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Scientific Session 1:
Optimal Blood Pressure
Management
Implication of the SPRINT trial
and BP Variability
Consultant Card...
Optimal Blood Pressure Management
Implication of the SPRINT Trial & Blood
Pressure Variability
Hypertension
3
 Leading risk factor for death and disability-adjusted life-years lost1
 Systolic hypertension is the com...
CONFIDENTIAL & PROPRIETARY—INTERNAL USE ONLY.
STRATEGIES CONTAINED HEREIN ARE NOT NECESSARILY ENDORSED BY PFIZER SENIOR
MA...
 Mdm Wong
52-year-old, executive
 Mother has hypertension in old age
 Trying to eat less fatty food
 Walks 30-40 minut...
6
How to take a proper office BP
(Canadian CHEP Guideline 2016)
Automated office BP equal to or better than manual BP
Uppe...
 better reflects true BP condition than office BP by separating
from medical environment
 Use for risk stratification:
...
Mortality with isolated and/or combined elevated
office, home, and ambulatory BP – PAMELA study
Pressioni Arteriose Monito...
Definitions of hypertension
by office and out-of-office blood pressure
Category Systolic
(mmHg)
Diastolic
(mmHg)
Office BP...
“white-coat” effect and masked hypertension
National Institute for Health and Clinical Excellence (NICE). Hypertension Cli...
11
• Usual duration is 24 hours
• Ensure at least two measurements
per hour during the person’s usual
waking hours (for ex...
12Confidential & Proprietary – For Internal Use Only – Do Not Disseminate Without Approval
Reference Values for Dipper Sta...
Kaplan-Meier curves reporting the cumulative incidence of cardiovascular events in the 4 categories of dipping pattern. Ad...
How to Monitor Home Blood Pressure
Mancia et al. Hypertension 2006;47:846-853
14
o Two consecutive blood pressure measurem...
Item Suggestions Description
Morning
measurement
time
• Sitting BP during 1 hour after
awakening
• After urination
• Befor...
Summary
 Office BP is recommended for screening and diagnosis of hypertension
 Diagnosis of hypertension should be based...
New evidence for controlling BPV
as part of hypertension management
Blood pressure variability (BPV) and its
management
What is BPV?
 Normal BP fluctuations occur in response to environmental challenges (eg,
stress or activities)1
 Blood pr...
BPV differs in extent between individuals
Rothwell PM. Lancet 2010;375:938-948
Patient 1 with lower BPV Patient 2 with hig...
BPV : how to measure
 ABPM can identify patients with morning surge and predicts CV events
better than office BP levels1
...
MBP surge: what is significant?
 MBP surge is defined as the morning BP (average of 2 hours after rising) minus the night...
The rapid rise of BP in the morning is one
of the critical risk variables for CV events
BP profile of untreated
hypertensi...
Stroke risk and BPV are lower in patients treated with CCBs vs
other antihypertensives despite similar mean BP
Rothwell. L...
NICE 2011 guidelines on the
management of BPV
National Institute for Health and Clinical Excellence (NICE). Hypertension C...
Amlodipine has long half-life
for the control of BPV
1. Kes et al. Curr Med Res Opin 2003;19:226-237
2. Flack et al. Eur H...
Bedtime administration of amlodipine +
olmesartan improves BPV and morning BP surge
Hoshino A, et al. Clin Exp Hypertens.2...
BPV in Hypertension Management
 Reducing BPV has been recognized as a potential target for improved
management of hyperte...
CONFIDENTIAL & PROPRIETARY—INTERNAL USE ONLY.
STRATEGIES CONTAINED HEREIN ARE NOT NECESSARILY ENDORSED BY PFIZER SENIOR
MA...
Guidelines for Target Blood Pressure
29
 Eighth Joint National Committee (JNC8, 2014)1,3:
<60 years or diabetes/CKD and ...
ACCORD: No difference in CV Eventsa in Patients with diabetes with
BP <120 and <140 mmHg
Cushman WC et al. New Engl J Med ...
SPRINT: Study Design
31
Intensive treatment
Target SBP <120 mmHg
Standard treatment
Target SBP <140 mmHg
• Age ≥50 years
•...
SPRINT:
Enrolment and Follow-up
Ambrosius WT. Clin Trials. 2014;11:532–46
Wright JT et al. New Engl J Med 2015;373:2103-16...
SPRINT: Patient Population
Wright JT et al. New Engl J Med 2015;373:2103-16
*All included in analysis (ITT)
† Increased ca...
34
SPRINT: Primary Outcome
Years
Cumulativehazard
243/4678 = 5.2%
319/4683 = 6.8%
ARR 1.6%
NNT = 61
SPRINT was terminated ...
CONFIDENTIAL & PROPRIETARY—INTERNAL USE ONLY.
STRATEGIES CONTAINED HEREIN ARE NOT NECESSARILY ENDORSED BY PFIZER SENIOR
MA...
CONFIDENTIAL & PROPRIETARY—INTERNAL USE ONLY.
STRATEGIES CONTAINED HEREIN ARE NOT NECESSARILY ENDORSED BY PFIZER SENIOR
MA...
37
SPRINT: Summary
 Intensive treatment to SBP goal <120 mmHg, compared with a standard goal of <140
mmHg resulted in sig...
• Office BP and out-of-office BP (ambulatory/home BP) have
complementary roles in management of hypertension
• Reduce both...
Thank You
39
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Optimal Blood Pressure Management Implication of the SPRINT Trial & Blood Pressure Variability

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5 in 10 hypertensive patients are not optimally controlled in Singapore

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Optimal Blood Pressure Management Implication of the SPRINT Trial & Blood Pressure Variability

  1. 1. Scientific Session 1: Optimal Blood Pressure Management Implication of the SPRINT trial and BP Variability Consultant Cardiologist Asian Heart & Vascular Centre drgoh.pingping@asianheart.com.sg Jointly organized by Dr Goh Ping Ping• 5 in 10 hypertensive patients are not optimally controlled in Singapore.1,2 • The adverse cardiovascular consequences of hypertension may depend on increased BP variability (BPV).3 References: 1. Nieh CC, Ho LM, J Sule, et al. Cross-sectional Study of Hypertension in a Neighborhood in Singapore. Insights Blood Press 2015, 1:1. 2. 2. Seow LSE, Subramaniam M, Abdin E, Vaingankar JA and Chong SA. Hypertension and its associated risks among Singapore elderly residential population. Journal of Clinical Gerontology and Geriatrics 2015;6(4): 125-132 3. Parati G, Ochoa JE, Lombardi C, Bilo G. Assessment and management of blood-pressure variability. Nat Rev Cardiol. 2013;10:143-55.
  2. 2. Optimal Blood Pressure Management Implication of the SPRINT Trial & Blood Pressure Variability
  3. 3. Hypertension 3  Leading risk factor for death and disability-adjusted life-years lost1  Systolic hypertension is the commonest form of hypertension in individuals aged 50 years and older2  Systematic review and large meta-analyses of placebo-controlled randomized clinical trials have shown that treating hypertension reduces risk of: Stroke by 35 to 40% Myocardial infarction by 15 to 25% Heart failure (by up to 64%)35 1. Lim SS et al. Lancet 2012;380:2224-60; 2. Franklin SS et al. Hypertension 2001;37:869-4 3. Chobanian AV et al. JAMA 2003;289:2560-72; 4. Neal B et al. Lancet 2000;356:1955-64; 5. Psaty BM et al. JAMA 1997;277:739-45
  4. 4. CONFIDENTIAL & PROPRIETARY—INTERNAL USE ONLY. STRATEGIES CONTAINED HEREIN ARE NOT NECESSARILY ENDORSED BY PFIZER SENIOR MANAGEMENT AND ARE SUBJECT TO FURTHER REVIEW BEFORE IMPLEMENTATION. Framingham Study: 6-year incidence of CHD by SBP and TC levels Kannel WB et al. Ann Intern Med 1961;55:33-50 4
  5. 5.  Mdm Wong 52-year-old, executive  Mother has hypertension in old age  Trying to eat less fatty food  Walks 30-40 minutes daily  Comes to see you at the clinic for upper respiratory tract infection Clinic BP: 156/93, repeated Comorbidities  High normal lipids  Not on meds  Had high BP during pregnancy
  6. 6. 6 How to take a proper office BP (Canadian CHEP Guideline 2016) Automated office BP equal to or better than manual BP Upper arm cuff with appropriate bladder size Lower cuff edge 3 cm above elbow crease, bladder centred over brachial artery Arm supported at level of the heart Quiet room (no rest period specified) No talking, no crossing of legs Take readings at 1 min and 2 min intervals
  7. 7.  better reflects true BP condition than office BP by separating from medical environment  Use for risk stratification:  Patients with high office BP but normal out-of-office BP (white-coat hypertension) have lower CV risk than patients with sustained hypertension  Patients with normal office BP but elevated out-of-office BP (masked hypertension) is frequently associated with CV risk factors and has increased risk of CV events  Close association with hypertension induced organ damage, especially left ventricular hypertrophy  Better prediction of CV morbidity and mortality than office BP 2013 European hypertension guidelines: ESH/ESC emphasize out-of-office BP measurement Mancia et al. J Hypertens 2013;31:1281-1357 7
  8. 8. Mortality with isolated and/or combined elevated office, home, and ambulatory BP – PAMELA study Pressioni Arteriose Monitorate e Loro Associazioni (PAMELA) Mancia et al. Hypertension 2006;47:846-853 8  Analysis of office, home, and ambulatory blood pressure in a population from Monza, Italy (n=2051) with outcomes of CV and non-CV death  69 CV and 233 all-cause deaths over 148 months  Increased home and 24-h BP had a greater risk of CV and all-cause death than increased office BP Incidence of CV and all-cause death and elevated BP over an average follow-up of 148 months.
  9. 9. Definitions of hypertension by office and out-of-office blood pressure Category Systolic (mmHg) Diastolic (mmHg) Office BP ≥140 and/or ≥90 Ambulatory BP Daytime (or awake) ≥135 and/or ≥85 Nighttime (or asleep) ≥120 and/or ≥70 24-h ≥130 and/or ≥80 Home BP ≥135 and/or ≥85 9 Mancia et al. J Hypertension 2013;31:1281-1357
  10. 10. “white-coat” effect and masked hypertension National Institute for Health and Clinical Excellence (NICE). Hypertension Clinical Guideline 127: http://www.nice.org.uk/guidance/cg127  White-coat effect: A discrepancy of more than 20/10 mmHg between clinic and average daytime ambulatory BP monitoring (ABPM) or average home BP monitoring (HBPM)  Masked hypertension: The converse of white-coat hypertension. Normal BP measurements in the office or clinic but episodes of elevated BP outside of the medical environment  For people identified as having a ‘white-coat effect’ or ‘masked hypertension’ consider daytime ABPM or HBPM as an adjunct to clinic BP measurements to monitor response to treatment 10
  11. 11. 11 • Usual duration is 24 hours • Ensure at least two measurements per hour during the person’s usual waking hours (for example, between 08:00 and 22:00). • Use the average value of at least 14 measurements taken during the person’s usual waking hours to confirm a diagnosis of hypertension • Recording is satisfactory if 70% of values are available • Diary on events likely to influence BP How to Read a 24-hour Ambulatory BP Report
  12. 12. 12Confidential & Proprietary – For Internal Use Only – Do Not Disseminate Without Approval Reference Values for Dipper Status <= 0% Reverse Dipper 0 to 10% Non-Dipper 10 to 15% Normal Dipper > 15% Extreme Dipper Calculation %Dip = (Average day SBP – Average night SBP) x 100% Average Day SBP
  13. 13. Kaplan-Meier curves reporting the cumulative incidence of cardiovascular events in the 4 categories of dipping pattern. Adjusted risk of cardiovascular events was increased in reverse dippers (P=0.031) and non dippers (P=0.003) when compared with dippers, whereas extreme dippers did not differ from dippers (P=0.73). Total mortality did not differ significantly across the dipping categories. Verdecchia P et al. Hypertension. 2012;60:34-42 BP dipping status predicts cardiovascular events 13
  14. 14. How to Monitor Home Blood Pressure Mancia et al. Hypertension 2006;47:846-853 14 o Two consecutive blood pressure measurements o at least 1 minute apart o Patient seated, without crossing legs, quiet environment o Measure twice daily, ideally in the morning and evening o at least 4 days, ideally for 7 days o Discard the measurements taken on the first day and use the average value of all the remaining measurements o Store in log book or memory equipped device o Possible advantage of telemonitoring
  15. 15. Item Suggestions Description Morning measurement time • Sitting BP during 1 hour after awakening • After urination • Before breakfast • Before taking medicines • After 1‒2 minutes rest • Morning interval is defined as the period from awakening to around 10AM. Despite it is recommended to measure during 1 hour, the time is not required to be controlled strictly. Patient compliance is most important • Keep the consistency of BP measurement: BP increases before urination and decreases after urination • Patient compliance: It is easier to measure during 1‒2 minutes after rest rather than 5 minutes. It can improve the compliance of self-monitoring • Reduce the variability of BP measurement: Diet significantly affects BP which increases during eating and decreases after eating • BP measurement before taking medicines is helpful to assess the effect of ‘surge’ on BP. It is also allowed to measure in 5‒10 minutes after taking medicines Measurement frequency • Measure 1‒3 times every time • Weekly frequency - Stable period: At least 3 times per week - Drug adjustment period: Perform home BP monitoring at least 5 times per week • Keep self-monitoring of BP as long as possible • The suggestions derived from Ohasama study. If subtracting the results of first 3 days from 8-day single BP measurement at home, the mean results of last 5 days are highly reproducible • Mandatory diary can reduce the compliance 15 Hypertension Res 2003;26:771-782
  16. 16. Summary  Office BP is recommended for screening and diagnosis of hypertension  Diagnosis of hypertension should be based on at least two BP measurements per visit and on at least two visits to the office  Out-of-office BP should be considered to confirm the diagnosis of hypertension, identify the type of hypertension, detect hypertensive episodes, and maximize prediction of CV risk (e.g. BP variability)  For out-of-office BP measurements, ABPM, or HBPM may be considered depending on indication, availability, ease, cost of use and, if appropriate, patient preference 16
  17. 17. New evidence for controlling BPV as part of hypertension management Blood pressure variability (BPV) and its management
  18. 18. What is BPV?  Normal BP fluctuations occur in response to environmental challenges (eg, stress or activities)1  Blood pressure variability (BPV) can be observed: – Over a 24-hour period with ambulatory BP monitoring (ABPM) showing hour-to-hour variability – Between clinic visits (visit-to-visit variability) in short and long term  Reducing BP fluctuation in addition to mean BP has recently been recognized as a potential target for improved management of hypertension to prevent vascular outcomes, particularly stroke2,3 1. Schillaci et al. Hypertension 2011;58:133-135 2. Rothwell. Lancet 2010;375:938-948. 3. Muntner et al. Hypertension 2011;57:160-166 18
  19. 19. BPV differs in extent between individuals Rothwell PM. Lancet 2010;375:938-948 Patient 1 with lower BPV Patient 2 with higher BPV Weeks 40 60 80 100 120 140 160 180 200 220 Bloodpressure (mmHg) 1 2 3 SBP DBP 40 60 80 100 120 140 160 180 200 220 Bloodpressure (mmHg) 1 2 3 Weeks Higher mean BP overall 19
  20. 20. BPV : how to measure  ABPM can identify patients with morning surge and predicts CV events better than office BP levels1  HBPM is a good alternative to 24-hour ABPM and variability has been correlated with target organ damage, CV outcomes, and stroke mortality1,2  The standard deviation (SD) and coefficient of variation (CV) of BP measurements are commonly used parameters3  Variation independent of the mean (VIM) is a transformation of SD uncorrelated with mean BP (statistical tool)3 1. Grossman. Diabetes Care 2013;36 Suppl 2:S307-311 2. Parati et al. Blood Press 2013;22:345-354 3. Dolan and O'Brien. Hypertension 2010;56:179-181 BPV indices Formula/derivation SD SD = √[∑(individual readings – sample mean)2/n] CV CV = SD/mean VIM SD/meanx 20
  21. 21. MBP surge: what is significant?  MBP surge is defined as the morning BP (average of 2 hours after rising) minus the nighttime lowest BP (average of 3 BPs)  sleep-trough surge of >55 mmHg is significant Kario et al. J Cardiovasc Pharmacol 2003;42:S87-S91 *P=0.001 21
  22. 22. The rapid rise of BP in the morning is one of the critical risk variables for CV events BP profile of untreated hypertension patients Mead et al. Br J Cardiol 2008;15:31-34 Incidences of MI and stroke at different time intervals 22 Numberofpatientswithevents(MI)n=339
  23. 23. Stroke risk and BPV are lower in patients treated with CCBs vs other antihypertensives despite similar mean BP Rothwell. Lancet 2010;375:938-948 Randomized trials with CCBs vs BBs, ACEIs, or ARBs comparing stroke risk and systolic BPV (SD) Mean SBP difference (95% CI) A Stroke risk Events/patients CCB Drug B NORDIL (vs BB/D) 159/5410 196/5471 ASCOT (vs BB) 327/9639 422/9618 ALLHAT (vs ACE) 377/9048 457/9054 Total 1326/43,623 1606/43,774 VALUE (vs ARB) 281/7596 322/7649 INVEST (vs BB) 176/11,267 201/11,309 CAMELOT (vs ACE) 6/663 8/673 0.5 1.5 0.81 (0.66 to 0.01) 0.77 (0.66 to 0.89) 0.82 (0.71 to 0.94) 0.87 (0.74 to 1.03) 0.88 (0.72 to 1.08) 0.76 (0.26 to 2.20) 0.82 (0.76 to 0.88) Odds ratio (95% CI) 0.5 1.5 B SBP at follow-up Mean (SD) Variance ratio (95% CI) CCB Drug B NORDIL (vs BB/D) 155.2 (16.3) 151.5 (17.4) 3.70 (3.07 to 4.33) ASCOT (vs BB) 138.4 (14.8) 140.3 (17.8) -1.90 (-2.36 to -1.44) Total -0.21 (-0.41 to -0.01) VALUE (vs ARB) 138.2 (13.8) 140.0 (16.2) -1.80 (-4.92 to 1.32) INVEST (vs BB) 131.0 (11.0) 131.0 (10.0) 0.00 (-0.27 to 0.27) CAMELOT (vs ACE) 124.5 (15.5) 123.6 (18.0) 0.60 (–1.20 to 2.40) ALLHAT (vs ACE) 137.1 (15.0) 138.4 (17.9) -1.30 (-1.78 to -0.82) 0.88 (0.83 to 0.93) 0.69 (0.67 to 0.72) 0.70 (0.67 to 0.73) 0.73 (0.68 to 0.77) 0.83 (0.80 to 0.86) 0.74 (0.64 to 0.86) 0.76 (0.74 to 0.77) 23
  24. 24. NICE 2011 guidelines on the management of BPV National Institute for Health and Clinical Excellence (NICE). Hypertension Clinical Guideline 127: http://www.nice.org.uk/guidance/cg127 BPV was most effectively reduced by CCB, closely followed by thiazide-type diuretics Those most at risk of increased SBP SD, ie, older hypertensive people, will already be treated with the most effective drug classes to suppress SBP SD, ie, a CCB (or a thiazide-like diuretic if a CCB is not indicated or tolerated) as Step 1 therapy CCBs are one of the antihypertensive classes of choice for BPV control 24
  25. 25. Amlodipine has long half-life for the control of BPV 1. Kes et al. Curr Med Res Opin 2003;19:226-237 2. Flack et al. Eur Heart J 1996;17(Suppl. A):16-20  Amlodipine is a long-acting CCB that blocks the calcium L-type channel1 o Slow association and dissociation ensure gradual onset and extended duration of pharmacodynamic activity o Long half-life (35‒50 hours), high oral bioavailability, and low renal clearance (7 mL/min/mg)  It maintains a smooth and sustained dilatation of the systemic arteriolar resistance vessels1  Amlodipine is a forgiving agent and maintains antihypertensive effectiveness following missed doses2 25
  26. 26. Bedtime administration of amlodipine + olmesartan improves BPV and morning BP surge Hoshino A, et al. Clin Exp Hypertens.2010;32:416-422. MBP surge24-hour SBP and DBP Hoshino et al. Clin Exp Hypertens 2010;32:416-22. 26
  27. 27. BPV in Hypertension Management  Reducing BPV has been recognized as a potential target for improved management of hypertension to prevent vascular outcomes, particularly stroke  The differential effects of CCBs compared with other agents like ACEI and BBs on BPV may account for the disparity in observed efficacy in reducing the risk of stroke  The most effective approach to preventing cardiovascular event is to use BP-lowering drugs that reduce both BPV and MBP in addition to mean BP, and to avoid situations that increase BPV 27
  28. 28. CONFIDENTIAL & PROPRIETARY—INTERNAL USE ONLY. STRATEGIES CONTAINED HEREIN ARE NOT NECESSARILY ENDORSED BY PFIZER SENIOR MANAGEMENT AND ARE SUBJECT TO FURTHER REVIEW BEFORE IMPLEMENTATION. SPRINT (Systolic Blood Pressure Intervention Trial)  Aim: To assess the most appropriate systolic blood pressure targets to reduce morbidity and mortality by comparing the benefit of treatment of SBP to a target of <120 mmHg versus a target of <140 mmHg  Primary hypothesis: The CVD composite event rate would be lower in the intensive therapy group compared with the standard therapy group
  29. 29. Guidelines for Target Blood Pressure 29  Eighth Joint National Committee (JNC8, 2014)1,3: <60 years or diabetes/CKD and ≥60 years: 140/90 mmHg  Patients ≥60 years: 150/90 mmHg  American Society of Hypertension/International Society of Hypertension (2014)2,3: <80 years: 140/90 mmHg ≥80 years: 150/90 mmHg 1. James PA et al. JAMA. 2014;311:507-20 2. Weber MA et al. J Hypertension. 2014;32:3-15
  30. 30. ACCORD: No difference in CV Eventsa in Patients with diabetes with BP <120 and <140 mmHg Cushman WC et al. New Engl J Med 2010;362:1575-85 30 n = 4733, type II DM Intensive arm – target SBP < 120 Standard arm – target SBP < 140 Follow-up = 4.7 years End-point: fatal MI, non-fatal stroke or CVD Mean baseline SBP (all participants) =139.2±15.8 mmHg
  31. 31. SPRINT: Study Design 31 Intensive treatment Target SBP <120 mmHg Standard treatment Target SBP <140 mmHg • Age ≥50 years • SBP 130180 mmHg (treated or untreated) • Additional CV risk (≥1)  Clinical or subclinical CVD (excluding stroke)  CKD (eGFR 20<60 ml/min/1.73 m2)  Framingham Risk Score for 10-year risk ≥15  Age ≥75 years Wright JT et al. New Engl J Med 2015;373:2103-16 All major antihypertensive classes can be used Chlorthalidone encouraged as primary thiazide Amlodipine encouraged as preferred CCB
  32. 32. SPRINT: Enrolment and Follow-up Ambrosius WT. Clin Trials. 2014;11:532–46 Wright JT et al. New Engl J Med 2015;373:2103-16 32 Intensive treatment N=4,678 Standard treatment N=4,683 Screened N=14,692 Randomized N=9,361 224 111 154 242 134 121 Consent withdrawn Discontinued intervention Lost to follow-up Analyzed (ITT) 4,678 4,683
  33. 33. SPRINT: Patient Population Wright JT et al. New Engl J Med 2015;373:2103-16 *All included in analysis (ITT) † Increased cardiovascular risk was one of the inclusion criteria ‡ Chronic kidney disease was defined as an estimated glomerular filtration rate of less than 60 ml per minute per 1.73 m2 of body-surface area. 33 Intensive Treatment (N = 4678)* Standard Treatment (N = 4683)* Criterion for increased cardiovascular risk — no. (%)† Age ≥75 yr Chronic kidney disease‡ Cardiovascular disease Clinical Subclinical Framingham 10-yr cardiovascular disease risk score ≥15% 1317 (28.2) 1330 (28.4) 940 (20.1) 779 (16.7) 247 (5.3) 2870 (61.4) 1319 (28.2) 1316 (28.1) 937 (20.0) 783 (16.7) 246 (5.3) 2867 (61.2) Female sex — no. (%) 1684 (36.0) 1648 (35.2) Age — yr Overall ≥75 yr 67.9 ± 9.4 79.8 ± 3.9 67.9 ± 9.5 79.9 ± 4.1
  34. 34. 34 SPRINT: Primary Outcome Years Cumulativehazard 243/4678 = 5.2% 319/4683 = 6.8% ARR 1.6% NNT = 61 SPRINT was terminated early (after mean follow-up of 3.26 years) on the recommendation of the DSMB because of a clear benefit of intensive therapy Wright JT et al. New Engl J Med 2015;373:2103-16
  35. 35. CONFIDENTIAL & PROPRIETARY—INTERNAL USE ONLY. STRATEGIES CONTAINED HEREIN ARE NOT NECESSARILY ENDORSED BY PFIZER SENIOR MANAGEMENT AND ARE SUBJECT TO FURTHER REVIEW BEFORE IMPLEMENTATION.35 SPRINT: All-cause Mortality Years Cumulativehazard 155/4678 = 3.3% 210/4683 = 4.5% ARR 1.2% NNT = 90 Wright JT et al. New Engl J Med 2015;373:2103-16
  36. 36. CONFIDENTIAL & PROPRIETARY—INTERNAL USE ONLY. STRATEGIES CONTAINED HEREIN ARE NOT NECESSARILY ENDORSED BY PFIZER SENIOR MANAGEMENT AND ARE SUBJECT TO FURTHER REVIEW BEFORE IMPLEMENTATION. Secondary outcomes  Significant reductions with intensive versus standard regimen in: – Heart failure (HR [95% CI] 0.62 [0.45-0.84], p=0.002) – Death from CV causes (HR [95% CI] 0.57 [0.38-0.85], p=0.005) – Primary outcome or death (HR [95% CI] 0.78 [0.67-0.90], p<0.001) Primary outcome in subgroups of interest  The benefit of intensive therapy was consistent across pre-specified subgroups: – Age (<75 vs. ≥75 y) – Previous CVD (yes vs. no) – SBP (≤132 mmHg vs. >132 but <145 mmHg vs. >145 mmHg) – Previous CKD (yes vs. no) Wright JT et al. New Engl J Med 2015;373:2103-16 36 SPRINT: Secondary Outcomes and Subgroups of Interest
  37. 37. 37 SPRINT: Summary  Intensive treatment to SBP goal <120 mmHg, compared with a standard goal of <140 mmHg resulted in significantly lower rates of fatal and nonfatal CV events and all cause mortality (trial prematurely stopped at 3.26 yrs)  30% reduction of composite endpoint including CV death, 25% reduction in mortality  Effect of intensive treatment was consistent across all pre-specified subgroups (age, gender, race, presence of CVD, SBP tertiles and renal function). One-third of patients are > 75 years old • SAEs (hypotension, syncope, electrolyte abnormalities and acute kidney injury/renal failure) were higher in intensive arm (38.3%) vs standard arm (31.2%); (p=0.14). Notably, there were no between-group differences in injurious falls or bradycardia  Overall, the authors concluded that the benefit of intensive BP lowering exceeded potential harm
  38. 38. • Office BP and out-of-office BP (ambulatory/home BP) have complementary roles in management of hypertension • Reduce both mean BP and BP variability to improve cardiovascular outcome • New data suggest that intensive BP lowering is beneficial 38 Summary
  39. 39. Thank You 39

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