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Medwave 2018;18(7):e7331 doi: 10.5867/medwave.2018.07.7331
Ranolazina como terapia antianginosa adicional en pacientes con enfermedad coronaria estable sintomática
Ranolazine as an additional antianginal therapy in patients with stable symptomatic coronary artery disease
Benjamín Sanfuentes, Juan Francisco Bulnes
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Palabras clave: Ranolazine, stable coronary artery disease, CAD, Epistemonikos, GRADE.

Abstract

INTRODUCTION
There are several effective therapeutic alternatives for stable coronary artery, in terms of prevention of cardiovascular morbidity and mortality. However, the best way to achieve symptomatic control is a matter of debate, particularly in those who do not respond to first-line therapy. This summary aims to evaluate the role of ranolazine as an additional therapy to standard antianginal treatment in patients with persistent symptoms.

METHODS
To answer this question we used Epistemonikos, the largest database of systematic reviews in health, which is maintained by screening multiple information sources, including MEDLINE, EMBASE, Cochrane, among others. We extracted data from the systematic reviews, reanalyzed data of primary studies, conducted a meta-analysis and generated a summary of findings table using the GRADE approach.

RESULTS AND CONCLUSIONS
We identified four systematic reviews including 16 studies overall, all of which were randomized trials. We concluded additional treatment with ranolazine might decrease the frequency of anginal episodes but increase adverse effects. It probably has no effect on the risk of death or acute myocardial infarction.


 
Problem

Coronary artery disease includes a wide range of clinical manifestations, from acute presentations, such as myocardial infarction, to chronic conditions, such as stable coronary artery disease. The latter has a significant impact on both mortality and quality of life. There are several pharmacological alternatives with proven effect on reducing mortality - both cardiovascular and total - and improving the quality of life through symptomatic relief. However, there is a subgroup of patients that does not respond adequately to such therapy.

Ranolazine is a drug that inhibits late sodium currents that are abnormally active in the ischemic myocardiocyte. Its effect prevents intracellular calcium overload (as it is exchanged for sodium) with the consequent diastolic dysfunction that underlies the angina. This is why it has been proposed as an effective therapeutic option in stable coronary disease with suboptimal response to conventional treatment.

Methods

To answer the question, we used Epistemonikos, the largest database of systematic reviews in health, which is maintained by screening multiple information sources, including MEDLINE, EMBASE, Cochrane, among others, to identify systematic reviews and their included primary studies. We extracted data from the identified reviews and reanalyzed data from primary studies included in those reviews. With this information, we generated a structured summary denominated FRISBEE (Friendly Summary of Body of Evidence using Epistemonikos) using a pre-established format, which includes key messages, a summary of the body of evidence (presented as an evidence matrix in Epistemonikos), meta-analysis of the total of studies when it is possible, a summary of findings table following the GRADE approach and a section of other considerations for decision-making. 

Key messages

  • Ranolazine might decrease the frequency of anginal episodes in stable symptomatic coronary artery disease, but the certainty of the evidence is low.
  • Ranolazine probably leads to an increase in the incidence of adverse effects.
  • Ranolazine probably results in little or no difference in mortality, incidence of acute myocardial infarction or quality of life in stable symptomatic coronary artery disease.
About the body of evidence for this question

What is the evidence.
See evidence matrix in Epistemonikos later

We found four systematic reviews [1],[2],[3],[4] that included 16 primary studies reported in 19 references [5],[6],[7],[8],[9],[10],[11],[12],[13],[14],[15],[16],
[17],[18],[19],[20],[21],[22],[23], all corresponding to randomized trials.

However, five trials were conducted in patients without stable coronary disease (microvascular angina or acute coronary syndrome) [7],[9],[10],[11],[22]; five used ranolazine as monotherapy [12],[13],[14],[17],[23]; and two measured clinically irrelevant outcomes (time to ST segment depression and mild adverse effects) [6],[16].

This table and the summary in general are based on four randomized trials that used ranolazine as an additional therapy in patients with stable coronary artery disease and reported outcomes critical for decision-making [5],[8],[18],[20].

What types of patients were included*

All trials included symptomatic adults with coronary artery disease confirmed by angiography.

One trial [20] included patients with ejection fraction less than 40%, while the remaining three excluded patients with severe heart failure (defined as NYHA functional class III or IV) [5],[18],[21].

All trials excluded patients with decompensated cardiac comorbidities (hypertension, pericarditis, among others) or systemic diseases (such as liver damage, chronic renal failure, diabetes). Likewise, three of the trials [5],[18],[21] excluded patients with a history of arrhythmia or comedication with proarrhythmic drugs.

The average age of the participants ranged from 61 to 72 years in the different trials.

What types of interventions were included*

All trials used ranolazine 1 g every 12 hours.

Additionally, one trial [20] used standard medical therapy with ranolazine 500 mg every 12 hours; while another trial [21] also used standard medical therapy associated with ranolazine 750 mg every 12 hours.

All trials compared against placebo associated with standard treatment.

What types of outcomes
were measured

The outcomes were grouped by the systematic reviews as follows:

  • All cause mortality
  • Acute myocardial infarction
  • Quality of life (measured with different scales: Seattle Angina Questionnaire (SAQ), Rose Dyspnea Scale (RDS), Medical Outcomes Short Form-36 (SF-36) and Patient's Global Impression of Change (PGIC)).
  • Frequency of anginal episodes.

The average follow-up of the trials was 5.75 months with a range from 9 weeks to 14 months.

* The information about primary studies is extracted from the systematic reviews identified, unless otherwise specified.

Summary of findings

The information on the effects of ranolazine on symptomatic stable coronary artery disease is based on four randomized trials involving 2364 patients.

Three trials measured all cause mortality (2053 patients) [5],[8],[18], three measured quality of life (1533 patients) [8],[18],[20], two reported acute myocardial infarction (1509 patients) [5],[18] and three reported the frequency of anginal episodes (2004 patients) [5],[8],[18].

The summary of findings is as follows:

  • Ranolazine might lead to little or no difference in mortality in stable symptomatic coronary artery disease, but the certainty of the evidence is low.
  • Ranolazine probably results in little or no difference in the incidence of acute myocardial infarction in stable symptomatic coronary artery disease. The certainty of the evidence is moderate.
  • Ranolazine probably results in little or no difference in quality of life. The certainty of the evidence is moderate.
  • Ranolazine might decrease the frequency of anginal episodes in patients with stable symptomatic coronary artery disease, but the certainty of the evidence is low.
  • Ranolazine probably leads to an increase in the incidence of adverse effects. The certainty of the evidence is moderate.

Follow the link to access the interactive version of this table (Interactive Summary of Findings - iSoF)

Other considerations for decision-making

To whom this evidence does and does not apply
  • The evidence presented in this summary applies to patients with stable coronary artery disease, generally older than 60 years, who despite being in standard antianginal treatment, remain symptomatic. Standard antianginal therapy refers to the use of beta-blockers or, alternatively, non-dihydropyridine calcium channel blockers associated with a long-acting nitrate as needed.
About the outcomes included in this summary
  • The outcomes selected in the summary of findings table are those considered critical for decision making by the authors of the summary. They coincide with the outcomes most frequently reported by systematic reviews identified.
  • The quality of life outcome was measured at different scales, so the size of the effect of the intervention was calculated using the standardized mean difference.
Balance between benefits and risks, and certainty of the evidence
  • As reported in the summary of findings table, the use of ranolazine increases the incidence of adverse effects. In addition, the fact that the certainty of the evidence associated to the anginal episodes frequency is low, the balance between benefits and risks is unfavorable.
Resource considerations
  • Currently, there is no certainty that ranolazine could have a benefit on patients with stable coronary disease, since the quality of the evidence is not sufficient for the outcomes studied. Therefore, it is not possible to make an adequate cost/ benefit balance.
What would patients and their doctors think about this intervention
  • Considering the existing evidence, most patients and physicians should lean against the use of ranolazine in patients with stable coronary artery disease.
  • However, in symptomatic patients despite standard antianginal treatment, they could opt for its use. In these cases it is important to inform about the limitations of the existing evidence.

Differences between this summary and other sources
  • The conclusions of this summary are in agreement with those of the only review that included the four randomized trials used in our analysis [3].
  • Our summary is in concordance with a guideline that considers the use of ranolazine in patients who remain symptomatic with standard antianginal treatment [24]. Another guideline considers its use in patients with contraindications to other antianginal agents, although this analysis was not the goal of our summary [25].
Could this evidence change in the future?
  • The probability that the conclusions of this summary change in the future varies depending on the outcome. For mortality and frequency of angina episodes, the probability is moderate according to the certainty of the current evidence. In turn, for the outcomes acute myocardial infarction and quality of life, the probability is low.
  • There are both systematic reviews [26] and ongoing randomized trials [27],[28] evaluating this question, that could provide relevant additional information or greater certainty of evidence for decision-making.
How we conducted this summary

Using automated and collaborative means, we compiled all the relevant evidence for the question of interest and we present it as a matrix of evidence.

Follow the link to access the interactive version: Ranolazine for ischemic heart disease.

Notes

The upper portion of the matrix of evidence will display a warning of “new evidence” if new systematic reviews are published after the publication of this summary. Even though the project considers the periodical update of these summaries, users are invited to comment in Medwave or to contact the authors through email if they find new evidence and the summary should be updated earlier.

After creating an account in Epistemonikos, users will be able to save the matrixes and to receive automated notifications any time new evidence potentially relevant for the question appears.

This article is part of the Epistemonikos Evidence Synthesis project. It is elaborated with a pre-established methodology, following rigorous methodological standards and internal peer review process. Each of these articles corresponds to a summary, denominated FRISBEE (Friendly Summary of Body of Evidence using Epistemonikos), whose main objective is to synthesize the body of evidence for a specific question, with a friendly format to clinical professionals. Its main resources are based on the evidence matrix of Epistemonikos and analysis of results using GRADE methodology. Further details of the methods for developing this FRISBEE are described here (http://dx.doi.org/10.5867/medwave.2014.06.5997)

Epistemonikos foundation is a non-for-profit organization aiming to bring information closer to health decision-makers with technology. Its main development is Epistemonikos database (www.epistemonikos.org).

Potential conflicts of interest

The authors do not have relevant interests to declare.

Licencia Creative Commons Esta obra de Medwave está bajo una licencia Creative Commons Atribución-NoComercial 3.0 Unported. Esta licencia permite el uso, distribución y reproducción del artículo en cualquier medio, siempre y cuando se otorgue el crédito correspondiente al autor del artículo y al medio en que se publica, en este caso, Medwave.

 

INTRODUCTION
There are several effective therapeutic alternatives for stable coronary artery, in terms of prevention of cardiovascular morbidity and mortality. However, the best way to achieve symptomatic control is a matter of debate, particularly in those who do not respond to first-line therapy. This summary aims to evaluate the role of ranolazine as an additional therapy to standard antianginal treatment in patients with persistent symptoms.

METHODS
To answer this question we used Epistemonikos, the largest database of systematic reviews in health, which is maintained by screening multiple information sources, including MEDLINE, EMBASE, Cochrane, among others. We extracted data from the systematic reviews, reanalyzed data of primary studies, conducted a meta-analysis and generated a summary of findings table using the GRADE approach.

RESULTS AND CONCLUSIONS
We identified four systematic reviews including 16 studies overall, all of which were randomized trials. We concluded additional treatment with ranolazine might decrease the frequency of anginal episodes but increase adverse effects. It probably has no effect on the risk of death or acute myocardial infarction.

Autores: Benjamín Sanfuentes[1,2], Juan Francisco Bulnes[2,3]

Filiación:
[1] Facultad de Medicina, Pontificia Universidad Católica de Chile, Santiago, Chile
[2] Proyecto Epistemonikos, Santiago, Chile
[3] Unidad Coronaria, Hospital Dr. Sótero del Río, Santiago, Chile

E-mail: jfbulnes@gmail.com

Correspondencia a:
[1] Centro Evidencia UC
Pontificia Universidad Católica de Chile
Diagonal Paraguay 476
Santiago
Chile

Citación: Sanfuentes B, Bulnes J. Ranolazine as an additional antianginal therapy in patients with stable symptomatic coronary artery disease. Medwave 2018;18(7):e7331 doi: 10.5867/medwave.2018.07.7331

Fecha de envío: 8/10/2018

Fecha de aceptación: 5/11/2018

Fecha de publicación: 12/11/2018

Origen: Este artículo es producto del Epistemonikos Evidence Synthesis Project de la Fundación Epistemonikos, en colaboración con Medwave para su publicación.

Tipo de revisión: Con revisión por pares sin ciego por parte del equipo metodológico del Epistemonikos Evidence Synthesis Project.

Ficha PubMed

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Banon D, Filion KB, Budlovsky T, Franck C, Eisenberg MJ. The usefulness of ranolazine for the treatment of refractory chronic stable angina pectoris as determined from a systematic review of randomized controlled trials. Am J Cardiol. 2014 Mar 15;113(6):1075-82. | CrossRef | PubMed |

Belsey J, Savelieva I, Mugelli A, Camm AJ. Relative efficacy of antianginal drugs used as add-on therapy in patients with stable angina: A systematic review and meta-analysis. Eur J Prev Cardiol. 2015 Jul;22(7):837-48. | CrossRef | PubMed |

Salazar CA, Basilio Flores JE, Veramendi Espinoza LE, Mejia Dolores JW, Rey Rodriguez DE, Loza Munárriz C. Ranolazine for stable angina pectoris. Cochrane Database Syst Rev. 2017 Feb 8;2:CD011747. | CrossRef | PubMed |

Savarese G, Rosano G, D'Amore C, Musella F, Della Ratta GL, Pellegrino AM, Formisano T, Vitagliano A, Cirillo A, Cice G, Fimiani L, del Guercio L, Trimarco B, Perrone-Filardi P. Effects of ranolazine in symptomatic patients with stable coronary artery disease. A systematic review and meta-analysis. Int J Cardiol. 2013 Nov 15;169(4):262-70. | CrossRef | PubMed |

Kosiborod M, Arnold SV, Spertus JA, McGuire DK, Li Y, Yue P, Ben-Yehuda O, Katz A, Jones PG, Olmsted A, Belardinelli L, Chaitman BR. Evaluation of ranolazine in patients with type 2 diabetes mellitus and chronic stable angina: results from the TERISA randomized clinical trial (Type 2 Diabetes Evaluation of Ranolazine in Subjects With Chronic Stable Angina). J Am Coll Cardiol. 2013 May 21;61(20):2038-45. | CrossRef | PubMed |

Pepine CJ, Wolff AA. A controlled trial with a novel anti-ischemic agent, ranolazine, in chronic stable angina pectoris that is responsive to conventional antianginal agents. Ranolazine Study Group. Am J Cardiol. 1999 Jul 1;84(1):46-50. | PubMed |

Wilson SR, Scirica BM, Braunwald E, Murphy SA, Karwatowska-Prokopczuk E, Buros JL, Chaitman BR, Morrow DA. Efficacy of ranolazine in patients with chronic angina observations from the randomized, double-blind, placebo-controlled MERLIN-TIMI (Metabolic Efficiency With Ranolazine for Less Ischemia in Non-ST-Segment Elevation Acute Coronary Syndromes) 36 Trial. J Am Coll Cardiol. 2009 Apr 28;53(17):1510-6. | CrossRef | PubMed |

Sendón JL, Lee S, Cheng ML, Ben-Yehuda O; CARISA study investigators. Effects of ranolazine on exercise tolerance and angina frequency in patients with severe chronic angina receiving maximally-tolerated background therapy: analysis from the Combination Assessment of Ranolazine In Stable Angina (CARISA) randomized trial. Eur J Prev Cardiol. 2012 Oct;19(5):952-9. | CrossRef | PubMed |

Mehta PK, Goykhman P, Thomson LE, Shufelt C, Wei J, Yang Y, Gill E, Minissian M, Shaw LJ, Slomka PJ, Slivka M, Berman DS, Bairey Merz CN. Ranolazine improves angina in women with evidence of myocardial ischemia but no obstructive coronary artery disease. JACC Cardiovasc Imaging. 2011 May;4(5):514-22. | CrossRef | PubMed |

Bairey Merz CN, Handberg EM, Shufelt CL, Mehta PK, Minissian MB, Wei J, Thomson LE, Berman DS, Shaw LJ, Petersen JW, Brown GH, Anderson RD, Shuster JJ, Cook-Wiens G, Rogatko A, Pepine CJ. A randomized, placebo-controlled trial of late Na current inhibition (ranolazine) in coronary microvascular dysfunction (CMD): impact on angina and myocardial perfusion reserve. Eur Heart J. 2016 May 14;37(19):1504-13. | CrossRef | PubMed | PMC |

Villano A, Di Franco A, Nerla R, Sestito A, Tarzia P, Lamendola P, Di Monaco A, Sarullo FM, Lanza GA, Crea F. Effects of ivabradine and ranolazine in patients with microvascular angina pectoris. Am J Cardiol. 2013 Jul 1;112(1):8-13. | CrossRef | PubMed |

Alexander KP, Weisz G, Prather K, James S, Mark DB, Anstrom KJ, Davidson-Ray L, Witkowski A, Mulkay AJ, Osmukhina A, Farzaneh-Far R, Ben-Yehuda O, Stone GW, Ohman EM. Effects of Ranolazine on Angina and Quality of Life After Percutaneous Coronary Intervention With Incomplete Revascularization: Results From the Ranolazine for Incomplete Vessel Revascularization (RIVER-PCI) Trial. Circulation. 2016 Jan 5;133(1):39-47. | CrossRef | PubMed |

Thadani U, Ezekowitz M, Fenney L, Chiang YK. Double-blind efficacy and safety study of a novel anti-ischemic agent, ranolazine, versus placebo in patients with chronic stable angina pectoris. Ranolazine Study Group. Circulation. 1994 Aug;90(2):726-34. | PubMed |

Chaitman BR, Skettino SL, Parker JO, Hanley P, Meluzin J, Kuch J, Pepine CJ, Wang W, Nelson JJ, Hebert DA, Wolff AA; MARISA Investigators. Anti-ischemic effects and long-term survival during ranolazine monotherapy in patients with chronic severe angina. J Am Coll Cardiol. 2004 Apr 21;43(8):1375-82. | PubMed |

Weisz G, Généreux P, Iñiguez A, Zurakowski A, Shechter M, Alexander KP, Dressler O, Osmukhina A, James S, Ohman EM, Ben-Yehuda O, Farzaneh-Far R, Stone GW; RIVER-PCI investigators. Ranolazine in patients with incomplete revascularisation after percutaneous coronary intervention (RIVER-PCI): a multicentre, randomised, double-blind, placebo-controlled trial. Lancet. 2016 Jan 9;387(10014):136-45. | CrossRef | PubMed |

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Edición Julio 2022
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