Evidence map›Paper›PMID 35722684›Full record

ArticleDiabetes & metabolism journal2023

Safety and Effectiveness of Empagliflozin in Korean Patients with Type 2 Diabetes Mellitus: Results from a Nationwide Post-Marketing Surveillance.

Jun Sung Moon, Nam Hoon Kim, Jin Oh Na, Jae Hyoung Cho, In-Kyung Jeong, Soon Hee Lee, Ji-Oh Mok, Nan Hee Kim, Dong Jin Chung, Jinhong Cho and 3 more

Open access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Diabetes & metabolism journal, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
0.8field-weighted citation impact, top 26% 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

6 citing papers in PubMed, 1 synthesis or guideline pooled it, 7 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Article
  5. Review
  6. 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

13 authors at 8 institutions in 1 country.

Jun Sung MoonDivision of Endocrinology and Metabolism, Department of Internal Medicine, Yeungnam University College of Medicine, Daegu, Korea.
Nam Hoon KimDepartment of Internal Medicine, Korea University Anam Hospital, Korea University College of Medicine, Seoul, Korea.
Jin Oh NaCardiovascular Center, Department of Internal Medicine, Korea University Guro Hospital, Seoul, Korea.
Jae Hyoung ChoDivision of Endocrinology and Metabolism, Department of Internal Medicine, College of Medicine, The Catholic University of Korea, Seoul, Korea.
In-Kyung JeongDivision of Endocrinology and Metabolism, Department of Internal Medicine, Kyung Hee University Hospital at Gangdong, College of Medicine, Kyung Hee University, Seoul, Korea.
Soon Hee LeeDivision of Endocrinology and Metabolism, Department of Internal Medicine, College of Medicine, Inje University, Busan, Korea.
Ji-Oh MokDivision of Endocrinology and Metabolism, Department of Internal Medicine, Soonchunhyang University Bucheon Hospital, Soonchunhyang University College of Medicine, Bucheon, Korea.
Nan Hee KimDepartment of Internal Medicine, Korea University Ansan Hospital, Korea University College of Medicine, Ansan, Korea.
Dong Jin ChungDivision of Endocrinology and Metabolism, Department of Internal Medicine, Chonnam National University Medical School, Gwangju, Korea.
Jinhong ChoBoehringer Ingelheim Korea Ltd., Seoul, Korea.
Dong Woo LeeBoehringer Ingelheim Korea Ltd., Seoul, Korea.
Sun Woo LeeBoehringer Ingelheim Korea Ltd., Seoul, Korea.
Kyu Chang WonDivision of Endocrinology and Metabolism, Department of Internal Medicine, Yeungnam University College of Medicine, Daegu, Korea.
Boehringer Ingelheim (South Korea) · KRInje University · KRKorea University · KRYeungnam University CollegeChonnam National University · KRKorea University Medical Center · KRKyung Hee University Hospital at Gangdong · KRSoonchunhyang University · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTo evaluate the safety and effectiveness of empagliflozin in routine clinical settings, we collected and assessed the clinical profiles of Korean patients with type 2 diabetes mellitus.

methodsThis was a post-marketing surveillance study of empagliflozin 10 and 25 mg. Information on adverse events and adverse drug reactions (ADRs) was collected as safety data sets. Available effectiveness outcomes, including glycosylated hemoglobin (HbA1c) level, fasting plasma glucose, body weight, and blood pressure, were assessed.

resultsThe incidence rate of ADRs was 5.14% in the safety dataset (n=3,231). Pollakiuria, pruritis genital, and weight loss were the most common ADRs. ADRs of special interest accounted for only 1.18%, and there were no serious events that led to mortality or hospitalization. In the effectiveness data set (n=2,567), empagliflozin significantly reduced the mean HbA1c level and body weight during the study period by -0.68%±1.39% and -1.91±3.37 kg (both P<0.0001), respectively. In addition, shorter disease duration, absence of dyslipidemia, and higher baseline HbA1c levels were identified as the clinical features characteristic of a "responder" to empagliflozin therapy.

conclusionEmpagliflozin is a safe and potent glucose-lowering drug in routine use among Korean patients with type 2 diabetes mellitus. It is expected to have better glycemic efficacy in Korean patients with poorly controlled type 2 diabetes mellitus.

Indexed as

Diabetes Mellitus, Type 2Hypoglycemic AgentsBenzhydryl CompoundsBody WeightGlucosidesGlycated HemoglobinHumansProduct Surveillance, PostmarketingRepublic of KoreaBenzhydryl CompoundsempagliflozinGlucosidesGlycated HemoglobinHypoglycemic AgentsDiabetes mellitus, type 2EmpagliflozinHypoglycemic agentsProduct surveillance, postmarketingSodium-glucose transporter 2 inhibitors

Identifiers

PMID35722684
PMCPMC9925151
OpenAlexW4283207582

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.