Chaturvedi Aditi, Singh Yogendra, Chaturvedi Harish, Thawani Vijay, Singla Sakshi, Parihar Deepak
Department of Pharmacology, Veer Chandra Singh Garhwali Government Medical Sciences and Research Institute, Srikot, Uttarakhand, India.
J Pharmacol Pharmacother. 2013 Jan;4(1):33-8. doi: 10.4103/0976-500X.107663.
To compare the efficacy and tolerability of Ivabradine (IVA) and Ranolazine (RAN) in chronic angina patients.
This was a follow-on, open-label trial conducted in a tertiary care hospital of Uttarakhand. Thirty patients each taking IVA 5 mg twice daily or RAN 500 mg twice daily were distributed to the respective groups. Patients were asked to fill a pretested questionnaire on frequency of anginal attacks and adverse reactions before and 2, 4 and 8 weeks after taking the respective medicines. Their blood pressure, heart rate and routine hematological and biochemical estimations were performed at baseline and after intervention. Results were statistically analyzed using different statistical tests, with P < 0.05 considered as significant.
There was no significant difference in the frequency of anginal attacks per week between the groups. The adverse drug reactions (ADRs) reported in the IVA group were dizziness (30%), headache (16.6%), backache (16.6%), vertigo (13.3%), blurred vision (13.3%), muscle cramps (10%), arthralgia (10%), cough and dyspnea (6.6%), hypersensitivity rash (6.6%), fever (3.3%) and nausea (3.3%). The ADRs in the RAN group were nausea (26.6%), dizziness (23.3%), vomiting (3.3%), constipation (3.3%) and vertigo (3.3%). The blood pressure, heart rate and routine hematological and biochemical evaluations did not show any significant difference in the pre-post values. IVA significantly decreased the resting heart rate after eight weeks of intervention.
Both antianginal agents appeared equiactive. However, RAN had a better safety and tolerability profile than IVA. Serum sickness-like reaction was an adverse event noticed with IVA, which needs causality establishment.
比较伊伐布雷定(IVA)和雷诺嗪(RAN)在慢性心绞痛患者中的疗效和耐受性。
这是一项在北阿坎德邦一家三级护理医院进行的开放性随访试验。将30名每日两次服用5mg IVA或每日两次服用500mg RAN的患者分别分配到各自的组中。要求患者在服用相应药物前以及服用后2周、4周和8周填写一份关于心绞痛发作频率和不良反应的预测试问卷。在基线和干预后测量他们的血压、心率以及进行常规血液学和生化评估。使用不同的统计检验对结果进行统计学分析,P<0.05被认为具有显著性。
两组之间每周心绞痛发作频率无显著差异。IVA组报告的药物不良反应(ADR)有头晕(30%)、头痛(16.6%)、背痛(16.6%)、眩晕(13.3%)、视力模糊(13.3%)、肌肉痉挛(10%)、关节痛(10%)、咳嗽和呼吸困难(6.6%)、过敏性皮疹(6.6%)、发热(3.3%)和恶心(3.3%)。RAN组的ADR有恶心(26.6%)、头晕(23.3%)、呕吐(3.3%)、便秘(3.3%)和眩晕(3.3%)。血压、心率以及常规血液学和生化评估在前后值之间未显示任何显著差异。干预8周后,IVA显著降低静息心率。
两种抗心绞痛药物似乎疗效相当。然而,RAN的安全性和耐受性优于IVA。血清病样反应是IVA引起的不良事件,需要确定因果关系。