Aims Digital therapeutics is a new approach to facilitate the non-pharmacological treatment of hypertension using software programmes such as smartphone applications and/or device algorithms. Based on promising findings from a small pilot trial, the HERB Digital Hypertension 1 (HERB-DH1) pivotal trial investigated the efficacy of digital therapeutics in patients with hypertension not receiving antihypertensive medication. Methods and results This prospective, open-label, randomized controlled study was performed at 12 sites in Japan. Patients with hypertension [office systolic blood pressure (SBP) 140 to <180 mmHg and 24 h SBP ≥130 mmHg] were randomly assigned 1:1 to the digital therapeutics group (HERB system + standard lifestyle modification) or control group (standard lifestyle modification alone). The primary efficacy endpoint was the mean change in 24 h ambulatory SBP from baseline to 12 weeks; key secondary efficacy endpoints were mean changes in office and home blood pressure (BP) from baseline to 12 weeks. All analyses were conducted in the full analysis set population. Between December 2019 and June 2020, 390 patients were randomly assigned to the digital therapeutics group (n = 199) or control (n = 191) group. Between-group differences in 24-h ambulatory, home, and office SBPs at 12 weeks were −2.4 (95% confidence interval −4.5 to −0.3), −4.3 (−6.7 to −1.9), and −3.6 (−6.2 to −1.0) mmHg, respectively. No major programme-related safety events occurred up to 24 weeks. Conclusion The HERB-DH1 pivotal study showed the superiority of digital therapeutics compared with standard lifestyle modification alone to reduce 24-h ambulatory, home, and office BPs in the absence of antihypertensive medications.

Purpose: Musculoskeletal diseases, including osteoarthritis (OA) and low back pain (LBP), are the leading causes of years lived with disability, and are associated with lowered quality-of-life, lost productivity, and increased healthcare costs. However, information publicly available regarding the Japanese real-world usage of prescription medications is limited. This study aimed to describe the clinical characteristics of patients with OA and chronic LBP (CLBP), and to investigate the patterns of medications and opioid use in Japanese real-world settings. Materials and methods: A retrospective study was conducted using a Japanese administrative claims database between 2013 and 2017. The outcomes were patient characteristics and prescription medications, and they were evaluated separately for OA and CLBP. Results: The mean age of 118,996 patients with OA and 256,402 patients with CLBP was 68.8±13.1 years and 64.8±16.4 years, respectively. Approximately 90% of patients with OA and CLBP were prescribed non-steroidal anti-inflammatory drugs (NSAIDs). Other prescriptions included hyaluronate injection (35.6%), acetaminophen (21.4%), and steroid injection (20.0%) in patients with OA, and pregabalin (39.0%) and acetaminophen (22.4%) in patients with CLBP. Weak opioids were prescribed to 10.7% and 20.6% of patients with OA and CLBP, respectively. The prescription of COX-2 inhibitors (OA: +6.5%; CLBP: +6.7%) and acetaminophen (OA: +16.4%; CLBP: +14.4%) increased between 2013 and 2017. The first commonly prescribed medication among patients with OA and CLBP were NSAIDs; hyaluronate injection (patients with OA) and pregabalin (patients with CLBP) were also common first-line medications. Acetaminophen, steroid injection (patients with OA), and weak opioids were prescribed more in the later phases of treatment. Conclusion: Most patients were prescribed limited classes of pain drugs, with NSAIDs being the most common pain medication in Japan for patients with OA and CLBP. Opioid prescription was uncommon, and were weak opioids when prescribed.

Digital therapeutics refers to the use of evidence-based therapeutic interventions driven by high-quality software programs to treat, manage, or prevent a medical condition. This approach is being increasingly investigated for the management of hypertension, a common condition that is the leading preventable cardiovascular disease risk factor worldwide. Digital interventions can help facilitate uptake of important guideline-recommended lifestyle modifications, reinforce home blood pressure monitoring, decrease therapeutic inertia, and improve medication adherence. However, current studies are only of moderate quality, and are highly heterogeneous in the interventions evaluated, comparator used, and results obtained. Therefore, additional studies are needed, focusing on the development of universally applicable and consistent digital therapeutic strategies designed with health care professional input and evaluation of these interventions in robust clinical trials with objective end points. Hopefully, the momentum for digital therapeutics triggered by the coronavirus disease 2019 pandemic can be utilized to maximize advancements in this field and drive widespread implementation.

This study investigated the association between salt intake and risk of disaster hypertension. We analyzed the data of surveys evaluating the health condition of evacuees in shelters after the Great East Japan Earthquake on April 30 and May 5, 2011. Among 272 subjects who completed the basic health condition questionnaire and underwent a medical examination, 158 (58%) had disaster hypertension (systolic blood pressure ≥140 mm Hg or diastolic blood pressure ≥90 mm Hg). Average estimated sodium intake assessed by spot urine was significantly associated with disaster hypertension (odds ratio per 1 g/d, 1.16; 95% CI, 1.05–1.30). When we defined the high risk factors for salt-sensitive hypertension as older age (≥65 years), obesity (body mass index, ≥25 kg/m 2 ), chronic kidney disease, and diabetes mellitus, estimated sodium intake was found to be a risk factor for disaster hypertension in the total group (odds ratio per 1 g/d, 1.27; 95% CI, 1.12–1.43) and even in the group without prevalent hypertension before disaster (n=146; odds ratio per 1 g/d, 1.46; 95% CI, 1.19–1.79). There was an interaction between estimated sodium intake and disaster hypertension according to the presence or absence of high risk of salt-sensitive hypertension in the group without prevalent hypertension ( P =0.03). Disaster hypertension conferred a risk of microalbuminuria (odds ratio, 3.00; 95% CI, 1.71–5.26; P <0.001). We conclude that increased estimated sodium intake was associated with disaster hypertension in evacuees after disaster. This association was noted in the population with high risk of salt-sensitive hypertension and without prevalent hypertension before natural disaster. Additionally, disaster hypertension was associated with subclinical organ damage.

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