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Burden of Proof
Proof of Principle
Quantification, Replication and Validation…
Standards of Evidence in Outcomes Research
...
2
Quantification, Replication and Validation…
Standards of Evidence in Outcomes Research
Outcomes research consists of an ...
3
Overview
Quantification, Replication, Validation by Example
 Prevalence, direct medical expenditures and indirect
produ...
The Economic Consequences of Rheumatoid Arthritis:
Analysis of Medical Expenditure Panel Survey (MEPS)
2004, 2005 and 2006...
Study Results: Prevalence
MEPS correctly reproduced 2004-2006
US census records for the US
population, validating the weig...
Direct Economic Cost: Incremental
Health Expenditures
6
2004 2005 2006
RA Healthcare Expenditures (per person) $4422.25 $2...
Productivity Loss: Workforce Production,
Absenteeism and Income Loss
7
WORKFORCE PARTICIPATION BY RA STATUS
NUMBER (%) OF
...
Heart Rate and
All-cause Mortality
9
Heart Rate: Background
Biology
 Semi-logarithmic relationship between heart
rate and life expectancy among mammals
 Ma...
10
Background
Epidemiology
 Singh (2001)
 Systematic review of thirteen large epidemiological studies
 Increasing risk ...
11
Cucharet
(multination
al)
GPRN
(Australia
) 300 GPs
(2% sample)
CCHS
(Denmark)
CASS
(Canad
a)
Singh
(multination
al)
Nu...
12
Methods
Compare apples to apples
 Singh – results converted to odds-ratios (ORs) and meta-
analysed
 Cucherat uses a ...
13
Methods
Table 1 of the Cucherat 2007 Publication
 Plug the initial heart rate reported at baseline and the
absolute ch...
14
Meta-analysis of Singh's Study
Study Name Statistics for Each
Study
Events / Total
Odds Ratio P-Value HR < 75 BPM HR >=...
15
Meta-Analysis of Cucherat’s Study
Groups by HR
Reduction
Levels
Study Name
Statistics for
Each Study
Events/Total
Odds ...
16
Comparative Weibull Regressions with Heart Rate at Baseline as a
Covariate
Results
CASS CCHS
1981-83
CCHS
1991-93
VARIA...
17
Comparative Weibull Regressions (Continued)
Results
CASS CCHS
1981-83
CCHS
1991-93
VARIABLES DEATH DEATH DEATH
EJECTION...
18
Results of GEE Analysis for All-Cause Mortality and Heart Rate
Results
Systolic Blood Pressure Diastolic Blood Pressure...
19
Precision and Comparability of Coefficient Estimates
Regression
Coefficients
(GEE/Meta regression)
Weibull
Survival Ana...
20
Validating ORs from Cucherat with Three Epidemiological Studies
Risk
Levels
Number of
Trials
Ave. Base
Reduction*
Cuche...
21
Recap
Cucharet 16 intervention studies
 Quantifies relationship
 Unable to control for BP
 Establishes correlation
C...
22
Accidental?
…..Dumb Luck?
23
Validated Diabetic-Risk Equations
Replication in Quantification
UK1 GERMANY2 USA3
Patient Population Size 2,137 3,190 4...
24
Comparative Odd-Ratio Plot for Adverse Events Associated with Opioid Use in
Post- Surgical Patients
HCUP (2005) and Pre...
25
Selected
Variables
Estimates Confidence Intervals P-Value
Intercept -45.08 -62.76 -27.40 <0.01
HDL-C -1.60 -3.14 -0.05 ...
26
Validation of Epidemiological Studies (PTC) and
GPRN HDL-C Mortality Equations
PTC reports that a 0.33 mmol/L increase ...
27
Replication of quantification
Validation
Reconciliation
……Standard of Evidence
28
MET THE BURDEN
PROVED THE PRINCIPLE
New Longitudinal
Outcomes Research
Analytical Technique
Redefining Outcomes Research
Key analytical change
 Annihilation of stagnant study cohorts
 Blood pressure readings are ...
Results: Changes in Systolic and Diastolic
Blood Pressure and Goal Attainment
31
Systolic Blood Pressure Diastolic Blood P...
Results: Special Patient Populations
3
2
African American Diabetic Obese Overweight
SBP
Parameter
Estimates
(95% CI)
DBP
P...
Global Health Economics
& Outcomes Research
Raising the Bar in Outcomes Research to Obtain Market
Access, Favorable Pricin...
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Health Economics and Outcomes Research: Minimizing Uncertainty

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Presentation demonstrating that replicating outcomes research minimizes uncertainty and elevates outcome measurement closer to casual inferences

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Health Economics and Outcomes Research: Minimizing Uncertainty

  1. 1. Burden of Proof Proof of Principle Quantification, Replication and Validation… Standards of Evidence in Outcomes Research W. Robert Simons
  2. 2. 2 Quantification, Replication and Validation… Standards of Evidence in Outcomes Research Outcomes research consists of an abundance of studies in a single data source Despite the rigour of methodologies as well as the source of publication, they remain a single study The guidelines such as NICE, PBAC, SMC, AMCP, etc. have gradients for the level of clinical evidence (e.g., multiple head-to-head RCTs, placebo controlled, non- randomised or indirect comparisons) Outcomes research with less rigourous standards imparts uncertainty
  3. 3. 3 Overview Quantification, Replication, Validation by Example  Prevalence, direct medical expenditures and indirect productivity losses as measured by work force participation, absenteeism and income loss in Rheumatoid Arthritis patients: 2004, 2005 and 2006  Heart rate and all-cause death  HbA1c, Treatment and Risk of Diabetic-related Complications  Pain Management and Adverse Events  HDL-C and mortality New Longitudinal Outcomes Research Analytical Technique  Annihilation of stagnant study cohorts
  4. 4. The Economic Consequences of Rheumatoid Arthritis: Analysis of Medical Expenditure Panel Survey (MEPS) 2004, 2005 and 2006 Data Methods  Medical expenditure panel survey 2004-2006  Multiple linear and semi-log regressions were applied to estimate total and annual medical expenditures and income loss associated with RA Outcomes  Prevalence  Direct medical expenditures  Indirect productivity losses  Work force participation  Absenteeism  Income loss 4
  5. 5. Study Results: Prevalence MEPS correctly reproduced 2004-2006 US census records for the US population, validating the weights RA prevalence in the US was 0.40% in 2004, 0.44% in 2005 and 0.43% in 2006 5
  6. 6. Direct Economic Cost: Incremental Health Expenditures 6 2004 2005 2006 RA Healthcare Expenditures (per person) $4422.25 $2901.59 $1882.42 Healthcare Expenditures: Overall Health vs Excellent Health Poor Health $9752.26 $8802.82 $7824.23 Fair Health $3731.77 $4305.90 $3354.11 Good Health $570.81 $967.45 $640.20 Very Good Health -$181.17 $147.68 $120.11
  7. 7. Productivity Loss: Workforce Production, Absenteeism and Income Loss 7 WORKFORCE PARTICIPATION BY RA STATUS NUMBER (%) OF EMPLOYED NON-RA PATIENTS NUMBER (%) OF EMPLOYED RA PATIENTS NUMBER (%) OF EMPLOYED NON-RA PATIENTS NUMBER (%) OF EMPLOYED RA PATIENTS NUMBER (%) OF EMPLOYED NON-RA PATIENTS NUMBER (%) OF EMPLOYED RA PATIENTS YEAR 2004 N= 34,403 YEAR 2005 N= 33,645 YEAR 2006 N= 34,145 <20 504(4.3) 1(100%) 433(3.9) 1(25) 502(4.4) 0(0) 20-39 6422(69.2) 6(35.3) 6141(68.6) 8(72.7) 5970(69.2) 6(54.5) 40-64 6709(70.5) 28(36.8) 6841(69.8) 34(39.5) 7018(71) 33(44) 65-79 597(20.2) 2(6.5) 496(18.7) 2(5.5) 680(22.1) 2(4.8) 80+ 34(3.8) 0(0) 35(3.8) 0(0) 38(3.7) 1(7.8) DAYS ABSENT FROM WORK BY RA STATUS NON-RA PATIENTS RA PATIENTS NON-RA PATIENTS RA PATIENTS NON-RA PATIENTS RA PATIENTS YEAR 2004 (p = 0.0021) YEAR 2005 (p = 0.0004) YEAR 2006 (p = 0.0006) MEAN STD STD ERROR MEAN STD STD ERROR MEAN STD STD ERROR MEAN STD STD ERROR MEAN STD STD ERROR MEAN STD STD ERROR 4.06 13.81 0.126 12.17 30.75 5.61 3.77 12.85 0.118 10.71 23.91 3.88 3.84 14.24 0.130 9.14 18.74 3.08 INCOME LOSS 2004 2005 2006 Income Loss Due to RA -$3,525.50* -$2,206.96* -$1,211.97* RA = Rheumatoid Arthritis * Statistically significant at 1%
  8. 8. Heart Rate and All-cause Mortality
  9. 9. 9 Heart Rate: Background Biology  Semi-logarithmic relationship between heart rate and life expectancy among mammals  Man is the exception *Source: Levine (1997) Heart Rate vs. Life Expectancy
  10. 10. 10 Background Epidemiology  Singh (2001)  Systematic review of thirteen large epidemiological studies  Increasing risk of all-cause death with increases in RHR irrespective of age, sex, and ethnic origin  Cucherat (2007)  Meta-analysis and meta-regression of sixteen placebo- controlled randomised clinical trials  (coefficient = 0.0249)  Intervention affecting heart rate significantly changes all- cause mortality Validating results from Cucharet  Coronary Artery Surgery Study (CASS)  The Copenhagen City Heart Study (CCHS)  General Practice Research Network (GPRN).
  11. 11. 11 Cucharet (multination al) GPRN (Australia ) 300 GPs (2% sample) CCHS (Denmark) CASS (Canad a) Singh (multination al) Number of studies or patients 16 intervention studies in post-MI patients 11,000 CAD patients Longitudinal GP visits, 19,698 Random population sample Panel survey: 1976-78, 81-83, 91-94, 2001-03. 24,913 Post cardiac surgery 13 epidemiological studies across multiple countries in healthy people 116,539 Follow-up mean 1.37 years 2.2 years 12 years 14.7 years 5 to 36 years Quality of evidence Highest Validates Cucharet with Australian data Validates GPRN Replicates CASS Reproduces Cucharet Reproduc es Cucharet Strongest Results consistent with Cucharet A Comparison of the Literature Background
  12. 12. 12 Methods Compare apples to apples  Singh – results converted to odds-ratios (ORs) and meta- analysed  Cucherat uses a regression (coefficient relating incremental changes in heart rate to the probability of death) as well as meta-analyses (odds-ratio)  CASS— Weibull survival regression with heart rate as a predictor  CCHS— Weibull as well as GEE (coefficient analogous to Cucherat’s regression coefficient  GPRN— GEE (coefficient analogous to Cucherat’s coefficient)  Odds ratios (ORs) produced from all sources of evidence
  13. 13. 13 Methods Table 1 of the Cucherat 2007 Publication  Plug the initial heart rate reported at baseline and the absolute change in heart rate from baseline for each of the 16 clinical trials into the CASS, CCHS and GPRN equations for all cause mortality HEART RATES FROM CUCHERAT CARDIOVASCULAR RISK EQUATIONS CASS CCHS GPRN RIP ODDS RATIOS REPORTED IN CUCHERAT Odds Ratios
  14. 14. 14 Meta-analysis of Singh's Study Study Name Statistics for Each Study Events / Total Odds Ratio P-Value HR < 75 BPM HR >= 75 BPM Chicago Western Electric 0.601 0.000 97/756 225/1143 Chicago Peoples Gas 0.587 0.000 124/700 143/533 Chicago HA Detection Project in Industry 0.749 0.014 167/3532 140/2252 Framingham Heart Study 0.667 0.000 149/8000 332/12000 Robert Koch Institute 0.978 0.001 296/3640 120/1039 Israeli Male Industrial 0.507 0.001 38/1349 74/1368 Overall Results 0.650 0.000 Results
  15. 15. 15 Meta-Analysis of Cucherat’s Study Groups by HR Reduction Levels Study Name Statistics for Each Study Events/Total Odds ratio Active Control Low CRIS 1.059 30/531 29/542 MDPIT 0.995 166/1232 167/1234 Australian / Swedish 0.962 45/263 47/266 Taylor 0.924 60/632 48/471 Wilhelmsson 0.477 7/114 14/116 DAVIT 0.793 95/878 119/897 Tretile Overall 0.914 Medium BHAT 0.715 138/1916 188/1921 EIS 1.325 57/858 45/883 APSI 0.489 17/298 34/309 Multicenter Int’l 0.782 102/1533 127/1520 Baber 1.072 28/355 27/365 Hjalmarson 0.623 40/698 62/697 Tretile Overall 0.782 High Hansteen 0.654 25/278 37/282 Julian 0.808 64/873 52/583 Wilcox 0.935 36/259 19/129 Norweigian 0.599 98/945 152/939 Tretile Overall 0.685 Complete Overall 0.806
  16. 16. 16 Comparative Weibull Regressions with Heart Rate at Baseline as a Covariate Results CASS CCHS 1981-83 CCHS 1991-93 VARIABLES DEATH DEATH DEATH INTERCEPT 4.25157 4.95531 5.84813 HEART RATE -0.00694 -0.00683 -0.00717 AGE CATEGORY (50-59 YEARS) -0.34182 -0.61060 -0.95736 AGE (60-69 YEARS) -0.76160 -0.98391 -1.58453 AGE (70-79 YEARS) -1.31332 -1.38566 -2.00030 MALE -0.13709 -1.81236 -2.52007 HYPERTENSION -0.10415 -0.25346 -0.35017 DIABETES -0.42727 -0.11786 -0.06230 FORMER SMOKER -0.11330 -0.30669 -0.20382 PRESENT SMOKER -0.40022 -0.08434 -0.12511 1 DISEASED VESSEL -0.47763 2 DISEASED VESSELS -0.73045 3 DISEASED VESSELS -0.98794
  17. 17. 17 Comparative Weibull Regressions (Continued) Results CASS CCHS 1981-83 CCHS 1991-93 VARIABLES DEATH DEATH DEATH EJECTION FRACTION 0.02202 BETA-BLOCKER USE 0.01453 MODERATE ACTIVITY -0.03356 -0.00608 -0.11371 MILD ACTIVITY -0.10955 SEDENTARY -0.20079 -0.16128 -0.31471 ANTIPLATELET USE -0.01053 DIURETIC USE -0.32735 -0.17573 -0.22675 LIPID LOWERING DRUGS -0.00184 ANTIHYPERTENSIVE MEDICATION -0.14423 -0.13021 CARDIAC MEDICATION -0.28235 -0.26095 TRANQUILIZERS -0.07124 -0.9259 LOG (SCALE) -0.09403 -0.58841 -0.42485
  18. 18. 18 Results of GEE Analysis for All-Cause Mortality and Heart Rate Results Systolic Blood Pressure Diastolic Blood Pressure VARIABLES ESTIMATE PROB > | Z | ESTIMATE PROB > | Z | (Intercept) -4.2618 <.0001 -4.6057 <.0001 Heart Rate 0.0268 0.0006 0.0400 <.0001 Age, 50 -2.7663 0.0005 -2.6555 0.0011 Age, 60 -1.2923 0.0002 -1.2836 0.0003 Age, 70 -0.7384 0.0004 -0.7677 0.0007 Male 0.3751 0.0142 0.4305 0.0044 Smoking, Present smoker 0.1921 0.4922 0.2238 0.4384 Smoking, Former smoker 0.0687 0.7335 0.0805 0.7039 Rate Product Pressure -0.0001 0.2379 -0.0003 0.0027 Systolic Blood Pressure> 150 mmHg 0.2370 0.0421 **** ***** Diastolic Blood Pressure > 100 mmHg ***** ***** 0.2278 0.2994 Angina -0.0051 0.9831 -0.0034 0.9890 Hypertension -0.5227 0.0098 ***** ***** Diabetes 0.1094 0.6602 0.0480 0.8537 Coronary Artery Disease -0.8599 0.1606 -0.8459 0.1601 Use of Beta Blockers 0.0489 0.8383 0.0870 0.7141 Use of Diuretics 0.2585 0.4413 0.2848 0.3928 Use of Lipid Low Agents -0.6587 0.0449 -0.6899 0.0449
  19. 19. 19 Precision and Comparability of Coefficient Estimates Regression Coefficients (GEE/Meta regression) Weibull Survival Analyses Cucherat 0.0249 (P=0.008) longitudinal HR GPRN 0.0268 (P=0.0006) longitudinal HR CASS -0.00694 (P<0.001) baseline HR CCHS 0.0159 (P<0.001) longitudinal HR -0.00683 (P<0.001) baseline HR Results
  20. 20. 20 Validating ORs from Cucherat with Three Epidemiological Studies Risk Levels Number of Trials Ave. Base Reduction* Cucherat (P=0.017) CASS CCHS GPRN Low 6 4.7 0.91 0.88 0.91 0.90 Medium 6 10.0 0.78 0.78 0.78 0.80 High 4 16.2 0.69 0.69 0.69 0.71 * Ave. Base Reduction: Absolute HR reduction (mean, bpm) Results
  21. 21. 21 Recap Cucharet 16 intervention studies  Quantifies relationship  Unable to control for BP  Establishes correlation CCHS & CASS & GPRN  Replicate odds ratios from Cucharet  All 3 control for BP and other co-variates Singh  13 studies closely replicate Odds Ratio from Cucharet MET THE BURDEN PROVED THE PRINCIPLE
  22. 22. 22 Accidental? …..Dumb Luck?
  23. 23. 23 Validated Diabetic-Risk Equations Replication in Quantification UK1 GERMANY2 USA3 Patient Population Size 2,137 3,190 497,716 Effect of Rx on Glycemic Control -0.99% -0.92% -0.89% Effect of Glycemic Control on Risk of Complication -0.388% -0.414% -0.436% 1. Simons WR, Kemo R and Bolinder B. A five year longitudinal analysis of the health benefits of transitioning toward insulin sooner in newly diagnosed type 2 diabetics. Value Health 3 2000. [no.5]DB3. 2. Simons WR, Vinod HD, Gerber RA and Bolinder B. Does rapid transition to insulin therapy in subjects with newly diagnosed type 2 diabetes mellitus benefit glyceamic control and diabetic related complications? A Germany population-based study. Exp Clin Endocrinol Diabetes 2006; 114:520-526. 3. Simons WR. The quantification of the relationship between t pharmacological intervention, HbA1c and diabetic related complications: A USA validation study. ISPOR 2009 Diabetes
  24. 24. 24 Comparative Odd-Ratio Plot for Adverse Events Associated with Opioid Use in Post- Surgical Patients HCUP (2005) and Premier (2005) H P H P H P H P H P H P H P H P H P H P H P H P 0 5 10 15 20 25 30 Dehydration Dehydration GastricPain FecalImpaction Post-OperativeIleus Post-OperativeIleus OtherBowlObstruction Constipation Constipation VomitPost-GISurgery NauseawithVomiting NauseawithVomiting NauseaOnly VomitingOnly VomitingOnly AbdominalPain Poisoning-Opiates Poisoning-Opiates Pruritus Nauseaand/orVomiting Nauseaand/orVomiting Pain Management in Post Surgical Patients
  25. 25. 25 Selected Variables Estimates Confidence Intervals P-Value Intercept -45.08 -62.76 -27.40 <0.01 HDL-C -1.60 -3.14 -0.05 0.04 LDL-C 0.30 <0.01 0.60 <0.05 Log Age 9.54 5.59 13.49 <0.01 Angina 0.87 -0.01 1.76 0.05 Diabetes 1.16 0.09 2.23 0.03 GEE Analysis Death in Patients With HDL-C Less Than 1.0 mmol/L Despite Taking a Statin With IHD
  26. 26. 26 Validation of Epidemiological Studies (PTC) and GPRN HDL-C Mortality Equations PTC reports that a 0.33 mmol/L increase in HDL-C is associated with about a third (33%) lower IHD mortality. That increase in HDL-C used in the HDL-C Mortality Equations from GPRN with bootstrapping reduces the hazard ratios by 29% [95% CI: -0.34 – -0.23], 30% [95% CI: -0.35 - -0.24] and 32% [95% CI: -0.38 - -0.26] for baseline HDL-C levels of 0.992 mmol/L, 0.9 mmol/L and 0.8 mmol/L, respectively. GPRN HDL-C Mortality Equation replicates 22 epidemiological studies with HDL-C and mortality. PTC = Prospective Trialists’ Collaborative
  27. 27. 27 Replication of quantification Validation Reconciliation ……Standard of Evidence
  28. 28. 28 MET THE BURDEN PROVED THE PRINCIPLE
  29. 29. New Longitudinal Outcomes Research Analytical Technique
  30. 30. Redefining Outcomes Research Key analytical change  Annihilation of stagnant study cohorts  Blood pressure readings are linked to the time of actual drug usage  Patients are allowed to transition or titrate  Patients are not confined to a single study cohort  All data are used in the analyses Objectives  Quantify and compare the effectiveness of various ARBs in achieving treatment goal, as well as reduction in systolic and diastolic blood pressure  Differentiate effectiveness in a number of special patient populations (e.g. African American, diabetic, obese, overweight patients) 30
  31. 31. Results: Changes in Systolic and Diastolic Blood Pressure and Goal Attainment 31 Systolic Blood Pressure Diastolic Blood Pressure Goal Attainment Parameter Estimate 95% Confidence Limits Estimate 95% Confidence Limits Marginal Effect 95% Confidence Limits Intercept 83.6875 83.0091 84.3660 46.8458 46.3319 47.3598 0.8424 0.8206 0.8642 Olmesartan 20mg -8.1876 -8.5582 -7.8170 -4.5671 -4.7823 -4.3519 0.2110 0.2012 0.2208 Losartan 50mg -5.4167 -5.7248 -5.1086 -3.2733 -3.4447 -3.1019 0.1393 0.1313 0.1474 Valsartan 80mg -6.4975 -6.8079 -6.1871 -3.6587 -3.8313 -3.4862 0.1687 0.1604 0.1769 Valsartan 160mg -5.9001 -6.6767 -5.1235 -3.5958 -3.9918 -3.1999 0.1348 0.1155 0.1542 Irbesartan 150mg -6.5180 -6.9856 -6.0504 -3.7411 -4.0010 -3.4811 0.1683 0.1559 0.1808 Olmesartan 20mg/HCTZ -10.1896 -10.7997 -9.5796 -5.6991 -6.0601 -5.3380 0.2404 0.2239 0.2568 Losartan 50mg/HCTZ -7.4682 -8.0013 -6.9351 -4.1043 -4.3960 -3.8125 0.1653 0.1516 0.1790 Valsartan 80mg/HCTZ -8.9511 -9.4101 -8.4920 -4.8933 -5.1580 -4.6287 0.2094 0.1972 0.2215 Valsartan 160mg/HCTZ -7.3538 -7.6920 -7.0156 -4.2095 -4.4036 -4.0154 0.1733 0.1645 0.1821 Irbesartan 150mg/HCTZ -8.4265 -9.1942 -7.6588 -4.8096 -5.2699 -4.3492 0.2080 0.1876 0.2285 Olmesartan 40mg -7.2622 -7.9972 -6.5273 -4.2729 -4.6471 -3.8987 0.1672 0.1492 0.1851 Losartan 100mg -5.8477 -6.4724 -5.2229 -3.4239 -3.7699 -3.0780 0.1473 0.1319 0.1627 Valsartan 320mg -5.5594 -6.6048 -4.5140 -3.4439 -4.0317 -2.8561 0.1280 0.1034 0.1525 Irbesartan 300mg -6.5013 -7.3308 -5.6718 -3.6268 -4.0703 -3.1832 0.1602 0.1393 0.1812 Olmesartan 40mg/HCTZ -9.7413 -10.4462 -9.0364 -5.6391 -6.0794 -5.1988 0.2116 0.1937 0.2295 Losartan 100mg/HCTZ -7.1166 -7.8399 -6.3932 -4.1585 -4.5702 -3.7467 0.1515 0.1340 0.1690 Valsartan 320mg/HCTZ -6.7834 -8.1713 -5.3955 -3.8899 -4.7517 -3.0282 0.1608 0.1237 0.1979 Irbesartan 300mg/HCTZ -7.4217 -8.3696 -6.4738 -3.9916 -4.5360 -3.4471 0.1738 0.1490 0.1986
  32. 32. Results: Special Patient Populations 3 2 African American Diabetic Obese Overweight SBP Parameter Estimates (95% CI) DBP Parameter Estimates (95% CI) Goal Attainment Marginal Effects (95% CI) SBP Parameter Estimates (95% CI) DBP Parameter Estimates (95% CI) Goal Attainment Marginal Effects (95% CI) SBP Parameter Estimates (95% CI) DBP Parameter Estimates (95% CI) Goal Attainment Marginal Effects (95% CI) SBP Parameter Estimates (95% CI) DBP Parameter Estimates (95% CI) Goal Attainment Marginal Effects (95% CI) Olmesartan -7.37 (-8.84,-5.91) -3.95 (-4.77, -3.13) 0.190 (0.153,0.227) -8.00 (-8.37,-7.64) -4.47 (-4.68,-4.26) 0.159 (0.132,0.185) -7.15 (-7.66,-6.65) -4.14 (-4.43,-3.84) 0.186 (0.173,0.199) -7.61 (-8.02,-7.21) -4.35 (-4.59,-4.12) 0.192 (0.182,0.203) Losartan -4.73 (-5.92,-3.53) -3.10 (-3.75,-2.46) 0.138 (0.109,0.167) -5.29 (-5.58,-4.99) -3.23 (-3.40,-3.06) 0.106 (0.087,0.126) -4.73 (-5.14,-4.32) -2.99 (-3.23,-2.75) 0.125 (0.114,0.136) -5.12 (-5.47,-4.76) -3.12 (-3.32,-2.92) 0.134 (0.125,0.143) Valsartan -4.46 (-5.85,-3.07) -3.17 (-3.88,-2.46) 0.128 (0.095,0.160) -6.26 (-6.54,-5.97) -3.60 (-3.76,-3.45) 0.137 (0.116,0.158) -5.92 (-6.34,-5.50) -3.47 (-3.72,-3.23) 0.150 (0.138,0.161) -6.24 (-6.58,-5.89) -3.59 (-3.78,-3.40) 0.159 (0.150,0.168) Irbesartan -4.13 (-6.26,-1.99) -3.21 (-4.37,-2.04) 0.114 (0.056,0.172) -6.42 (-6.88,-5.97) -3.68 (-3.93,-3.43) 0.162 (0.135,0.189) -5.96 (-6.59,-5.34) -3.47 (-3.82,-3.12) 0.151 (0.134,0.168) -6.25 (-6.74,-5.77) -3.66 (-3.93,-3.40) 0.160 (0.147,0.173) Olmesartan HCTZ -9.71 (-11.49,-7.92) -5.36 (-6.30,-4.43) 0.205 (0.158,0.252) -10.01 (-10.60,-9.42) -5.61 (-5.98,-5.24) 0.159 (0.121,0.197) -8.98 (-9.67,-8.28) -5.28 (-5.68,-4.89) 0.216 (0.198,0.234) -9.30 (-9.86,-8.74) -5.41 (-5.73,-5.09) 0.218 (0.203,0.232) Losartan HCTZ -6.65 (-8.35,-4.96) -3.93 (-4.83,-3.04) 0.146 (0.107,0.185) -7.28 (-7.79,-6.77) -3.92 (-4.20,-3.64) 0.115 (0.081,0.149) -6.72 (-7.38,-6.05) -3.96 (-4.34,-3.57) 0.153 (0.135,0.170) -6.85 (-7.41,-6.29) -4.00 (-4.31,-3.69) 0.155 (0.141,0.170) Valsartan HCTZ -7.32 (-8.42,-6.21) -4.00 (-4.68,-3.32) 0.164 (0.136,0.192) -7.72 (-7.99,-7.44) -4.34 (-4.50,-4.19) 0.123 (0.101,0.145) -7.29 (-7.68,-6.90) -4.04 (-4.28,-3.80) 0.173 (0.162,0.184) -7.58 (-7.91,-7.26) -4.28 (-4.47,-4.09) 0.180 (0.171,0.189) Irbesartan HCTZ -6.25 (-8.83,-3.66) -4.35 (-6.17,-2.53) 0.160 (0.096,0.224) -8.09 (-8.81,-7.36) -4.51 (-4.94,-4.08) 0.124 (0.079,0.169) -6.86 (-7.71,-6.01) -3.99 (-4.52,-3.46) 0.166 (0.142,0.189) -7.61 (-8.32,-6.91) -4.40 (-4.83,-3.97) 0.189 (0.169,0.209) Amlodipine -5.06 (-6.52,-3.60) -2.86 (-3.69,-2.03) 0.068 (0.033,0.103) -6.20 (-6.76,-5.63 -3.64 (-3.97,-3.31) 0.029 (-0.011,0.068) -1.39 (-1.84,-0.94) -0.67 (-0.92,-0.42) 0.067 (0.049,0.084) -3.74 (-4.18,-3.29) -2.35 (-2.61,-2.09) 0.087 (0.073,0.101)
  33. 33. Global Health Economics & Outcomes Research Raising the Bar in Outcomes Research to Obtain Market Access, Favorable Pricing and Support Core Brand Messages

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