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Research Article
Junichi Mukai
Kitasato University
Corresponding Author
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- The author has confirmed that a statement listing potential conflicts of interest or lack thereof is included in the text.
We conducted a literature review and meta-analysis of safety profiles of sodium-glucose co-transporter 2 (SGLT2) inhibitors in Japanese patients with diabetes mellitus (DM). The electronic databases MEDLINE, CENTRAL, and Ichushi-web were searched for studies from their inception through to August 2019 and there was no language restriction. Trials were included in the analysis if they were randomized controlled trials (RCTs) (1) comparing the effects of SGLT2 inhibitors with a placebo in Japanese patients with DM ≤ 18 years, and (2) reporting HbA1c and at least one adverse event. We calculated risk ratios with 95%CI and used a random-effects model. Twenty-two out of the 765 RCTs retrieved were ultimately included in the present review, and only one RCT included patients with type 1 DM. The durations of RCTs ranged between 4 and 24 weeks. In comparisons with a placebo, SGLT2 inhibitors were associated with similar risks of hypoglycemia, urinary tract infection, genital infection, hypovolemia, and fracture. The outcomes of treatments with SGLT2 inhibitors among Japanese patients with DM suggest favorable safety profiles. However, further evidence from studies with a longer duration, involving more diverse populations, or including individual SGLT2 inhibitors is needed to resolve the limitations of the present study.
Keywords
sodium-glucose co-transporter 2 (SGLT2) inhibitors , diabetes mellitus, Japanese patients
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CURRENT STATUS: Under Review
Version 2
Posted 24 Mar, 2021
No community comments so far
Review #1 received
Received 11 Apr, 2021
Reviewer #3 agreed
On 06 Apr, 2021
Reviewer #1 agreed
On 06 Apr, 2021
Reviewer #2 agreed
On 06 Apr, 2021
Reviewers invited
Invitations sent on 30 Mar, 2021
Editor assigned
On 30 Mar, 2021
Editor invited
On 17 Mar, 2021
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On 17 Mar, 2021
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On 10 Mar, 2021
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This preprint is under consideration at Scientific Reports. A preprint is a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Research Article
Junichi Mukai
Kitasato University
Corresponding Author
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Under Review
Version 2
Posted 24 Mar, 2021
No community comments so far
Review #1 received
Received 11 Apr, 2021
Reviewer #3 agreed
On 06 Apr, 2021
Reviewer #1 agreed
On 06 Apr, 2021
Reviewer #2 agreed
On 06 Apr, 2021
Reviewers invited
Invitations sent on 30 Mar, 2021
Editor assigned
On 30 Mar, 2021
Editor invited
On 17 Mar, 2021
Submission checks complete
On 17 Mar, 2021
First submitted
On 10 Mar, 2021
License:
This work is licensed under a CC BY 4.0 License. Read Full License
Declarations:
Declarations
- The author has confirmed that a statement listing potential conflicts of interest or lack thereof is included in the text.
We conducted a literature review and meta-analysis of safety profiles of sodium-glucose co-transporter 2 (SGLT2) inhibitors in Japanese patients with diabetes mellitus (DM). The electronic databases MEDLINE, CENTRAL, and Ichushi-web were searched for studies from their inception through to August 2019 and there was no language restriction. Trials were included in the analysis if they were randomized controlled trials (RCTs) (1) comparing the effects of SGLT2 inhibitors with a placebo in Japanese patients with DM ≤ 18 years, and (2) reporting HbA1c and at least one adverse event. We calculated risk ratios with 95%CI and used a random-effects model. Twenty-two out of the 765 RCTs retrieved were ultimately included in the present review, and only one RCT included patients with type 1 DM. The durations of RCTs ranged between 4 and 24 weeks. In comparisons with a placebo, SGLT2 inhibitors were associated with similar risks of hypoglycemia, urinary tract infection, genital infection, hypovolemia, and fracture. The outcomes of treatments with SGLT2 inhibitors among Japanese patients with DM suggest favorable safety profiles. However, further evidence from studies with a longer duration, involving more diverse populations, or including individual SGLT2 inhibitors is needed to resolve the limitations of the present study.
Figure 1
Figure 2
Figure 3
Figure 4
Figure 5
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