Transcript Abbott Oncology Pipeline

MAVIK Canadian studies
Mavik® TRAIL
HTN Phase IV
HTN PMOS
1.
BP control
2.
ISH, diabetics
HTN PMOS
1.
BP control
2.
MAU, eGFR,ISH
Sites (n)
192
601
570
Patients (n)
2096
8787
8001
Start-End Dates
Presentation Title
Date7/18/2015
Apr 2004-May 2005 Mar 2006-Dec 2008 Dec 2008-(Aug2011)
Baseline characteristics
Mavik® TRAIL
(complete)
(complete)
(ongoing)
Mean age
56.6
58.5
58.0
Mean BP at Baseline
mm Hg
154.4/91.8
152.3/89.7
150.69/89.6
(+/-SD12.3/8.2)
(+/-SD16.1/10.8)
(+/-SD15.3/10.7)
Mean BP mm Hg
Month 6
128.2/77.8
NA
132.2/79.2
NA
-21.7 / -12.6
-19.4 / -10.1
NA
at wk 14
at 6-mos
at 12 mos
(Home vs office)
Mean BP reduction
Presentation Title
Date7/18/2015
Characteristics
P06-119
A prospective, multi-center, non-interventional, observational study with
601 primary-care physicians across Canada, to describe the
effectiveness and drug utilization patterns with Mavik ® in the
management of hypertension (a real-life clinical practice setting).
601 sites enrolled 8787 subjects (ITT cohort)
56.6% of subjects were naïve to anti-HTN treatment at Baseline
3-mos visit completed n=6489 (73.8%)
6-mos visit completed n=5325 (60.6%)
Drop Outs n=3462 (39.4%)
962 (10.9%) subjects reported AE; 97/962 subjects reported SAE,
among them 15 deaths reports – none attributed to Mavik ®
Presentation Title
Date7/18/2015
CV Risk Factors at Baseline
Presentation Title
Date7/18/2015
Dyslipidemia
n = 2724 (31.0%)
Diabetes
n = 1900 (21.6%)
CAD
n = 556 (6.3%)
Renal dysfunction
n = 310 (3.5%)
P06-119
67.3% of all patients reached CHEP-specified
target levels (SBP/DBP<140/90)
P06-119
Mean BP at Baseline
152.3 / 89.7 mmHg
Mean SBP drop
-19.4 mmHg
Mean DBP drop
-10.1 mmHg
32.7%
67.3%
Achieved after 6 months of treatment ITT population n=5325
Presentation Title
Date7/18/2015
Mean BP at 6 months
132.6 / 79.3 mmHg
30.6% of Diabetics reached CHEP-specified
target levels (SBP/DBP<130/80 mmHg) at
Month 6
P06-119
n = 1149
Presentation Title
Date7/18/2015
72.8% of Diabetics reached
SBP/DBP<140/90 mmHg at Month 6 P06-119
n = 1149
Presentation Title
Date7/18/2015
66.6% of ISH patients reached CHEP-specified
target levels (SBP<140 mmHg) at Month 6 P06-119
n = 1620
Presentation Title
Date7/18/2015
Compliance, Adherence,
Safety
P06-119
Patient-reported compliance: 90.1% at 3-month and 82% at 6-month
treatment with Mavik®
Adherance to treatment 92.9% at 3-month and 95.4% at 6-month
treatment with Mavik®
10.9% (962/8787) subjects reported one or more AE (353 discontinued
the study)
97 patients out of 962 reported 129 SAEs – none attributed to Mavik®
Drop-Out rate 39.4% (n=3462) mostly due to loss to FU (78.2%)
Presentation Title
Date7/18/2015