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PS-065 Ivabradine prescription according to pharmacovigilance risk assessment committee restrictions
  1. J Marco del Río,
  2. A Valladolid Walsh,
  3. S Plata Paniagua,
  4. L Victorio García,
  5. G Romero Candel,
  6. M Díaz Rangel,
  7. N Monteagudo Martínez,
  8. F Sánchez Rubio,
  9. E Domingo Chiva,
  10. EM García Martínez
  1. Complejo Hospitalario Universitario de Albacete, Pharmacy, Albacete, Spain


Background The Pharmacovigilance Risk Assessment Committee (PRAC) published restrictions on the use of ivabradine in 2014 for patients diagnosed with chronic stable angina pectoris (CSAP):

  • begin treatment only if resting heart rate (HR) is >70 bpm, initial dose not exceeding 5 mg bid (2.5 mg bid for patients older than 75 years);

  • maximum maintenance dose 7.5 mg bid;

  • monitor HR before starting treatment and after changing dose;

  • withdraw treatment in the case of atrial fibrillation (AF); and

  • do not use ivabradine combined with diltiazem or verapamil.

Purpose To review ivabradine prescriptions in our patients and compliance with PRAC guidelines.

Material and methods An observational, prospective study was carried out between February and May 2015. Every patient diagnosed with CSAP and treated with ivabradine was included. Data collected: gender, age, HR, dates in which treatment was started and discontinued, diagnosis, initial and maintenance dose, diltiazem or verapamil treatment and occurrence of AF. The prescription was considered adequate if it followed every PRAC recommendation.

Results 34 patients were prescribed ivabradine and 17 were included in our study based on a CSAP diagnosis. At the beginning, resting HR was >70 bpm and initial dose was 5 mg bid for all patients (none was older than 75 years). Maintenance dose was never above 7.5 mg bid. In 4 patients, ivabradine was withdrawn, in 3 due to the development of AF and the other one after a pharmaceutical intervention warning the physician that a combination of diltiazem and ivabradine was prescribed.

Compliance with PRAC guidelines was found in 16 of 17 patients (94%).

Conclusion 3 out of 17 patients (17.6%) developed AF during treatment, a higher percentage than that showed in the SIGNIFY1 study (4.6%). We strongly believe that treatment with ivabradine should be closely monitored by hospital pharmacists regarding its pharmacological and safety profile.

References and/or Acknowledgements

  1. Fox K, Ford I, Steg PG, et al. Bradycardia and atrial fibrillation in patients with stable coronary artery disease treated with ivabradine: an analysis from the SIGNIFY study. Eur Heart J 2015;Sep 17:ehv451

References and/or AcknowledgementsNo conflict of interest.

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