InterCure, UK Limited (Manufacturer of RESPeRATE). 1st

Hello,
Thank you for your interest in RESPeRATE. This
pack contains important clinical & NHS prescription
information for your doctor - who may not yet be fully
aware of the benefits of RESPeRATE.
Having read the information – if your NHS doctor
considers RESPeRATE to be the right treatment for you,
he/she will prescribe it at standard NHS prescription rate.
Alternatively, you can purchase RESPeRATE Ultra or
Ultra Duo models direct from www.resperate.co.uk or by
calling us Toll-free on 0800-177-7778. Please note that if
you purchase RESPeRATE privately – it will be backed
by a 30 day, unconditional money-back guarantee.
“After 2 years of taking
medication my blood
pressure was stuck at
140/95. After 8 weeks of
using RESPeRATE my BP
was down to 130/85. This
product has changed my life
- thank you so much.”
Lynne Harris,
Guildford, Surrey,
To obtain RESPeRATE (Rx Model) once you have received an NHS prescription:
1.
Freepost your prescription to us or take it to your local pharmacy
Freepost your prescription in the nearest Royal Mail Post Box as soon as you
leave the surgery using the printable envelope included and receive RESPeRATE
directly to your home at no extra charge. Alternatively, take it your local
pharmacy and we will arrange for your RESPeRATE to be shipped to them – and
all you have to do is go back and pick it up.
If you have to pay for your prescriptions, simply call Freephone on
0800 195 0160, and our NHS-licensed partner, Daylong, will take a secure
payment from you over the phone. For help email [email protected].
If you prefer to use your own envelope, please pop your completed prescription
form inside and address it to: Freepost DY501, Daylong, 10 Cossall Industrial
Estate, Ilkeston, Derbyshire, DE7 9BR. Please make sure you provide your name,
address and telephone number or email address in case we need to contact you.
2.
Activate your 90-day complimentary access to the RESPeRATE Cares
Personalised Coaching Programme.
Lowering blood pressure is easier with support – in the same way that it’s easier
to achieve results in the gym if you’re lucky enough to have a personal trainer.
Our RESPeRATE Cares Personalised Coaching programme will keep you on the
path to lower blood pressure.
Why wait? Get RESPeRATE today – and start to lower your own blood pressure.
If you have any questions please do not hesitate to call - or email us.
Good luck!With best wishes from
RESPeRATE Support Team
0800-177-7778 (Toll-free)
[email protected]
InterCure, UK Limited (Manufacturer of RESPeRATE).
1st Floor, No.76, New Bond Street ● London UK ● W1S 1RX
www.resperate.co.uk
0800-177-7778 (Toll-free)
BUSINESS REPLY SERVICE
Licence No. DY 501
Freepost-DY501
Daylong
10 Cossall Industrial Estate
Ilkeston
Derbyshire
DE7 9BR
Daylong is backed by Credenhill Limited NHS Suppliers for over 55 years
Name & Surname
Address
Address
(*Write your
phone and email
on the back side
of the page
(inside the
envelope) in case
we need to
contact you.)
Dear Doctor,
Thank you for your interest in RESPeRATE.
This Pack includes a product brochure and a one-page
clinical overview of registration and post marketing
clinical studies.
The NHS Prescription Service recently approved
RESPeRATE for inclusion in the NHS Drug Tariff under
a new section: adjunctive treatment for hypertension. The
inclusion was granted after a detailed review of clinical
studies, patient satisfaction analysis and cost benefit
economic model. The inclusion reflects NHS belief in
RESPeRATE as a new and cost-effective option for the
treatment of hypertension
RESPeRATE is primarily recommended for patients who:
•
are aged 65+ with not-yet-at-target blood pressure
- in spite of appropriate antihypertensive medication
•
have diabetes with hypertension
•
are diagnosed with isolated systolic hypertension
•
have refractory hypertension
•
refuse medication or experience side effects
“The lack of side effects, the
demonstrated efficacy, and
compliance
demonstrate
that there is a potential
benefit of using this therapy
in
clinical
practice,
especially
when
pharmacologic therapy has
already failed to achieve BP
control.”
RESPeRATE:
nonpharmacological
treatment of hypertension.
Cardiology in Review.
2011;19:47-51.
There are no known contraindications and have been no adverse reactions to the use
of RESPeRATE.
As an NHS clinician you can now prescribe it to all appropriate hypertensive patients
at a cost of a standard NHS prescription rate. For RESPeRATE (Rx model) use 3314564 PIP Code.
The RESPeRATE is also available for patients wanting or able to self-pay, £200
directly from the manufacturer or through selected pharmacies.
For more information on how RESPeRATE will benefit you – and your patients please call our Medical Liaison Director 0845-460-6113 (local call rate) or email
[email protected].
Sincerely,
InterCure Clinical Support Team
InterCure, UK Limited.
1 ST floor 76, New Bond Street ● London, UK ● W1S 1RX
www.resperate.co.uk
0845-460-6113
The New Treatment
Option For Hypertension.
• Validated in 10 clinical trials
• No side effects
• Pleasant and easy to use
Seven out of ten hypertensive Britons do not have their blood pressure under control. Pharmacological
interventions and lifestyle modifications may not be enough to achieve goal blood pressure.   
RESPeRATE offers an additional option clinically proven to lower blood pressure with no side effects.
Lower Blood Pressure with No Side Effects
3
RESPeRATE is the first and only device based
therapy indicated for the adjunctive treatment
of hypertension.
• 14/8 mm/Hg average sustained blood
pressure reduction within 8 weeks
• Validated in 10 clinical studies published
in peer-reviewed medical journals
• No observed side effects
• Pleasant and easy to use
HOW RESPeRATE Works
RESPeRATE’s breathing sensor, placed on the upper abdomen,
automatically analyses the patient’s breathing pattern and
creates a personalized programme of distinct inhale and
exhale tones. By gradually prolonging the exhalation tone to
slow down breathing, RESPeRATE leads the patient into the
therapeutic zone of less than 10 breaths a minute with minimal
respiratory efforts.
As a result sympathetic neural activity is reduced, decreasing
peripheral resistance in small blood vessels, and lowering blood
pressure.
After each session of device guided breathing, respiration
returns to normal, but the beneficial impact on blood pressure
accumulates. Used routinely for 15 minutes a day, RESPeRATE
demonstrates a significant, sustained blood pressure reduction
beyond the reduction from concurrent treatments.
The device has a built in tutorial, which guides the patients
effortlessly through its use. The tutorial will check the sensor
position and guide the patient through an abbreviated session.
It takes approximately 10 minutes to familiarize with the device.
The device also comes with a full instruction manual, quick start
guide and trouble shooting guide. Specifically designed for
older generations, 97% of RESPeRATE users find the device easy
to use (Source: Ipsos Vantis).
Ear Buds
RESPeRATE analyzes
your breathing and
interactively composes
prolonged inhale and
exhale tones
RESPeRATE
Device
Breathing
Sensor
You synchronize your
breathing to RESPeRATE’s
personalized guiding tones
Clinical situations in
which RESPeRATE is
particularly useful:
• Patients aged 65+ with uncontrolled BP in spite
of medication
• Diabetic patients with hypertension
• Isolated systolic hypertension
• Hypertensive patients resistant to anti-hypertensive drugs.
• Patients with uncontrolled BP, who suffer side effects
or refuse medication.
Healthcare Provider FAQs
Can the breathing exercises be performed
alone, without the device?
Routinely practicing the type of structured, effortless
breathing exercises that have been shown to reduce
blood pressure is very difficult without a personalized
coach such as RESPeRATE.
What is the recommended course
of treatment for RESPeRATE?
Studies have shown RESPeRATE delivers significant
blood pressure reductions if used for 15 minutes at a time,
at least three to four times per week, in order to attain
40 or more minutes of slow breathing (<10 breaths
per minute). Additional use is associated with further
blood pressure reductions so it is recommended
to use RESPeRATE daily.
PROVEN EFFICACY in 10
Independent Clinical Trials
2-10
• Average BP reduction:
14 mmHg systolic and 8 mmHg diastolic1
(initially uncontrolled), independent of
gender and medication status
• Significant, consistent results
measured at the clinic2-10, at home3-7
and with 24-hour ambulatory blood
pressure monitor 6,10
• Greater BP reductions for:
- older patients (18/8 mmHg for >age 65)
- higher baseline BP1
- the more time spent
in slow breathing4
RESPeRATE Significantly
Reduces High Blood Pressure
RESPeRATE
Control
How long does it take to realize a BP reduction?
In clinical trials, most patients saw a clinically significant
reduction in blood pressure after just three to four weeks
of treatment with RESPeRATE. Further reductions
accumulate with consistent use.
How long do the effects of using
RESPeRATE last?
Clinical studies show that RESPeRATE can provide
a sustained, all-day reduction in blood pressure
with regular use. Compliance is good as most
patients find RESPeRATE relaxing and pleasant to use.
Control Group: Relaxation treatment (Walkman
with relaxing music)2, placebo intervention
by home blood pressure monitor 3,4 and both.5
What is the safety profile of RESPeRATE?
The FDA labeling has no contraindications and there
are no known side effects with the use of RESPeRATE.
For more information about the clinical studies
visit www.resperate.co.uk/clinician
REFERENCES
[1] Elliott et al, Medscape General Medicine, 2006; 8(3).
[2] Schein M et al, J Human Hyperten 2001; 15(4): 271–278.
[3] Meles E et al, Am J Hyperten 2004; 17:370-74.
[4] Elliott et al, J Clin Hyperten 2004; 6(10) 553-559.
[5] Grossman E et al, J Human Hyperten 2001; 15(4): 263 -269.
[6] Rosenthal T et al, Am J Hyperten 2001; 14(1): 74 -76.
[7] Viskoper R et al, Am J Hyperten 2003; Vol16:484-487.
[8] Bae JH et al, Korean Hypertension J, 2006; 1:19-23.
[9] Schein et al, J Human Hyperten 2009; 23(5), 325-331.
[10] Aydin et al, J Hyperten 2008; 26 (1), S371.
[11] Parati et al, Am J Hyperten, 2002; 15(4,2)182A.
For a full list of publications,
visit www.resperate.co.uk/clinician
We are committed to lowering blood pressure
Our Scientific Affairs department will be happy to help you with questions and suggestions.
0845 460 6113
Scientific Affairs
InterCure Ltd, Units 7-9 Romsey Industrial Estate,
Romsey, Hants, SO51 0AD
Please Note: RESPeRATE should only be used as a part of an overall health program for achieving goal blood pressure, as recommended
by a doctor. RESPeRATE can be safely used in conjunction with medications and lifestyle modifications such as diet and exercise.
Non-Drug Blood Pressure-Lowering Device: An Overview
Henry Black, MD, Joseph Izzo, Jr. MD
Introduction
Reduction of high blood pressure (BP) by nonpharmacological means (i.e. lifestyle modifications) is widely
recommended, either as primary prevention or therapy or as
adjunctive treatment with antihypertensive drugs. Several
recent clinical trials have demonstrated that 8 weeks of daily
at-home use of a device that slows breathing rate lowers BP1-7,.
Mechanism of Action
Inappropriately high sympathetic nervous outflow from the
central nervous system is believed to be an important
component in the pathophysiology of acute and chronic
hypertension that stimulates increases in cardiac output and
peripheral resistance. Elevated sympathetic activity is often
associated with desensitization of arterial and cardiopulmonary
baroreceptors, which leads to increased BP fluctuation and
sustained elevations in resting pressures.
Slow breathing (< 10 breaths/minute), especially with
prolonged exhalation, appears to reduce sympathetic nerve
traffic and thus causes arteriolar dilatation. The process is
believed to be initiated by activated pulmonary
mechanoreceptors, which respond to the increased tidal volume
that accompanies slow breathing, and act in concert with
cardiac mechanoreceptors to inhibit sympathetic outflow8.
Device Description
The new device (RESPeRATE®, InterCure Inc., Fort Lee,
NJ) consists of a control box (about the size of a paperback
book) containing a microprocessor, a belt-type respiration
sensor (which functions as a respiration sensor), and
headphones (to provide feedback to the patient). During a
session of device-guided breathing, the device analyzes the
breathing rate and pattern and creates a personalized melody
composed of two distinct tones – one tone for inhalation, one
for exhalation. As the patient synchronizes breathing with the
tones, the device gradually prolongs the exhalation tone and
slows the breathing rate to <10 breaths/minute.
A record of the patient’s use of the device is stored in the
microprocessor for quantitation of total time of device use and
adherence to the regimen.
Clinical Studies
Seven separate studies1-7 have examined the decrease in
office blood pressure for subjects who used the device for 15
minutes/day for 8 weeks, compared to “control” interventions
(listening to relaxing music1 or home BP monitoring4-5 or
both2). Four studies were double-blind and randomized1,2,5,8;
one was controlled and randomized4, and two were open-label
experiences3,6.
A total of 286 individuals participated in the seven studies:
55% were men; 78% were drug-treated, with average age of 58
years; Body Mass Index of 28 kg/m2; and initial office BP of
150/90 mmHg (9% pre-hypertensive; 25% Stage 2).
The decrease in office BP after 8 weeks of device-guided
breathing among those with uncontrolled hypertension was
14/8 mmHg, compared to control treatment of 9/4 mmHg
(p = 0.008 and p = 0.002, respectively for systolic and diastolic
BPs). The difference was independent of gender and
medication status. Control of BP (< 140/90 mmHg) was seen
more commonly in the group that used the device: 26% vs. 4%
of those with initial Stage 2 hypertension (> 160/100 mmHg,
p < 0.005); and 48% vs. 34% for those with initial Stage 1
hypertension (140-159/90-99 mmHg, p < 0.05).
The drop in office BP was directly related to the duration of
slow breathing during the 8 weeks of treatment; those who
used the device to achieve slow breathing more than 15
minutes/day had the greatest lowering of office BPs. It usually
takes 3-5 weeks to achieve a sustained reduction in home BP.
Larger decreases in office BPs were seen in older individuals
and those with higher baseline BPs, whether taking
antihypertensive medication or not. Verification of BP
lowering has also been seen with home BP measurements (for
up to 6 months of use7) and ambulatory BP monitoring3.
Usage Guidelines and Administration
The device is indicated by the US FDA for the reduction of
stress and as an adjunctive therapy in hypertension that can be
combined with standard antihypertensive drugs and nonpharmacologic interventions.
The clinical situations in which RESPeRATE appears
particularly useful are: 1) pre-hypertensives and white-coat or
labile hypertensives who might benefit from reducing stress
and sympathetic activity; 2) patients with isolated systolic
hypertension; and 3) resistant hypertensive patients
(uncontrolled BP despite use of a diuretic and at least 2 other
medications at maximum dosage).
There are no known contraindications or adverse reactions to
use of the device to guide slow breathing.
Patients should be instructed to use the device routinely in
15-minute daily sessions, aiming to accumulate at least 45
minutes of slow breathing per week (as indicated by the
device’s display). Patients should be made aware that results,
just like physical conditioning, may take a few weeks to
become fully manifested and that without continued device use,
any achieved benefits would likely be diminished.
Summary
Routine use of a device to guide slow breathing significantly
lowers office measurements of blood pressure without adverse
effects. This modality may be a useful adjunct to current
antihypertensive medications and to non-pharmacologic
interventions in achieving better blood pressure control.
Reprints, full indication for use and additional information
can be found at www.resperate.com/MD .
References
1.
2.
3.
4.
5.
6.
7.
8.
Schein et al. J Human Hyperten 2001; 15:271-278.
Grossman et al. J Human Hyperten 2001; 15:263-269.
Rosenthal et al. Am J Hyperten 2001; 14:74-76.
Meles, et al. Am J Hyperten 2004, 17:370–374.
Elliott, et al. J Clin Hyperten 2004 6(10): 553-559.
Viskoper et al. Am J Hyperten 2003, 16:484-487.
Elliott et al. J Hyperten 2004; 22(2):S116
Parati et al. in Hypertension Primer, Lippincott, Williams, and Wilkins, 2003; Ch. A40,
p117-120.
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