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Determinants of angiotensin-converting enzyme inhibitor prescription in severe heart failure with left ventricular systolic dysfunction:: The EPICAL study

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AMERICAN HEART JOURNAL 2000年第4期139卷 624-631页

作者： Echemann, M Zannad, F Briançon, S Juillière, Y Mertès, PM Virion, JM Villemot, JP CHU CIC INSERM F-54035 Nancy France Hop Marin Serv Epidemiol & Evaluat Clin Nancy France Univ Henri Poincare Fac Med Pharmacol Clin Lorraine France

Background Angiotensin-converting enzyme (ACE) inhibitors have been demonstrated to reduce morbidity and mortality rates in patients with heart failure with left ventricular systolic dysfunction. Nevertheless, these drugs are underutilized in current practice and prescribed at doses below those usually recommended. The aim of this work was to identify the social, demographic, laboratory, clinical, and therapeutic factors associated with nonprescription of ACE inhibitors and/or their prescription at doses below those recommended in the treatment of severe long-term congestive heart failure (CHF). Methods and Results An epidemiologic observational study, EPICAL (EPidemiologie de l'Insuffisance Cardiaque Avancee en Lorraine), studied 417 patients with severe CHF surviving after the index hospitalization. Multivariate logistic regression determined the factors associated with ACE inhibitor nonprescription and with their prescription at lower-than-recommended doses. ACE inhibitors were taken by 75% of the patients but 38% took lower-than-recommended doses. Factors shown to be associated with nonprescription included patients >65 years of age with renal impairment (odds ratio 19.5, confidence interval [CI] 7.9-48.0), nonsinus cardiac rhythm (odds ratio 2.0, CI 1.2-3.2), and prescription of potassium-sparing diuretics (odds ratio 2.4, CI 1.2-4.7). Renal impairment was the single most important factor associated with prescription of lower-than-recommended doses, particularly in elderly patients. Conclusions Our results underline the need for optimal and better use of ACE inhibitor therapy. CHF treatment guidelines must be more uniformly applied by all physicians caring for patients with heart failure.

关键词：慢性病剂量效应关系药物用药计划表药物利用/统计学和数值数据法国肾功能试验处方药物/统计学和数值数据前瞻性研究心缩期/药物作用心室功能障碍左/诊断心室功能障碍左/药物疗法女(雌)性人类男(雄)性中年人

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VIDARABINE THERAPY OF COMPLICATED HERPES-SIMPLEX KERATITIS

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AMERICAN JOURNAL OF OPHTHALMOLOGY 1976年第5期81卷 642-649页

作者： ODAY, DM POIRIER, RH JONES, DB ELLIOTT, JH VANDERBILT UNIV SCH MEDDEPT OPHTALMOLNASHVILLETN 37232 UNIV TEXAS SCH MEDDIV OPHTALMOLSAN ANTONIOTX 78284 BAYLOR UNIV COLL MED DEPT OPHTHALMOLHOUSTONTX

Patients with active herpetic epithelial keratitis who had toxic reactions or were resistant to idoxuridine received vidarabine. Only one of 35 cases of herpetic epithelial keratitis without stromal disease failed to heal. Of 21 patients with active epithelial keratitis complicating stromal keratitis or uveitis, 11 had complete reepithelialization by day 14. 2 Patients were removed from the trial as treatment failures. The remaining cases healed in 21 to 48 days. In most instances, the stromal keratitis was inactivated when the epithelial ulcer healed. In the authors' patients treated with vidarabine, healing of herpes simplex epithelial ulcers was biphasic: Stage 1, progression from an active to an inactive viral ulcer, and Stage 2, complete reepithelialization.

关键词：肾上腺皮质激素类/治疗应用角膜溃疡/药物疗法用药计划表抗药性微生物药物疗法联合碘苷/治疗应用角膜炎树枝状/药物疗法软膏嘌呤核苷类/治疗应用葡萄膜炎/药物疗法阿糖腺苷/治疗应用伤口愈合/药物作用人类

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DEFINING THE PATIENT GROUP FOR COST-EFFECTIVE WITHDRAWAL OF ANTIHYPERTENSIVE THERAPY

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PHARMACOECONOMICS 1995年第3期7卷 221-228页

作者： KRAKOFF, LR WASSERTHEILSMOLLER, S 1.Mount Sinai School of Medicine New York New York USA 2.Englewood Hospital and Medical Center 350 Engle Street Englewood New Jersey 07631 USA 3.Albert Einstein College of Medicine Bronx New York USA

Many people receiving drug treatment for hypertension have had good control of their blood pressure for several years. It is feasible, and might be desirable, to discontinue drug treatment in selected groups of these patients if their long term outcome was not adversely affected. A few small series and 2 larger trials indicate that withdrawal of antihypertensive medication can be followed by 1 to 4 years of normal blood pressure, especially for those with mild hypertension (pretreatment diastolic blood pressure < 100mm Hg) and who have no evidence of target organ damage. In the 2 randomised trials of withdrawing medication emerging from the High Blood Pressure Detection and Follow-up Program, the addition of nutritional interventions (bodyweight reduction and/or dietary salt restriction) was shown to enhance the likelihood that antihypertensive drugs could be deferred for long intervals. Sustained bodyweight reduction for overweight patients with mild hypertension was the most successful approach. Short term nonpharmacological programmes have been evaluated for their economic effects on this process through cost-effectiveness and cost-benefit analyses. The available studies imply that reduced costs and decreased adverse effects associated with withdrawal of antihypertensive medication are offset by cost of the nonpharmacological interventions needed to maximise continued blood pressure control. Other influences, such as willingness to pay for nonpharmacological management or change in sense of well-being when on or off medication, need consideration for comprehensive cost-effectiveness analyses. Development of highly acceptable, effective and low cost alternative interventions that focus on those most likely to respond and remain compliant are necessary before withdrawal of antihypertensive medication becomes widely accepted for management of most drug treated hypertensive patients.

关键词：抗高血压药/投药和剂量抗高血压药/经济学抗高血压药/治疗应用血压/药物作用费用效益分析/方法用药计划表药费支出随访研究高血压/膳食疗法高血压/药物疗法高血压/经济学治疗结果人类

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Comparison of manual versus ambulatory blood pressure measurements with pharmacokinetic-pharmacodynamic modeling of antihypertensive compounds:: Application to moxonidine

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CLINICAL PHARMACOLOGY & THERAPEUTICS 2000年第1期68卷 18-27页

作者： Trocóniz, IF de Alwis, DP Tillmann, C Callies, S Mitchell, M Schaefer, HG Eli Lilly & Co Ltd Dept Clin Pharmacol Windlesham GU20 6PH Surrey England Univ Navarra Fac Pharm Dept Pharm & Pharmaceut Technol E-31080 Pamplona Spain

Objectives: To compare the results of the pharmacokinetic-pharmacodynamic analyses of 24-hour ambulatory blood pressure measurements and manual blood pressure data in patients receiving moxonidine, Methods: 32 patients with borderline to mild-to-moderate hypertension were enrolled in a double-blind, placebo-controlled phase II study. After receiving placebo for 1 week (run-in phase), the patients were randomly allocated to the placebo or the 0,6-, 0,9-, or 1,2-mg dose groups. Placebo and moxonidine were administered once daily for 1 week (drug-treatment phase). Pour 24-hour ambulatory blood pressure measurement profiles were obtained for each individual. Plasma samples (n = 9) and four measurements of manual blood pressure were taken at the start and end of the drug-treatment phase. Two additional manual blood pressure measurements were taken during the run-in and drug-treatment phases. Results: Pharmacokinetics was described by a one-compartment model. For the 24-hour ambulatory blood pressure measurements, baseline circadian patterns were described with a two-cosine function model that included interindividual and interoccasion variability, Pharmacodynamics was described with use of an effect-compartment model [k(e)0 = 0.37 (1/h)] and an E-max model. For diastolic blood pressure the maximum drug-induced decrease (E-max) was 30.9 mm Hg and the steady-state plasma drug concentration eliciting half of maximum effect (C-50) was 1.33 mu g/L. Interindividual variability was estimated for k(e0) (24.8%) and E-max (33.3%). For the manual blood pressure measurements, data was described by a time-invariant baseline model combined with an effect-compartment model and an E-max,, model. Mean population estimates were in agreement with those obtained during the analysis of 24-hour ambulatory blood pressure measurements. However, interindividual variability could be estimated for the baseline parameter only. Conclusions: Although similar typical population estimates for the drug

关键词：抗高血压药/药理学血压/药物作用血压测定/仪器和设备血压测定/方法血压监测便携式双盲法用药计划表高血压/药物疗法咪唑类/投药和剂量咪唑类/药代动力学咪唑类/药理学模型统计学疾病严重程度指数时间因素成年人老年人女(雌)性人类男(雄)性中年人

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Medication adherence in chronic disease: Issues in posttransplant immunosuppression

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TRANSPLANTATION PROCEEDINGS 2007年第5期39卷 1287-1300页

作者： Hansen, R. Seifeldin, R. Noe, L. Hlth Econ Ovat Res Grp San Francisco CA 94105 USA Astellas Pharma US Inc Hlth Econ & Outcomes Res Deerfield IL USA

Poor medication adherence is a widespread problem that undermines the potential benefits of medical treatment. Typical adherence rates among chronic disease patients are approximately 50%, and these low adherence rates have a substantial economic impact, estimated at $100 to $300 billion annually. Nonadherence to immunosuppressants among transplant recipients is surprisingly frequent, and the consequences are serious. Among adult renal transplant patients, the median rate of nonadherence is approximately 22% and is associated with acute rejection episodes and approximately 36% of all graft losses. In the United States, nonadherence results in an estimated 903 episodes of acute rejection and 1319 renal transplants failures annually, costing approximately $15 million and $100 million, respectively. Drug regimen complexity is known to impact adherence. Research demonstrates an inverse relationship between dosing frequency and medication adherence in various chronic diseases, with once-daily dosing resulting in the highest adherence rates. Reducing the dosing frequency may positively impact both clinical and patient-reported outcomes, as well as health care costs. However, the increased costs of less frequently administered drugs must be outweighed by the net savings achieved through improved adherence rates and better health outcomes. If trends among patients with chronic diseases apply, once-daily dosing regimens may improve adherence rates by approximately 6% to 14% among renal transplant patients and could substantially reduce the number of acute rejection episodes and graft failures, although the exact economic impact is difficult to estimate. Further research into adherence issues in transplant patients and the potential clinical and economic benefits of once-daily dosing of immunosuppressants is warranted.

关键词： Chronic Disease Drug Administration Schedule Humans Immunosuppressive Agents 慢性病用药计划表免疫抑制剂病人依从移植免疫学患者拒绝治疗 Medication Adherence Kidney Transplantation acute graft rejection Chronic Disease Immunosuppressive Agents Dosing Economic impact Drug Administration Schedule

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Chronopharmacology of antitumor effect induced by interferon-β in tumor-bearing mice

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JOURNAL OF PHARMACOLOGY AND EXPERIMENTAL THERAPEUTICS 2000年第2期294卷 746-752页

作者： Takane, H Ohdo, S Yamada, T Yukawa, E Higuchi, S Kyushu Univ Grad Sch Dept Clin Pharmacokinet Div Pharmaceut SciHigashi Ku Fukuoka 8128582 Japan

The mechanisms underlying the dosing time-dependent change in the antitumor effect of interferon-beta (IFN-beta) were investigated based on the sensitivity of tumor cells and the pharmacokinetics of the drug. Tumor-bearing mice were housed under standardized light-dark cycle conditions (lights on at 7:00 AM, off at 7:00 PM) with food and water available ad libitum. The antitumor effect of IFN-beta (0.5 MI.U./kg, intratumoral) was more efficient in early light phase than in early dark phase. The higher antitumor effect of IFN-beta was observed when specific binding of IFN receptor and DNA synthesis in tumor cells increased, and the lower effect was observed when these levels decreased. The dosing time-dependent effect of IFN-beta was supported by the time-dependent expression of transcription factor (signal transducers and activators of transcription 1) and cell proliferation inhibitor (p21 wild-type p53-activated fragment 1) protein induced by IFN-beta. There was a significant dosing time-dependent change in IFN-beta concentration in tumor, with a higher level in early light phase and a lower level in early dark phase. The dosing time-dependent change of IFN-beta concentration in tumor was associated with that of IFN-beta-induced antitumor effect. These results suggest that by choosing the most suitable dosing time for IFN-beta, the efficacy of the drug can be increased in certain experimental and clinical situations.

关键词：抗肿瘤药/投药和剂量抗肿瘤药/药代动力学细胞周期/药物作用细胞分裂/药物作用细胞存活/药物作用昼夜节律/生理学周期素依赖激酶抑制剂p21 细胞周期蛋白类/代谢 DNA结合蛋白质类/代谢剂量效应关系药物用药计划表干扰素α/代谢干扰素β/投药和剂量干扰素β/药代动力学黑色素瘤实验性/药物疗法黑色素瘤实验性/代谢黑色素瘤实验性/病理学小鼠近交C57BL 肿瘤移植受体干扰素αβ 受体干扰素/代谢 STAT1转录因子反式激活因子类/代谢动物人类男(雄)性小鼠

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CURRENT THERAPIES IN OSTEOSARCOMA

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CANCER TREATMENT REVIEWS 1975年第1期2卷 77-83页

作者： HANDELSMAN, H CARTER, SK NCI CANC THERAPY EVAL DIV CANC TREATMENT BETHESDA MD 20014 USA

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Antiretroviral activity and safety of abacavir in combination with selected HIV-1 protease inhibitors in therapy-naive HIV-1-infected adults

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ANTIVIRAL THERAPY 2001年第2期6卷 105-114页

作者： McMahon, D Lederman, M Haas, DW Haubrich, R Stanford, J Cooney, E Horton, J Kelleher, D Ross, L Cutrell, A Lee, D Spreen, W Mellors, JW Univ Pittsburgh Vet Adm Med Ctr Pittsburgh PA 15260 USA Case Western Reserve Univ Cleveland OH 44106 USA Vanderbilt Univ Nashville TN USA Univ Calif San Diego San Diego CA 92103 USA Univ Missouri Sch Med Kansas City MO 64108 USA Kansas City AIDS Res Consortium Kansas City MO USA Yale New Haven Med Ctr New Haven CT 06504 USA Carolinas Med Ctr Charlotte NC 28203 USA GlaxoWellcome Res Triangle Pk NC USA

Objective: To assess antiretroviral efficacy and safety of abacavir in combination with selected HIV-1 protease inhibitors. Design: A 48-week, open-label study. Materials and methods: Eighty-two antiretroviral naive HIV-1-infected adults (CD4 cell count greater than or equal to 100 cells/mm(3), plasma HIV-1 RNA greater than or equal to 5000 copies/ml) were randomly assigned to receive abacavir (300 mg twice daily) in combination with standard doses of one of five protease inhibitors: indinavir, saquinavir soft-gel, ritonavir, nelfinavir or amprenavir. Adults who met protocol-defined switch criteria at or after week 8 could modify their randomized therapy. Antiretroviral activity was assessed by the proportion of subjects with plasma HIV-1 RNA less than or equal to 400 and less than or equal to 50 copies/ml, and by changes in plasma HIV-1 RNA levels and CD4 cell counts. Safety was assessed by monitoring clinical adverse events and laboratory abnormalities. Results: At week 48, the proportion of subjects in the indinavir, saquinavir, ritonavir, nelfinavir and amprenavir groups with plasma HIV-1 RNA less than or equal to 400 copies/ml was 53, 50, 50, 41 and 56%, respectively, and the proportion with HIV-1 RNA less than or equal to 50 copies/ml was 47, 56, 50, 47, and 44%, respectively (by intent-to-treat analysis). Median reductions from baseline in plasma HIV-1 RNA for each group ranged from 1.7 to 2.4 log(10) copies/ml. The median CD4 cell count increase from baseline was 195, 131, 116, 136 and 259 cells/mm(3) in the indinavir, saquinavir, ritonavir, nelfinavir, and amprenavir groups, respectively. Overall, the most common adverse events attributed to study drugs were diarrhoea, nausea, malaise/fatigue, headache and perioral paresthesia. The frequency of treatment-limiting adverse events did not differ between groups. Conclusions: Abacavir is safe and effective when used in combination with a protease inhibitor.

关键词：投药口服抗HIV药/投药和剂量抗HIV药/治疗应用 CD4淋巴细胞计数 CD8阳性T淋巴细胞/药物作用双脱氧核苷类/投药和剂量双脱氧核苷类/治疗应用用药计划表药物疗法联合基因型 HIV感染/血液 HIV感染/药物疗法 HIV感染/病毒学 HIV蛋白酶抑制药/投药和剂量 HIV蛋白酶抑制药/治疗应用 HIV-1/药物作用 RNA 病毒/血液时间因素成年人女(雌)性人类男(雄)性

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Chronic hepatitis C and interferon alpha:: Conventional and cumulative meta-analyses of randomized controlled trials

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AMERICAN JOURNAL OF GASTROENTEROLOGY 1999年第3期94卷 581-595页

作者： Cammà, C Giunta, M Pinzello, G Morabito, A Verderio, P Pagliaro, L Osped Vincenzo Cervello Div Med Interna I-90146 Palermo Italy CNR Ist Metodol Diagnost Avanzate Palermo Italy Univ Palermo Ist Med Gen & Pneumol Palermo Italy Univ Milan Ist Stat Med & Biometria I-20122 Milan Italy

OBJECTIVE: The purpose of this study was to evaluate the clinical usefulness of surrogate markers of the interferon effect (i.e., alanine aminotransferase levels and serum HCV-RNA status) as predictors of long term response, and to identify the optimal schedule of treatment for patients with chronic hepatitis C by means of meta-analysis. METHODS: Pertinent randomized clinical trials and prospective studies were selected using MEDLINE (1986-1996), a reference list from published articles or reviews. Twenty-six prospective studies reporting data on surrogate markers of interferon response were selected. Thirty-nine trials comparing interferon alpha to no treatment and 25 trials comparing different schedules of interferon were reviewed. Conventional meta-analysis according to the DerSimonian and Laird method was used for the pooling of results. RESULTS: The pooled probability of late relapse among sustained responders with negative serum HCV-RNA 6 months after treatment was very low (8.7%;95% confidence interval 5.8-11.6%). The overall risk difference between treated and control groups was 16.63% (95% confidence interval 11.95-21.31%) for sustained aminotransferase normalization. Therapy with higher interferon dose compared with standard dose significantly improves the rare of sustained response (pooled risk difference 10.56%, 95% CI 5.47-15.65%). Cumulative meta-analyses suggest that a clear dose-response relationship exists across a wide range of interferon dosages. The multivariate meta-regression model confirms that the total interferon dose is an independent predictor of sustained response and that it seems more important than the length of treatment. CONCLUSIONS: Testing for serum HCV-RNA, 6 months after interferon therapy in sustained biochemical responders, is useful for predicting long term response. The current standard total interferon dose of 234 mega-units is suboptimal. Further trials that directly compare different schedules of treatment are needed. (Am

关键词：丙氨酸转氨酶/血液用药计划表肝炎病毒属/分离和提纯肝炎丙型慢性/诊断肝炎丙型慢性/治疗肝炎丙型慢性/病毒学干扰素α/投药和剂量干扰素α/治疗应用 RNA 病毒/分析人类

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Reduced postoperative atrial fibrillation using multidrug prophylaxis

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JOURNAL OF CARDIAC SURGERY 1999年第6期14卷 437-443页

作者： Ott, RA Gutfinger, DE Alimadadian, H Miller, M Selvan, A Weinberg, D Hlapcich, WL Tanner, TM Anaheim Mem Med Ctr Anaheim CA USA

Background: Atrial fibrillation (AFIB) is the most common complication following coronary artery bypass grafting (CABG). Despite three decades of recognition, efforts to reduce the high incidence reported (15%-30%) have been largely unsuccessful. Reasons for postoperative AFIB are likely multifactorial. As a result, we defined a multidrug prophylaxis based on agents known to be individually effective. This method was applied prospectively to a series of consecutive CABG patients with the goal of reducing the incidence of new-onset postoperative AFIB. Methods: Isolated CABG with cardiopulmonary bypass was performed on 517 consecutive patients. A rapid recovery protocol emphasizing AFIB multidrug prophylaxis was applied to all patients. All patients received 10 mug of triiodothyronine intraoperatively when the clamp on the aorta was released. Immediately following CABG, parenteral magnesium was administered to assure a serum magnesium > 2.2 mEq/dL. Thyroxine 200 mug was administered parenterally to all patients on postoperative days 1 and 2. Metoprolol (25 mg to 100 mg/day) was begun on all patients after extubation provided: heart rate > 85 beats/min and systolic blood pressure > 130 mmHg. Parenteral procainamide (12 mg/kg) loading dose, followed by a maintenance dose (2 mg/min), was used for patients who developed premature atrial contractions (> 1/min), nonsustained supraventricular tachycardia, or any episodes of atrial fibrillation. All patients also received postoperative digitalization, steroids, and aggressive diuresis. Results: The 30-day operative mortality was 3.7%. The overall incidence of new-onset postoperative AFIB was 10.3% (53 patients). There was no major difference in operative mortality (7.5% vs 3.2%, p = 0.23), Parsonnet risk score, or intraoperative variables between AFIB patients and the non-AFIB patients. Patients presenting with a preoperative acute myocardial infarction (p < 0.05), left main stenosis 70% (p < 0.01),

关键词：抗心律失常药/投药和剂量心房颤动/诊断心房颤动/死亡率心房颤动/预防和控制冠状动脉分流术剂量效应关系药物用药计划表药物疗法联合心电描记术/药物作用镁/投药和剂量美托洛尔/投药和剂量手术后并发症/诊断手术后并发症/死亡率手术后并发症/预防和控制普鲁卡因胺/投药和剂量前瞻性研究存活率甲状腺素/投药和剂量三碘甲状腺原氨酸/投药和剂量老年人女(雌)性人类男(雄)性中年人

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