Purpose: Treatment of ulcerative proctitis (UP) is aimed at controlling inflammation and reducing symptoms. While orally administered 5-aminosalicylates (“5-ASAs”) traditionally have been the mainstay of acute and maintenance therapy for UP, 5-ASA suppositories or enemas are generally considered to be first-line therapy, due to evidence that they are more effective at inducing and maintaining remission. Little is known, however, about how UP is typically treated in community-based practice. Methods: Using a large US healthcare claims database, we identified all persons with evidence of newly diagnosed UP (ICD-9-CM 556.2, 556.3) between 1/1/2005 and 12/31/2007, based on: (1) ≥2 encounters for UP ≤90 days apart; (2) evidence of sigmoidoscopy/colonoscopy within 60 days of first visit for UP (“index date”); and (3) no evidence of receipt of any medication used to treat UP (eg, 5-ASA, glucocorticoid, etc.) in the year preceding index date. All patients were followed for 365 days from their index date. We examined pharmacotherapy for UP over post-index periods of 30 days and 365 days alternatively. Results: We identified a total of 518 patients with newly diagnosed UP. Mean (SD) age was 48 (16) years, and there were equal numbers of men and women. Forty-five percent of patients were seen by a gastroenterologist at initial visit. In the 30-day post-index period, 37% of patients had evidence of receipt of mesalamine suppository; 23%, an oral 5-ASA; 12%, mesalamine enema; 12%, rectal hydrocortisone; and 6%, oral prednisone. Antidiarrheals, antimetabolites, and TNF inhibitors were rarely used. Over the entire 365-day post-index period, the number of patients ever-prescribed 5-ASA suppositories increased to 45%; oral 5-ASAs, 38%; 5-ASA enemas, 18%; and systemic glucocorticoids, 20%. Combination and sequential treatment was frequent. Over 365 days, 24% of patients had evidence of receipt of both oral and rectal 5-ASAs; 11%, rectal 5-ASAs and rectal steroids; 2%, rectal 5-ASAs and budesonide; and 11%, rectal 5-ASAs and systemic steroids. Conclusion: While local therapy is commonly prescribed in patients with newly diagnosed UP, approximately one in four patients receive an oral 5-ASA preparation. In the year following diagnosis, one in five patients receive systemic steroids—a marker of failure of conservative therapy and/or disease progression. Our findings suggest that treatment of newly diagnosed UP by community-based physicians largely conforms to guidelines and recommendations. Support: This research was funded by Axcan Pharma Inc., which manufactures and markets a 5-ASA suppository (Canasa®). Disclosure: This research was funded by Axcan Pharma Inc., which manufactures and markets a 5-ASA suppository (Canasa®).
Although information concerning the attainment of goal blood pressure for patients commencing antihypertensive therapy is available from controlled trials, no studies have examined this issue in the context of typical clinical practice.To examine attainment of blood pressure control over time in patients initiating antihypertensive therapy in clinical practice.Using an electronic medical records database, we identified all adults with systolic blood pressure (SBP)/diastolic blood pressure (DBP) of 140/90 mm Hg or higher who initiated antihypertensive drug therapy. Subjects were stratified into subgroups based on the presence of high-risk conditions or characteristics described by the Joint National Committee on the Prevention, Detection, Evaluation, and Treatment of High Blood Pressure in their seventh report as "compelling indications" (eg, diabetes) or "special situations" (eg, obesity). Blood pressure control was examined in terms of goal attainment and reductions in blood pressure using last available readings at days 90, 180, and 360, following therapy initiation.Among the 10,345 study subjects, 47% had compelling indications and 39% had special situations. In the former group, 62% (95% CI 61 to 64) of patients with Stage 1 hypertension (140-159/90-99 mm Hg) attained blood pressure less than 140/90 mm Hg by day 360; among those with Stage 2 hypertension (> or =160/100 mm Hg), the corresponding figure was 48% (95% CI 46 to 50). In the latter group, 64% (95% CI 61 to 66) and 55% (95% CI 53 to 57) of patients with Stage 1 and Stage 2 hypertension, respectively, attained blood pressure less than 140/90 mm Hg by day 360. Among those without high-risk conditions, these percentages were 63% (95% CI 59 to 67) and 55% (95% CI 52 to 59). Among patients with diabetes or chronic kidney disease, 25% (95% CI 24 to 26) attained blood pressure less than 130/80 mm Hg by day 360.Many patients starting antihypertensive therapy in clinical practice fail to achieve blood pressure control within the first year. Control is no better, and perhaps worse, among patients at highest risk of adverse outcomes.
e15197 Background: Bone is a common site of metastatic involvement in patients (pts) with PC. Bony metastases (mets) are often associated with SREs (spinal cord compression [SCC], pathologic fracture [PF], surgery to bone [SB], radiotherapy to bone [RT]). Skeletal complications cause significant morbidity and mortality. Current estimates of SRE risk come principally from randomized clinical trials. Information from routine clinical practice is limited. Methods: Using the tumor registry and electronic data stores at a large U.S. Midwest healthcare system that serves approximately 800,000 persons, we retrospectively identified all pts aged ≥18 yrs with primary PC and newly diagnosed bone mets between 1/1/95 and 12/31/09. Electronic medical records were reviewed by trained abstractors for evidence of SREs between date of bone mets diagnosis and death, loss to follow-up, or end of study for evidence of first SRE. Cumulative incidence of SREs was estimated in the presence of competing risk of death. Results: We identified a total of 420 men with primary PC and newly diagnosed bone mets; 42 pts had evidence of SREs at initial diagnosis of bone mets and were excluded from the analyses. Among the remaining 378 pts, mean (SD) age was 72.7 yrs (9.8 yrs); 38% were Caucasian and 58% were African-American. Median duration of follow-up after diagnosis of bone mets was 17.1 months (mos). At 12 mos, cumulative incidence of SREs was 31.6% (SCC, 6.1%; PF, 15.0%; SCC and/or PF, 19.1%; SB, 3.9%; RT, 24.4%) (Table). Corresponding figures at 24 mos were 45.3% (SCC, 12.5%; PF, 22.2%; SCC and/or PF, 30.2%; SB, 6.2%; RT, 34.9%). Relatively few pts (14.6%) received intravenous bisphosphonates prior to SRE. Conclusions: Pts with PC in routine clinical practice are at high risk of SREs following initial diagnosis of bone mets. [Table: see text]
Background: OM is a common toxicity of conditioning regimens for HSCT that has been associated with adverse clinical and economic outcomes. Methods: A retrospective study of approximately 400 consecutive HSCT recipients was undertaken at a single academic center. Data were collected via chart review on days with ulcerative mucositis and selected outcomes including days with fever, days of parenteral narcotic therapy, incidence of Grade III or IV (Common Toxicity Criteria) infection, total inpatient days (LOS), and total inpatient charges. Data are reported here for the 115 MM patients who underwent AU HSCT after high-dose MP conditioning. Results: Mean age of study subjects was 54 years. Seventeen percent of patients received total body irradiation. Bone marrow was the source of most grafts. The relationship between duration of ulcerative mucositis and the outcomes of interest is reported below. Conclusions: Duration of ulcerative OM is associated with worse clinical and economic outcomes in MM patients undergoing AU HSCT following high-dose MP conditioning (Table1) .Table 1Outcomes of AU HSCT Following High-Dose Conditioning for MM, by Days with Ulcerative MucositisDays with Ulcerative Mucositis (Quartile)IIIIIIIVOutcomesn = 32n = 33n = 25n = 25P-value⁎Test for linear trend; Cochran-Armitage for dichotomous and GLM for continuous measures.Fever days (mean,SD)1.0 (1.9)1.9 (3.2)2.5 (2.5)3.1 (3.7).0058Narcotic therapy days (mean,SD)0.7 (1.7)3.9 (3.5)4.4 (3.5)8.8 (5.2)<.0001Infection (%)10.0 (31.3)10.0 (30.3)12.0 (48.0)9.0 (36.0).4115LOS (mean,SD)18.3 (3.1)19.8 (3.5)19.9 (3.4)23.1 (3.5)<.0001Inpatient charges (mean,SD) (× 10,000)11.7 (3.2)12.3 (3.8)11.8 (2.1)15.5 (6.0).0016 Test for linear trend; Cochran-Armitage for dichotomous and GLM for continuous measures. Open table in a new tab
Purpose: To examine the characteristics and healthcare costs of fibromyalgia syndrome (FMS) patients in clinical practice. Materials and methods: Using a US health-insurance database, we identified all patients, aged ≥ 18 years, with any healthcare encounters for FMS (ICD-9-CM diagnosis code 729.1) in each year of the 3-year period, 1 July 2002 to 30 June 2005. A comparison group was then constituted, consisting of randomly selected patients without any healthcare encounters for FMS during this 3-year period. Comparison group patients were matched to FMS patients based on age and sex. Characteristics and healthcare costs of FMS patients and comparison group patients were then examined over the 1-year period, 1 July 2004 to 30 June 2005 (the most recent year for which data were available at the time of the study). Results: The study sample consisted of 33,176 FMS patients and an identical number in the comparison group. Mean age was 46 years, and 75% were women. FMS patients were more likely to have various comorbidities, including painful neuropathies (23% vs. 3% for comparison group), anxiety (5% vs. 1%), and depression (12% vs. 3%) (all p < 0.001); they also were more likely to have used pain-related pharmacotherapy (65% vs. 34% for comparison group; p < 0.001). Mean (SD) total healthcare costs over 12 months were about three times higher among FMS patients [$9573 ($20,135) vs. $3291 ($13,643); p < 0.001]; median costs were fivefold higher ($4247 vs. $822; p < 0.001). Conclusions: Patients with FMS have comparatively high levels of comorbidities and high levels of healthcare utilization and cost.
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.To examine patterns of infliximab use in patients with RA.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.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 > or =30% between the initial and final infusions; one-third had their dose increased by > or =50%.Many patients with RA beginning treatment with infliximab have their frequency of infusions and/or medication dose increased within the first 12 months.
FOR over a century, there have been recurrent claims that capitalist economic development is characterized by a process of unbalanced growth, with technical and institutional changes unevenly distributed among industries. Theorists as diverse as Marx (1867, chapter 25) and Galbraith (1952, chapter 7) have suggested that, though the history of most industries is one of ongoing technical change and increasing concentration of production and capital, there nonetheless exists a recognizable collection of backward industries within which such a process has not occurred. Most recently, these ideas about uneven industrial development have been conceptualized in terms of the analytical construct of industrial dualism.' Proponents of the theory of the dual economyhave suggested that the American economy is composed of two distinct industrial groups: a core of powerful, concentrated, unionized, capital intensive, technologically progressive industries, and a periphery composed of industries marked by the absence of these features. Despite increasing interest in the theory of the dual economy in recent years-in large part, stimulated by heightened interest in dual labor market theories-there has been remarkably little effort devoted to investigating whether the American industrial structure can be characterized accurately as dualistic.2 In section I, a factor analytic test of the theory is proposed. Section II discusses the data employed in the study, and section III suggests plausible guidelines to aid in the interpretation of factor analysis findings. The results, presented in section IV, suggest that a dimension of core-periphery variation characterizes the data examined, and section V will show that this variation is consistent with the hypothesis of industrial dualism.
