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    Clinical Trial Results:
    UMPIRE - Use of a Multidrug Pill In Reducing cv Events - a randomised controlled trial of fixed dose combination medication and usual care in those at high risk of cardiovascular disease.

    Summary
    EudraCT number
    		 2009-016278-34
    Trial protocol
    		 IE   GB   NL  
    Global end of trial date
    31 Jul 2012

    Results information
    Results version number
    		 v1(current)
    This version publication date
    14 May 2020
    First version publication date
    14 May 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    241849
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01057537
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Imperial College London
    Sponsor organisation address
    South Kensington Campus, London, United Kingdom, SW7 2AZ
    Public contact
    Simon Thom, Imperial College London, s.thom@imperial.ac.uk
    Scientific contact
    Simon Thom, Imperial College London, s.thom@imperial.ac.uk
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    31 Jul 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Jul 2012
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Jul 2012
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary aim of the trial is to assess whether a treatment strategy based on a cardiovascular 'polypill' (a multi-drug pill containing a fixed dose combination of 4 cardiovascular medications) compared to usual cardiovascular medications (similar medications but taken as single tablets) will improve adherence to prescribed medications (i.e. the patient is taking the medications they have been prescribed correctly). Difference in blood pressure and cholesterol between the beginning and end of the trial will serve as indicators of adherence to medication.
    Protection of trial subjects
    N/A
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    10 Jun 2010
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Netherlands: 335
    Country: Number of subjects enrolled
    United Kingdom: 336
    Country: Number of subjects enrolled
    Ireland: 333
    Country: Number of subjects enrolled
    India: 1000
    Worldwide total number of subjects
    2004
    EEA total number of subjects
    1004
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    1179
    From 65 to 84 years
    815
    85 years and over
    10

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants in Europe were recruited via research databases, hospital clinics, and general practice registries at 3 trial centers in London, England; Dublin, Ireland; and Utrecht, the Netherlands. Indian participants were recruited via hospital specialist clinics in 28 centers across the country.

    Pre-assignment
    Screening details
    		 A total of 2138 potential participants were screened, 134 were ineligible and 2004 were randomized (1000 in India and 1004 in Europe) between July 2010 and July 2011.

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Fixed-Dose Combination (FDC)
    Arm description
    		 Participants received either version 1 of 2 FDC formulations chosen by the trial physician: version 1 (aspirin, 75 mg; simvastatin, 40 mg; lisinopril, 10 mg; and atenolol, 50 mg) or version 2 (aspirin, 75 mg; simvastatin, 40 mg; lisinopril, 10 mg; and hydrochlorothiazide, 12.5 mg).
    Arm type
    		 Experimental

    Investigational medicinal product name
    FDC Formulation 1
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    FDC Formulation 1 (Aspirin 75 mg, Simvastatin 40 mg, Lisinopril 10 mg and Atenolol 50 mg). The FDC was taken once daily.

    Investigational medicinal product name
    FDC Formulation 2
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    FDC Formulation 2 (Aspirin 75 mg, Simvastatin 40 mg, Lisinopril 10 mg, and Hydrochlorothiazide 12.5 mg). The FDC was taken once daily.

    Arm title
    		 Usual Care
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Usual Care
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Usual Care

    Number of subjects in period 1
    		Fixed-Dose Combination (FDC) Usual Care
    Started
    1002
    1002
    Completed
    955
    952
    Not completed
    47
    50
         Adverse event, serious fatal
    17
    15
         Consent withdrawn by subject
    26
    28
         Other
    4
    7

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Fixed-Dose Combination (FDC)
    Reporting group description
    		 Participants received either version 1 of 2 FDC formulations chosen by the trial physician: version 1 (aspirin, 75 mg; simvastatin, 40 mg; lisinopril, 10 mg; and atenolol, 50 mg) or version 2 (aspirin, 75 mg; simvastatin, 40 mg; lisinopril, 10 mg; and hydrochlorothiazide, 12.5 mg).

    Reporting group title
    Usual Care
    Reporting group description
    		 -

    Reporting group values
    		 Fixed-Dose Combination (FDC) Usual Care Total
    Number of subjects
    		 1002 1002 2004
    Age categorical
    Units: Subjects
        Adults (18-74)
    		 1002 1002 2004
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 62.1 ( 10.4 ) 61.6 ( 10.8 ) -
    Gender categorical
    Units: Subjects
        Female
    		 185 177 362
        Male
    		 817 825 1642
    Systolic Blood Pressure
    Units: mm Hg
        arithmetic mean (standard deviation)
    		 137 ( 21.3 ) 137.7 ( 21.1 ) -
    Diastolic Blood Pressure
    Units: mm Hg
        arithmetic mean (standard deviation)
    		 77.4 ( 12 ) 78.1 ( 11.5 ) -
    low-density lipoprotein cholesterol (LDL-C)
    Units: mg/dL
        arithmetic mean (standard deviation)
    		 90.5 ( 32.5 ) 92.5 ( 36 ) -

    End points

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    End points reporting groups
    Reporting group title
    Fixed-Dose Combination (FDC)
    Reporting group description
    		 Participants received either version 1 of 2 FDC formulations chosen by the trial physician: version 1 (aspirin, 75 mg; simvastatin, 40 mg; lisinopril, 10 mg; and atenolol, 50 mg) or version 2 (aspirin, 75 mg; simvastatin, 40 mg; lisinopril, 10 mg; and hydrochlorothiazide, 12.5 mg).

    Reporting group title
    Usual Care
    Reporting group description
    		 -

    Primary: Adherence to medication

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    End point title
    		 Adherence to medication
    End point description
    Number of participants who adhere to the medication
    End point type
    Primary
    End point timeframe
    18 months
    End point values
    		 Fixed-Dose Combination (FDC) Usual Care
    Number of subjects analysed
    961
    960
    Units: Number of participants
    829
    621
    Statistical analysis title
    		 Adherence
    Statistical analysis description
    Relative risks (RRs) of self-reported adherence to indicated medications at the end of the study were calculated using log-binomial regression including randomized treatment. Adjusted analyses included randomized treatment, baseline value (either SBP, LDL-C, or baseline adherence) plus age, sex, country, and established disease as covariates.
    Comparison groups
    Fixed-Dose Combination (FDC) v Usual Care
    Number of subjects included in analysis
    1921
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Relative Risk
    Parameter type
    		 Log-binomal regression
    Point estimate
    1.33
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.26
         upper limit
    		 1.41

    Primary: Systolic Blood Pressure

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    End point title
    		 Systolic Blood Pressure
    End point description
    End point type
    Primary
    End point timeframe
    18 months
    End point values
    		 Fixed-Dose Combination (FDC) Usual Care
    Number of subjects analysed
    961
    960
    Units: mm Hg
        arithmetic mean (full range (min-max))
    129.2 (128.1 to 130.2)
    131.7 (130.7 to 132.8)
    Statistical analysis title
    		 Systolic Blood Pressure
    Statistical analysis description
    The primary analysis of mean differences in changes in SBP at the end of study between the FDC and usual care groups was conducted using analysis of covariance including the randomized treatment and baseline SBP. Longitudinal analyses using generalized linear models with a compound-symmetry covariance structure were used as sensitivity analyses for the 3 primary end points.
    Comparison groups
    Fixed-Dose Combination (FDC) v Usual Care
    Number of subjects included in analysis
    1921
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 < 0.001
    Method
    		 log-binomial regression
    Parameter type
    		 Log-binomal regression
    Point estimate
    -2.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4
         upper limit
    		 -1.1
    Notes
    [1] - Adjusted analyses included randomized treatment, baseline value plus age, sex, country, and established disease as covariates.

    Primary: Low-density lipoprotein cholesterol

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    End point title
    		 Low-density lipoprotein cholesterol
    End point description
    End point type
    Primary
    End point timeframe
    18 months
    End point values
    		 Fixed-Dose Combination (FDC) Usual Care
    Number of subjects analysed
    961
    960
    Units: mg/dL
        arithmetic mean (full range (min-max))
    84.2 (82.5 to 85.8)
    88.4 (86.7 to 90)
    Statistical analysis title
    		 Low-density lipoprotein cholesterol
    Statistical analysis description
    The primary analysis of mean differences in changes in LDL-C at the end of study between the FDC and usual care groups was conducted using analysis of covariance including the randomized treatment and baseline LDL-C.
    Comparison groups
    Fixed-Dose Combination (FDC) v Usual Care
    Number of subjects included in analysis
    1921
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [2]
    P-value
    		 < 0.001
    Method
    		 log-binomial regression
    Parameter type
    		 Log-binomal regression
    Point estimate
    -4.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.6
         upper limit
    		 -1.9
    Notes
    [2] - Adjusted analyses included randomized treatment, baseline value plus age, sex, country, and established disease as covariates.

    Secondary: Diastolic Blood Pressure

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    End point title
    		 Diastolic Blood Pressure
    End point description
    End point type
    Secondary
    End point timeframe
    18 months
    End point values
    		 Fixed-Dose Combination (FDC) Usual Care
    Number of subjects analysed
    961
    960
    Units: mm Hg
        arithmetic mean (full range (min-max))
    72.8 (72.2 to 73.5)
    75.2 (74.7 to 75.8)
    Statistical analysis title
    		 Diastolic Blood Pressure
    Statistical analysis description
    Continuous secondary end points including diastolic BP were assessed using analysis of covariance.
    Comparison groups
    Fixed-Dose Combination (FDC) v Usual Care
    Number of subjects included in analysis
    1921
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Log-binomial regression
    Parameter type
    		 log-binomial regression
    Point estimate
    -2.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.3
         upper limit
    		 -1.6

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    18 months
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10.0
    Reporting groups
    Reporting group title
    Fixed-Dose Combination (FDC)
    Reporting group description
    		 Participants received either version 1 of 2 FDC formulations chosen by the trial physician: version 1 (aspirin, 75 mg; simvastatin, 40 mg; lisinopril, 10 mg; and atenolol, 50 mg) or version 2 (aspirin, 75 mg; simvastatin, 40 mg; lisinopril, 10 mg; and hydrochlorothiazide, 12.5 mg).

    Reporting group title
    Usual Care
    Reporting group description
    		 -

    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: This is correct as reported.
    Serious adverse events
    		 Fixed-Dose Combination (FDC) Usual Care
    Total subjects affected by serious adverse events
         subjects affected / exposed
    118 / 1002 (11.78%)
    102 / 1002 (10.18%)
         number of deaths (all causes)
    17
    15
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Neoplasms benign and malignant
         subjects affected / exposed
    13 / 1002 (1.30%)
    11 / 1002 (1.10%)
         occurrences causally related to treatment / all
    0 / 13
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Vascular disorders
         subjects affected / exposed
    11 / 1002 (1.10%)
    12 / 1002 (1.20%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Surgical and medical procedures
         subjects affected / exposed [2]
    3 / 961 (0.31%)
    2 / 960 (0.21%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    General disorders and administration site conditions
         subjects affected / exposed [3]
    8 / 961 (0.83%)
    8 / 960 (0.83%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Immune system disorders
         subjects affected / exposed [4]
    0 / 961 (0.00%)
    1 / 960 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Reproductive system and breast disorders
         subjects affected / exposed [5]
    1 / 961 (0.10%)
    6 / 960 (0.63%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Respiratory, thoracic and mediastinal disorders
         subjects affected / exposed [6]
    5 / 961 (0.52%)
    3 / 960 (0.31%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Psychiatric disorders
         subjects affected / exposed [7]
    1 / 961 (0.10%)
    2 / 960 (0.21%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Investigations
         subjects affected / exposed [8]
    1 / 961 (0.10%)
    0 / 960 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Injury, poisoning and procedural complications
         subjects affected / exposed [9]
    7 / 961 (0.73%)
    5 / 960 (0.52%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Congenital, familial and genetic disorders
         subjects affected / exposed [10]
    0 / 961 (0.00%)
    1 / 960 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac disorders
         subjects affected / exposed
    42 / 1002 (4.19%)
    27 / 1002 (2.69%)
         occurrences causally related to treatment / all
    0 / 42
    0 / 27
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Nervous system disorders
         subjects affected / exposed
    9 / 1002 (0.90%)
    13 / 1002 (1.30%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Blood and lymphatic system disorders
         subjects affected / exposed [11]
    1 / 961 (0.10%)
    0 / 960 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastrointestinal disorders
         subjects affected / exposed
    10 / 1002 (1.00%)
    11 / 1002 (1.10%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hepatobiliary disorders
         subjects affected / exposed [12]
    1 / 961 (0.10%)
    1 / 960 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Skin and subcutaneous tissue disorders
         subjects affected / exposed [13]
    0 / 961 (0.00%)
    1 / 960 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal and urinary disorders
         subjects affected / exposed [14]
    5 / 961 (0.52%)
    3 / 960 (0.31%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Musculoskeletal and connective tissue disorders
         subjects affected / exposed [15]
    3 / 961 (0.31%)
    6 / 960 (0.63%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Infections and infestations
         subjects affected / exposed
    16 / 1002 (1.60%)
    10 / 1002 (1.00%)
         occurrences causally related to treatment / all
    0 / 16
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Metabolism and nutrition disorders
         subjects affected / exposed [16]
    3 / 961 (0.31%)
    5 / 960 (0.52%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Notes
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: This is correct as reported.
    [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: This is correct as reported.
    [4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: This is correct as reported.
    [5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: This is correct as reported.
    [6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: This is correct as reported.
    [7] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: This is correct as reported.
    [8] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: This is correct as reported.
    [9] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: This is correct as reported.
    [10] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: This is correct as reported.
    [11] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: This is correct as reported.
    [12] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: This is correct as reported.
    [13] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: This is correct as reported.
    [14] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: This is correct as reported.
    [15] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: This is correct as reported.
    [16] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: This is correct as reported.
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Fixed-Dose Combination (FDC) Usual Care
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 1002 (0.00%)
    0 / 1002 (0.00%)

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/24002278
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