Angiotensin-II receptor blockers (ARBs)
Medicines Management Programme Preferred Drugs
Angiotensin-II Receptor Blockers (ARBs)
Approved by:
Date approved: Version:
Prof. Michael Barry, Clinical Lead, Medicines Management Programme (MMP).
07/02/2022
4.0
Table of contents
1. Purpose ..................................................................................................................................1 2. Definitions..............................................................................................................................1 3. Angiotensin-II receptor blockers............................................................................................2 4. Preferred angiotensin-II receptor blocker .............................................................................3 5. Selection criteria ....................................................................................................................4
5.1 Licensed therapeutic indications .....................................................................................4 5.1.1 Hypertension .............................................................................................................6 5.1.2 Heart failure...............................................................................................................6
5.2 Clinical outcome data.......................................................................................................7 5.2.1 Meta-analyses and systematic reviews in the treatment of hypertension ..............8 5.2.2 Meta-analyses and systematic reviews in the treatment of heart failure................9
5.3 Clinical guidelines for the treatment of hypertension and heart failure.......................10 5.3.1 Hypertension ...........................................................................................................10 5.3.2 Heart failure.............................................................................................................17
5.4 Adverse drug reactions ..................................................................................................21 5.5 Contraindications & cautions .........................................................................................24
5.5.1 Contraindications.....................................................................................................24 5.5.2 Cautions ...................................................................................................................25 5.6 Drug interactions............................................................................................................26 5.7 Patient factors ................................................................................................................28 5.8 Cost.................................................................................................................................28 5.9 National prescribing trends............................................................................................32 6. Nitrosamine impurity...........................................................................................................37 7. Conclusion............................................................................................................................39 8. References ...........................................................................................................................40 9. Bibliography .........................................................................................................................43
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Tables
Table 1: Licensed therapeutic indications and frequency of administration for ARBs .............5 Table 2: Clinical guidelines for the treatment of hypertension...............................................11 Table 3: Clinical practice guidance for the treatment of hypertension ..................................12 Table 4: Clinical guidelines for the treatment of heart failure ................................................17 Table 5: Clinical practice guidance for the treatment of heart failure ....................................17 Table 6: Common adverse drug reactions of individual ARBs (as per SmPC) .........................22 Table 7: The defined daily dose of each ARB for the treatment of mild-moderate hypertension .................................................................................................................................................. 30 Table 8: Breakdown of total number of prescriptions for different strengths of ARBs on all community drug schemes from January 2019 - December 2019............................................35
Figures
Figure 1: Combined total number of prescriptions for ARBs on all community drug schemes 2011-2019 ..................................................................................................................................2 Figure 2: Total expenditure for ARBs on all community drug schemes 2011-2019 ..................3 Figure 3: PCRS reimbursed cost of 28 dosage units of each ARB ............................................29 Figure 4: PCRS reimbursed cost of 28 dosage units based on defined daily dose ..................30 Figure 5: Distribution of the volume of claims reimbursed by the PCRS for ARBs on all community drug schemes July 2019 - June 2020 ....................................................................32 Figure 6: Number of prescriptions for ARBs on all community drug schemes July 2019 - June 2020 .........................................................................................................................................33 Figure 7: Total expenditure for each ARB on all community drug schemes July 2019 - June 2020 .........................................................................................................................................34 Figure 8: Total number of prescriptions annually for each ARB on all community drug schemes 2011 ? 2019 .............................................................................................................................36
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List of abbreviations
ACC
American College of Cardiology
ACE
Angiotensin-converting enzyme
ACE2
Angiotensin-converting enzyme 2
ADR
Adverse drug reaction
AHA
American Heart Association
ARB
Angiotensin-II receptor blocker
ARNI
Angiotensin receptor-neprilysin inhibitor
AT1
Angiotensin type 1
BIHS
British and Irish Hypertension Society
BP
Blood pressure
CCB
Calcium channel blocker
CDS
Community Drug Schemes
CHMP
Committee for Medicinal Products for Human Use
CYP
Cytochrome P450
DDD
Defined daily dose
DPS
Drugs Payment Scheme
EMA
European Medicines Agency
ESC
European Society of Cardiology
ESH
European Society of Hypertension
GMS
General Medical Services
HPRA
Health Products Regulatory Authority
HSE
Health Service Executive
ICGP
Irish College of General Practitioners
LTI
Long Term Illness
LVEF
Left Ventricular Ejection Fraction
MRA
Mineralocorticoid receptor antagonist
MMP
Medicines Management Programme
NICE
National Institute for Health and Care Excellence
NSAID
Non-steroidal anti-inflammatory drug
NYHA
New York Heart Association
PCRS
Primary Care Reimbursement Service
RAS
Renin-Angiotensin System
RAAS
Renin-Angiotensin-Aldosterone System
SGLT2
Sodium-glucose co-transporter 2
SmPC
Summary of Product Characteristics
WHO
World Health Organisation
Acknowledgements
The MMP wishes to acknowledge the National Medicines Information Centre (NMIC) for their input and contributions to this document.
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1. Purpose
Candesartan has been the Health Service Executive-Medicines Management Programme (HSE-MMP) preferred angiotensin-II receptor blocker (ARB) since July 2014.1 The purpose of this report is to review the choice of preferred ARB in light of the current available evidence.
The MMP aims to promote safe, effective and cost-effective prescribing. The Preferred Drugs Initiative identifies a single `preferred drug' within a therapeutic drug class, and offers prescribers useful guidance on selecting, prescribing and monitoring this drug for a particular condition. In this case, the use of ARBs in the management of patients with cardiovascular conditions, in particular hypertension and heart failure is reviewed.
Prescribers are encouraged to make the preferred drug their drug of first choice, when initiating an ARB and when there is a need to change from one ARB to another in the treatment of hypertension and heart failure.
This report should be used in conjunction with clinical judgement and decision making appropriate to the individual patient. Prescribers should refer to sources such as the Summary of Product Characteristics (SmPC) to inform decisions made concerning individual patients.
2. Definitions
For the purpose of this report, the associated ingredient cost refers to the reimbursed cost of the named ARB as listed on the HSE-Primary Care Reimbursement Service (PCRS) website (pcrs.ie). Reimbursed ARBs licensed for the treatment of hypertension and heart failure are included in this review.
The Community Drug Schemes (CDS) referred to throughout this document include the Drugs Payment Scheme (DPS), Long Term Illness (LTI) scheme and the General Medical Services (GMS) scheme. Data in relation to the CDS is limited by its inability to capture prescriptions that are solely funded by the patient, and therefore not reimbursed under any of the statefunded CDS e.g. prescriptions that fall below the co-payment threshold on the DPS.
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