Richard Hobbs Frederick D, Gensini Gianfranco, John Mancini Giovanni B, Manolis Athanasios J, Bauer Beverly, Genest Jacques, Feldman Ross D, Harvey Peter, Jenssen Trond G, da Silva Pedro Marques
University of Birmingham, Edgbaston, Birmingham, UK.
Eur J Cardiovasc Prev Rehabil. 2009 Aug;16(4):472-80. doi: 10.1097/HJR.0b013e32832b63f5.
Single-pill amlodipine/atorvastatin targets the two most common modifiable cardiovascular risk factors, hypertension and dyslipidaemia. We evaluated the clinical utility of this single pill to help patients across Europe and Canada achieve country-specific targets for blood pressure (BP) and low-density lipoprotein cholesterol (LDL-C).
Two 16-week, open-label studies conducted in 122 study centres across the United Kingdom and Canada (JEWEL 1) and 113 centres across 11 European countries (JEWEL 2).
Patients with uncontrolled BP and controlled/uncontrolled LDL-C qualifying for treatment according to local governing guidelines were administered single-pill amlodipine/atorvastatin with appropriate lifestyle modification. Eight dosages of amlodipine/atorvastatin (5/10-10/80 mg) were titrated to achieve country-specific BP and LDL-C targets. The primary outcome was the percentage of patients reaching country-specific BP and LDL-C targets in 16 weeks.
Among 2245 patients enrolled in the studies (JEWEL 1, n = 1138; JEWEL 2, n = 1107), 62.9% in JEWEL 1 and 50.6% in JEWEL 2 achieved both country-specific BP and LDL-C goals. BP was reduced by 20.4/10.7 and 21.8/12.6 mmHg in JEWEL 1 and JEWEL 2, respectively, and reductions in LDL-C were 0.90 mmol/l (34.8 mg/dl) and 1.09 mmol/l (42.2 mg/dl), respectively. The most common adverse events were peripheral oedema (11.0%), joint swelling (2.9%) and headache (2.9%), of which, only oedema was linked to study treatment.
Single-pill amlodipine/atorvastatin is an effective and well-tolerated treatment, which in a real-world setting helped more than half of the patients achieve both BP and LDL-C targets as recommended by local guidelines. Although fewer patients met their goals in JEWEL 2 than JEWEL 1, reductions in BP and LDL-C were slightly greater in JEWEL 2, suggesting that the observed differences are likely because of more stringent targets in Europe than in the UK/Canada.
氨氯地平/阿托伐他汀单片制剂针对两种最常见的可改变心血管危险因素，即高血压和血脂异常。我们评估了这种单片制剂在帮助欧洲和加拿大患者实现特定国家的血压（BP）和低密度脂蛋白胆固醇（LDL-C）目标方面的临床效用。
在英国和加拿大的122个研究中心开展了两项为期16周的开放标签研究（JEWEL 1），以及在11个欧洲国家的113个中心开展了另一项研究（JEWEL 2）。
根据当地管理指南，对血压未得到控制且LDL-C处于控制/未控制状态且符合治疗条件的患者给予氨氯地平/阿托伐他汀单片制剂，并进行适当的生活方式调整。滴定8种剂量的氨氯地平/阿托伐他汀（5/10 - 10/80毫克）以实现特定国家的血压和LDL-C目标。主要结局是在16周内达到特定国家血压和LDL-C目标的患者百分比。
在纳入研究的2245例患者中（JEWEL 1组，n = 1138；JEWEL 2组，n = 1107），JEWEL 1组62.9%的患者和JEWEL 2组50.6%的患者实现了特定国家的血压和LDL-C目标。JEWEL 1组和JEWEL 2组的血压分别降低了20.4/10.7和21.8/12.6 mmHg，LDL-C的降低幅度分别为0.90 mmol/L（34.8 mg/dl）和1.09 mmol/L（42.2 mg/dl）。最常见的不良事件是外周水肿（11.0%）、关节肿胀（2.9%）和头痛（2.9%），其中只有水肿与研究治疗有关。
氨氯地平/阿托伐他汀单片制剂是一种有效且耐受性良好的治疗方法，在实际应用中帮助超过一半的患者实现了当地指南推荐的血压和LDL-C目标。尽管JEWEL 2组中达到目标的患者比JEWEL 1组少，但JEWEL 2组的血压和LDL-C降低幅度略大，这表明观察到的差异可能是因为欧洲的目标比英国/加拿大更严格。
