IBS prevalence in veterans and its associations with psychological factors

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Key clinical point: Irritable bowel syndrome (IBS) is prevalent among veterans and is associated with significant psychological comorbidities.

 

Major finding: Overall, 28.4% of veterans met Rome IV IBS criteria, and significant associations of IBS with anxiety (adjusted odds ratio [aOR], 3.47; P < .001), depression (aOR, 2.88; P < .001), post-traumatic stress disorder (aOR, 3.09; P < .001), prior infectious enteritis (aOR, 4.44; P < .001), and a history of bowel problems after antibiotics (aOR, 1.84; P = .005) were observed.

 

Study details: The data come from a cross-sectional survey including 858 veteran respondents (mean age, 53.6 years), of whom 244 had IBS.

 

Disclosures: The authors declared no conflicts of interest.

 

Source: Shin A et al. The prevalence, humanistic burden, and healthcare impact of irritable bowel syndrome (IBS) among United States veterans. Clin Gastroenterol Hepatol. 2022 (Aug 11). Doi: 10.1016/j.cgh.2022.08.005.

 

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Key clinical point: Irritable bowel syndrome (IBS) is prevalent among veterans and is associated with significant psychological comorbidities.

 

Major finding: Overall, 28.4% of veterans met Rome IV IBS criteria, and significant associations of IBS with anxiety (adjusted odds ratio [aOR], 3.47; P < .001), depression (aOR, 2.88; P < .001), post-traumatic stress disorder (aOR, 3.09; P < .001), prior infectious enteritis (aOR, 4.44; P < .001), and a history of bowel problems after antibiotics (aOR, 1.84; P = .005) were observed.

 

Study details: The data come from a cross-sectional survey including 858 veteran respondents (mean age, 53.6 years), of whom 244 had IBS.

 

Disclosures: The authors declared no conflicts of interest.

 

Source: Shin A et al. The prevalence, humanistic burden, and healthcare impact of irritable bowel syndrome (IBS) among United States veterans. Clin Gastroenterol Hepatol. 2022 (Aug 11). Doi: 10.1016/j.cgh.2022.08.005.

 

Key clinical point: Irritable bowel syndrome (IBS) is prevalent among veterans and is associated with significant psychological comorbidities.

 

Major finding: Overall, 28.4% of veterans met Rome IV IBS criteria, and significant associations of IBS with anxiety (adjusted odds ratio [aOR], 3.47; P < .001), depression (aOR, 2.88; P < .001), post-traumatic stress disorder (aOR, 3.09; P < .001), prior infectious enteritis (aOR, 4.44; P < .001), and a history of bowel problems after antibiotics (aOR, 1.84; P = .005) were observed.

 

Study details: The data come from a cross-sectional survey including 858 veteran respondents (mean age, 53.6 years), of whom 244 had IBS.

 

Disclosures: The authors declared no conflicts of interest.

 

Source: Shin A et al. The prevalence, humanistic burden, and healthcare impact of irritable bowel syndrome (IBS) among United States veterans. Clin Gastroenterol Hepatol. 2022 (Aug 11). Doi: 10.1016/j.cgh.2022.08.005.

 

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Somatization and celiac disease among primary risk factors for IBS

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Key clinical point: Somatization and celiac disease are the primary risk factors associated with irritable bowel syndrome (IBS) in both men and women.

 

Major finding: The risk for IBS was almost 4-fold higher in men (adjusted odds ratio [aOR] 4.786; 95% CI 4.544-5.041) and women (aOR 5.326; 95% CI 4.863-5.832) experiencing somatization, with the second important influencing factor being celiac disease (men: aOR 4.107; 95% CI 3.132-5.385; women: aOR 3.783; 95% CI 3.310-4.323).

 

Study details: This study included 31,918 participants who met the Rome III criteria for IBS and completed the Digestive Health Questionnaire.

 

Disclosures: This study was supported by QW of the National Natural Science Foundation of China and the National Office for Philosophy and Social Sciences. The authors declared no potential conflicts of interest.

 

Source: Wang K et al. Factors related to irritable bowel syndrome and differences among subtypes: A cross-sectional study in the UK Biobank. Front Pharmacol. 2022;13:905564 (Aug 26). Doi: 10.3389/fphar.2022.905564

 

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Key clinical point: Somatization and celiac disease are the primary risk factors associated with irritable bowel syndrome (IBS) in both men and women.

 

Major finding: The risk for IBS was almost 4-fold higher in men (adjusted odds ratio [aOR] 4.786; 95% CI 4.544-5.041) and women (aOR 5.326; 95% CI 4.863-5.832) experiencing somatization, with the second important influencing factor being celiac disease (men: aOR 4.107; 95% CI 3.132-5.385; women: aOR 3.783; 95% CI 3.310-4.323).

 

Study details: This study included 31,918 participants who met the Rome III criteria for IBS and completed the Digestive Health Questionnaire.

 

Disclosures: This study was supported by QW of the National Natural Science Foundation of China and the National Office for Philosophy and Social Sciences. The authors declared no potential conflicts of interest.

 

Source: Wang K et al. Factors related to irritable bowel syndrome and differences among subtypes: A cross-sectional study in the UK Biobank. Front Pharmacol. 2022;13:905564 (Aug 26). Doi: 10.3389/fphar.2022.905564

 

Key clinical point: Somatization and celiac disease are the primary risk factors associated with irritable bowel syndrome (IBS) in both men and women.

 

Major finding: The risk for IBS was almost 4-fold higher in men (adjusted odds ratio [aOR] 4.786; 95% CI 4.544-5.041) and women (aOR 5.326; 95% CI 4.863-5.832) experiencing somatization, with the second important influencing factor being celiac disease (men: aOR 4.107; 95% CI 3.132-5.385; women: aOR 3.783; 95% CI 3.310-4.323).

 

Study details: This study included 31,918 participants who met the Rome III criteria for IBS and completed the Digestive Health Questionnaire.

 

Disclosures: This study was supported by QW of the National Natural Science Foundation of China and the National Office for Philosophy and Social Sciences. The authors declared no potential conflicts of interest.

 

Source: Wang K et al. Factors related to irritable bowel syndrome and differences among subtypes: A cross-sectional study in the UK Biobank. Front Pharmacol. 2022;13:905564 (Aug 26). Doi: 10.3389/fphar.2022.905564

 

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Supplementation with a multistrain probiotic improves leaky gut in patients with IBS-D

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Key clinical point: Supplementation with a multistrain probiotic for 30 days improved intestinal permeability, stool consistency, and health-related quality-of-life (QoL) in a considerable proportion of patients with diarrhea-predominant irritable bowel syndrome (IBS-D).

 

Major finding: On day 30, the intestinal permeability improved or normalized in 81.5% of patients, with the intestinal permeability decreasing by 3.4 units (P = .0005), the Bristol Stool Scale score decreasing by 0.9 units (P = .0057), and the IBS-QoL total score increasing by 8.0 points (95% CI 3.0-12.9). The multistrain probiotic was well tolerated.

 

Study details: The data come from a pilot, open-label, prospective, phase 4 study including 30 patients with IBS-D and leaky gut who received 2 capsules of multistrain probiotic daily for 30 days.

 

Disclosures: This study was sponsored by PiLeJe Laboratoire. SA Abdellah and C Gal declared being employees of PiLeJe Laboratoire. L Laterza and A Gasbarrini reported ties with various sources.

 

Source: Ait Abdellah S et al. Effect of a multistrain probiotic on leaky gut in patients with diarrhea-predominant irritable bowel syndrome (IBS-D): A pilot study. Dig Dis. 2022 (Aug 25). Doi: 10.1159/000526712

 

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Key clinical point: Supplementation with a multistrain probiotic for 30 days improved intestinal permeability, stool consistency, and health-related quality-of-life (QoL) in a considerable proportion of patients with diarrhea-predominant irritable bowel syndrome (IBS-D).

 

Major finding: On day 30, the intestinal permeability improved or normalized in 81.5% of patients, with the intestinal permeability decreasing by 3.4 units (P = .0005), the Bristol Stool Scale score decreasing by 0.9 units (P = .0057), and the IBS-QoL total score increasing by 8.0 points (95% CI 3.0-12.9). The multistrain probiotic was well tolerated.

 

Study details: The data come from a pilot, open-label, prospective, phase 4 study including 30 patients with IBS-D and leaky gut who received 2 capsules of multistrain probiotic daily for 30 days.

 

Disclosures: This study was sponsored by PiLeJe Laboratoire. SA Abdellah and C Gal declared being employees of PiLeJe Laboratoire. L Laterza and A Gasbarrini reported ties with various sources.

 

Source: Ait Abdellah S et al. Effect of a multistrain probiotic on leaky gut in patients with diarrhea-predominant irritable bowel syndrome (IBS-D): A pilot study. Dig Dis. 2022 (Aug 25). Doi: 10.1159/000526712

 

Key clinical point: Supplementation with a multistrain probiotic for 30 days improved intestinal permeability, stool consistency, and health-related quality-of-life (QoL) in a considerable proportion of patients with diarrhea-predominant irritable bowel syndrome (IBS-D).

 

Major finding: On day 30, the intestinal permeability improved or normalized in 81.5% of patients, with the intestinal permeability decreasing by 3.4 units (P = .0005), the Bristol Stool Scale score decreasing by 0.9 units (P = .0057), and the IBS-QoL total score increasing by 8.0 points (95% CI 3.0-12.9). The multistrain probiotic was well tolerated.

 

Study details: The data come from a pilot, open-label, prospective, phase 4 study including 30 patients with IBS-D and leaky gut who received 2 capsules of multistrain probiotic daily for 30 days.

 

Disclosures: This study was sponsored by PiLeJe Laboratoire. SA Abdellah and C Gal declared being employees of PiLeJe Laboratoire. L Laterza and A Gasbarrini reported ties with various sources.

 

Source: Ait Abdellah S et al. Effect of a multistrain probiotic on leaky gut in patients with diarrhea-predominant irritable bowel syndrome (IBS-D): A pilot study. Dig Dis. 2022 (Aug 25). Doi: 10.1159/000526712

 

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Increased risk for IBS among women with endometriosis

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Key clinical point: Endometriosis is associated with a 3-fold increase in the risk for irritable bowel syndrome (IBS), with 1 in every 5 women with endometriosis having IBS.

 

Major finding: The odds of IBS were significantly higher in women with endometriosis compared with healthy controls (odds ratio 2.97; 95% CI 2.17-4.06), and the pooled prevalence of IBS among women with endometriosis was 23.4% (95% CI 9.7%-37.2%).

 

Study details: This study evaluated the prevalence of IBS in endometriosis (meta-analysis of 6 studies) and association between endometriosis and IBS (meta-analysis of 11 studies involving 18,887 patients with endometriosis and 77,171 healthy controls).

 

Disclosures: This study did not report any source of funding. The authors declared no conflicts of interest.

 

Source: Nabi MY et al. Endometriosis and irritable bowel syndrome: A systematic review and meta-analyses. Front Med (Lausanne). 2022;9:914356 (Jul 25). Doi: 10.3389/fmed.2022.914356

 

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Key clinical point: Endometriosis is associated with a 3-fold increase in the risk for irritable bowel syndrome (IBS), with 1 in every 5 women with endometriosis having IBS.

 

Major finding: The odds of IBS were significantly higher in women with endometriosis compared with healthy controls (odds ratio 2.97; 95% CI 2.17-4.06), and the pooled prevalence of IBS among women with endometriosis was 23.4% (95% CI 9.7%-37.2%).

 

Study details: This study evaluated the prevalence of IBS in endometriosis (meta-analysis of 6 studies) and association between endometriosis and IBS (meta-analysis of 11 studies involving 18,887 patients with endometriosis and 77,171 healthy controls).

 

Disclosures: This study did not report any source of funding. The authors declared no conflicts of interest.

 

Source: Nabi MY et al. Endometriosis and irritable bowel syndrome: A systematic review and meta-analyses. Front Med (Lausanne). 2022;9:914356 (Jul 25). Doi: 10.3389/fmed.2022.914356

 

Key clinical point: Endometriosis is associated with a 3-fold increase in the risk for irritable bowel syndrome (IBS), with 1 in every 5 women with endometriosis having IBS.

 

Major finding: The odds of IBS were significantly higher in women with endometriosis compared with healthy controls (odds ratio 2.97; 95% CI 2.17-4.06), and the pooled prevalence of IBS among women with endometriosis was 23.4% (95% CI 9.7%-37.2%).

 

Study details: This study evaluated the prevalence of IBS in endometriosis (meta-analysis of 6 studies) and association between endometriosis and IBS (meta-analysis of 11 studies involving 18,887 patients with endometriosis and 77,171 healthy controls).

 

Disclosures: This study did not report any source of funding. The authors declared no conflicts of interest.

 

Source: Nabi MY et al. Endometriosis and irritable bowel syndrome: A systematic review and meta-analyses. Front Med (Lausanne). 2022;9:914356 (Jul 25). Doi: 10.3389/fmed.2022.914356

 

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IBS symptoms affecting more than two-thirds of patients with IBD

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Key clinical point: More than two-thirds of patients with inflammatory bowel disease (IBD) were affected by irritable bowel syndrome (IBS)-type symptoms, which were associated with worse depression, anxiety, somatoform symptoms, and quality-of-life scores.

 

Major finding: Overall, 67.2% of patients reported IBS-type symptoms at least once during the follow-up, with anxiety, depression, and somatoform symptom scores being worse in patients with vs without IBS-type symptoms (P < .001).

 

Study details: The data come from a 6-year longitudinal follow-up study including 760 individuals with well-characterized IBD.

 

Disclosures: This study was funded by The Leeds Teaching Hospitals Charitable Foundation and Tillotts Pharma U.K. Ltd. The authors declared no conflicts of interest.

 

Source: Fairbrass KM et al. Natural history and impact of irritable bowel syndrome-type symptoms in inflammatory bowel disease during 6 years of longitudinal follow-up. Aliment Pharmacol Ther. 2022 (Aug 22). Doi: 10.1111/apt.17193

 

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Key clinical point: More than two-thirds of patients with inflammatory bowel disease (IBD) were affected by irritable bowel syndrome (IBS)-type symptoms, which were associated with worse depression, anxiety, somatoform symptoms, and quality-of-life scores.

 

Major finding: Overall, 67.2% of patients reported IBS-type symptoms at least once during the follow-up, with anxiety, depression, and somatoform symptom scores being worse in patients with vs without IBS-type symptoms (P < .001).

 

Study details: The data come from a 6-year longitudinal follow-up study including 760 individuals with well-characterized IBD.

 

Disclosures: This study was funded by The Leeds Teaching Hospitals Charitable Foundation and Tillotts Pharma U.K. Ltd. The authors declared no conflicts of interest.

 

Source: Fairbrass KM et al. Natural history and impact of irritable bowel syndrome-type symptoms in inflammatory bowel disease during 6 years of longitudinal follow-up. Aliment Pharmacol Ther. 2022 (Aug 22). Doi: 10.1111/apt.17193

 

Key clinical point: More than two-thirds of patients with inflammatory bowel disease (IBD) were affected by irritable bowel syndrome (IBS)-type symptoms, which were associated with worse depression, anxiety, somatoform symptoms, and quality-of-life scores.

 

Major finding: Overall, 67.2% of patients reported IBS-type symptoms at least once during the follow-up, with anxiety, depression, and somatoform symptom scores being worse in patients with vs without IBS-type symptoms (P < .001).

 

Study details: The data come from a 6-year longitudinal follow-up study including 760 individuals with well-characterized IBD.

 

Disclosures: This study was funded by The Leeds Teaching Hospitals Charitable Foundation and Tillotts Pharma U.K. Ltd. The authors declared no conflicts of interest.

 

Source: Fairbrass KM et al. Natural history and impact of irritable bowel syndrome-type symptoms in inflammatory bowel disease during 6 years of longitudinal follow-up. Aliment Pharmacol Ther. 2022 (Aug 22). Doi: 10.1111/apt.17193

 

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High degree of fatty liver and NAFLD tied to increased incident IBS risk

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Key clinical point: The risk for incident irritable bowel syndrome (IBS) was significantly higher in individuals in the highest vs lowest quartile of nonalcoholic fatty liver index and in those with a diagnosis of nonalcoholic fatty liver disease (NAFLD).

 

Major finding: The risk of developing IBS was 21% higher among individuals in the highest vs lowest quartile of fatty liver index (hazard ratio [HR] 1.21; Ptrend < .001) and 13% higher among patients with vs without NAFLD (HR 1.13; 95% CI 1.05-1.17).

 

Study details: Findings are from an analysis of 396,838 participants from a large-scale prospective cohort who were free from IBS, any cancer, inflammatory bowel disease, alcoholic liver disease, and celiac disease, of which 38.6% had an NAFLD diagnosis.

 

Disclosures: This study was funded by the National Natural Science Foundation of China. The authors declared no conflicts of interest.

 

Source: Wu S et al. Non-alcoholic fatty liver is associated with increased risk of irritable bowel syndrome: A prospective cohort study. BMC Med. 2022;20(1):262 (Aug 22). Doi: 10.1186/s12916-022-02460-8

 

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Key clinical point: The risk for incident irritable bowel syndrome (IBS) was significantly higher in individuals in the highest vs lowest quartile of nonalcoholic fatty liver index and in those with a diagnosis of nonalcoholic fatty liver disease (NAFLD).

 

Major finding: The risk of developing IBS was 21% higher among individuals in the highest vs lowest quartile of fatty liver index (hazard ratio [HR] 1.21; Ptrend < .001) and 13% higher among patients with vs without NAFLD (HR 1.13; 95% CI 1.05-1.17).

 

Study details: Findings are from an analysis of 396,838 participants from a large-scale prospective cohort who were free from IBS, any cancer, inflammatory bowel disease, alcoholic liver disease, and celiac disease, of which 38.6% had an NAFLD diagnosis.

 

Disclosures: This study was funded by the National Natural Science Foundation of China. The authors declared no conflicts of interest.

 

Source: Wu S et al. Non-alcoholic fatty liver is associated with increased risk of irritable bowel syndrome: A prospective cohort study. BMC Med. 2022;20(1):262 (Aug 22). Doi: 10.1186/s12916-022-02460-8

 

Key clinical point: The risk for incident irritable bowel syndrome (IBS) was significantly higher in individuals in the highest vs lowest quartile of nonalcoholic fatty liver index and in those with a diagnosis of nonalcoholic fatty liver disease (NAFLD).

 

Major finding: The risk of developing IBS was 21% higher among individuals in the highest vs lowest quartile of fatty liver index (hazard ratio [HR] 1.21; Ptrend < .001) and 13% higher among patients with vs without NAFLD (HR 1.13; 95% CI 1.05-1.17).

 

Study details: Findings are from an analysis of 396,838 participants from a large-scale prospective cohort who were free from IBS, any cancer, inflammatory bowel disease, alcoholic liver disease, and celiac disease, of which 38.6% had an NAFLD diagnosis.

 

Disclosures: This study was funded by the National Natural Science Foundation of China. The authors declared no conflicts of interest.

 

Source: Wu S et al. Non-alcoholic fatty liver is associated with increased risk of irritable bowel syndrome: A prospective cohort study. BMC Med. 2022;20(1):262 (Aug 22). Doi: 10.1186/s12916-022-02460-8

 

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Home BP monitoring in older adults falls short of recommendations

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Just over 51% of older hypertensive adults regularly check their own blood pressure, compared with 48% of those with blood pressure–related health conditions (BPHCs), based on a 2021 survey of individuals aged 50-80 years.

“Guidelines recommend that patients use self-measured blood pressure monitoring (SBPM) outside the clinic to diagnose and manage hypertension,” but just 61% of respondents with a BPHC and 68% of those with hypertension said that they had received such a recommendation from a physician, nurse, or other health care professional, Melanie V. Springer, MD, and associates said in JAMA Network Open.

The prevalence of regular monitoring among those with hypertension, 51.2%, does, however, compare favorably with an earlier study showing that 43% of adults aged 18 and older regularly monitored their BP in 2005 and 2008, “which is perhaps associated with our sample’s older age,” said Dr. Springer and associates of the University of Michigan, Ann Arbor.

The current study, they noted, is the first to report “SBPM prevalence in adults ages 50 to 80 years with hypertension or BPHCs, who have a higher risk of adverse outcomes from uncontrolled BP than younger adults.” The analysis is based on data from the National Poll on Healthy Aging, conducted by the University of Michigan in January 2021 and completed by 2,023 individuals.

The frequency of home monitoring varied among adults with BPHCs, as just under 15% reported daily checks and the largest proportion, about 28%, used their device one to three times per month. The results of home monitoring were shared with health care professionals by 50.2% of respondents with a BPHC and by 51.5% of those with hypertension, they said in the research letter.

Home monitoring’s less-than-universal recommendation by providers and use by patients “suggest that protocols should be developed to educate patients about the importance of SBPM and sharing readings with clinicians and the frequency that SBPM should be performed,” Dr. Springer and associates wrote.

The study was funded by AARP, Michigan Medicine, the National Institute of Neurological Disorders and Stroke, and the Department of Veterans Affairs. One investigator has received consulting fees or honoraria from SeeChange Health, HealthMine, the Kaiser Permanente Washington Health Research Institute, the Robert Wood Johnson Foundation, AbilTo, Kansas City Area Life Sciences Institute, American Diabetes Association, Donaghue Foundation, and Luxembourg National Research Fund.

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Just over 51% of older hypertensive adults regularly check their own blood pressure, compared with 48% of those with blood pressure–related health conditions (BPHCs), based on a 2021 survey of individuals aged 50-80 years.

“Guidelines recommend that patients use self-measured blood pressure monitoring (SBPM) outside the clinic to diagnose and manage hypertension,” but just 61% of respondents with a BPHC and 68% of those with hypertension said that they had received such a recommendation from a physician, nurse, or other health care professional, Melanie V. Springer, MD, and associates said in JAMA Network Open.

The prevalence of regular monitoring among those with hypertension, 51.2%, does, however, compare favorably with an earlier study showing that 43% of adults aged 18 and older regularly monitored their BP in 2005 and 2008, “which is perhaps associated with our sample’s older age,” said Dr. Springer and associates of the University of Michigan, Ann Arbor.

The current study, they noted, is the first to report “SBPM prevalence in adults ages 50 to 80 years with hypertension or BPHCs, who have a higher risk of adverse outcomes from uncontrolled BP than younger adults.” The analysis is based on data from the National Poll on Healthy Aging, conducted by the University of Michigan in January 2021 and completed by 2,023 individuals.

The frequency of home monitoring varied among adults with BPHCs, as just under 15% reported daily checks and the largest proportion, about 28%, used their device one to three times per month. The results of home monitoring were shared with health care professionals by 50.2% of respondents with a BPHC and by 51.5% of those with hypertension, they said in the research letter.

Home monitoring’s less-than-universal recommendation by providers and use by patients “suggest that protocols should be developed to educate patients about the importance of SBPM and sharing readings with clinicians and the frequency that SBPM should be performed,” Dr. Springer and associates wrote.

The study was funded by AARP, Michigan Medicine, the National Institute of Neurological Disorders and Stroke, and the Department of Veterans Affairs. One investigator has received consulting fees or honoraria from SeeChange Health, HealthMine, the Kaiser Permanente Washington Health Research Institute, the Robert Wood Johnson Foundation, AbilTo, Kansas City Area Life Sciences Institute, American Diabetes Association, Donaghue Foundation, and Luxembourg National Research Fund.

Just over 51% of older hypertensive adults regularly check their own blood pressure, compared with 48% of those with blood pressure–related health conditions (BPHCs), based on a 2021 survey of individuals aged 50-80 years.

“Guidelines recommend that patients use self-measured blood pressure monitoring (SBPM) outside the clinic to diagnose and manage hypertension,” but just 61% of respondents with a BPHC and 68% of those with hypertension said that they had received such a recommendation from a physician, nurse, or other health care professional, Melanie V. Springer, MD, and associates said in JAMA Network Open.

The prevalence of regular monitoring among those with hypertension, 51.2%, does, however, compare favorably with an earlier study showing that 43% of adults aged 18 and older regularly monitored their BP in 2005 and 2008, “which is perhaps associated with our sample’s older age,” said Dr. Springer and associates of the University of Michigan, Ann Arbor.

The current study, they noted, is the first to report “SBPM prevalence in adults ages 50 to 80 years with hypertension or BPHCs, who have a higher risk of adverse outcomes from uncontrolled BP than younger adults.” The analysis is based on data from the National Poll on Healthy Aging, conducted by the University of Michigan in January 2021 and completed by 2,023 individuals.

The frequency of home monitoring varied among adults with BPHCs, as just under 15% reported daily checks and the largest proportion, about 28%, used their device one to three times per month. The results of home monitoring were shared with health care professionals by 50.2% of respondents with a BPHC and by 51.5% of those with hypertension, they said in the research letter.

Home monitoring’s less-than-universal recommendation by providers and use by patients “suggest that protocols should be developed to educate patients about the importance of SBPM and sharing readings with clinicians and the frequency that SBPM should be performed,” Dr. Springer and associates wrote.

The study was funded by AARP, Michigan Medicine, the National Institute of Neurological Disorders and Stroke, and the Department of Veterans Affairs. One investigator has received consulting fees or honoraria from SeeChange Health, HealthMine, the Kaiser Permanente Washington Health Research Institute, the Robert Wood Johnson Foundation, AbilTo, Kansas City Area Life Sciences Institute, American Diabetes Association, Donaghue Foundation, and Luxembourg National Research Fund.

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Vibegron fails to improve IBS-symptoms in phase 2 trial

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Key clinical point: Once-daily 75 mg vibegron was not associated with a clinically significant improvement in irritable bowel syndrome (IBS)-associated abdominal pain in women with diarrhea-predominant IBS (IBS-D) or mixed diarrhea/constipation IBS (IBS-M).

 

Major finding: At week 12, the percentage of women with IBS-D (40.9% vs 42.9%; P = .8222) or IBS-M (28.9% vs 24.4%; P = .6151) experiencing ≥30% improvement in IBS-associated abdominal pain was not significantly different with vibegron vs placebo. The incidence of treatment-emergent adverse events was comparable between the treatment groups.

 

Study details: The data come from a phase 2 randomized controlled trial including 222 adult women with IBS-D or IBS-M who were randomly assigned to receive 75 mg vibegron (n = 111) or placebo (n = 111).

 

Disclosures: This study was funded by Urovant Sciences. J King, D Shortino, C Schaumburg, and C Haag-Molkenteller declared being former employees of Urovant Sciences. Some authors declared receiving research grants or serving as consultants or on scientific advisory boards for various sources, including Urovant Sciences.

 

Source: Lacy BE et al. Efficacy and safety of vibegron for the treatment of irritable bowel syndrome in women: Results of a randomized, double-blind, placebo-controlled phase 2 trial. Neurogastroenterol Motil. 2022;e14448 (Aug 16). Doi: 10.1111/nmo.14448

 

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Key clinical point: Once-daily 75 mg vibegron was not associated with a clinically significant improvement in irritable bowel syndrome (IBS)-associated abdominal pain in women with diarrhea-predominant IBS (IBS-D) or mixed diarrhea/constipation IBS (IBS-M).

 

Major finding: At week 12, the percentage of women with IBS-D (40.9% vs 42.9%; P = .8222) or IBS-M (28.9% vs 24.4%; P = .6151) experiencing ≥30% improvement in IBS-associated abdominal pain was not significantly different with vibegron vs placebo. The incidence of treatment-emergent adverse events was comparable between the treatment groups.

 

Study details: The data come from a phase 2 randomized controlled trial including 222 adult women with IBS-D or IBS-M who were randomly assigned to receive 75 mg vibegron (n = 111) or placebo (n = 111).

 

Disclosures: This study was funded by Urovant Sciences. J King, D Shortino, C Schaumburg, and C Haag-Molkenteller declared being former employees of Urovant Sciences. Some authors declared receiving research grants or serving as consultants or on scientific advisory boards for various sources, including Urovant Sciences.

 

Source: Lacy BE et al. Efficacy and safety of vibegron for the treatment of irritable bowel syndrome in women: Results of a randomized, double-blind, placebo-controlled phase 2 trial. Neurogastroenterol Motil. 2022;e14448 (Aug 16). Doi: 10.1111/nmo.14448

 

Key clinical point: Once-daily 75 mg vibegron was not associated with a clinically significant improvement in irritable bowel syndrome (IBS)-associated abdominal pain in women with diarrhea-predominant IBS (IBS-D) or mixed diarrhea/constipation IBS (IBS-M).

 

Major finding: At week 12, the percentage of women with IBS-D (40.9% vs 42.9%; P = .8222) or IBS-M (28.9% vs 24.4%; P = .6151) experiencing ≥30% improvement in IBS-associated abdominal pain was not significantly different with vibegron vs placebo. The incidence of treatment-emergent adverse events was comparable between the treatment groups.

 

Study details: The data come from a phase 2 randomized controlled trial including 222 adult women with IBS-D or IBS-M who were randomly assigned to receive 75 mg vibegron (n = 111) or placebo (n = 111).

 

Disclosures: This study was funded by Urovant Sciences. J King, D Shortino, C Schaumburg, and C Haag-Molkenteller declared being former employees of Urovant Sciences. Some authors declared receiving research grants or serving as consultants or on scientific advisory boards for various sources, including Urovant Sciences.

 

Source: Lacy BE et al. Efficacy and safety of vibegron for the treatment of irritable bowel syndrome in women: Results of a randomized, double-blind, placebo-controlled phase 2 trial. Neurogastroenterol Motil. 2022;e14448 (Aug 16). Doi: 10.1111/nmo.14448

 

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Mesalazine not superior to placebo for global improvement of IBS symptoms

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Key clinical point: An 8-week treatment with mesalazine offered no clear benefits over placebo for global improvement of irritable bowel syndrome (IBS) symptoms.

 

Major finding: A similar proportion of patients receiving mesalazine vs placebo reported satisfactory relief of IBS symptoms during 50% of the treatment weeks (36% vs 30%; P = .40); however, the improvement in abdominal bloating was significantly greater in the mesalazine vs placebo group (P = .02).

 

Study details: The data come from a randomized controlled trial including 181 patients with IBS who were assigned to an 8-week treatment with 2400 mg mesalazine orally or placebo once daily.

 

Disclosures: This study was funded by Eurostars project grant from Tillotts Pharma AB and by the Swedish state. Some authors declared receiving research grants or serving as consultants or on advisory boards for various sources, including Tillotts Pharma.

 

Source: Tejera VC et al. Randomised clinical trial and meta-analysis: Mesalazine treatment in irritable bowel syndrome—Effects on gastrointestinal symptoms and rectal biomarkers of immune activity. Aliment Pharmacol Ther. 2022;56(6):968-979 (Aug 8). Doi: 10.1111/apt.17182

 

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Key clinical point: An 8-week treatment with mesalazine offered no clear benefits over placebo for global improvement of irritable bowel syndrome (IBS) symptoms.

 

Major finding: A similar proportion of patients receiving mesalazine vs placebo reported satisfactory relief of IBS symptoms during 50% of the treatment weeks (36% vs 30%; P = .40); however, the improvement in abdominal bloating was significantly greater in the mesalazine vs placebo group (P = .02).

 

Study details: The data come from a randomized controlled trial including 181 patients with IBS who were assigned to an 8-week treatment with 2400 mg mesalazine orally or placebo once daily.

 

Disclosures: This study was funded by Eurostars project grant from Tillotts Pharma AB and by the Swedish state. Some authors declared receiving research grants or serving as consultants or on advisory boards for various sources, including Tillotts Pharma.

 

Source: Tejera VC et al. Randomised clinical trial and meta-analysis: Mesalazine treatment in irritable bowel syndrome—Effects on gastrointestinal symptoms and rectal biomarkers of immune activity. Aliment Pharmacol Ther. 2022;56(6):968-979 (Aug 8). Doi: 10.1111/apt.17182

 

Key clinical point: An 8-week treatment with mesalazine offered no clear benefits over placebo for global improvement of irritable bowel syndrome (IBS) symptoms.

 

Major finding: A similar proportion of patients receiving mesalazine vs placebo reported satisfactory relief of IBS symptoms during 50% of the treatment weeks (36% vs 30%; P = .40); however, the improvement in abdominal bloating was significantly greater in the mesalazine vs placebo group (P = .02).

 

Study details: The data come from a randomized controlled trial including 181 patients with IBS who were assigned to an 8-week treatment with 2400 mg mesalazine orally or placebo once daily.

 

Disclosures: This study was funded by Eurostars project grant from Tillotts Pharma AB and by the Swedish state. Some authors declared receiving research grants or serving as consultants or on advisory boards for various sources, including Tillotts Pharma.

 

Source: Tejera VC et al. Randomised clinical trial and meta-analysis: Mesalazine treatment in irritable bowel syndrome—Effects on gastrointestinal symptoms and rectal biomarkers of immune activity. Aliment Pharmacol Ther. 2022;56(6):968-979 (Aug 8). Doi: 10.1111/apt.17182

 

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Continuous cuffless monitoring may fuel lifestyle change to lower BP

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Wearing a cuffless device on the wrist to continuously monitor blood pressure was associated with a significantly lower systolic BP at 6 months among hypertensive adults, real-world results from Europe show.

“We don’t know what they did to reduce their blood pressure,” Jay Shah, MD, Division of Cardiology, Mayo Clinic Arizona, Phoenix, told this news organization.

“The idea is that because they were exposed to their data on a continual basis, that may have prompted them to do something that led to an improvement in their blood pressure, whether it be exercise more, go to their doctor, or change their medication,” said Dr. Shah, who is also chief medical officer for Aktiia.

Dr. Shah presented the study at the Hypertension Scientific Sessions, San Diego.
 

Empowering data

The study used the Aktiia 24/7 BP monitor; Atkiia funded the trial. The monitor passively and continually monitors BP values from photoplethysmography signals collected via optical sensors at the wrist.

After initial individualized calibration using a cuff-based reference, BP measurements are displayed on a smartphone app, allowing users to consistently monitor their own BP for long periods of time.

Aktiia received CE mark in Europe in January 2021 and is currently under review by the U.S. Food and Drug Administration.

Dr. Shah and colleagues analyzed systolic BP (SBP) trends among 838 real-world Aktiia users in Europe (age 57 ± 11 years; 14% women) who consistently used the monitor for 6 months.

Altogether, they had data on 375 (± 287) app interactions, 3,646 (± 1,417) cuffless readings per user, and 9 (± 7) cuff readings per user.

Traditional cuff SBP averages were calculated monthly and compared with the SBP average of the first month. A t-test analysis was used to detect the difference in SBP between the first and successive months.

On the basis of the mean SBP calculated over 6 months, 136 participants were hypertensive (SBP > 140 mm Hg) and the rest had SBP less than 140 mm Hg.



Hypertensive users saw a statistically significant reduction in SBP of –3.2 mm Hg (95% CI, –0.70 to –5.59; P < .02), beginning at 3 months of continual cuffless BP monitoring, which was sustained through 6 months.

Among users with SBP less than 140 mm Hg, the mean SBP remained unchanged.

“The magnitude of improvement might look modest, but even a 5 mm Hg reduction in systolic BP correlates to a 10% decrease in cardiovascular risk,” Dr. Shah told this news organization.

He noted that “one of the major hurdles is that people may not be aware they have high blood pressure because they don’t feel it. And with a regular cuff, they’ll only see that number when they actually check their blood pressure, which is extremely rare, even for people who have hypertension.”

“Having the ability to show someone their continual blood pressure picture really empowers them to do something to make changes and to be aware, [as well as] to be a more active participant in their health,” Dr. Shah said.

He said that a good analogy is diabetes management, which has transitioned from single finger-stick glucose monitoring to continuous glucose monitoring that provides a complete 24/7 picture of glucose levels.

 

 

Transforming technology

Offering perspective on the study, Harlan Krumholz, MD, SM, with Yale New Haven Hospital and Yale School of Medicine, New Haven, Conn., said that having an accurate, affordable, unobtrusive cuffless continuous BP monitor would “transform” BP management.

Courtesy Yale University
Dr. Harlan M. Krumholz

“This could unlock an era of precision BP management with empowerment of patients to view and act on their numbers,” Dr. Krumholz said in an interview.

“We need data to be confident in the devices – and then research to best leverage the streams of information – and strategies to optimize its use in practice,” Dr. Krumholz added.

“Like any new innovation, we need to mitigate risks and monitor for unintended adverse consequences, but I am bullish on the future of cuffless continuous BP monitors,” Dr. Krumholz said.

Dr. Krumholz said that he “applauds Aktiia for doing studies that assess the effect of the information they are producing on BP over time. We need to know that new approaches not only generate valid information but that they can improve health.”
 

Ready for prime time?

In June, the European Society of Hypertension issued a statement noting that cuffless BP measurement is a fast-growing and promising field with considerable potential for improving hypertension awareness, management, and control, but because the accuracy of these new devices has not yet been validated, they are not yet suitable for clinical use.

Also providing perspective, Stephen Juraschek, MD, PhD, research director, Hypertension Center of Excellence at Healthcare Associates, Beth Israel Deaconess Medical Center, Boston, said that “there is a lot of interest in cuffless BP monitors due to their ease of measurement, comfort, and ability to obtain BP measurements in multiple settings and environments, and this study showed that the monitoring improved BP over time.”

“It is believed that the increased awareness and feedback may promote healthier behaviors aimed at lowering BP. However, this result should not be conflated with the accuracy of these monitors,” Dr. Juraschek cautioned.

He also noted that there is still no formally approved validation protocol by the Association for the Advancement of Medical Instrumentation.

“While a number of cuffless devices are cleared by the FDA through its 510k mechanism (that is, demonstration of device equivalence), there is no formal stamp of approval or attestation that the measurements are accurate,” Dr. Juraschek said in an interview.

In his view, “more work is needed to understand the validity of these devices. For now, validated, cuff-based home devices are recommended for BP measurement at home, while further work is done to determine the accuracy of these cuffless technologies.”

The study was funded by Aktiia. Dr. Shah is an employee of the company. Dr. Krumholz has no relevant disclosures. Dr. Juraschek is a member of the Validate BP review committee and the AAMI sphygmomanometer committee.

A version of this article first appeared on Medscape.com.

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Wearing a cuffless device on the wrist to continuously monitor blood pressure was associated with a significantly lower systolic BP at 6 months among hypertensive adults, real-world results from Europe show.

“We don’t know what they did to reduce their blood pressure,” Jay Shah, MD, Division of Cardiology, Mayo Clinic Arizona, Phoenix, told this news organization.

“The idea is that because they were exposed to their data on a continual basis, that may have prompted them to do something that led to an improvement in their blood pressure, whether it be exercise more, go to their doctor, or change their medication,” said Dr. Shah, who is also chief medical officer for Aktiia.

Dr. Shah presented the study at the Hypertension Scientific Sessions, San Diego.
 

Empowering data

The study used the Aktiia 24/7 BP monitor; Atkiia funded the trial. The monitor passively and continually monitors BP values from photoplethysmography signals collected via optical sensors at the wrist.

After initial individualized calibration using a cuff-based reference, BP measurements are displayed on a smartphone app, allowing users to consistently monitor their own BP for long periods of time.

Aktiia received CE mark in Europe in January 2021 and is currently under review by the U.S. Food and Drug Administration.

Dr. Shah and colleagues analyzed systolic BP (SBP) trends among 838 real-world Aktiia users in Europe (age 57 ± 11 years; 14% women) who consistently used the monitor for 6 months.

Altogether, they had data on 375 (± 287) app interactions, 3,646 (± 1,417) cuffless readings per user, and 9 (± 7) cuff readings per user.

Traditional cuff SBP averages were calculated monthly and compared with the SBP average of the first month. A t-test analysis was used to detect the difference in SBP between the first and successive months.

On the basis of the mean SBP calculated over 6 months, 136 participants were hypertensive (SBP > 140 mm Hg) and the rest had SBP less than 140 mm Hg.



Hypertensive users saw a statistically significant reduction in SBP of –3.2 mm Hg (95% CI, –0.70 to –5.59; P < .02), beginning at 3 months of continual cuffless BP monitoring, which was sustained through 6 months.

Among users with SBP less than 140 mm Hg, the mean SBP remained unchanged.

“The magnitude of improvement might look modest, but even a 5 mm Hg reduction in systolic BP correlates to a 10% decrease in cardiovascular risk,” Dr. Shah told this news organization.

He noted that “one of the major hurdles is that people may not be aware they have high blood pressure because they don’t feel it. And with a regular cuff, they’ll only see that number when they actually check their blood pressure, which is extremely rare, even for people who have hypertension.”

“Having the ability to show someone their continual blood pressure picture really empowers them to do something to make changes and to be aware, [as well as] to be a more active participant in their health,” Dr. Shah said.

He said that a good analogy is diabetes management, which has transitioned from single finger-stick glucose monitoring to continuous glucose monitoring that provides a complete 24/7 picture of glucose levels.

 

 

Transforming technology

Offering perspective on the study, Harlan Krumholz, MD, SM, with Yale New Haven Hospital and Yale School of Medicine, New Haven, Conn., said that having an accurate, affordable, unobtrusive cuffless continuous BP monitor would “transform” BP management.

Courtesy Yale University
Dr. Harlan M. Krumholz

“This could unlock an era of precision BP management with empowerment of patients to view and act on their numbers,” Dr. Krumholz said in an interview.

“We need data to be confident in the devices – and then research to best leverage the streams of information – and strategies to optimize its use in practice,” Dr. Krumholz added.

“Like any new innovation, we need to mitigate risks and monitor for unintended adverse consequences, but I am bullish on the future of cuffless continuous BP monitors,” Dr. Krumholz said.

Dr. Krumholz said that he “applauds Aktiia for doing studies that assess the effect of the information they are producing on BP over time. We need to know that new approaches not only generate valid information but that they can improve health.”
 

Ready for prime time?

In June, the European Society of Hypertension issued a statement noting that cuffless BP measurement is a fast-growing and promising field with considerable potential for improving hypertension awareness, management, and control, but because the accuracy of these new devices has not yet been validated, they are not yet suitable for clinical use.

Also providing perspective, Stephen Juraschek, MD, PhD, research director, Hypertension Center of Excellence at Healthcare Associates, Beth Israel Deaconess Medical Center, Boston, said that “there is a lot of interest in cuffless BP monitors due to their ease of measurement, comfort, and ability to obtain BP measurements in multiple settings and environments, and this study showed that the monitoring improved BP over time.”

“It is believed that the increased awareness and feedback may promote healthier behaviors aimed at lowering BP. However, this result should not be conflated with the accuracy of these monitors,” Dr. Juraschek cautioned.

He also noted that there is still no formally approved validation protocol by the Association for the Advancement of Medical Instrumentation.

“While a number of cuffless devices are cleared by the FDA through its 510k mechanism (that is, demonstration of device equivalence), there is no formal stamp of approval or attestation that the measurements are accurate,” Dr. Juraschek said in an interview.

In his view, “more work is needed to understand the validity of these devices. For now, validated, cuff-based home devices are recommended for BP measurement at home, while further work is done to determine the accuracy of these cuffless technologies.”

The study was funded by Aktiia. Dr. Shah is an employee of the company. Dr. Krumholz has no relevant disclosures. Dr. Juraschek is a member of the Validate BP review committee and the AAMI sphygmomanometer committee.

A version of this article first appeared on Medscape.com.

Wearing a cuffless device on the wrist to continuously monitor blood pressure was associated with a significantly lower systolic BP at 6 months among hypertensive adults, real-world results from Europe show.

“We don’t know what they did to reduce their blood pressure,” Jay Shah, MD, Division of Cardiology, Mayo Clinic Arizona, Phoenix, told this news organization.

“The idea is that because they were exposed to their data on a continual basis, that may have prompted them to do something that led to an improvement in their blood pressure, whether it be exercise more, go to their doctor, or change their medication,” said Dr. Shah, who is also chief medical officer for Aktiia.

Dr. Shah presented the study at the Hypertension Scientific Sessions, San Diego.
 

Empowering data

The study used the Aktiia 24/7 BP monitor; Atkiia funded the trial. The monitor passively and continually monitors BP values from photoplethysmography signals collected via optical sensors at the wrist.

After initial individualized calibration using a cuff-based reference, BP measurements are displayed on a smartphone app, allowing users to consistently monitor their own BP for long periods of time.

Aktiia received CE mark in Europe in January 2021 and is currently under review by the U.S. Food and Drug Administration.

Dr. Shah and colleagues analyzed systolic BP (SBP) trends among 838 real-world Aktiia users in Europe (age 57 ± 11 years; 14% women) who consistently used the monitor for 6 months.

Altogether, they had data on 375 (± 287) app interactions, 3,646 (± 1,417) cuffless readings per user, and 9 (± 7) cuff readings per user.

Traditional cuff SBP averages were calculated monthly and compared with the SBP average of the first month. A t-test analysis was used to detect the difference in SBP between the first and successive months.

On the basis of the mean SBP calculated over 6 months, 136 participants were hypertensive (SBP > 140 mm Hg) and the rest had SBP less than 140 mm Hg.



Hypertensive users saw a statistically significant reduction in SBP of –3.2 mm Hg (95% CI, –0.70 to –5.59; P < .02), beginning at 3 months of continual cuffless BP monitoring, which was sustained through 6 months.

Among users with SBP less than 140 mm Hg, the mean SBP remained unchanged.

“The magnitude of improvement might look modest, but even a 5 mm Hg reduction in systolic BP correlates to a 10% decrease in cardiovascular risk,” Dr. Shah told this news organization.

He noted that “one of the major hurdles is that people may not be aware they have high blood pressure because they don’t feel it. And with a regular cuff, they’ll only see that number when they actually check their blood pressure, which is extremely rare, even for people who have hypertension.”

“Having the ability to show someone their continual blood pressure picture really empowers them to do something to make changes and to be aware, [as well as] to be a more active participant in their health,” Dr. Shah said.

He said that a good analogy is diabetes management, which has transitioned from single finger-stick glucose monitoring to continuous glucose monitoring that provides a complete 24/7 picture of glucose levels.

 

 

Transforming technology

Offering perspective on the study, Harlan Krumholz, MD, SM, with Yale New Haven Hospital and Yale School of Medicine, New Haven, Conn., said that having an accurate, affordable, unobtrusive cuffless continuous BP monitor would “transform” BP management.

Courtesy Yale University
Dr. Harlan M. Krumholz

“This could unlock an era of precision BP management with empowerment of patients to view and act on their numbers,” Dr. Krumholz said in an interview.

“We need data to be confident in the devices – and then research to best leverage the streams of information – and strategies to optimize its use in practice,” Dr. Krumholz added.

“Like any new innovation, we need to mitigate risks and monitor for unintended adverse consequences, but I am bullish on the future of cuffless continuous BP monitors,” Dr. Krumholz said.

Dr. Krumholz said that he “applauds Aktiia for doing studies that assess the effect of the information they are producing on BP over time. We need to know that new approaches not only generate valid information but that they can improve health.”
 

Ready for prime time?

In June, the European Society of Hypertension issued a statement noting that cuffless BP measurement is a fast-growing and promising field with considerable potential for improving hypertension awareness, management, and control, but because the accuracy of these new devices has not yet been validated, they are not yet suitable for clinical use.

Also providing perspective, Stephen Juraschek, MD, PhD, research director, Hypertension Center of Excellence at Healthcare Associates, Beth Israel Deaconess Medical Center, Boston, said that “there is a lot of interest in cuffless BP monitors due to their ease of measurement, comfort, and ability to obtain BP measurements in multiple settings and environments, and this study showed that the monitoring improved BP over time.”

“It is believed that the increased awareness and feedback may promote healthier behaviors aimed at lowering BP. However, this result should not be conflated with the accuracy of these monitors,” Dr. Juraschek cautioned.

He also noted that there is still no formally approved validation protocol by the Association for the Advancement of Medical Instrumentation.

“While a number of cuffless devices are cleared by the FDA through its 510k mechanism (that is, demonstration of device equivalence), there is no formal stamp of approval or attestation that the measurements are accurate,” Dr. Juraschek said in an interview.

In his view, “more work is needed to understand the validity of these devices. For now, validated, cuff-based home devices are recommended for BP measurement at home, while further work is done to determine the accuracy of these cuffless technologies.”

The study was funded by Aktiia. Dr. Shah is an employee of the company. Dr. Krumholz has no relevant disclosures. Dr. Juraschek is a member of the Validate BP review committee and the AAMI sphygmomanometer committee.

A version of this article first appeared on Medscape.com.

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