Antianginal efficacy of ranolazine when added to treatment with amlodipine - The ERICA (Efficacy of Ranolazine In Chronic Angina) Trial

被引:269
作者
Stone, Peter H.
Gratsiansky, Nikolay A.
Blokhin, Alexey
Huang, I-Zu
Meng, Lixin
机构
[1] Brigham & Womens Hosp, Div Cardiovasc, Boston, MA 02115 USA
[2] Inst Physicochem Med, Ctr Atherosclerosis, Moscow, Russia
[3] Outpatient Clin, Med Ctr Russian Federat Patients Management Dept, Moscow, Russia
[4] CV Therapeut, Palo Alto, CA USA
关键词
D O I
10.1016/j.jacc.2006.05.044
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
OBJECTIVES The purpose of this study was to determine if ranolazine improves angina in stable coronary patients with persisting symptoms despite maximum recommended dose of amlodipine. BACKGROUND Ranolazine is a unique antianginal agent that has been effective in stable angina, but it has not been studied in the setting of maximum recommended doses of conventional antianginal agents. METHODS Stable patients with coronary disease and >= 3 anginal attacks per week despite maximum recommended dosage of amlodipine (10 mg/day) were randomized to 1,000 mg ranolazine or placebo twice a day for 6 weeks. Primary end point was the frequency of angina episodes per week during the double-blind treatment phase. Efficacy was also assessed by nitroglycerin consumption per week and the Seattle Angina Questionnaire (SAQ). Adjustment for multiple testing of secondary end points used a hierarchic closed testing procedure. Efficacy was assessed in subgroups based on baseline angina frequency, concomitant long-acting nitrate use, gender, and age. Safety was assessed by adverse events and electrocardiogram evaluations. RESULTS A total of 565 patients were randomized: 281 patients to ranolazine and 284 patients to placebo. Baseline characteristics were similar between treatment groups. At baseline, angina frequency averaged 5.63 +/- 0.18 episodes/week, and nitroglycerin consumption averaged 4.72 +/- 0.21 tablets/week. Compared with placebo, ranolazine significantly reduced frequency of angina episodes (2.88 +/- 0.19 on ranolazine vs. 3.31 +/- 0.22 on placebo; p = 0.028) and nitroglycerin consumption (2.03 +/- 0.20 on ranolazine vs. 2.68 +/- 0.22; p = 0.014), with treatment effect that appeared consistent across subgroups. The median angina weekly episode rate at baseline was 4.5 per week. Subgroup analysis showed statistically significant reductions of angina frequency, nitroglycerin use, and SAQ angina frequency for patients with a baseline frequency 4.5 per week but only of angina frequency for those with baseline frequency <= 4.5 per week. Patients with more frequent angina appeared to have a more pronounced treatment effect. No hemodynamic changes were observed. Ranolazine was well tolerated. CONCLUSIONS Ranolazine significantly reduced frequency of angina and nitroglycerin consumption compared with placebo and was well tolerated.
引用
收藏
页码:566 / 575
页数:10
相关论文
共 50 条
[21]   COST-EFFECTIVENESS OF RANOLAZINE ADDED TO STANDARD OF CARE TREATMENT IN PATIENTS WITH CHRONIC ANGINA AND TYPE 2 DIABETES [J].
Coleman, Craig I. ;
Weeda, Erin R. ;
Nguyen, Elaine ;
Kohn, Christine .
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, 2018, 71 (11) :204-204
[22]   Cost-Effectiveness of Ranolazine Added to Standard-of-Care Treatment in Patients With Chronic Stable Angina Pectoris [J].
Kohn, Christine G. ;
Parker, Matthew W. ;
Limone, Brendan L. ;
Coleman, Craig I. .
AMERICAN JOURNAL OF CARDIOLOGY, 2014, 113 (08) :1306-1311
[23]   Antianginal efficacy of Omapatrilat in patients with chronic angina pectoris [J].
Chaitman, BR ;
Ivleva, AY ;
Ujda, M ;
Lenis, JHF ;
Toth, C ;
Stieber, DM ;
Reisin, LH ;
Pangerl, AM ;
Friedman, JB ;
Lawrence, JH .
AMERICAN JOURNAL OF CARDIOLOGY, 2005, 95 (11) :1283-1289
[24]   Comparative antianginal efficacy of ranolazine in young (&lt;65 years) versus elderly (≥65 years) patients:: Results of the MARISA trial [J].
Jansky, P ;
Skettino, S ;
Chaitman, BR ;
Dequattro, V ;
Hanley, PC ;
Kuch, JK ;
Parker, JO ;
Nelson, JJ ;
Hebert, D ;
Wolff, AA .
CIRCULATION, 2000, 102 (18) :712-712
[26]   COST UTILITY OF RANOLAZINE IN THE SYMPTOMATIC TREATMENT OF PATIENTS WITH CHRONIC ANGINA PECTORIS IN SPAIN [J].
Ramos-Goni, J. M. ;
Hidalgo, A. ;
Villoro, R. .
VALUE IN HEALTH, 2011, 14 (07) :A381-A381
[27]   Ranolazine reduces angina frequency and severity and improves quality of life: Observational study in patients with chronic angina under ranolazine treatment in Greece (OSCAR-GR) [J].
Alexopoulos, Dimitrios ;
Kochiadakis, George ;
Afthonidis, Dimitrios ;
Barbetseas, John ;
Kelembekoglou, Paraskevas ;
Limberi, Sotiria ;
Spanos, Anastasios ;
Triantafyllidis, Georgios .
INTERNATIONAL JOURNAL OF CARDIOLOGY, 2016, 205 :111-116
[29]   Safety and efficacy of extended-release ranolazine in patients aged 70 years or older with chronic stable angina pectoris [J].
Rich, Michael W. ;
Crager, Michael ;
Mckay, Charles R. .
AMERICAN JOURNAL OF GERIATRIC CARDIOLOGY, 2007, 16 (04) :216-221
[30]   A literature review to evaluate the economic value of ranolazine for the symptomatic treatment of chronic angina pectoris [J].
Vellopoulou, Katerina ;
Kourlaba, Georgia ;
Maniadakis, Nikos ;
Vardas, Panagiotis .
INTERNATIONAL JOURNAL OF CARDIOLOGY, 2016, 211 :105-111