Objectives: To analyze strategies of management of patients with diabetic polyneuropathy (DPN) considering the prevalence of DPN and diabetic foot (DF) in Russia. MethOds: The analysis was based on epidemiologic data on DPN and DF, and placebo controlled trials (ALADIN III for alpha-lipoic acid, and D. Ziegler study for Actovegin). Strategies with alpha-lipoic acid (1st group) and with Actovegin (2st group) were compared. In both cases, a 160-day course consisted of 20 days of parenteral injection in hospital, and 140 days of outpatient oral administration. Clinical outcomes and health care system costs were analyzed; cost-effectiveness ratio (CER) was calculated. The share of patients without DF was the main measure of effectiveness. Costs of the drugs, and hospital and outpatient treatment for budget holder were evaluated in two equal-sized groups. During the sensitivity analysis, clinical outcomes (risk of DF) were modeled with increment of 100 persons from 100 to 1000 patients. Results: The cohort of 10 000 patients with type 2 diabetes mellitus contained 6100 patients with DPN including 3700 patients with medium or severe stages. 2100 persons were in risk group for DF, including 1100 patients with high risk. 410 and 330 patients had DF in alpha-lipoic acid group and Actovegin group, respectively. The number of amputations in these groups was 70 and 56. The costs of 160-day treatment was 64,929.73 RUB in the 1st group, and 64,355.73 RUB in the 2nd group. The share of patients without DF was 70.02% and 62.7%. CER were 103,556.19 in alpha-lipoic acid group, and 91,910.50 in Actovegin group. The sensitivity analysis confirmed the advantage of Actovegin administration cOnclusiOns: The study showed clinical and pharmacoeconomic advantages of Actovegin administration in patients with DPN and DF. This strategy has more preferable CER and lower costs for public health care system.
A741 process timelines, requested reimbursement mode, STC, RPA, MoHD, discrepancy between requested conditions and MoHD, information from BIA and ICER value if applicable, and key findings from available clinical analyses. ConClusions: Health care systems based on public money should treat all applicants equally if the conditions for the decision are similar and should provide equal access to benefits for patients with similar needs. The database gathers information on all precedent decisions of marketing authorization and public payer practices of similar products or similar indications. This approach opens up the possibility for improvement of transparency and decision-making practices not only in Poland, but in each country. PRM62 CoMPaRison of iCd-9 to iCd-10 CRosswalks deRived By PhysiCian and CliniCal CodeR vs. autoMated Methods
Objectives: The British Association of Dermatologists Biologic Interventions Register (BADBIR) is a long-term pharmacovigilance register of patients with psoriasis treated with biologic therapies. The objectives were to describe patterns of use of index biologics for biologic-naïve psoriasis patients in BADBIR by: (i) country; and (ii) comorbid psoriatic arthritis (PsA). MethOds: 7495 patients receiving biologics were recruited from 153 dermatology centres across the United Kingdom and the Republic of Ireland (ROI). Registrations from 01/09/2007 (cohort inception) to 01/01/2016 were included. Patients receiving their first biologic therapy (infliximab, etanercept, adalimumab or ustekinumab) were classified as "biologic-naïve" at registration. Proportions of registrations to each therapy by country and PsA were examined. Results: 6140 biologic-naïve patients (82%) registered to BADBIR (median age 45 years, inter-quartile range 36-54; 60% male). Adalimumab (57%) was the most common index biologic (23% etanercept; 18% ustekinumab; 2% infliximab). 76% registrations were in England (9% Scotland; 5% Northern Ireland (NI); 5% ROI; 5% Wales). Adalimumab registrations were highest (73%) in NI (56% England; 48% ROI; 69% Scotland; 46% Wales); etanercept accounted for 46% registrations in ROI (22% England; 15% NI; 21% Scotland; 34% Wales); ustekinumab registrations were highest (20%) in England (11% NI; 6% ROI; 9% Scotland; 18% Wales). PsA was recorded as a comorbidity in 18% of patients at registration. For patients with concomitant PsA, 62% were commenced on adalimumab (25% etanercept; 10% ustekinumab). From 2009 to 2015, registrations for patients with concomitant PsA to ustekinumab and adalimumab increased (4% to 30% and 51% to 61%, respectively), while etanercept registrations decreased (42% to 9%). cOnclusiOns: Adalimumab was the most commonly prescribed index biologic drug across the United Kingdom and ROI. The availability of biologics has influenced prescribing practices. Future work will explore the influence of guidelines for biologic use on prescribing patterns.
To evaluate reduction whether endoscopic screening reduces mortality from gastric cancer, a population-based cohort study was performed in Japan, where both radiographic screening and endoscopic screening for gastric cancer have been conducted. MethOds: The subjects were selected from among participants in gastric cancer screening in 2 cities (Tottori and Yonago) from 2007 to 2008. The subjects were defined as participants aged 40-79 years with no gastric cancer screening in the previous year. Follow-up related to mortality was continued from the date of the first screening to the date of death or up to December 31, 2013. A Cox proportional hazards model was used to estimate the relative risks (RRs) of incident gastric cancer, gastric cancer death, all cancer deaths except gastric cancer death, and all-cause death except gastric cancer death. Results: The subjects were 9,950 participants in endoscopic screening and 4,324 participants in radiographic screening. The endoscopic screening group showed a 67% reduction from gastric cancer compared to that of radiographic screening group (RR adjusted by sex, age group, and city of residence = 0.327, 95%CI: 0.117-0.905). The adjusted RR of endoscopic screening was 0.966 (95%: 0.674-1.385) for all cancer deaths except gastric cancer death and 0.932 (95%:0.742-1.170) for all-cause deaths except gastric cancer death. cOnclusiOns: The results of the present study suggest that endoscopic screening can decrease mortality from gastric cancer by 67% compared with radiographic screening. The results are consistent with the previous studies that showed that endoscopic screening reduces mortality reduction from gastric cancer.
Background: Population-based prevalence and incidence data of arterial thromboembolic events (ATEE) in breast cancer (BC) patients are lacking in the published literature.Objectives: The occurrence of ATEE before and after BC diagnosis was compared with cancer-free controls in a population-based setting.Methods: Women who had a first hospitalization for BC between 2002 and 2007 were selected from the PHARMO Record Linkage System (RLS), which includes drug use and hospitalization data from approximately 3 million residents in the Netherlands. BC patients were matched 1:10 by age with cancer-free controls, using the date of diagnosis as the index date for both BC patients and controls. ATEE were defined as a myocardial infarction, unstable angina, ischemic stroke, and transient ischemic attack requiring hospitalization and were assessed 12 mo before and after the index date.Results: The analysis included 11,437 BC patients, with a mean ± SD age of 59 ± 14 years. ATEE before the index date were twice as frequent among BC patients compared with cancer-free controls (Table 1), though prevalence was < 1% in both groups. The incidence of developing ATEE in the 12-mo follow-up period was 6.2 per 1000 person years among patients and 3.8 among controls (Table 2). BC patients experienced 1.7 times higher risk of ATEE compared with controls. This risk was attenuated but remained statistically significant after adjusting for prior cardiovascular or thromboembolic event hospitalization and prior antithrombotic or cardiovascular drug use (HR=1.3 [95%CI: 1.0-1.7]). The increase in risk was slightly higher for cerebrovascular compared with coronary events. Independent risk factors for developing ATEE were age (≥ 65 vs < 65 years), prior use of antihypertensives or antidiabetic drugs, and total hospital stay > 10 days during the first 6 months of follow-up.Table 1. Prevalence of ATEE 12 mo Before BC Diagnosis BC Patients (N=11,473) %Cancer-free Patients (N=114,730) %Odds Ratio (95% CI)ATEE0.70.32.0 (1.6-2.6)Myocardial Infarction0.30.12.9 (1.9-4.2)Unstable Angina0.20.11.5 (0.9-2.3)Ischemic Stroke0.10.11.8 (1.0-3.1)Transcient Ischemic Attack0.10.02.1 (1.2-4.0) Table 2. Incidence of ATEE 12 mo After BC Diagnosis BC Patients (N=11,473) IR per 1000 PYCancer-free Controls (N=114,730) IR per 1000 PYHazard Ratio (95% CI)ATEE6.23.81.7 (1.3-2.2)Myocardial Infarction1.71.31.4 (0.8-2.2)Unstable Angina1.61.21.4 (0.8-2.2)Ischemic Stroke1.60.82.0 (1.2-3.3)Transcient Ischemic Attack1.40.82.5 (1.4-4.3) Conclusions: In this large population-based study, the occurrence of the arterial thromboembolic events was low. However, BC patients were at significantly higher risk of developing ATEE compared with cancer-free controls. These results emphasize the need for careful observation of BC patients after diagnosis. Citation Information: Cancer Res 2009;69(24 Suppl):Abstract nr 2050.
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