STATE OF THE ART BP ASSESSMENT

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2 STATE OF THE ART BP ASSESSMENT PROFESSOR MOLECULAR PHARMACOLOGY CONWAY INSTITUE UNIVERSITY COLLEGE DUBLIN CO-CHAIRMAN BLOOD PRESCSURE MANAGEMENT IN LOW RESOURCE SETTINGS CENTRE FOR INTERNATIONAL HUMANITARIAN COOPERATION FORDHAM UNIVERSITY NEW YORK MEDICAL DIRECTOR dabl LIMITED DUBLIN IRELAND

3 LESSONS FROM CLINICAL PRACTICE

4 SCIPIONE RIVA-ROCCI NICOLAI SERGEIVICH KOROTKOV 1910

5 CONVENTIONAL BP MEASUREMENT CLINIC SPHYGMO TEMPERATURE HEIGHT HUMIDITY POSITION & TILT NOISE LEVEL OF HG OBSERVER CLOGGED VENT TRAINING MAINTENANCE BIAS STETHOSCOPE DIGIT PREFERENCE SUBJECT INATTENTION ANXIETY RAPPORT RECENT EXERCISE HEARING & VISION MEAL OR TOBACCO DISTANCE OBESITY ELDERLY CUFF/BLADDER ARRHYTHMIA CUFF CONDITION POSTURE APPLICATION ARM LEVEL BLADDER SIZE ARM SUPPORT BLADDER POSITION RIGHT OR LEFT?

6 WHITE COAT HYPERTENSION 20 25% MASKED HYPERTENSION 10 15% CBPM ~ INCORRECT DIAGNOSIS 30 40%

7 The Charitable Infirmary at Jervis Street Blood Pressure Unit founded 1979

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9 Faced with a patient with borderline hypertension, the doctor should be slow to diagnose hypertension until some attempt has been made to categorise the behaviour of blood pressure over time: ambulatory blood pressure measurement is the best way to do this. O Brien E. BMJ 1988:297;

10 MEASUREMENT ACCURACY

11 SERIES OF VALIDATION PROTOCOLS Stergiou G et al. BP Monit 2010;15:39 48.

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13 USER-FRIENDLY SOFTWARE

14 LEVELS OF NORMALITY WINDOWS OF 24-H PROFILE dabl Ireland Owens P, Atkins N, O Brien E. Diagnosis of White Coat Hypertension by Ambulatory Blood Pressure Monitoring. Hypertension 1999;34:

15 NORMAL 24-HOUR PATTERN dabl Ireland

16 COMPUTER-GENERATED REPORTS dabl Ireland The ABPM indicates normal 24-hour systolic & diastolic blood pressure (128 / 78 mmhg daytime, 110 / 62 mmhg night-time).

17 CONCISE REPORT

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19 Hypertension published online Jan 26 th 2009 ABPM TREND REPORT

20 CLINICAL USE n Mean White-Coat Window SBP DBP HR Daytime SBP DBP HR Night-time SBP DBP HR hour SBP DBP HR RESEARCH

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22 WHITE COAT HYPERTENSION 20-25% hypertensive population 2011 dabl Limited The ABPM shows marked white-coat hypertension (205/100 mmhg) with otherwise normal 24-hour systolic & diastolic blood pressure (128/68 mmhg daytime and 112/54 mmhg night-time). OFFICE HYPERTENSION AMBULATORY NORMOTENSION 156/88 mmhg 128/68 mmhg

23 MASKED HYPERTENSION 10-15% of general population 2011 dabl Limited The ABPM shows mild daytime systolic & diastolic hypertension (147 / 93 mmhg) and normal nighttime systolic & diastolic blood pressure (111 / 66 mmhg). OFFICE NORMOTENSION AMBULATORY HYPERTENSION 124/62 mmhg 147/93 mmhg

24 DIPPERS AND NON-DIPPERS DIPPERS Day/Night > 10/5 mmhg NON-DIPPERS Day/Night < 10/5 mmhg DIPPERS Stroke 3 % NON-DIPPERS Stroke 23 % O Brien et al. Lancet 1988

25 ADJUSTED 5-YEAR RISK OF CARDIOVASCULAR DEATH ACCORDING TO CBPM & ABPM Nighttime 24-hour Daytime Clinic Nighttime 24-hour Daytime Clinic Adjusted for other covariates Dolan et al. Hypertension 2005;46:1-6

26 DIPPING PATTERN 2011 dabl Limited The ABPM shows severe daytime systolic hypertension (181 mmhg), moderate daytime diastolic hypertension (117 mmhg) and normal night-time systolic & diastolic blood pressure (111/68 mmhg).

27 NON-DIPPING PATTERN 2011 dabl Limited The ABPM shows severe 24-hour systolic & diastolic hypertension (210/134 mmhg daytime and 205/130 mmhg night-time).

28 MORNING SURGE 2011 dabl Limited

29 ISOLATED SYSTOLIC HYPERTENSION 2011 dabl Limited The ABPM indicates severe 24-hour isolated systolic hypertension (176/68 mmhg daytime and 169/70 mmhg night-time).

30 AUTONOMIC FAILURE 2011 dabl Limited

31 HYPERTENSIVE - NON DIPPER Shortoprilol 50 mg mane

32 HYPERTENSIVE - NON DIPPER 2011 dabl Limited Longoprolol 20 mg mane

33 WHAT DO THE INTERNATIONAL GUIDELINES SAY?

34 ABPM GUIDELINES INDICATION BHS 2000 ESH 2003 BRAZIL 2005 AHA 2005 JAPAN 2012 AUST 2012 SUSPECTED WCH Yes Yes Yes Yes Yes Yes WC EFFECT Yes Yes - - Yes Yes SUSPECTED MH Yes Yes Yes Yes Yes Yes DIPPING STATUS Yes Yes - Yes Yes Yes RESISTANT HT Yes Yes - Yes Yes Yes DRUG EFFICACY Yes Yes Yes Yes Yes Yes HYPOTENSION Yes Yes Yes Yes Yes Yes BP VARIABILITY Yes - SECONDARY HT Yes - SLEEP APNOEA Yes

35 NATIONAL INSTITUTE FOR CLINICAL EXCELLENCE (NICE) GUIDELINE 2011

36 IF THE CLINIC BLOOD PRESSURE IS 140/90 MMHG OR HIGHER, OFFER AMBULATORY BLOOD PRESSURE MONITORING (ABPM) TO CONFIRM THE DIAGNOSIS OF HYPERTENSION. NICE Final Recommendation 2011

37 GENERAL HYPERTENSION GUIDELINES INDICATION JNC VII 2003 BHS IV 2004 ESC ESH 2007 LATIN AMER 2009 ITALY 2008 CHEP 2011 SA 2012 TAI- WAN 2012 SUSPECTED HT YES NICE 2011 SUSPECTED WCH Yes Yes Yes Yes Yes Yes Yes Yes Yes WC EFFECT Yes Yes SUSPECTED MH Yes Yes - Yes - No DIPPING STATUS - Yes Yes Yes Yes Yes Yes - No RESISTANT HT Yes Yes Yes Yes Yes Yes Yes Yes - DRUG EFFICACY - Yes Yes Yes Yes Yes Yes - No HYPOTENSION Yes Yes Yes Yes Yes Yes - Yes No BP VARIABILITY - Yes Yes Yes Yes Yes Yes Yes -

38 NICE OBJECTIVE SAVE MONEY FOR THE NHS Lancet 2011;736:1184-7

39 PHARMACOLOGICAL TRIALS OF CV DRUGS

40 THE TIME HAS SURELY COME WHERE STUDIES OF ANTIHYPERTENSIVE DRUG EFFICACY WHICH DO NOT ASSESS BLOOD PRESSURE OVER 24 HOURS SHOULD NO LONGER BE ACCEPTABLE. O Brien E. J Hypertens 1989:7;

41 Millar Craig et al. BMJ 1979;i:

42 Millar Craig et al. BMJ 1979;i:

43 The circadian rhythm of blood pressure raises many questions about the timing of antihypertensive drug dosage and the effects of traditional regimens. Single measurements in outpatient clinics are unlikely to yield useful information on the effects of drugs on this basic cycle. If treatment aims at lowering blood pressure to a "normal level (140/90 mm Hg) clearly it is desirable to lower it to that level throughout the 24-hour cycle. Millar Craig et al. BMJ 1979;i:

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46 Hypertension published online Jan 26 th 2009

47 VISIT-TO-VISIT BPV IN ASCOT-BPLA 4.5 Hypertension published online Jan 26 th 2009 Average within-visit CV SBP Atenolol Amlodipine Baseline 3 months 1 year 2 year 3 year 4 year 5 year Follow-up

48 BLOOD PRESSURE VARIABILITY Marked BPV Less BPV

49 HOPE STUDY New Eng J Med 2002 RAMIPRIL ~ REDUCTION IN CV MORTALITY REDUCTION IN BP ~ 3/2 mmhg ACE INHIBITORS ~ HIGH-RISK PATIENTS ABPM SUB-STUDY ~ 1 YEAR LATER WHOPPING 17/8 mmhg NOCTURNAL FALL 10/4 mmhg REDUCTION IN 24-H ABPM

50 REAL-TIME ANALYSIS OF ABPM IS ESSENTIAL

51 ABPM Page (Rejected ABPM)

52 ABPM Page (Accepted ABPM)

53 PHARMACOLOGICAL TRIALS OF NON-CV DRUGS

54 Various Technologies and Means to Measure Blood Pressure in Clinical Trials

55 SELF-MEASUREMENT OF BLOOD PRESSURE (SBPM)

56 ESH RECOMMENDATIONS FOR SBPM Parati G,Stergiou GS, O Brien E, et al on behalf of the ESH Working Group on Blood Pressure Monitoring. European Society of Hypertension guidelines for blood pressure monitoring at home: J Hypertens 2008, 26: m REST, 30 m NO SMOKING or CAFFEINE, RELAXED SEATED, BACK SUPPORT, ARM ON TABLE, LEGS UNCROSSED 7 DAYS OF MEASUREMENTS 2 MEASUREMENTS, 1-2 MIN INTERVALS, AM & PM DISCARD FIRST DAY MEASUREMENTS AVERAGE 6 DAYS MEASUREMENT APPROXIIMATE EQUIVALENT TO DAYTIME ABPM NO NOCTURNAL DATA, NO PATTERNS ABPM and SBPM ~ DIFFERENT DATA ~ COMPLIMENTARY TECHNIQUES

57 Drug Information Journal, 2011; 45: In my view, a better question regarding ABPM is whether all systemically available drugs intended for chronic use merit a careful assessment of their effects on vital signs by ABPM. Norman Stockbridge. Drug Information Journal, 2011; 45:

58 SINCE CBPM IN 1896 SUPERLATIVE TECHNOLOGY

59 Hypertension published online Jan 26 th 2009 CARD(X)PLORE DEVICE

60 ABPM Variability

61 Hypertension published online Jan 26 th 2009

62 From the scientific viewpoint, we believe that it is now time to utilize the technique of ABPM to obtain a fuller understanding of the patterns of noncardiovascular drug-induced BP responses than was ever possible with CBPM. J Clin Hypertens 2012

63 CONCLUSION ~ PLEA PHARMACOLOGICL TRIALS ~ ABPM SCIENCE MUST DIRECT INDUSTRY ACCURATE & EFFICIENT ABPM HARDWARE DUAL OR TREBLE PURPOSE DEVICES STANDARDISED ANALYTICAL SOFTWARE CENTRAL HOSTING & FEED-BACK REAL-TIME MONITORING & ANALYSIS SCIENTIFIC REALITY ~ PROCEDURAL APATHY

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