per LY for each regimen. Results of this analysis indicated that Rd may be a cost-effective alternative to VMP as initial treatment for transplant-ineligible patients with MM, with an incremental cost-effectiveness ratio well within the levels for recent advancements in oncology.

Objectives: We estimated the total US hospital costs associated with acute bacterial skin and skin structure infection (ABSSSI) admissions as well as the admissions that may have been potential candidates for outpatient parenteral antimicrobial therapy (OPAT). Methods: We assessed inpatient admissions for ABSSSI from the Premier database (2011–2014), focusing on all admissions of adults with length of stay (LOS) ≥ 1 days and a primary diagnosis of erysipelas, cellulitis/abscess, or wound infection. We performed a detailed analysis of 2014 admissions for patient, treatment, hospital, and economic characteristic variables. Using published selection criteria, we identified a subset of patients admitted in 2014 who may have been potential candidates for OPAT. Results: We analyzed 277,971 admissions. In 2014, most admissions were for cellulitis without major complications or comorbidities; mean ± SD LOS was 4.0 ± 3.0 days, and total hospital cost per admission was $6400 ± $6874, 54% of which was attributable to room costs. Among 2014 admissions, 14% involved patients with clinical characteristics suggesting that they were consistent with guideline recommendations for exclusive treatment with OPAT. Compared with all admissions in the year, these admissions were of younger patients (aged 50 vs. 55 years), admitted more frequently for cellulitis (90% vs. 70%), with shorter LOS (2.8 ± 1.8 days), and lower mean total hospital cost per admission ($4080 ± $3066). Conclusions: Admissions for ABSSSI impose a substantial cost to US hospitals, with half of costs attributable to room costs. When extrapolated to all US patients admitted to the hospital for ABSSSI during 2014, had OPAT guidelines been universally followed, admissions may have been reduced by 14%, thereby saving US hospitals $161 million.

Although clinical guidelines for management of community-acquired pneumonia (CAP) in non-intensive care unit ("non-ICU") hospitalized patients have changed substantially over the last decade, it is unknown how treatment of this disease has evolved over this period.Using data from100 U.S. hospitals, we identified all adults (aged ≥18 years) hospitalized for CAP between January 1, 2000, and June 30, 2009 ("study period"). We excluded patients admitted to ICU24 hours of admission, those not starting antibiotics24 hours of admission, those not receiving antibiotics for ≥48 hours (if alive), and those with probable healthcare-associated pneumonia. We defined "initial therapy" as all parenteral antibiotics received ≤24 hours of admission, and we examined changes in such therapy over the study period. The statistical significance of changes in initial therapy was ascertained using 2-tailed χ tests.We identified 40,392 patients who met all selection criteria. In 2000, the most frequently used initial regimens were levofloxacin (24.0% of all such admissions), ceftriaxone (9.0%), cefotaxime (7.3%), ceftriaxone plus levofloxacin (3.2%) and azithromycin plus cefotaxime (3.0%); in 2009, they were ceftriaxone plus azithromycin (18.5%), levofloxacin (12.7%), ceftriaxone (6.6%), moxifloxacin (4.7%) and ceftriaxone + levofloxacin (3.2%). Use of single-agent regimens declined between 2000 and 2009 (from 48.2%-30.0%); use of vancomycin almost doubled (13.1%-23.3%). All findings were statistically significant (P0.01).Initial antibiotic therapy for non-ICU CAP has changed substantially in the United States over the past decade, in line with evidence of widespread antibiotic resistance, evolving treatment guidelines and, most recently, quality improvement initiatives that tie hospital payments to guideline-based care.

Objective To examine patterns of pharmacotherapy and health care utilization and costs prior to total knee replacement (TKR) or total hip replacement (THR) in patients with osteoarthritis (OA). Methods Using a large US health insurance claims database, we identified all patients with OA who were ages ≥40 years and had undergone TKR or THR between January 1, 2006 and December 31, 2007. Patients with

Objective: The aim of this analysis was to assess alternative methods of identification of patients treated with peritoneal dialysis (PD) in health care claims databases for possible use in future analyses of costs of this treatment modality. Methods: Using a US health insurance claims database spanning January 1, 2004, to December 31, 2006, we identified all patients with renal failure who satisfied a case-finding algorithm for PD anticipated to be highly specific, but not necessarily sensitive—namely, ≥2 claims for PD-related physician services (algorithm 1). All claims from these patients were assessed to identify additional PD-related codes, from which 6 additional algorithms were developed, each of which focused on specific categories of billing codes (eg, diagnostic, procedural/service, equipment). Patient selection was then reimplemented using these alternative algorithms. Concordance between the various algorithms and the extent to which resulting samples were similar in terms of patient characteristics, health care resource utilization, and costs were assessed. Results: We identified a total of 132,274 patients in the database with ≥1 claim for renal failure and valid enrollment data. Among these patients, a total of 2329 satisfied case-selection criteria for algorithm 1, and 4031 patients met criteria for at least 1 of the 7 algorithms for PD. The most sensitive algorithm identified 2859 patients who might have received PD; the least sensitive, 211. Concordance between algorithms was relatively poor. Patients identified using each algorithm were similar, however, with respect to mean age (45–50 years), sex (54%–56% male), and the prevalence of selected comorbidities. Annualized median health care costs were similar across the various algorithms (range, US $80,967-$118,668). Conclusions: Based on the results from this analysis, it seems that health care providers bill insurers for PD-related care using a variety of codes. Investigators using health insurance claims data for analyses of patients treated with PD need to take this into account.

Purpose: To examine the use of pregabalin in patients with painful neuropathic disorders under the care of general practitioners (GPs) in the U.K. Materials and Methods: Using a large U.K. database of GP encounters, we identified all persons aged ≥ 18 years with at least one GP encounter with a diagnosis of a painful neuropathic disorder (eg, postherpetic neuralgia, diabetic peripheral neuropathy) between January 1, 2004 and July 31, 2006. Among these patients, we then identified those who initiated therapy with pregabalin; the date of initial receipt of pregabalin was designated the “index date.” We then examined use of pregabalin over the 6-month period following this date (“follow-up”), as well as changes in the use of other pain-related medications (eg, opioids, tricyclic antidepressants [TCAs], other antiepileptics [AEDs]) between the 6-month period preceding the index date (“pretreatment”) and follow-up. Patients with less than 6 months of pretreatment and follow-up data were excluded, as were those without any encounters during pretreatment for a painful neuropathic disorder. Results: A total of 1,400 patients (1.4% of all identified patients with painful neuropathic disorders) initiated therapy with pregabalin and met all other entry criteria; mean age was 62 years, and 58% were women. During pretreatment, most (54%) patients received three or more different types of pain-related medications. During follow-up, patients averaged four prescriptions for pregabalin, totaling 93 therapy days. Compared with pretreatment, fewer patients received other pain-related medications during follow-up, including TCAs (37% during pretreatment vs. 27% during follow-up), opioids (64% vs. 55%), and AEDs other than pregabalin (36% vs. 16%) (all P

To examine characteristics and patterns of healthcare utilization of patients with fibromyalgia (FM) under the care of general practitioners (GPs) in Germany.Retrospective cohort study, using a large electronic database with information on GP encounters in Germany (IMS MediPlus). We identified all patients, agedor =18 years, with any encounters for FM (ICD-10 diagnosis code M79.7) between February 1, 2004 and January 31, 2007. We also constituted a comparison group consisting of randomly selected patients with one or more GP encounters - but none for FM - during this period, who we matched to FM patients based on age and sex. Characteristics and healthcare utilization of patients in the FM and comparison groups were then examined over the 1-year period, February 1, 2006-January 31, 2007.Prevalence of co-morbidities; use of pain-related pharmacotherapy; number of GP office visits; number of specialist referrals; and number of sick notes (physician-excused absences from work).The study sample consisted of 4983 FM patients and an identical number in the comparison group. Mean age was 58 years; 87% were women. The prevalence of various co-morbidities was greater among FM patients, including painful neuropathies (33% vs. 18% for comparison group) and depression (20% vs. 5%) (both p0.01); more FM patients also received pain-related pharmacotherapy (67% vs. 28%; p0.01). Compared with patients in the comparison group, FM patients averaged approximately twice as many GP visits (11.4 [SD=10.1] vs. 5.8 [7.5]), referrals (4.5 [5.2] vs. 2.2 [3.6]), and sick notes (0.6 [1.8] vs. 0.3 [1.1]) (all p0.01).Information in the study database is limited to GP encounters, and the sensitivity and specificity of our case-finding methods are unknown.Patients with FM under the care of GPs in Germany have comparatively more co-morbidities and higher levels of healthcare utilization.

Initial antibiotic therapy in hospitalized adults with complicated intra-abdominal infection (cIAI) usually is empiric. We explored the economic consequences of failure of such therapy in this patient population.Using a large U.S. multi-institutional database, we identified all hospitalized adults admitted between April 1, 2003, and March 31, 2004; who had any cIAI; underwent laparotomy, laparoscopy, or percutaneous drainage of an intra-abdominal abscess ("surgery"); and received intravenous (IV) antibiotics. Initial therapy was characterized in terms of all IV antibiotics received, on the day of or one day before initial surgery. Antibiotic failure was designated on the basis of the need for reoperation or receipt of other IV antibiotics postoperatively. Switches to narrower spectrum agents and changes in regimen prior to discharge with no other evidence of clinical failure were not counted as antibiotic failures. Using multivariable linear regression, duration of IV antibiotic therapy, hospital length of stay, and total inpatient charges were compared between patients who did and did not fail initial therapy. Mortality was compared using multivariable logistic regression.Among 6,056 patients who met the study entrance criteria, 22.4% failed initial antibiotic therapy. Patients who failed received an additional 5.6 days of IV antibiotic therapy (10.4 total days [95% confidence interval 10.1, 10.8] days vs. 4.8 total days [4.8, 4.9] for those not failing), were hospitalized an additional 4.6 days (11.6 total days [11.3, 11.9] vs. 6.9 total days [6.8, 7.0], respectively), and incurred $6,368 in additional inpatient charges ($16,520 [$16,131, $16,919] vs. $10,152 [$10,027, $10,280]) (all, p0.01). They also were more likely to die in the hospital (9.5% vs. 1.3%; multivariable odds ratio 3.58 [95% confidence interval 2.53, 5.06]).Failure of initial IV antibiotic therapy in hospitalized adults with cIAIs is associated with longer hospitalization, higher hospital charges, and a higher mortality rate.

Patients with cancer may receive erythropoiesis-stimulating agents (ESAs), including darbepoetin alfa (DA) or epoetin alfa (EA), to treat cancer-related anemia (CRA). DA and EA differ, however, with respect to their assumed duration of effect and thus their approved frequency of dosing, complicating direct comparison of their doses and costs.The objective of this study was to examine, from the perspective of a third-party payer, patterns of use and costs of DA and EA in patients with CRA, using episode-based methodology to account for differences in assumed duration of effect and frequency of dosing with these products.Using a large US health insurance claims database, we identified all patients with cancer who received ESAs between January 1, 2005, and June 30, 2005 (study period). For each such patient, we identified all unique episodes of care (EOCs) with DA or EA, and then compared mean weekly dose and cost of ESA therapy within these EOCs, which were calculated using the ratio of total dose received and total cost of ESA therapy, respectively, to total EOC duration; only the first EOC for each patient was considered. EOCs were assumed to begin on the date of first ESA administration within the study period, and end on the date of final ESA administration (within the episode) plus an assumed duration of effect based on the ESA received and corresponding dose. We also estimated the ratio of mean weekly dose of EA (in units) to mean weekly dose of DA (in micrograms) (EA/DA weekly dose ratio). Multivariate regression was used to control for differences in baseline characteristics of EA and DA patients.We identified a total of 1226 patients with complete EOCs with ESAs (EA, 381; DA, 845). DA patients were more likely to have had evidence of receipt of chemotherapy (54% vs 47% for EA; P = 0.02); they also had more comorbidities (mean Charlson comorbidity scores, 4.3 and 3.9, respectively; P0.01). Estimated mean (95% CI) weekly dose within EOCs was 97 microg (94-99) for DA, and 43,184 U (40,181-46,589) for EA; EA/DA weekly dose ratio was 445:1. Adjustment for differences in patient characteristics yielded a slightly lower ratio (403:1). Results were sensitive to the exclusion of EOCs consisting of a single administration of ESA therapy and/or the addition of an assumed duration of effect to the final ESA dose administered.Cost comparisons of DA and EA are sensitive to the assumed duration of effect added to the final dose of ESA therapy, especially for EOCs with relatively few administrations.

Using a large US health insurance claims database, we identified all persons aged 18 years or older with 2 or more medical encounters in calendar year 2000 for painful neuropathic disorders (PNDs). We also identified an age- and gender-matched group of patients without PNDs (matched control subjects). We then compared the clinical characteristics and economic costs of PND patients with those of matched control subjects. There were a total of 55,686 patients with PNDs in the study database. The most frequently noted PNDs were back and neck pain with neuropathic involvement (62.3% of PND patients), causalgia (12.1%), and diabetic neuropathy (10.8%). In comparison with matched control subjects, PND patients were more likely to have other pain-related conditions, including fibromyalgia (6.0% vs 0.6% for control subjects), osteoarthritis (13.6% vs 3.6%), and other chronic comorbidities, such as coronary heart disease (13.6% vs 6.5%) and depression (6.4% vs 2.3%). Total calendar year 2000 health care charges were 3-fold higher for PND patients than matched control subjects ($17,355 vs $5,715, respectively). Our results suggest that patients with PNDs are generally in poorer health and have higher health care costs than their peers without these conditions. Perspective Use of nonsteroidal anti-inflammatory agents and opioids was widespread in patients with PNDs, while relatively few received antiepileptic drugs and tricyclic antidepressants, both of which are often more effective against neuropathic pain. Our study raises questions about the optimality of PND treatment in clinical practice.

BACKGROUND Venous thromboembolism (VTE) is a frequent and potentially costly complication of major orthopedic surgery. OBJECTIVE To estimate the economic consequences of VTE following major orthopedic surgery. METHODS Using a large healthcare claims database, we identified all patients who underwent total hip replacement, major knee surgery, or hip fracture repair from January 1993 to December 1998. Patients with clinical VTE (cases) were identified based on a diagnosis of deep vein thrombosis or pulmonary embolism within 90 days of surgery (index admission) and ≥1 prescription for warfarin or unfractionated heparin within 30 days of the date of initial VTE diagnosis. Each case was matched (using age and procedure type) to 2 randomly selected patients who did not have any claims for clinical VTE (matched controls). Utilization and billed charges were then examined over a 90-day period following admission. Cases were stratified based on whether VTE was first noted during the index admission or thereafter. RESULTS A total of 11 960 patients were identified who underwent total hip replacement, major knee surgery, or hip fracture repair (n = 3171, 3955, 4834, respectively). Over a 90-day period, 259 patients (2.2%) developed clinical VTE. Most cases (61.8%) occurred after hospital discharge. For patients with in-hospital VTE, mean length of stay for the index admission was 4.5 days longer than that of matched controls (11.1 vs 6.6); by day 90, there was a 5.4-day difference in total hospital days. Mean billed charges for the index admission were $17 552 higher ($52 037 vs $34 485); the difference rose to $18 834 by day 90 ($54 480 vs $35 646). For patients who developed clinical VTE following hospital discharge, there was a 3.4-day difference in total hospital days at day 90 (10.2 vs 6.8) as a result of readmissions for VTE; mean total billed charges at day 90 were $5765 higher ($41 411 vs $35 646) CONCLUSION Among patients who have undergone major orthopedic surgery, the economic consequences of VTE are substantial, regardless of the setting in which it occurs.

Background: Postherpetic neuralgia (PHN) is a chronic painful disorder that sometimes develops after an acute episode of herpes zoster infection (shingles) and can be difficult to treat. Although opioids are sometimes effective for chronic neuropathic pain, adverse effects are common, particularly among the elderly, and may cause many patients to discontinue therapy. Objective: This study examined changes in opioid use after the initiation of gabapentin therapy in patients with PHN. Methods: A health insurance claims database was used to identify all persons aged ≥ 18 years who began therapy with gabapentin in 2000 or 2001 and had either (1) ≥2 medical claims with a diagnosis of PHN during the 6-month period before the first receipt of gabapentin (index date) or (2) 1 such claim ≤14 days before the index date. Persons who were not continuously eligible for medical and drug benefits for 6 months before and after the index date (pretreatment and follow-up, respectively) were dropped from the study sample. Use of opioids, including both short- and long-acting formulations, was compared between pretreatment and follow-up. Patients were stratified in the study analyses by whether they received 1 or ≥2 prescriptions for gabapentin. Results: Forty-five patients with PHN began therapy with gabapentin during the period of interest; 35 (77.8%) received ≥2 prescriptions for gabapentin. The proportion of patients receiving opioids decreased significantly between pretreatment and follow-up (from 88.9% to 71.1%; P = 0.03); the mean number of opioid prescriptions per patient also decreased significantly (from 3.9 to 3.0; P = 0.03). These reductions were observed only in patients who received ≥2 prescriptions for gabapentin; there was no significant change in opioid use among those who received only 1 prescription for gabapentin. Conclusion: In this study, initiation of gabapentin therapy in patients with PHN was associated with a reduction in the use of opioid analgesics.

Consequences of initial antibiotic failure in patients hospitalized for complicated skin and skin-structure infections (cSSSI) are not well understood.Using data from100 hospitals in the United States, we identified all adults hospitalized for cSSSI between January 1, 2000 and June 30, 2009. We defined "initial therapy" as all parenteral antibiotics administered24 h of admission, and such therapy was assumed to have failed if the patient (1) received new antibiotic(s) subsequently (excluding similar/narrower spectrum antibiotics or those begun at discharge), or (2) underwent drainage/debridement/amputation72 h after admission. We limited attention to the 40 most commonly used antibiotic regimens in 2009. We compared clinical and economic outcomes of patients who experienced initial treatment failure and those who did not.The rate of initial treatment failure was 16.6% in acute infections (n=13,498), 34.1% in chronic/ulcerative infections (n=1,116), and 26.7% in surgical site infections (SSIs) (n=2,929). Treatment failure was associated with 4.1-7.3 additional days in the hospital and $11,995-$23,655 in additional inpatient charges; the case fatality rate was from 4- to 12-fold higher in patients who experienced treatment failure than in those who did not (all comparisons, p0.01).Initial treatment failure in patients hospitalized for cSSSI is associated with significantly worse clinical outcomes, longer hospital stays, and higher hospital charges than with successful initial treatment.

To identify risk factors for initial treatment failure in patients with community-acquired pneumonia (CAP) in non-intensive care unit (non-ICU) settings, and to characterize the association between initial treatment failure and length of stay, total hospital charges, and mortality.Retrospective cohort study. Using data from100 US hospitals, this study identified all adults (age ≥18 years) hospitalized for pneumonia between January 1, 2000 and June 30, 2009 who began antibiotic therapy within 24 h of admission and were treated for at least 48 h if alive; patients admitted to intensive care within the first 24 h in hospital were excluded. Initial therapy was defined as all parenteral antibiotics administered within the first 24 h in hospital. Treatment failure was assessed based on subsequent receipt of new antibiotic(s), excluding agents of similar/narrower spectrum and those begun at discharge. Multivariate logistic regression was used to identify risk factors for treatment failure, and multivariate linear and logistic regression to compare length of stay, total hospital charges, and in-hospital mortality between patients experiencing initial treatment failure and those who did not.Among 32,324 patients with non-ICU CAP, 4695 (14.6%) experienced initial treatment failure, most often within 72 h of hospital admission. Significant predictors of initial treatment failure included malnourishment (OR = 1.87; 95% CI = 1.60-2.18), receipt of vasoactive medications within 24 h of admission (1.51 [1.17-1.94]), and renal failure (1.45 [1.32-1.59]). Treatment failure was associated with higher case fatality (8.5% vs 3.3%), longer hospital stays (mean [SD] = 10.1 [8.1] days vs 4.9 [3.3] days), and higher total hospital charges ($37,602 [$71,876] vs $14,371 [$21,633]) (all comparisons, p0.01). Study limitations include possible inclusion of patients with healthcare-associated pneumonia (HCAP) in the study sample, our focus on the 40 most commonly used antibiotic regimens, and indirect measurement of treatment failure.Approximately one in seven non-ICU CAP patients experience failure of initial antibiotic therapy. Risk of failure is higher for patients with significant comorbidities and/or severe infections. Non-ICU patients who experience initial treatment failure have significantly longer hospital stays, higher total hospital charges, and higher rates of mortality.

Background Selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, and benzodiazepine anxiolytics are used in the US to treat generalized anxiety disorder (GAD). While benzodiazepines typically provide rapid symptomatic relief, long-term use is not recommended due to risks of dependency, sedation, falls, and accidents. Methods Using a US health insurance database, we identified all persons with GAD (ICD-9-CM diagnosis code 300.02) who began a long-term course of treatment (≥90 days) with a benzodiazepine anxiolytic between 1/1/2003 and 12/31/2007, We compared healthcare utilization and costs over the six-month periods preceding and following the date of treatment initiation (“pretreatment” and “post-treatment”, respectively), and focused attention on accident-related encounters (e.g., for treatment of fractures) and care received for other reasons possibly related benzodiazepine use (e.g., sedation, dizziness). Results A total of 866 patients met all study entry criteria; 25% of patients began treatment on an add-on basis (i.e., adjunctive to escitalopram, paroxetine, sertraline, or venlafaxine), while 75% of patients did not receive concomitant therapy. Mean total healthcare costs increased by $2334 between the pretreatment and post-treatment periods (from $4637 [SD=$9840] to $6971 [$17,002]; p Conclusions Healthcare costs increase in patients with GAD beginning long-term (≥90 days) treatment with a benzodiazepine anxiolytic; a substantial proportion of this increase is attributable to care associated with accidents and other known sequelae of long-term benzodiazepine use.

Background Clinical characteristics and patterns of healthcare utilization in patients with painful neuropathic disorders (PNDs) who are under the care of general practitioners (GPs) in the UK are not well understood. Methods Using a large electronic UK database, we identified all adults (age ≥ 18 years) with any GP encounters between 1 January 2006 - 31 December 2006 at which a diagnosis of PND was noted ("PND patients"). An age-and gender-matched comparison group also was constituted consisting of randomly selected patients with one or more GP encounters-but no mention of PNDs-during this period. Characteristics and patterns of healthcare utilization of patients in the two groups were then examined over the one-year study period. Results The study sample consisted of 31,688 patients with mention of PNDs and an equal number of matched comparators; mean age was 56 years, and 62% were women. The prevalence of various comorbidities was higher among patients in the PND group, including digestive disorders (31% vs. 17% for comparison group), circulatory disorders (29% vs. 22%), and depression (4% vs. 3%) (all p < 0.01). Receipt of prescriptions for pain-related pharmacotherapy also was higher among PND patients, including nonsteroidal anti-inflammatory drugs (56% of PND patients had one or more such prescriptions vs. only 22% in the comparison group), opioids (49% vs. 12%), tricyclic antidepressants (20% vs. 1%), and antiepileptics (12% vs. 1%) (all p < 0.01). PND patients also averaged significantly more GP visits (22.8 vs. 14.2) and referrals to specialists (2.8 vs. 1.4) over one year (both comparisons p < 0.01). Conclusions Patients with PNDs under the care of GPs in the UK have relatively high levels of use of healthcare services and pain-related pharmacotherapy.

Invasive meningococcal disease (IMD) is under-reported in countries that do not employ polymerase-chain reaction for surveillance because culture-negative cases are omitted. To evaluate a clinically based, case-finding method, we developed case definitions for "probable," "compatible with," and "possible, but unlikely" IMD, respectively, based on supportive documentation (e.g., discharge diagnosis of meningococcal infection, culture-negative bacterial meningitis, petechiae/purpura, Gram-negative diplococci on Gram stain) and weight of clinical evidence, which we then applied to electronic health records for all children aged ≤5 y who were admitted to approximately 100 US hospitals between January 2000 and June 2009. Among 47,863 qualifying admissions, 16 children had culture-positive IMD, 5 had "probable" IMD, and 5 had illness "compatible with" IMD. Five additional children had disease considered "possible but unlikely" IMD. Our case-finding methods suggest that culture-based ascertainment may underestimate the number of IMD cases by 31-63%, supporting findings in other nations that culture-based reporting provides incomplete information on disease incidence and therefore underestimates the potential benefits of routine vaccination of young children against meningococcal disease.

To characterize adherence with antidepressants, antiepileptic drugs, and beta blockers as prophylaxis against migraine in typical clinical practice.Using a large US health insurance claims database (calendar years 2003 to 2005), we identified all patients with migraine who began prophylaxis with selected antidepressants, antiepileptic drugs, or beta blockers ("study agents"). Patients not continuously enrolled for 6 months prior to start of prophylaxis ("pretreatment") and for 6 months subsequently ("follow-up") were excluded. Treatment cohorts were constituted based on the type of prophylaxis received. Adherence with migraine prophylaxis was examined by type of agent received using medication possession ratios (MPRs), defined as total days with medication divided by total follow-up days. MPR0.80 was considered indicative of nonadherence.A total of 4,634 patients met all entry criteria and received antidepressants (n = 1,803), antiepileptics (n = 1,896), or beta blockers (n = 935) on their index date. Over the next 6 months, the mean (SD) number of prescriptions for study agents was 2.7 (1.9) for antidepressants, 2.9 (2.0) for antiepileptics, and 2.8 (2.0) for beta blockers, totaling 91.0 (71.4), 98.7 (75.6), and 96.7 (73.0) therapy-days, respectively. Mean MPR at 6 months was 0.48 for antidepressants, 0.51 for antiepileptics, and 0.51 for beta blockers. By the end of the follow-up, 73.4%, 70.2%, and 67.6% of patients who initiated migraine prophylaxis with antidepressants, antiepileptics, and beta blockers, respectively, were designated nonadherent (ie, MPR0.80).Our findings suggest that many patients who begin migraine prophylaxis with antidepressants, antiepileptics, or beta blockers are no longer taking these medications at 6 months.

Background The purpose of this study was to compare pre- and post-surgical healthcare costs in commercially insured total joint arthroplasty (TJA) patients with osteoarthritis (OA) in the United States (U.S.). Methods Using a large healthcare claims database, we identified patients over age 39 with hip or knee OA who underwent unilateral primary TJA (hip or knee) between 1/1/2006 and 9/30/2007. Utilization of healthcare services and costs were aggregated into three periods: 12 months "pre-surgery," 91 days "peri-operative," and 3 to 15 month "follow-up," Mean total pre-surgery costs were compared with follow-up costs using Wilcoxon signed-rank test. Results 14,912 patients met inclusion criteria for the study. The mean total number of outpatient visits declined from pre-surgery to follow-up (18.0 visits vs 17.1), while the percentage of patients hospitalized increased (from 7.5% to 9.8%) (both p < 0.01). Mean total costs during the follow-up period were 18% higher than during pre-surgery ($11,043 vs. $9,632, p < 0.01), largely due to an increase in the costs of inpatient care associated with hospital readmissions ($3,300 vs. $1,817, p < 0.01). Pharmacotherapy costs were similar for both periods ($2013 [follow-up] vs. $1922 [pre-surgery], p = 0.33); outpatient care costs were slightly lower in the follow-up period ($4338 vs. $4571, p < 0.01). Mean total costs for the peri-operative period were $36,553. Conclusions Mean total utilization of outpatient healthcare services declined slightly in the first year following TJA (exclusive of the peri-operative period), while mean total healthcare costs increased during the same time period, largely due to increased costs associated with hospital readmissions. Further study is necessary to determine whether healthcare costs decrease in subsequent years.

OBJECTIVE To estimate direct and indirect economic costs among private-sector employees with osteoarthritis (OA). METHODS Using a large US employer benefits database, we identified all employees with evidence of OA during calendar year 2007, and compared their costs of health care and work loss to age-and-sex-matched employees without evidence of OA in that year. RESULTS Private-sector employees with OA (n = 2399) averaged 62.9 days of absenteeism versus 36.7 days among matched comparators (n = 2399) (P < 0.01). Mean total direct costs among these persons were $17,751 and $5057, respectively (P < 0.01); 34% of health care costs among persons with OA arose from medical encounters with listed diagnoses of OA. Mean total indirect costs were two-fold higher among persons with OA ($5002 versus $2120 for those without OA; P < 0.01). CONCLUSIONS Private-sector employees with OA have higher direct and indirect costs than those without this condition.

To compare healthcare utilization and costs in the year preceding and following initial diagnosis of fibromyalgia (FM).Using a large US health insurance claims database, we identified all persons with newly diagnosed FM (International Classification of Diseases, Ninth Revision, Clinical Modification diagnosis code 729.1) between January 1, 2003, and December 31, 2005 ("FM patients"). Each patient's first-noted claim with a diagnosis of FM was designated the "index date," and all pharmacy, outpatient, and inpatient claims were compiled over the 12-month periods preceding and following this date ("prediagnosis" and "postdiagnosis," respectively). Patients with incomplete pre- or postdiagnosis data were excluded. Healthcare utilization and costs were compared between the 2 periods.A total of 1803 patients met all study inclusion criteria; mean (SD) age was 50.4 (9.4) years; 91% were women. Comorbidities were common, including arthritis (21% of study subjects), back pain (20%), and painful neuropathic disorders (16%). The percentage of study subjects receiving various pain-related medications increased from pre- to postdiagnosis, including opioids (51.3% vs 55.9%), antiepileptics (22.6% vs 28.6%), and tricyclic antidepressants (15.5% vs 21.2%) (all P.01). Mean total healthcare costs also increased by $1725 between these periods (mean [95% confidence interval]: $9324 [$8655, $10,092] vs $11,049 [$10,245, $11,973], respectively; P.01).Patients with FM are often seen for other medical problems prior to initial diagnosis. Levels of healthcare utilization and costs are high during both the pre- and postdiagnosis periods.

To compare healthcare utilization and costs in patients with end-stage renal disease (ESRD) beginning peritoneal dialysis (PD) or hemodialysis (HD).Retrospective cohort study.Using a US health insurance database, we identified all patients with ESRD who began dialysis between January 1, 2004, and December 31, 2006. Patients were designated as PD patients or as HD patients based on first-noted treatment. Patients with less than 6 months of pretreatment data and those with less than 12 months of data following initiation of dialysis ("pretreatment" and "follow-up," respectively) were dropped from the study sample. The PD patients were matched to HD patients using propensity scoring to control for differences in pretreatment characteristics. Healthcare utilization and costs were then compared over 12 months between propensity-matched PD patients and HD patients using paired t tests and Wilcoxon signed rank tests for continuous variables and using Bowker and McNemar tests for categorical variables, as appropriate.A total of 463 patients met all study entrance criteria; 56 (12%) began treatment with PD, and 407 (88%) began treatment with HD. Fifty PD patients could be propensity matched to an equal number of HD patients. The HD patients were more than twice as likely as matched PD patients to be hospitalized over the subsequent 12 months (hazard ratio, 2.17; 95% confidence interval, 1.34-3.51; P.01). Their median healthcare costs over the 12-month follow-up period were $43,510 higher ($173,507 vs $129,997 for PD patients, P = .03).Among patients with ESRD, PD patients are less likely than HD patients to be hospitalized in the year following initiation of dialysis. They also have significantly lower total healthcare costs.

Background Several medications commonly used to treat generalized anxiety disorder (GAD) have been designated "potentially inappropriate" for use in patients aged ≥65 years because their risks may outweigh their potential benefits. The actual extent of use of these agents in clinical practice is unknown, however. Methods Using a database with information from encounters with general practitioners (GP) in Germany, we identified all patients, aged ≥65 years, with any GP office visits or dispensed prescriptions with a diagnosis of GAD (ICD-10 diagnosis code F41.1) between 10/1/2003 and 9/30/2004 ("GAD patients"). Among GAD-related medications (including benzodiazepines, tricyclic antidepressants [TCAs], selective serotonin reuptake inhibitors, venlafaxine, hydroxyzine, buspirone, pregabalin, and trifluoperazine), long-acting benzodiazepines, selected short-acting benzodiazepines at relatively high dosages, selected TCAs, and hydroxyzine were designated "potentially inappropriate" for use in patients aged ≥ 65 years, based on published criteria. Results A total of 975 elderly patients with GAD were identified. Mean age was 75 years, and 72% were women; 29% had diagnoses of comorbid depression. Forty percent of study subjects received potentially inappropriate agents – most commonly, bromazepam (10% of all subjects), diazepam (9%), doxepin (7%), amitriptyline (5%), and lorazepam (5%). Twenty-three percent of study subjects received long-acting benzodiazepines, 10% received short-acting benzodiazepines at relatively high doses, and 12% received TCAs designated as potentially inappropriate. Conclusion GPs in Germany often prescribe medications that have been designated as potentially inappropriate to their elderly patients with GAD – especially those with comorbid depressive disorders. Further research is needed to ascertain whether there are specific subgoups of elderly patients with GAD for whom the benefits of these medications outweigh their risks.

Using a large database with information from general practitioners (GP) throughout Germany, we identified all adults (age > or = 18 years) with encounters for painful neuropathic disorders (PNDs) between August 1, 2005 and July 31, 2006 (PND patients). We also constituted an age- and sex-matched comparison group, consisting of randomly selected patients without any GP encounters for PNDs during the same period. Selected characteristics were then compared between PND patients and those in the comparison group over the 1-year study period. The study sample consisted of 275,685 PND patients and a similar number in the matched comparison group; mean age was 53.7 years, and 57% were women. PND patients were more likely than matched comparators to have encounters for various comorbidities, including circulatory system disorders (47% vs. 20%, respectively), depression (9% vs. 2%), and anxiety (4% vs. 1%) (all P < 0.01). They also were more likely to have received pain-related medications (57% vs. 13% for comparison group; P < 0.01)--most commonly, nonsteroidal anti-inflammatory drugs, benzodiazepines, and opioids, and less often, tricyclic antidepressants and anti-epileptics. PND patients averaged 7.3 more GP visits during the year (mean [95% CI] = 9.9 [9.9, 9.9] vs. 2.6 [2.6, 2.7] for comparison group); they also had significantly more specialist referrals and physician-excused absences from work (all P < 0.01). Patients with PNDs under the care of GPs in Germany have comparatively more comorbidities and higher levels of use of healthcare services. The pain-related medications that these patients receive raise concerns that PNDs may not be optimally treated in these settings.

Objective.To estimate the consequences of failure of initial antibiotic therapy for patients with complicated skin and skin-structure infections.Design.Retrospective cohort study.Setting.Large US multihospital database.Patients.We identified a total of 47,219 patients (age 18 years or older) who were admitted to the hospital for complicated skin and skin-structure infections from April 1, 2003, through March 31, 2004, and who received intravenous antibiotics during the first 2 hospital-days (ie, initial antibiotic therapy). Failure of therapy was defined as drainage, debridement, or receipt of other intravenous antibiotics at any subsequent time (except for changes to narrower-spectrum agents or any therapy change immediately before discharge). Predictors of failure of antibiotic therapy and mortality were examined using multivariate logistic regression. Analysis of covariance was used to estimate the impact of treatment failure on duration of intravenous antibiotic therapy, length of stay, and total inpatient charges.Results.For 10,782 admitted patients (22.8%), there was evidence of failure of initial antibiotic therapy. In multivariate analyses, treatment failure was associated with receipt of vasoactive medications during the first 2 hospital-days (odds ratio [OR], 1.66 [95% confidence interval {CI}, 1.19-2.31]), initiation of antibiotic therapy in the intensive care unit (OR, 1.53 [95% CI, 1.28-1.84]), and the patient's Charlson comorbidity index (OR per 1-point increase, 1.06 [95% CI, 1.04-1.08]); treatment failure was also was associated with a 3-fold increase in mortality (OR, 2.91 [95% CI, 2.34-3.62]). Compared with patients for whom initial treatment was successful, patients who experienced treatment failure received intravenous antibiotic therapy for a mean of 5.7 additional days, were hospitalized for a mean of 5.4 additional days, and incurred a mean of $5,285 (in 2003 dollars) in additional inpatient charges (all P Conclusion.Failure of initial antibiotic therapy in the treatment of complicated skin and skin-structure infections is associated with significantly worse clinical and economic outcomes.

Purpose To describe patterns of use of tricyclic antidepressants (TCAs) (eg, amitriptyline, nortriptyline) among older patients with diabetic peripheral neuropathy (DPN). Materials and methods Using a large, integrated, US health-insurance claims database, we identified all patients who received TCAs between January 1, 1999 and June 30, 2001 ("study period"). Among these persons, we then selected those who: (1) were aged >or=65 years as of the date of first receipt of a TCA during the study period; and (2) had one or more healthcare encounters with a diagnosis of DPN in the 30-day period immediately preceding date of first receipt of a TCA. We then examined the prevalence of selected comorbidities and concurrent use of medications which might render inappropriate the prescribing of TCAs, based on a listing of contraindications, warnings, and precautions found in the package inserts for these medications. Patterns of TCA prescribing were examined, based on information on paid claims. Results There were 349 DPN patients, aged >or=65 years, who received TCAs. Mean age was 73.8 years, 55.9% were women, and 17.9% had diagnoses of depression. Most patients (84.0%) began therapy with amitriptyline. Almost one-half of study patients had indicators of potentially inappropriate TCA use, primarily cardiovascular comorbidities. Mean TCA dose among patients with and without these indicators was 23.3 (+/-13.4) mg and 25.4 (+/-15.3) mg, respectively (P=0.42). Conclusions The high prevalence of contraindications, warnings, or precautions and the low level of TCA exposure suggest that many older patients with DPN who receive TCAs may be inappropriately treated.

Using a large US health insurance claims database, we identified all persons aged > or =18 years with > or =2 medical encounters with diagnoses of cancer and > or =2 medical encounters with diagnoses of painful neuropathies in calendar year (CY) 2000; persons with seizure disorders or depression were excluded. We then examined the use of antiepileptics (AEDs), tricyclic antidepressants (TCAs) and other pain-related pharmacotherapy among these selected persons, as proxied by pharmacy dispenses. A total of 956 persons were identified who met all entry criteria; 17% received AEDs in CY2000 and 14% received TCAs. Gabapentin was the most widely used AED (92% of all AED patients); amitriptyline was the most widely used TCA (79% of all TCA patients). Patients who received AEDs and/or TCAs were similar in age, gender and the presence of metastases to those who had not received these medications; they were more likely to have received other pain-related therapies, however, including short-acting opioids (73% vs. 53%; P < 0.01) and long-acting opioids (23% vs. 8%; P < 0.01). Use of AEDs and TCAs appears to be relatively low among cancer patients with painful neuropathies. Further research is needed to better understand reasons for this finding, as well as its potential implications for pain management in this patient population.

To describe patterns of use of tricyclic antidepressants (TCAs) (e.g., amitriptyline, nortriptyline) in older patients with painful neuropathies.Using a large US health insurance claims database, we identified all persons who: (1) received a TCA between 1 January 1999 and 30 June 2001, (2) were agedor =65 years as of the date of their first prescription for a TCA during this period, and (3) had one or more health care encounters for the treatment of a painful neuropathy in the 30-day period immediately preceding their initial receipt of a TCA. We then examined the prevalence of selected comorbidities and/or concurrent use of medications that might render the prescribing of a TCA inappropriate, based on a listing of contraindications, warnings, and precautions found in the package inserts for these agents. Patterns of TCA use also were examined, based on information on paid claims.A total of 1,732 patients met all inclusion and exclusion criteria for the study. Their mean age was 74.6 years; 60.3% were women. Amitriptyline was the most frequently prescribed TCA (79.4% of patients). Forty-one percent of study subjects receiving TCAs had conditions--primarily cardiovascular--that render the use of such agents potentially inappropriate. The mean daily dose of TCAs was universally low (about 23 mg).The high prevalence of conditions rendering the use of TCAs potentially inappropriate, along with relatively low daily dosages, suggest that many older patients with painful neuropathies who are prescribed these agents may be suboptimally treated.

BACKGROUND Infliximab, in combination with methotrexate, is indicated for the treatment of moderate to severe active rheumatoid arthritis (RA). While there is anecdotal evidence that many patients beginning infliximab therapy have their dose and/or frequency of infusions increased over time (“dose intensification”), relatively little is known about actual patterns of use in clinical practice. OBJECTIVE To examine patterns of infliximab use in patients with RA. METHODS Using a large US healthcare claims database, all patients with RA who initiated infliximab therapy between January 1, 2000, and September 30, 2001, were identified. The date of each patient's first claim for infliximab was identified and designated as the index date; attention was limited to patients who received infliximab for at least one year. Patterns of infliximab use were then examined over the 12-month period following the index date, based on information on paid claims. RESULTS Fifty-three patients met all entry criteria; the mean age was 61 years, and 81% were women. Twenty-eight percent of patients received >8 infusions over 12 months. The mean dose of infliximab at initial infusion was 296.2 mg; at final infusion, it was 401.9 mg (36% increase). One-half of study subjects had their dose of infliximab increased by ≥30% between the initial and final infusions; one-third had their dose increased by ≥50%. CONCLUSIONS Many patients with RA beginning treatment with infliximab have their frequency of infusions and/or medication dose increased within the first 12 months.

Although older adults with painful neuropathic disorders (PNDs) would appear to be at elevated risk for receiving potentially inappropriate pain-related medications, the extent of such drug use in this population is unknown.The goal of this study was to assess the use of potentially inappropriate pain-related medications among patients with PNDs agedor=65 years.Using a large, integrated US health insurance database, we identified all persons agedor=65 years withor=2 medical encounters involving diagnoses of PNDs during calendar year 2000. Patients with30 days of continuous eligibility for health benefits during the study year were excluded from the sample. Use of potentially inappropriate pain-related medications (as defined by the 1997 Beers criteria) was then examined based on information contained in paid pharmacy claims for all remaining patients.We identified 22,668 patients with PNDs agedor=65 years (mean [SD] age, 73.9 [6.0] years; 58.6% female). Almost one half (11,233 [49.6%]) of patients receivedor=1 potentially inappropriate pain-related medication, including propoxyphene (26.7%) and amitriptyline (10.2%). Women were more likely than men to receive these medications (54.2% vs 43.0%, respectively; P0.01), and use increased with age (47.6%, 51.8%, and 52.8% in those aged 65-74 years, 75-84 years, andor=85 years, respectively; overall comparison, P0.01). Among patients with only 1 PND, the use of potentially inappropriate medications was highest among those with postherpetic neuralgia (70.1%).Use of potentially inappropriate pain-related medications among older adults with PNDs is common. Further research is needed to ascertain whether the benefits of these agents outweigh their risks in this population.

Opioid use and health care charges during the final year of life in patients with metastatic cancer who received controlled-release oxycodone (CRO), transdermal fentanyl (TF), or controlled-release morphine sulfate (CRM) were examined in the following study. A total of 704 patients were identified who met study entry criteria; CRO, TF, or CRM was the first-received long-acting opioid (LAO) during the last year of life for 36% (N = 250), 29% (N = 203), and 36% (N = 251) of study subjects, respectively. On average, patients initiated LAO therapy three to four months before death. One-half of patients received less than 60 days of LAO therapy. Mean total health care charges in the final year of life were dollars 84,572 for patients receiving CRO, dollars 90,935 for patients receiving TF, and dollars 76,446 for patients receiving CRM. Patients receiving TF started LAO therapy closer to their date of death, and had significantly higher hospitalization charges than did patients receiving CRO and CRM.

BACKGROUND Patterns of therapy switching in patients receiving long-acting opioids have not been well documented. OBJECTIVE To compare therapy switching among patients beginning treatment with controlled-release (CR) oxycodone, transdermal fentanyl, or CR morphine sulfate. METHODS Using a US healthcare claims database, we identified patients beginning treatment with CR oxycodone, transdermal fentanyl, or CR morphine sulfate between July 1, 1998, and December 31, 1999. We compiled claims for each patient for 6 months following therapy initiation and compared the incidence of therapy switching among the 3 groups. We also estimated total healthcare charges for patients who switched therapy versus those who did not. RESULTS We identified 1931, 668, and 449 patients beginning therapy with CR oxycodone, transdermal fentanyl, and CR morphine sulfate, respectively; 16.7%, 25.0%, and 35.9%, respectively, had cancer. For patients without cancer, rates of therapy switching at 6 months were 10.6% (CR oxycodone), 19.0% (transdermal fentanyl), and 26.0% (CR morphine sulfate); for those with cancer, rates were 23.8%, 24.6%, and 29.8%, respectively. Multivariate hazard ratios (vs CR morphine sulfate) for therapy switching in patients without cancer were 0.36 (95% CI, 0.27 to 0.47) for CR oxycodone and 0.69 (0.51 to 0.94) for transdermal fentanyl; for those with cancer, corresponding hazard ratios were 0.72 (0.50 to 1.03) and 0.76 (0.50 to 1.16). Total healthcare charges were significantly (p < 0.01) higher for patients who switched therapy than those who did not ($23 965 vs $14 299 in pts. without cancer; $58 259 vs $39 618 for those with cancer). CONCLUSIONS Patients without cancer who receive CR oxycodone or transdermal fentanyl are less likely to switch therapy than those receiving CR morphine sulfate. Total healthcare charges are higher for patients who switch therapy.

This study documents the use of oral and transdermal opioids among patients with metastatic cancer during their final year of life. Using a large, integrated health-insurance claims database, we identified all patients who had metastatic lung, breast, colorectal, prostate, or breast cancer and who also died in 1998 or 1999. We then examined all pharmacy claims for these patients over their final 12 months of life. A total of 2,132 patients were identified who met study entrance criteria. Among patients with bone metastases (n=717), 86.9% received opioids at some point during their final year of life; 71.2% of those without bone metastases (n=1,415) received them. Corresponding figures for long-acting opioids were 52.9% and 23.5%. Coverage ratios (total days supplied/total noninstitutionalized days) for any opioids and long-acting opioids were 25.1% and 12.5%, respectively, among patients with bone metastases, and 13.9% and 4.2% for those without bone metastases. During the final month of life, these ratios were 50.8% and 31.3%, and 28.7% and 13.1%. These relatively low rates of opioid use among patients with metastatic cancer in their final year of life suggest that pain in many cases may be suboptimally treated.

Background Patterns of healthcare utilization and costs in patients beginning pharmacotherapy for generalized anxiety disorder (GAD) have not been well characterized. Methods Using a large US health insurance database, we identified all patients with evidence of GAD (ICD-9-CM diagnosis code 300.02) who initiated pharmacotherapy with medications commonly used to treat GAD (eg, selective serotonin reuptake inhibitors [SSRIs], venlafaxine, benzodiazepines) between 1/1/2003 and 12/31/2007. We examined healthcare utilization and costs over the 12-month periods preceding and following date of initial receipt of such therapy ("pretreatment" and "follow-up", respectively). Patients with incomplete data were excluded. Results A total of 10,275 patients met all study inclusion criteria. Forty-eight percent of patients received SSRIs; 34%, benzodiazepines; and 6%, venlafaxine. SSRIs and venlafaxine were about three times more likely to be used on a long-term basis (> 90 days) than benzodiazepines (p < 0.01). In general, levels of healthcare utilization were higher during follow-up than pretreatment. Mean (SD) total healthcare costs increased from $4812 ($10,006) during pretreatment to $7182 ($22,041) during follow-up (p < 0.01); costs of GAD-related pharmacotherapy during follow-up were $420 ($485). Conclusions More than one-half of patients initiating pharmacotherapy for GAD receive either SSRIs or venlafaxine. Levels of healthcare utilization and costs are greater in the year following initiation of therapy than in the immediately preceding one.

Background Little is known concerning the degree to which initiation of sildenafil for pulmonary arterial hypertension (PAH) impacts patterns of healthcare utilization and costs. Methods Using a large US health insurance claims database, we identified all patients with evidence of PAH (ICD-9-CM diagnosis codes 416.0, 416.8) who received sildenafil between 1/1/2005 and 9/30/2008. Date of the first-noted prescription for sildenafil was designated the “index date,” and claims data were compiled for all study subjects for 6 months prior to their index date (“pretreatment”) and 6 months thereafter (“follow-up”); patients with incomplete data during either of these periods were excluded. Healthcare utilization and costs were then compared between pretreatment and follow-up for all study subjects. Results A total of 567 PAH patients were identified who began therapy with sildenafil and met all other study entry criteria. Mean (SD) age was 52 (10) years; 73% were women. Healthcare utilization was largely unchanged between pretreatment and follow-up, the only exceptions being decreases in the mean number of emergency department visits (from 0.7 to 0.5 per patient; p Conclusions The cost of sildenafil therapy may be partially offset by reductions in other healthcare costs.