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

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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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