InterCure, UK Limited (Manufacturer of RESPeRATE). 1st
Transcription
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. RR overview March 05 izzo and black