Evidence map›Paper›PMID 31065934›Full record

ArticleClinical drug investigation2019

Adverse Drug Reaction Profile of SGLT2 Inhibitor-Associated Diabetic Ketosis/Ketoacidosis in Singapore and their Precipitating Factors.

Michael Limenta, Christine S C Ho, Jalene W W Poh, Su-Yen Goh, Dorothy S L Toh

Open access · hybridAbstract read
In one paragraph

Article in Clinical drug investigation, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
2.9field-weighted citation impact, top 9% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 24 citations in OpenAlex.

  1. Euglycemic Diabetic Ketoacidosis: Clinical Suspicion and Diagnosis.Clinical medicine insights. Endocrinology and diabetes · 2026
    Review
  2. Article
  3. Article
  4. Review
  5. Article
  6. Article
  7. Review
  8. Review
  9. Article
  10. Article
  11. Diabetic Ketoacidosis in COVID-19: Unique Concerns and Considerations.The Journal of clinical endocrinology and metabolism · 2020
    Article
  12. Article
  13. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 2 institutions in 1 country.

Michael LimentaVigilance and Compliance Branch, Health Product Regulation Group, Health Science Authority, 11 Biopolis Way, #11-01, Helios, Singapore, 138667, Singapore. michael_limenta@hsa.gov.sg.ORCID http://orcid.org/0000-0002-1242-2783
Christine S C HoVigilance and Compliance Branch, Health Product Regulation Group, Health Science Authority, 11 Biopolis Way, #11-01, Helios, Singapore, 138667, Singapore.
Jalene W W PohVigilance and Compliance Branch, Health Product Regulation Group, Health Science Authority, 11 Biopolis Way, #11-01, Helios, Singapore, 138667, Singapore.
Su-Yen GohDepartment of Endocrinology, Singapore General Hospital, Outram Road, Singapore, 169608, Singapore.
Dorothy S L TohVigilance and Compliance Branch, Health Product Regulation Group, Health Science Authority, 11 Biopolis Way, #11-01, Helios, Singapore, 138667, Singapore.
Health Sciences Authority · SGSingapore General Hospital · SG

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND 

objectiveAs of December 2017, 20 diabetic ketosis (DK)/diabetic ketoacidosis (DKA) cases associated with sodium-glucose co-transporter 2 inhibitors (SGLT2i) had been reported to the Health Sciences Authority (HSA), Singapore. We aimed to provide a detailed analysis of the profile of these cases.

methodsAs part of the emerging safety issue monitoring, the HSA followed up on SGLT2i-associated DK/DKA cases with the reporters to obtain the missing and/or supplementary information. Descriptive statistics were employed to summarise the data collected, while the Mann-Whitney test was employed to evaluate the differences between typical and euglycaemic DKA cases as well as between genders.

resultsAll cases led to hospitalisation but were non-fatal. Where reported, the majority (71-85%) of DK/DKA cases occurred within 180 days of SGLT2i therapy initiation and involved female patients and/or patients with long-standing type 2 diabetes mellitus (T2DM). Apart from the difference in blood glucose levels, no differences in the profile between the typical and euglycaemic DKA cases were noted. Known precipitating factors were identified in all cases. Acute illnesses, particularly infections and abscesses, were the most commonly reported precipitating factors, followed by insulin dose reduction/cessation.

conclusionsBased on the profile of the reported cases, it is imperative to maintain clinical vigilance for DK/DKA, especially during the first 6 months of SGLT2i treatment and more so in female patients and/or patients with long-standing T2DM. Prompt evaluation and management of underlying precipitating factors is also important to assess and mitigate the risk of developing DK/DKA during treatment with SGLT2i.

Indexed as

AdultBlood GlucoseDiabetes Mellitus, Type 2Diabetic KetoacidosisFemaleHumansInsulinKetosisMaleMiddle AgedPrecipitating FactorsSingaporeSodium-Glucose Transporter 2 InhibitorsYoung AdultBlood GlucoseInsulinSodium-Glucose Transporter 2 Inhibitors

Identifiers

PMID31065934
PMCPMC6592972
OpenAlexW2944484313

What Socratic holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.