Luis M. Ruilope, MD- Digital therapeutics and lifestyle: the start of a new era in the management of arterial hyperte...

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Luis M. Ruilope is a professor at the Autonoma University's Department of Public Health and Preventive Medicine and the director of the Instituto de Investigación 12 de Octubre's Cardiovascular and Renal Risk, both in Madrid, Spain. His main areas of interest include hypertension and cardiovascular risk. In this video Dr. Ruilope speaks on Digital therapeutics and lifestyle.

Link to Abstract-

Hypertension, defined as a clinic blood pressure (BP) of less than 140/90 mmHg according to the most recent European [European Society of Cardiology (ESC)/European Society of Hypertension (ESH)] guidelines1, affects nearly a third of adults worldwide, and it is still one of the leading causes of premature death. 2

The 'westernized way of life,' which is characterized not only by physical inactivity and unhealthy dietary habits, which have resulted in a true pandemic of overweight/obesity, but also by frequent disruption of circadian rhythms with poor sleep patterns and high levels of psychosocial stress, is likely to increase the prevalence of hypertension in the years ahead.

3 In contrast, 'non-westernized' populations (e.g., hunter–gatherers like the Hadza, or foragers–horticulturists like the Tsimané or Yanomani) who continue to live in ways that are similar to those that have characterized human evolution (with high levels of daily physical activity and sleep–wake cycles corresponding to natural dark–light exposure, among other things) have a very low prevalence of hypertension, with virtually no evidence of age-related 3 The ESC/ESH guidelines, on the other hand, consider an optimal lifestyle (i.e. 150–300 minutes of moderate–vigorous physical activity per week, dynamic resistance such as lifting weights two–three times per week, increased consumption of vegetables, fresh fruits, fish, nuts, and unsaturated fatty acids, sodium intake 2000 mg/day, maintaining a body mass index of 20–25 kg/m2, moderate alcohol intake, and avoiding smoking) to be the only treatment needed for people with mild 1 Indeed, prescribing antihypertensive medicines at the outset has no effect on the incidence of CVD or death in people with moderate hypertension who are at low risk, and may potentially increase the risk of adverse events (e.g. hypotension, electrolyte abnormalities, or acute kidney injury). 4

In fact, there is strong evidence that living a healthy lifestyle can help prevent or control hypertension.

3 For example, a network meta-analysis (n = 39 742 participants) indicated that exercise programs and antihypertensive medication were equally beneficial in lowering blood pressure in people with hypertension.

5 There is also strong evidence for body weight reductions back to normal values in people who are overweight or obese,6 sodium restriction in people who have been diagnosed with hypertension,7 and the Dietary Approaches to Stop Hypertension (DASH) diet in people who have pre-hypertension or hypertension.

8 Furthermore, while more study is needed, accumulating evidence supports the use of less "traditional" techniques, such as circadian entrainment and stress management strategies, notwithstanding the need for more research. 3

The molecular processes explaining the effects of lifestyle intervention against hypertension are multisystemic, in contrast to the many antihypertensive medications. Preventing obesity and insulin resistance, improving vascular health—through improved redox and inflammatory status, or a healthy pattern of vessel remodelling in those who exercise regularly (i.e. an increase in the luminal diameter of conduit and resistance arteries, as well as the capillary density of skeletal muscle tissue)—and reducing sympathetic nervous system overactivity are just a few examples (SNS). 3 Regular exercise can also help to lower blood pressure through 'non-traditional' mechanisms, such as the release of muscle-derived factors (usually, but not always, small peptides) known as'myokines,' which are produced in the exercise environment and can travel through the bloodstream to induce a variety of beneficial effects, such as reduced inflammation or vasorelaxation. 9

However, in our modern communities, one of the primary issues with lifestyle modifications is sustainability. The effects of exercise intervention to lower blood pressure in young individuals with pre-hypertension/hypertension are lost after 12 months, according to meta-analytical evidence. 10 Similarly, a recent network meta-analysis indicated that while varied diets result in considerable weight and blood pressure reductions after 6 months, there are essentially no advantages beyond 12 months. 11 How can we effectively increase Westerners' adherence to healthy lifestyle interventions? One option is to exploit the present over-reliance on cellphones and other devices as a health tool. A new notion of personalised medical follow-up (dubbed "mHealth"), along with efforts by companies like Google and Apple to make their devices into mobile health centers, might usher in a new era in medicine. Another initiative along these lines is 'Digital therapeutics,' which aims to make disease management easier by encouraging people to make lifestyle changes. Despite the fast increasing availability of mobile technology aimed at improving blood pressure management, scientific evidence of their efficacy remains scarce. 12,13

The findings of HERB-DH1, a pivotal trial investigating the efficacy and safety of Digital therapeutics (a 12-week intervention followed by a 12-week follow-up) in patients with untreated essential hypertension (baseline office and ambulatory 24 h BP 140/90 mmHg and 130/80 mmHg, respectively) are reported in this issue of the European Heart Journal by Kario et al.14. HERB mobile is a new interactive smartphone software that encourages extensive lifestyle changes (such as lowering salt intake, controlling body weight, exercising, improving sleep patterns, stress coping, and limiting alcohol use) that can lead to a considerable reduction in blood pressure. Kario et al.14 developed their trial in three steps: I a lecture and advising program, followed by (ii) lifestyle interventions and (iii) self-planning and evaluation with participants, who were then encouraged to adopt the various lifestyle alterations into their lives. The intervention group showed a significant reduction in office, home, and 24-hour BP when compared to a control group that received lifestyle recommendations without the support of the mobile app, followed by improved BP control with the addition of antihypertensive medication in the second part of the study. These results were accompanied by improvements in secondary outcomes such as bigger salt intake reductions and lower body weight.

Kario et al.14's findings are intriguing and add to the body of knowledge about how to achieve adequate goals in arterial hypertension. Aside from the necessity to replicate these findings in additional cohorts, there are a few factors to consider. One is the intervention's long-term viability, with variations in blood pressure between groups marginally reduced after 24 weeks. Adherence to interventions is a crucial challenge in this regard. In this regard, participants in the study by Kario et al. showed near ideal adherence, as evidenced by a >95 percent engagement rate with the mobile app and >90 percent completion of the trial's recommendations in steps I and (ii). Future studies should show whether adherence, as well as the BP advantages, can be sustained over time. On the other hand, in order to use the app appropriately, physicians in charge must develop an adequate contact with the patient, which may constitute a time constraint. This new methodology may, in our judgment, be led by well-trained nurses. Finally, it has to be seen whether this unique method can prevent the development of sustained hypertension in persons with pre-hypertension, which would be a huge breakthrough in the area.

To effectively apply healthy lifestyle modifications for the prevention and control of arterial hypertension, more effort is required. Digital therapies, for example, could pave the way for a new era in which new millennium technology can be employed to help us return to a more "traditional" (non-westernized) way of life (Graphical Abstract).