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Cited by 255Blood Pressure and Hypertension StudiesDiabetes Treatment and ManagementHeart Failure Treatment and Management

The DOI matches its Crossref record, with a small difference in title or year; 37 of the 37 references it cites were found in a registry or an index.

Twenty-Four-Hour Blood Pressure–Lowering Effect of a Sodium-Glucose Cotransporter 2 Inhibitor in Patients With Diabetes and Uncontrolled Nocturnal Hypertension: Results From the Randomized, Placebo-Controlled SACRA Study

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Kario, Kazuomi, Okada, Kenta, Kato, Mitsutoshi, Nishizawa, Masafumi, Yoshida, Tetsuro, Asano, Tsuguyoshi, Uchiyama, Kazuaki, Niijima, Yawara, Katsuya, Tomohiro, Urata, Hidenori, Osuga, Jun-ichi, Fujiwara, Takeshi, Yamazaki, Shoji, Tomitani, Naoko, Kanegae, Hiroshi, Hoshide, Satoshi, Yamamoto, Mitsuyoshi, Eguchi, Kazuo, Mizuno, Atsushi, Nakano, Shigeru, Kemi, Yuta, Iwashita, Chie, Wada, Kyouichi, Kaneko, Azusa, Ryan, Nicola·2019·Circulation
DOI 10.1161/circulationaha.118.037076PMC PMC6493695
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Abstract

Background: The risk of cardiovascular disease and mortality in salt-sensitive patients with diabetes mellitus and uncontrolled nocturnal hypertension is high. The SACRA (Sodium-Glucose Cotransporter 2 [SGLT2] Inhibitor and Angiotensin Receptor Blocker [ARB] Combination Therapy in Patients With Diabetes and Uncontrolled Nocturnal Hypertension) study investigated changes in blood pressure (BP) with empagliflozin plus existing antihypertensive therapy. Methods: This multicenter, double-blind, parallel study was conducted in Japan. Adult patients with type 2 diabetes mellitus and uncontrolled nocturnal hypertension receiving stable antihypertensive therapy including angiotensin receptor blockers were randomized to 12 weeks’ treatment with empagliflozin 10 mg once daily or placebo. Clinic BP was measured at baseline and weeks 4, 8, and 12; 24-hour ambulatory BP monitoring was performed at baseline and week 12; and morning home BP was determined for 5 days before each visit. The primary efficacy end point was change from baseline in nighttime BP (ambulatory BP monitoring). Results: One hundred thirty-two nonobese, older patients with well-controlled blood glucose were randomized (mean age 70 years, mean body mass index 26 kg/m 2 ). Empagliflozin, but not placebo, significantly reduced nighttime systolic BP versus baseline (–6.3 mm Hg; P =0.004); between-group difference in change from baseline was –4.3 mm Hg ( P =0.159). Reductions in daytime, 24-hour, morning home, and clinic systolic BP at 12 weeks with empagliflozin were significantly greater than with placebo (–9.5, –7.7, –7.5, and –8.6 mm Hg, respectively; all P ≤0.002). Between-group differences in body weight and glycosylated hemoglobin reductions were significant, but small (–1.3 kg and –0.33%; both P <0.001). At 4 weeks, N-terminal pro-B-type natriuretic peptide levels were reduced to a greater extent in the empagliflozin versus placebo group (–12.1%; P =0.013); atrial natriuretic peptide levels decreased with empagliflozin versus placebo at weeks 4 and 12 (–8.2% [ P =0.008] and –9.7% [ P =0.019]). Changes in antihypertensive medication during the study did not differ significantly between groups. Conclusions: Nonseverely obese older diabetes patients with uncontrolled nocturnal hypertension showed significant BP reductions without marked reductions in glucose with the addition of empagliflozin to existing antihypertensive and antidiabetic therapy. Use of sodium-glucose cotransporter 2 inhibitors in specific groups (eg, those with nocturnal hypertension, diabetes, and high salt sensitivity) could help reduce the risk of heart failure and cardiovascular mortality. Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT03050229.

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Authors
Kario, K., Okada, K., Kato, M., Nishizawa, M., Yoshida, T., Asano, T., Uchiyama, K., Niijima, Y., Katsuya, T., Urata, H., Osuga, J.-I., Fujiwara, T., Yamazaki, S., Tomitani, N., Kanegae, H., Hoshide, S., Yamamoto, M., Eguchi, K., Mizuno, A., Nakano, S., Kemi, Y., Iwashita, C., Wada, K., Kaneko, A., & Ryan, N.
Affiliations
  • Jichi Medical University (JP)
  • Kato Clinic of Internal Medicine, Tokyo, Japan (M.K.).
  • Asano Kanamachi Clinic, Tokyo, Japan (T.A.).
  • Uchiyama Clinic, Niigata, Japan (K.U.).
  • Kan-etsu Chuoh Hospital, Gunma, Japan (Y.N.).
  • The University of Osaka (JP)
  • Fukuoka University (JP)
  • Utsunomiya Higashi Hospital, Tochigi, Japan (J.O.).
Corresponding author
Kario, Kazuomi
ORCID
Venue
Circulation
Publisher
Ovid Technologies (Wolters Kluwer Health)
Published
2019-04-30
Volume
139
Issue
18
Pages
2089-2097
ISSN
  • 0009-7322 (ISSN-L)
  • 1524-4539
DOI
10.1161/circulationaha.118.037076
PMC
PMC6493695
OpenAlex
W2903192033
Cited by
251
References
37
Citations by year
2026: 15 · 2025: 28 · 2024: 23 · 2023: 40 · 2022: 45 · 2021: 42 · 2020: 37 · 2019: 20
FWCI
26.03
Type
journal article
Language
en
Open access
Licence
cc-by-nc-nd
Locations
  • Circulation (publishedVersion, cc-by-nc-nd)
  • Europe PMC (PubMed Central) (publishedVersion)
  • PubMed Central (publishedVersion)
  • PubMed (publishedVersion)
Funders
Japan Society for the Promotion of Science (16K09514)
Topics
  • Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Blood Pressure and Hypertension Studies
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Treatment and Management
  • Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Heart Failure Treatment and Management
Keywords
empagliflozin, SGLT2 inhibitors, nocturnal hypertension, type 2 diabetes, blood pressure reduction, ambulatory blood pressure monitoring, angiotensin receptor blockers, N-terminal pro-brain natriuretic peptide, atrial natriuretic peptide, body weight, HbA1c, cardiovascular risk, salt-sensitive hypertension, older adults

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