Hobbs F D Richard
University of Birmingham, Edgbaston, Birmingham, UK.
Vasc Health Risk Manag. 2007;3(5):711-9.
In order to prevent cardiovascular events, it is essential to effectively manage overall risk of cardiovascular disease. However, despite guideline recommendations to this effect, current management of the major, modifiable cardiovascular risk factors such as hypertension and dyslipidemia is disconnected and patient adherence to therapy is poor. This is particularly important for patients with multiple cardiovascular risk factors, who are often prescribed multiple medications. The JEWEL study program investigated the use of single-pill amlodipine/atorvastatin as a strategy to improve management of these patients. The JEWEL program consisted of two 16-week, international, open-label, multicenter, titration-to-goal studies in patients with hypertension and dyslipidemia. The two studies differed based on country of enrollment and certain tertiary endpoints, but the overall designs were very similar. Patients were enrolled from 255 centers across Canada and 13 European countries. The study was designed to assess the efficacy, safety, and utility of amlodipine/atorvastatin single-pill therapy in a real-world setting. Patients were initiated at a dose of amlodipine 5 mg/atorvastatin 10 mg, unless previously treated, and were uptitrated as necessary. The primary efficacy parameter was the percentage of patients, at different levels of cardiovascular risk, achieving country-specific guideline-recommended target levels for blood pressure and lipids. A secondary analysis of efficacy measured attainment of the same single goal for blood pressure across all study participants (JEWEL I and II) and the same single goal for LDL-C across all study participants (JEWEL I and II). The program utilized a newly developed questionnaire to gain better understanding of participants' beliefs and behaviors towards medical treatment of their multiple risk factors. Approximately 2850 patients were enrolled in the program, which was completed in August 2005. The JEWEL program assessed the effectiveness of a single pill (amlodipine/atorvastatin) in targeting the two principal risk factors for cardiovascular disease simultaneously to achieve nationally applicable treatment targets in a routine clinical practice setting.
为预防心血管事件，有效管理心血管疾病的整体风险至关重要。然而，尽管有相关指南建议，但目前对高血压和血脂异常等主要可改变心血管危险因素的管理缺乏连贯性，患者对治疗的依从性也很差。这对于有多种心血管危险因素且常被开具多种药物的患者尤为重要。JEWEL研究项目调查了使用氨氯地平/阿托伐他汀单片制剂作为改善这些患者管理的策略。JEWEL项目包括两项针对高血压和血脂异常患者的为期16周的国际开放标签多中心达标滴定研究。两项研究因入选国家和某些次要终点而有所不同，但总体设计非常相似。患者来自加拿大和13个欧洲国家的255个中心。该研究旨在评估氨氯地平/阿托伐他汀单片疗法在实际临床环境中的疗效、安全性和实用性。除非患者之前接受过治疗，否则起始剂量为氨氯地平5毫克/阿托伐他汀10毫克，并根据需要进行剂量上调。主要疗效参数是处于不同心血管风险水平的患者达到各国特定指南推荐的血压和血脂目标水平的百分比。疗效的次要分析测量了所有研究参与者（JEWEL I和II）实现相同单一血压目标的情况以及所有研究参与者（JEWEL I和II）实现相同单一低密度脂蛋白胆固醇目标的情况。该项目使用了一份新开发的问卷，以更好地了解参与者对其多种危险因素药物治疗的信念和行为。该项目共招募了约2850名患者，于2005年8月完成。JEWEL项目评估了单片制剂（氨氯地平/阿托伐他汀）在常规临床实践环境中同时针对心血管疾病的两个主要危险因素以实现全国适用治疗目标的有效性。
