Attached files
| file | filename |
|---|---|
| 8-K - FORM 8-K - ReShape Lifesciences Inc. | d438076d8k.htm |
| EX-99.1 - PRESS RELEASE DATED NOVEMBER 7, 2012 - ReShape Lifesciences Inc. | d438076dex991.htm |
 Abstract
Katherine S Tweden, PhD
a
, Mark B Knudson, PhD
a
,
Scott
A
Shikora,
MD
b
,
Robert
M
Carey,
MD
a
EnteroMedics, Inc, St. Paul, MN;
b
Brigham and Women’s Hospital, Boston, MA;
c
University of Virginia Health System, Charlottesville, VA
13195
Intermittent Neural
Transmission Block Of The
Intra-abdominal Vagus Induces
Sustained Blood Pressure
Reduction In Obese Subjects
Exhibit 99.2
c |
 Financial Disclosures
This clinical trial was completely funded
by EnteroMedics Inc.,
St. Paul, MN, USA |
 Background
•
Intermittent block of the intra-abdominal
vagus (VBLOC) using an implantable
device has been shown to cause
significant EWL in obese subjects.
•
We tested the hypothesis that VBLOC
would improve blood pressure (BP) prior
to significant WL in obese subjects with a
diagnosis of hypertension (HT) or elevated
BP at baseline. |
 Methods
BP was measured at baseline, weekly to 4
wk and monthly to 12 mo during a
randomized, controlled trial to evaluate
weight loss in 294 obese subjects.
HT was defined by JNC-7 guidelines
(group A) or if subjects had HT history
(group B); the analysis was performed in a
subset
of
subjects
who
had
9
hrs
therapy delivered per day to 12 mo. |
 Demographics
Group A
Subjects with elevated BP
Group B
Subjects with history of HT
n
37
58
BMI (kg/m
)
41±1
41±1
Age (years)
50±1
51±1
Female/Male Ratio
31/6
47/11
2 |
 Change
in SBP and DBP and %EWL Over 12 months
Figure 2: Relationship of Change in SBP
(mmHg) to 12 Months Compared to %EWL
(Group B)
Figure 3: Relationship of Change in DBP
(mmHg) to 12 Months Compared to %EWL
(Group B) |
 SBP
and DBP Reduction Compared to %EWL at 6 months
Fig 4: Relationship of Change in SBP
(mmHg) at 6 Months Compared to %EWL
(Group B), p=0.52, r=0.09
Fig 5: Relationship of Change in DBP
(mmHg) at 6 Months Compared to %EWL
(Group B), p=0.82, r=0.03 |
 SBP
and DBP Reduction Compared to Baseline BP at 12 mo
Figure 6: Relationship of Change in SBP
(mmHg) at 12 Months Compared to Baseline
(Group B), p<0.0001, r= -0.6
Figure 7: Relationship of Change in DBP
(mmHg) at 12 Months Compared to Baseline
(Group B), p<0.0001, r= -0.61 |
 Discussion
•
Change in BP in hypertensive subjects and
subjects with elevated BP occurred prior to
weight loss and was sustained to 12 months
•
BP reduction was independent of weight loss
magnitude
•
Higher baseline values of BP were associated
with larger reductions in BP levels |
 Conclusions
•
VBLOC induced clinically significant, sustained
BP reduction at 1 year in obese subjects with a
history of HT or elevated BP prior to therapy.
•
These data suggest that VBLOC therapy may
offer major non-pharmacologic BP reduction for
obese subjects with HT.
•
These findings will need to be confirmed in a
prospective, randomized, controlled trial to
clarify the role of this therapy in hypertension
treatment. |