A Randomized Comparative Study on Efficacy and Safety Profile of Ivabradine and Ranolazine, in Patients of Chronic Stable Angina Pectoris
Background: Ischemic heart disease is one of the leading causes of global disease burden. Despite treatment with standard therapy, many patients with chronic stable angina pectoris remain symptomatic making it an urgent necessity to introduce new strategies. Hence this study was planned to compare the efficacy and tolerability of Ivabradine and Ranolazine; the two novel antianginal drugs.
Methods: This was a single blind, randomised, controlled trial. Thirty patients each taking IVA 5 mg twice daily or RAN 500 mg twice daily were randomised into two groups. Patients filled a pretested questionnaire on frequency of angina attacks and adverse reactions experienced at baseline and 2, 4 and 8 weeks. The haemodynamic parameters, routine laboratory investigations were evaluated at the baseline and after intervention. Results: There was no significant difference in the frequency of angina attacks per week between the IVA and RAN study groups. There was a statistically significant difference (P < 0.01) in the number of patients reporting ADR from the IVA group as compared to RAN group. In the IVA group, the most common ADR was dizziness (36.6%); whereas nausea (30%) and dizziness (23.3%) was most common in RAN group. The routine haematological and biochemical evaluations did not show any significant difference between the baseline and post intervention. However, IVA significantly decreased the resting heart rate after eight weeks of intervention.. Conclusion: Both IVA and RAN are comparable and efficacious antianginal agents. However, RAN had a better safety and tolerability profile than IVA.
2. Gravel GM, Tardif JC. Ivabradine: The evidence of its therapeutic impact in angina. Core Evid 2008;3:1‑12.
3. Belardinelli L, Shryock JC, Fraser H. 2006a. Inhibition of the late sodium current as a potential cardio protective principle: effects of the late sodium current inhibitor ranolazine. Heart, 92(Suppl IV):iv6–iv14.
4. Riccioni G. Ivabradine: From molecular basis to clinical effectiveness. AdvTher 2010; 27:160‑7.
5. Simon L, Ghaleh B, Puybasset L, Guidicelli JF, Berdeaux A. Coronary and haemodynamic effects of S16257, a new bradycardic agent, in resting and exercising conscious dogs. J Pharmacol Exp Ther 1995;275:659‑66.
6. Chaitman BR, Skettino SL, Parker JO, Hanley P, Meluzin J, Kuch J, et al. Anti‑ischemic effects and long‑term survival during ranolazine monotherapy in patients with chronic severe angina. J Am Coll Cardiol 2004;43:1375‑82.
7. Borer JS, Fox K, Jaillon P, Lerebours G.; Ivabradine investigators group. Antianginal and antiischemic effects of ivabradine, an If inhibitor, in stable angina: A randomized, double ‑blind, multi centered, placebo‑controlled trial. Circulation 2003;107:817‑23.
8. Belardinelli L, Antzelevitch C, Fraser H. Inhibition of late (sustained/ persistent) sodium current: A potential drug target to reduce intracellular sodium‑dependent calcium overload and its detrimental effects on cardiomyocyte function. Eur Heart J 2004;6:I3‑7.
9. Ver Donck L, Borgers M, Verdonck F. Inhibition of sodium and calcium overload pathology in the myocardium: A new cytoprotective principle. Cardiovasc Res 1993; 27:349‑57.
10. Electronic Medicines Compendium (eMC). Procoralan™ (ivabradine hydrochloride) [summary of product characteristics]. Servier Laboratories Ltd. (last updated: 09/12/2010). Available from: http://www.emc.medicines. Org.uk/medicine/17188/SPC/Procoralan [Last accessed on 19/5/2010].
11. Stone PH, Chaitman BR, Koren A, Crager M. Abstract 3362: Effects of Ranolazine as monotherapy and combination therapy on rate pressure product at rest and during exercise: Results from the MARISA and CARISA trials. Circulation 2006;114:715.
12. Ruzyllo W, Ford IF, Tendera MT. Anti‑anginal efficacy and safety of ivabradine compared with amlodipine in patients with stable effort angina pectoris: A 3‑month randomised, double blind, multicentre, non inferiority trial. Drugs 2007;67:393‑405.
13. Cervetto L, Demontis GC, Gargini C. Cellular mechanisms underlying the pharmacological induction of phosphenes. Br J Pharmacol 2007;150:383‑90.
14. Tardif JC, Ford I, Tendera M, Bourassa MG, Fox K. Efficacy of ivabradine, a new selective If inhibitor, compared with atenolol in patients with chronic stable angina. Eur Heart J 2005;26:2529‑36.
15. Chaturvedi A, Singh Y, Chaturvedi H, Thawani V, Singla S, Parihar D. Comparison of the efficacy and tolerability of ivabradine and ranolazine in patients of chronic stable angina pectoris. J Pharmacol Pharmacother 2013;4:33-8.
16. Drug Details PROCORALAN 5 mg and 7.5 mg coated tablets. Available from: http://www.epgonline.org/mobile/drug‑details.cfm/id/DR004072/ page/atoz/ letter/ P/ language/ LG0001/startrow_drug/161/drugName/PROCORALAN‑5‑mg‑and‑7.5‑mg ‑coated‑tablets [Last accessed on 20/5/2011].
17. Mener DJ, Negrini C, Blatt A. Itching like mad. Am J Med 2009;8:732‑4.