Health outcomes research in medicine最新文献

WITHDRAWN: Utility and Work Productivity Data for Economic Evaluation of Breast Cancer Therapies in the Netherlands and Sweden 撤回:荷兰和瑞典乳腺癌治疗经济评估的效用和工作效率数据

Health outcomes research in medicine

Pub Date : 2012-12-05 DOI: 10.1016/J.EHRM.2012.11.003

G. Frederix, N. Quadri, A. Hövels, F. V. D. Wetering, H. Tamminga, J. Schellens, A. Lloyd

引用次数: 0

Health Care Utilization and Costs among Medicaid-enrolled Patients with Schizophrenia Experiencing Multiple Psychiatric Relapses 参保精神分裂症患者多次精神疾病复发的医疗保健利用和费用

Health outcomes research in medicine

Pub Date : 2012-11-01 DOI: 10.1016/j.ehrm.2012.06.003

Sudeep J. Karve PhD , Jessica M. Panish MHS , Riad G. Dirani PhD , Sean D. Candrilli PhD

Objective

This study compared all-cause and schizophrenia-related health care utilization and costs among patients with schizophrenia using second-generation oral antipsychotics (SGOAs) and experiencing ≥2 psychiatric-related relapses with those experiencing <2 relapses.

Study Design

Patients with schizophrenia who initiated SGOA therapy were identified in the MarketScan^® Medicaid Multi-State database between July 1, 2004 and December 31, 2007. Patients were stratified by <2 psychiatric-related relapse events and ≥2 psychiatric-related relapse events during the 12-month period following SGOA initiation. All-cause and schizophrenia-related health care utilization and costs were estimated for each cohort in various care settings. Univariate and multivariate regression analyses were conducted to assess the differences in all-cause and schizophrenia-related health care utilization and costs between the 2 cohorts. No adjustments were made for multiple inferential statistical tests.

Results

The cohort consisted of 19,813 patients, of whom 3714 (18.75%) had ≥2 psychiatric-related relapse events during the follow-up period. On average, patients with ≥2 psychiatric-related relapse events were younger than patients with <2 psychiatric-related relapse events (42.62 years vs. 44.21 years; P < 0.001), and the all-cause and schizophrenia-related inpatient costs were approximately 12 and 23 times higher, respectively. The mean covariate-adjusted predicted schizophrenia-related total medical costs per patient were significantly higher among patients with ≥2 psychiatric-related relapse events than among patients with <2 psychiatric-related relapse events ($17,910 vs. $10,346; P < 0.001).

Conclusion

Patients who received an SGOA and experienced ≥2 psychiatric-related relapse events within the first year of treatment incurred significantly greater all-cause and schizophrenia-related total medical costs than those with <2.

目的比较使用第二代口服抗精神病药(SGOAs)且有≥2次精神相关复发的精神分裂症患者与有≥2次精神相关复发的精神分裂症患者的全因及精神分裂症相关医疗保健的利用和费用。研究设计:在2004年7月1日至2007年12月31日期间，在MarketScan®Medicaid多州数据库中确定了接受SGOA治疗的精神分裂症患者。在SGOA开始后的12个月内，患者按精神相关复发事件和≥2次精神相关复发事件进行分层。在不同的护理环境中，估计每个队列的全因和精神分裂症相关的医疗保健利用和费用。进行单因素和多因素回归分析，以评估两组患者在全因和精神分裂症相关的医疗保健利用和费用方面的差异。多项推论统计检验未作调整。结果该队列包括19,813例患者，其中3714例(18.75%)在随访期间有≥2次精神相关复发事件。平均而言，≥2次精神相关复发事件的患者比≥2次精神相关复发事件的患者年轻(42.62岁vs 44.21岁;P & lt;0.001)，全因和精神分裂症相关的住院费用分别高出约12倍和23倍。共变量调整后的平均预测精神分裂症相关总医疗费用在≥2次精神相关复发事件的患者中显著高于≥2次精神相关复发事件的患者(17,910美元vs. 10,346美元;P & lt;0.001)。结论接受SGOA治疗且治疗一年内出现≥2次精神相关复发事件的患者的全因和精神分裂症相关总医疗费用明显高于接受SGOA治疗的患者。

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引用次数: 13

Satisfaction with Treatment in Type 2 Diabetes Patients Requiring Insulin Treatment in Buenos Aires, Argentina 阿根廷布宜诺斯艾利斯2型糖尿病患者对胰岛素治疗的满意度

Health outcomes research in medicine

Pub Date : 2012-11-01 DOI: 10.1016/j.ehrm.2012.11.001

Andrés Pichon-Riviere MD, MSc, PhD , Vilma Irazola MD, MSc , Andrea Beratarrechea MD , Andrea Alcaraz MD, MSc , Carolina Carrara MD

Objective

To assess different dimensions of treatment satisfaction in patients with type 2 diabetes mellitus (T2DM) receiving insulin therapy.

Study Design

Cross-sectional study. We included 183 patients with T2DM followed by diabetes specialists in an ambulatory setting: 93 treated with neutral protamine Hagedorn insulin (NPH) and 90 with insulin glargine (IG). We used a Spanish version of the Diabetes Treatment Satisfaction Questionnaire (DTSQ) for Argentina.

Results

Overall treatment satisfaction was 30.04 (SD 5.40) for a maximum score of 36. The lowest score observed was for the satisfaction item “Flexibility of treatment” (4.7 out of 6, SD 1.27), and the highest score for the item “Recommending treatment to others” (5.39 out of 6, SD 1.23). In patients treated with IG, the overall treatment satisfaction score was 30.56 (SD 4.43); and 29.64 (SD 6.13) for those receiving NPH, not reaching a statistically significant difference. Perception of hypoglycemia was infrequent, with a mean score of 1.82 out of 6 (SD 1.62). For hyperglycemia, the mean score was 2.62 out of 6 (SD 1.54). In both cases, we found no difference between patients treated with IG and those treated with NPH insulin.

Conclusion

This is the first study describing patient satisfaction with treatment in T2DM patients in Argentina. We have found levels of treatment satisfaction similar or greater to those described in developed countries. We expect that the results of this study may encourage physicians not to delay the initiation of insulin therapy in poorly controlled patients.

目的评价2型糖尿病(T2DM)患者胰岛素治疗满意度的不同维度。研究设计横断面研究。我们纳入了183例T2DM患者，由糖尿病专家在门诊随访:93例接受中性鱼精蛋白Hagedorn胰岛素(NPH)治疗，90例接受甘精胰岛素(IG)治疗。我们在阿根廷使用西班牙语版的糖尿病治疗满意度问卷(DTSQ)。结果患者总体治疗满意度为30.04 (SD 5.40)，最高评分为36分。得分最低的是满意度项目“治疗的灵活性”(4.7分，SD 1.27)，得分最高的是“向他人推荐治疗”(5.39分，SD 1.23)。IG患者的总体治疗满意度评分为30.56分(SD 4.43);NPH组为29.64 (SD 6.13)，差异无统计学意义。低血糖的感觉并不常见，平均得分为1.82分(SD 1.62)。对于高血糖，平均评分为2.62分(SD 1.54)。在这两种情况下，我们发现IG和NPH胰岛素治疗的患者之间没有差异。结论:这是阿根廷第一个描述T2DM患者治疗满意度的研究。我们发现治疗满意度水平与发达国家相似或更高。我们希望这项研究的结果可以鼓励医生不要延迟胰岛素治疗的开始对控制不良的患者。

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引用次数: 1

Changing Regulations, Changing Care? 改变法规，改变护理?

Health outcomes research in medicine

Pub Date : 2012-11-01 DOI: 10.1016/j.ehrm.2012.11.002

Donald E. Stull Jr. PhD (Editor-in-Chief)

引用次数: 0

Long-term Adherence to Hormone Therapy in Medicaid-enrolled Women with Breast Cancer 参加医疗补助的乳腺癌妇女长期坚持激素治疗

Health outcomes research in medicine

Pub Date : 2012-11-01 DOI: 10.1016/j.ehrm.2012.10.001

Jun Wu PhD, Dana Stafkey-Mailey PharmD, PhD, Charles L. Bennett MD, PhD

Objective

This study assessed long-term adherence to hormone therapy in women with breast cancer enrolled in Medicaid.

Methods

We identified women diagnosed with nonmetastatic breast cancer (2000–2008) and prescribed tamoxifen or aromatase inhibitors (AIs) as hormone therapy within 1 year of diagnosis in the South Carolina Central Cancer Registry and South Carolina Medicaid linked data set. All the patients were followed-up for 1, 2, 3, or 4 years after initiation of hormone therapy. Adherence rate was measured as proportion of days covered (PDC) by tamoxifen or AIs in a given interval (1, 2, 3, or 4 years). Predictors of adherence to hormone therapy (PDC ≥80%) were identified using generalized linear models for repeated measures.

Results

The population consisted of 612 eligible women who filled at least one prescription for AIs (n = 339, 55%) or tamoxifen (n = 273, 45%) within 1 year of diagnosis. The mean PDCs were 71% in the first year and 49% after 4 years. Only 25% of women receiving hormone therapy maintained a PDC of at least 80% after 4 years.

Conclusions

Long-term use of hormone therapy remains low in the study population. Early interventions must be undertaken to improve adherence over the treatment period.

目的:本研究评估参与医疗补助计划的乳腺癌患者对激素治疗的长期依从性。方法:在南卡罗来纳中央癌症登记处和南卡罗来纳医疗补助相关数据集中，我们确定诊断为非转移性乳腺癌的妇女(2000-2008年)，并在诊断后1年内处方他莫昔芬或芳香化酶抑制剂(AIs)作为激素治疗。所有患者在激素治疗开始后随访1年、2年、3年或4年。依从率以他莫昔芬或AIs在给定间隔(1,2,3或4年)中覆盖天数(PDC)的比例来测量。使用重复测量的广义线性模型确定激素治疗依从性的预测因子(PDC≥80%)。结果612名符合条件的女性在诊断后1年内至少服用过一次AIs (n = 339,55%)或他莫昔芬(n = 273,45%)。第一年的平均PDCs为71%，4年后为49%。在接受激素治疗的女性中，只有25%的人在4年后的PDC值保持在80%以上。结论:在研究人群中，激素治疗的长期使用仍然很低。必须采取早期干预措施，以提高治疗期间的依从性。

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引用次数: 8

Outcomes-based Risk-sharing Schemes: Is There a Potential Role in the Asia-Pacific Markets? 基于结果的风险分担计划:在亚太市场是否有潜在的作用?

Health outcomes research in medicine

Pub Date : 2012-11-01 DOI: 10.1016/j.ehrm.2012.07.002

Lisbet Coulton BA , Lieven Annemans PhD , Rob Carter PhD , Maya Baltazar Herrera FASP, PhD , Hasbullah Thabrany MPH, DRPH , Jeremy Lim MBBS, MPH, MRCS (Edin), MMed (Surg), FAMS , Kenneth K.C. Lee BS (Pharm), MPhil, PhD , Wen Chen PhD , Nathorn Chaiyakunapruk PharmD, PhD , Herng-Der Chern MD, PhD , Tae-Jin Lee PhD , Hiroshi Nakamura PhD , Tony Yen-Huei Tarn MS, PhD , Abdulkadir Keskinaslan MD, MBA, MPH

Objectives

To provide a commentary on outcomes-based risk-sharing schemes in Europe and the US, and to assess characteristics of such schemes and whether they have a potential role in the Asia-Pacific markets. This commentary also examines current experience in the Asia-Pacific markets and considers criteria for such agreements as they might relate to the different health care environments.

Summary

Future opportunities for patient access schemes, and specifically, a role for outcomes-based risk-sharing schemes, exist in the Asia-Pacific markets. Four types of agreements across the Asia-Pacific markets were identified that are not purely outcomes-based or risk-sharing, but cover innovative high-cost medicines, areas of high unmet need, areas affecting small patient populations, and medicines where the evidence is uncertain. Key factors for consideration are the public environment and the general acceptance of such agreements; the level of available resources that impact the health care priorities in each market and the public demand for access to medicines and to innovation. The ability to undertake such agreements appears to depend significantly on the degree of centralized decision-making and the dominance of a “single payer” for negotiation; the ability to manage data – both to undertake health technology assessments and to have systems/infrastructure to collect data and demonstrate outcomes; the nature of local health care structures and the capabilities to implement schemes where the financing is linked to outcomes. Caution was shared across markets with a trend to “watch and wait” while evidence emerges elsewhere.

目的对欧洲和美国基于结果的风险分担计划进行评论，并评估这些计划的特征以及它们是否在亚太市场具有潜在的作用。本评论还审查了亚太市场目前的经验，并考虑了此类协议的标准，因为它们可能与不同的卫生保健环境有关。亚太市场存在患者可及性方案的未来机会，特别是基于结果的风险分担方案的作用。在亚太市场确定了四种类型的协议，这些协议并非纯粹以结果为基础或风险分担，而是涵盖创新型高成本药物、未满足需求高的领域、影响患者人数少的领域以及证据不确定的药物。考虑的关键因素是公共环境和对这类协定的普遍接受程度;影响每个市场卫生保健优先事项的现有资源水平，以及公众对获得药品和创新的需求。签订这种协定的能力似乎在很大程度上取决于集中决策的程度和“单一付款人”在谈判中的主导地位;管理数据的能力——既进行卫生技术评估，又拥有收集数据和展示结果的系统/基础设施;地方保健结构的性质和执行筹资与结果挂钩的计划的能力。市场普遍持谨慎态度，在其他地方出现证据时，市场倾向于“观察并等待”。

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引用次数: 9

Comparative Effectiveness of On-Pump versus Off-Pump Coronary Artery Bypass Grafting Among Elderly Patients: A Propensity Score-Matched Analysis 老年患者开泵与不开泵冠状动脉旁路移植术的疗效比较:倾向评分匹配分析

Health outcomes research in medicine

Pub Date : 2012-11-01 DOI: 10.1016/j.ehrm.2012.09.002

Manasi Datar MS , Yi Yang MD, PhD , Rohan Mahabaleshwarkar MS , John P. Bentley PhD , Benjamin F. Banahan III PhD

Objective

Coronary artery bypass grafting (CABG) is a procedure used to restore blood flow to the heart for patients with coronary artery disease. The purpose of this study was to compare the effectiveness of on-pump versus off-pump CABG in elderly patients using the 2006–2008 5% national sample of Medicare administrative claims.

Study Design

A retrospective matched cohort study design was used. Elderly patients (over 65 years of age) undergoing CABG between July 1, 2006 and June 30, 2008 were identified using International Classification of Diseases, 9^th Revision, Clinical Modification codes. Propensity scores were used to match patients undergoing on-pump versus off-pump CABG in a ratio of 1:1. Outcomes assessed in this study include a composite cardiovascular end point consisting of postoperative acute myocardial infarction, stroke, or revascularization (percutaneous coronary intervention or CABG) and all-cause mortality. Descriptive statistics were reported along with Kaplan-Meier estimates. Postoperative risk of adverse cardiovascular outcomes and all-cause mortality in these groups was compared using Cox proportional hazards models.

Results

The matched sample consisted of 5356 patients (2678 patients in each group). The risk of composite outcome in the 2 groups was not significantly different (hazard ratio [HR] 0.915; P = 0.316). The risk of all-cause mortality was significantly lower among on-pump CABG patients compared with off-pump CABG patients (HR 0.544; P < 0.0001).

Conclusion

This study shows that elderly patients undergoing on-pump CABG have a lower risk of mortality as compared with those receiving off-pump CABG. Caution should be exercised when recommending elderly patients for off-pump CABG.

目的冠状动脉旁路移植术(CABG)是一种用于恢复冠状动脉疾病患者心脏血流的手术。本研究的目的是利用2006-2008年5%的全国医疗保险行政索赔样本，比较老年患者使用泵送与非泵送CABG的有效性。研究设计采用回顾性匹配队列研究设计。2006年7月1日至2008年6月30日期间接受CABG的老年患者(65岁以上)使用《国际疾病分类》第九版临床修改代码进行鉴定。倾向评分用于匹配接受有泵和无泵CABG的患者，比例为1:1。本研究评估的结果包括一个复合心血管终点，包括术后急性心肌梗死、中风或血运重建术(经皮冠状动脉介入治疗或CABG)和全因死亡率。描述性统计与Kaplan-Meier估计一起报告。使用Cox比例风险模型比较两组患者的术后不良心血管结局风险和全因死亡率。结果匹配样本5356例(每组2678例)。两组患者发生综合结局的风险无显著差异(风险比[HR] 0.915;p = 0.316)。与非体外循环CABG患者相比，非体外循环CABG患者全因死亡风险显著降低(HR 0.544;P & lt;0.0001)。结论:与非体外循环CABG相比，接受非体外循环CABG的老年患者死亡风险较低。建议老年患者行非体外循环冠脉搭桥时应谨慎。

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引用次数: 1

Associations between Joblessness and Oral Anti-diabetic Medication Adherence in US Diabetic Working-age Adults 失业与美国糖尿病工作年龄成人口服抗糖尿病药物依从性之间的关系

Health outcomes research in medicine

Pub Date : 2012-08-01 DOI: 10.1016/j.ehrm.2012.06.001

Mary L. Davis-Ajami PhD , Milap C. Nahata PharmD , Gregory Reardon RPh, PhD , Eric E. Seiber PhD , Rajesh Balkrishnan PhD

Objective

To assess potential associations between joblessness and oral anti-diabetic (OAD) medication adherence in US diabetic working-age adults.

Study Design

A retrospective longitudinal panel design used pooled 2001-2007 Medical Expenditure Panel Survey (MEPS) data forming a nationally representative sample of diabetic individuals, ages 24-59 years. Pregnancy, seasonal job status, retired persons, a student designation, and those prescribed insulin were excluded. Adherence was measured using the proportion of days covered (PDC). A PDC ≥0.80 was classified as adherent. Descriptive statistics and multivariate regression analysis accounting for the MEPS' complex survey design were conducted.

Results

There were 2256 individuals (means: age 48.3 years [SD 8.15], body mass index 31.1 [SD 0.30], Charlson Comorbidity Index 0.37 [SD 0.79]) who met study criteria. Thirty-four percent were jobless at the first interview round and 29% remained jobless all 5 interview rounds during the 2-year panel period. Reasons cited for joblessness included: waiting to start a new job (73%) and unable to work due to illness or disability (20%). Negligible proportions cited staying home to care for family members or maternity leave as reasons for joblessness. Proportionately, more individuals were nonadherent (55%, SE 0.006). Joblessness was associated with a 16% significant reduction in the PDC (β −15.9, P < 0.001), and a 25% less likelihood of OAD medication adherence compared with those employed (odds ratio 0.75; 95% confidence interval, 0.64-0.90, P = 0.002), while holding all other variables constant.

Conclusions

The results indicate that jobless working-age individuals with diabetes were significantly less likely to adhere to OAD medication than employed individuals.

目的评估美国糖尿病工作年龄成人失业与口服抗糖尿病药物依从性之间的潜在关联。研究设计采用回顾性纵向面板设计，采用2001-2007年医疗支出面板调查(MEPS)数据，形成具有全国代表性的24-59岁糖尿病患者样本。排除怀孕、季节性工作状态、退休人员、学生和处方胰岛素者。使用覆盖天数比例(PDC)来测量依从性。PDC≥0.80为粘附。对MEPS的复杂调查设计进行了描述性统计和多元回归分析。结果符合研究标准的2256例患者(平均年龄48.3岁[SD 8.15]，体重指数31.1 [SD 0.30]， Charlson合并症指数0.37 [SD 0.79])。34%的人在第一轮面试时就失业了，29%的人在两年的小组讨论期间的5轮面试中都失业了。失业的原因包括:等待开始新工作(73%)和由于疾病或残疾无法工作(20%)。几乎没有人把在家照顾家人或休产假作为失业的原因。不成比例地，更多的个体不粘附(55%，SE 0.006)。失业与PDC显著降低16%相关(β - 15.9, P <0.001)，并且与那些使用OAD药物的人相比，OAD药物依从性降低了25%(优势比0.75;95%置信区间，0.64-0.90,P = 0.002)，同时保持所有其他变量不变。结论失业的工作年龄糖尿病患者坚持服用OAD药物的可能性明显低于就业人群。

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引用次数: 5

Clinician Education Improves Lipid Monitoring in Patients Taking Second-Generation Antipsychotic Agents, Nationally and Locally 临床医生教育提高了全国和地方第二代抗精神病药物患者的血脂监测

Health outcomes research in medicine

Pub Date : 2012-08-01 DOI: 10.1016/j.ehrm.2012.05.002

Sandra Haas Binford MAEd, Monique D. Johnson MD, CCMEP, Robert S. Kennedy MA, Joy Bartnett Leffler BS, MLA, NASW, CSE, CME Outfitters, LLC

Background

Continuing medical education (CME) seeks to improve patient health by promoting clinician practice change. Many patients with a diagnosis of either bipolar disorder or schizophrenia are predisposed to cardiovascular risk, and the use of second-generation antipsychotic (SGA) medications that can cause significant weight gain and altering of lipid profiles may compound this risk. An educational analysis identified a performance gap related to psychiatrists' gathering of baseline lipid data in their patients.

Objective

This study analyzes the degree to which participation in 2 CME activities improves clinicians' rates of lipid monitoring in patients with mental illness who take SGAs.

Study Design

After participation in 1 or 2 CME activities on improved cardiometabolic monitoring in patients with major mental illness—in which one activity focused on schizophrenia and the other on bipolar disorder—a nationwide group (NG) of clinician learners was surveyed about lipid monitoring practices among patients during these patients' first 16 weeks of SGA therapy over a 12-month period. Responses from the NG were compared with those from 1) a nationwide control group (CG) and 2) a local group of activity participants at the Lindner Center of HOPE—Cincinnati, Ohio (LG), whose measured rates were documented via medical records data extraction; the LG also received institutional encouragement and support for practice change for lipid monitoring in these patients.

Results

Percentages of patients monitored by clinicians in the NG increased by 18.0 percentage points over 1 year from baseline (P = 0.00001) and represented a rate change that was higher than that seen in the CG (P < 0.00001). Gross, median monitoring rates in the NG increased from 27.5% to 80.0%, and all clinicians at or above the 75th percentile of monitoring rates monitored 100% of their patients after participating. Monitoring rate increases for clinicians in the NG were greater among clinicians with higher patient counts. The LG saw a 28 percentage-point increase (from 27.5% to 55.5%), representing a 102% increase over the baseline LG rate and a 56% increase over the rate change seen in the NG.

Conclusions

CME interventions can improve lipid-monitoring practices among clinicians who treat patients with major mental illness who take SGAs. Local, institutional support for guideline-recommended monitoring may increase nationwide CME-induced change yet further.

继续医学教育(CME)旨在通过促进临床医生实践的改变来改善患者的健康。许多被诊断为双相情感障碍或精神分裂症的患者易患心血管疾病，而使用第二代抗精神病药物(SGA)会导致体重显著增加和血脂改变，这可能会加剧这种风险。一项教育分析确定了与精神科医生收集患者基线脂质数据有关的表现差距。目的分析参加两项CME活动对服用SGAs的精神疾病患者临床医生血脂监测率的提高程度。研究设计:在参与了1 - 2个主要精神疾病患者改善心脏代谢监测的CME活动(其中一个活动专注于精神分裂症，另一个活动专注于双相情感障碍)后，对全国临床医生学习者组(NG)进行了为期12个月的SGA治疗的前16周患者的脂质监测实践调查。将NG的反应与1)全国对照组(CG)和2)俄亥俄州辛辛那提林德纳希望中心(LG)当地活动参与者组的反应进行比较，后者的测量率通过医疗记录数据提取记录;LG还得到了机构的鼓励和支持，以改变这些患者的血脂监测实践。结果临床医生监测的NG组患者的百分比在1年内比基线增加了18.0个百分点(P = 0.00001)，并且比CG组的变化率高(P <0.00001)。总体而言，NG的中位监测率从27.5%增加到80.0%，所有监测率达到或高于第75百分位的临床医生在参与后对其患者进行了100%的监测。在患者数量较多的临床医生中，临床医生对NG的监测率增加更大。LG的利率上升了28个百分点(从27.5%上升到55.5%)，比LG的基准利率上升了102%，比NG的利率变化上升了56%。结论scme干预可以改善临床医生治疗服用SGAs的重性精神疾病患者的血脂监测实践。地方机构对指南建议的监测的支持可能会进一步增加全国范围内由cme引起的变化。

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引用次数: 1

Changes in Patient-reported Neuropsychiatric Outcomes during the SENSE Trial: First-line Treatment with Two Nucleoside Analogues plus Etravirine or Efavirenz 在SENSE试验中患者报告的神经精神结局的变化:两种核苷类似物加依曲维林或依非韦伦的一线治疗

Health outcomes research in medicine

Pub Date : 2012-08-01 DOI: 10.1016/j.ehrm.2012.06.002

Chloe Orkin MD , Mark Nelson MD , Christine Katlama MD , Philippe Morlat MD, PhD , Hansjakob Furrer MD , Yvon van Delft MSc , Marjolein Janssen MSc , Andrew Hill PhD , Stephan Marks MD

Background

Efavirenz treatment has been associated with an increased risk of neuropsychiatric adverse events, some of which may last for only the first few weeks of treatment.

Methods

In this double-blind placebo-controlled trial, 157 treatment-naïve patients with human immunodeficiency virus (HIV) RNA >5000 copies/mL, were randomized 1:1 to either etravirine 400 mg once daily (n = 79), or efavirenz 600 mg once daily (n = 78), plus 2 nucleoside analogues. At screening, baseline, and during the trial, subjects completed the HIV-Patient Symptoms Profile (HPSP) questionnaire on the impact of adverse events associated with their treatment. There were 14 symptom domains, with 5 classified as neuropsychiatric and 9 other domains. The mean scores of each domain were compared between the arms at the Week 2 and Week 48 visits.

Results

The treatment arms were comparable at baseline (overall median CD4 count 302 cells/uL, median HIV RNA 4.8 log10 copies/mL). In the analysis of the HPSP questionnaire, the mean score for the domains of dizziness and sleep of the etravirine arm was significantly better than the efavirenz arm at Week 2. There were no significant differences between the arms at Week 48, for any of the domains. At the baseline visit, patients with a medical history of neuropsychiatric adverse events had significantly worse scores in the neuropsychiatric domains (P < 0.01). During the trial, patients with at least one neuropsychiatric adverse event had significantly worse scores in the neuropsychiatric domains of the HPSP questionnaire (P < 0.01).

Conclusions

In the SENSE trial, dizziness and sleep disorders showed significantly worse HPSP scores in the efavirenz arm, compared with the etravirine arm at the Week 2 visit. However, at Week 48 there were no significant differences between the treatment arms in any domain of the patient HPSP. This suggests that the impact of efavirenz on quality of life may be short term for the majority of patients.

背景:defavirenz治疗与神经精神不良事件的风险增加有关，其中一些不良事件可能只持续治疗的前几周。方法在这项双盲安慰剂对照试验中，157例treatment-naïve人类免疫缺陷病毒(HIV) RNA >5000拷贝/mL的患者，以1:1的比例随机分配到etravirine 400 mg每日1次(n = 79)或efavirenz 600 mg每日1次(n = 78)，加2种核苷类似物。在筛查、基线和试验期间，受试者完成了与治疗相关的不良事件影响的hiv患者症状概况(HPSP)问卷。共有14个症状域，其中5个为神经精神症状域，9个为其他症状域。在第2周和第48周访问时比较各组之间每个领域的平均得分。结果治疗组在基线时具有可比性(总中位数CD4细胞计数302细胞/uL，中位数HIV RNA 4.8 log10拷贝/mL)。在HPSP问卷的分析中，在第2周，依曲维林组的头晕和睡眠领域的平均得分明显优于依非韦伦组。在第48周，两组之间在任何领域都没有显著差异。在基线就诊时，有神经精神不良事件病史的患者在神经精神领域的得分明显较差(P <0.01)。在试验期间，至少有一项神经精神不良事件的患者在HPSP问卷的神经精神领域得分明显较差(P <0.01)。在SENSE试验中，在第2周访问时，与依曲维林组相比，依非韦伦组的头晕和睡眠障碍的HPSP评分明显更差。然而，在第48周，治疗组之间在患者HPSP的任何领域没有显着差异。这表明，对大多数患者来说，依非韦伦对生活质量的影响可能是短期的。

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引用次数: 2