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Risks of therapeutic interchange in HFrEF

Session Poster Session 2

Speaker Giuseppe M C Rosano

Event : Heart Failure 2018

  • Topic : heart failure
  • Sub-topic : Chronic Heart Failure: Pharmacotherapy
  • Session type : Poster Session

Authors : G Marazzi (Rome,IT), G Caminiti (Rome,IT), F Pelliccia (Rome,IT), L Iaia (Rome,IT), L Cacciotti (Rome,IT), G Cice (Naples,IT), R Massaro (Rome,IT), B Sposato (Rome,IT), M Volterrani (Rome,IT), G M C Rosano (Rome,IT)

Authors:
G Marazzi1 , G Caminiti1 , F Pelliccia2 , L Iaia3 , L Cacciotti4 , G Cice5 , R Massaro1 , B Sposato1 , M Volterrani1 , G M C Rosano1 , 1San Raffaele Pisana Hospital IRCCS - Rome - Italy , 2Umberto I Polyclinic of Rome, Cardiology - Rome - Italy , 3Giovanni Calibita Fatebenefratelli Hospital - Rome - Italy , 4Ospedale Vannini - Rome - Italy , 5Second University of Naples - Naples - Italy ,

Citation:

Therapeutic interchange or substitution of an originator cardiovascular drug with a generic drugs or drugs that are similar, albeit not identical, has raised several safety.  Generic drugs are believed to be therapeutically similar.  However, the interchangeability between generic drugs and the bio-creep that reduces their therapeutic equivalence to the originator may pose efficacy and safety issues in patients where a narrow therapeutic interval should be sought.

We assessed the pharmacodynamics equivalence of branded and generic beta-blockers in 612 patients with heart failure and reduced ejection fraction (HFrEF).  Patients were started and up-titrated on branded bisoprolol/carvedilol/nebivolol/metoprolol and referred to their general practitioner for continuation of their prescriptions. Heart rate and blood pressure were assessed at discharge and at 1 and 3 months. At discharge heart rate was 62+7 bpm and blood pressure was  118+12 mmHg.Patients who remained on branded beta-blockers at 3 months showed no significant change in either heart rate or blood pressure while patients switched to generic beta-blockers showed a significant variability in heart rate and blood pressure values at 3 months compared to end of up-titration (Table 1). Patients switched to generic beta-blockers showed a greater need of dose adjustment and augmentation of diuretic therapy.  No difference between branded beta-blockers and branded generics was detected.

These findings suggest that in patients with HFrEF therapeutic interchange should be practiced with caution.  Originator and branded generics have similar pharmacodynamics while non-branded generics do not guarantee adequate safety and efficacy, thereby suggesting that drugs to be used in HFrEF should be classified as drugs with narrow therapeutic interval.

Branded beta-blockers (pooled)

Generic beta-blockers (pooled)

Mean age

Male

Diabetics

Hypertensives

NYHA III

NYHA II

67+8

72%

23%

45%

38%

62%

67+8

74%

25%

41%

32%

68%

Patients at 3 month

Heart Rate at 3 months

Systolic Blood Pressure at 3 month

Patients requiring unplanned visits/hospitalisations/increased diuretic therapy

236

61+6

118+16

2

369

66+11*

124+25*

14

*=p<0.02 Heart rate (bpm) - Blood pressure (mmHg)

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