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

Moon, Jun Sung; Kim, Nam Hoon; Na, Jin Oh; Cho, Jae Hyoung; Jeong, In‐Kyung; Lee, Soon Hee; Mok, Ji‐Oh; Kim, Nan Hee; Chung, Dong Jin; Cho, Jinhong; Lee, Dong Woo; Lee, Sun Woo; Won, Kyu Chang

doi:10.4093/dmj.2021.0356

Cited by 5 publications

(4 citation statements)

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“…The subgroup analysis indicated that individual SGLT-2 inhibitors were not associated with the risk of RTIs in Asia. A meta-analysis also showed that SGLT-2 inhibitors were associated with a similar risk of RTIs compared to placebo in Japanese patients with T2DM ( 122 ).…”

Section: Discussionmentioning

confidence: 99%

Comparative safety of different sodium-glucose transporter 2 inhibitors in patients with type 2 diabetes: a systematic review and network meta-analysis of randomized controlled trials

Li,

Liu,

Zhang

et al. 2023

Front. Endocrinol.

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BackgroundsThe safety of different sodium-glucose transporter 2 (SGLT-2) inhibitors remains uncertain due to the lack of head-to-head comparisons.MethodsThis network meta-analysis (NMA) was performed to compare the safety of nine SGLT-2 inhibitors in patients with type 2 diabetes (T2DM). PubMed, Embase, Cochrane Central Register of Controlled Trials and ClinicalTrials.gov were searched for studies published in English before August 30, 2022. Published and unpublished randomized controlled trials (RCTs) comparing the safety of individual SGLT-2 inhibitors in patients with T2DM were included. A Bayesian NMA with random effects model was applied. Subgroup and sensitivity analyses were performed. The quality of the evidence was evaluated using the Confidence in Network Meta-Analysis framework.ResultsNine SGLT-2 inhibitors were evaluated in 113 RCTs (12 registries) involving 105,293 adult patients. Reproductive tract infections (RTIs) were reported in 1,967 (4.51%) and 276 (1.01%) patients in the SGLT-2 inhibitor and placebo groups, respectively. Furthermore, pollakiuria was reported in 233 (2.66%) and 45 (0.84%) patients, respectively. Compared to placebo, a significantly higher risk of RTIs was observed with canagliflozin, ertugliflozin, empagliflozin, remogliflozin, dapagliflozin, and sotagliflozin, but not with luseogliflozin and ipragliflozin, regardless of gender. An increased risk of pollakiuria was observed with dapagliflozin [odds ratio (OR) 10.40, 95% confidence interval (CI) 1.60-157.94) and empagliflozin (OR 5.81, 95%CI 1.79-32.97). Remogliflozin (OR 6.45, 95%CI 2.18-27.79) and dapagliflozin (OR 1.33, 95%CI 1.10-1.62) were associated with an increased risk of urinary tract infections (UTIs). Instead, the included SGLT-2 inhibitors had a protective effect against acute kidney injury (AKI). No significant differences were found for hypovolemia, renal impairment or failure, fracture, diabetic ketoacidosis (DKA), amputation, and severe hypoglycemia between the SGLT-2 inhibitor and the placebo groups.ConclusionIn patients with T2DM, dapagliflozin was associated with an increased risk of RTIs, pollakiuria, and UTIs. Empagliflozin increased the risk of RTIs and pollakiuria. Remogliflozin increased the risk of UTIs. None of the SGLT-2 inhibitors showed a significant difference from the placebo for hypovolemia, renal impairment or failure, fracture, DKA, amputation, and severe hypoglycemia. The findings guide the selection of SGLT-2 inhibitors for patients with T2DM based on the patient’s profiles to maximize safety.Systematic review registrationhttps://www.crd.york.ac.uk/prospero, identifier CRD42022334644.

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Section: Discussionmentioning

confidence: 99%

Comparative safety of different sodium-glucose transporter 2 inhibitors in patients with type 2 diabetes: a systematic review and network meta-analysis of randomized controlled trials

Li,

Liu,

Zhang

et al. 2023

Front. Endocrinol.

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“…Namun demikian, pasien yang diobati dengan empagliflozin dalam praktik klinis mungkin memiliki karakteristik yang berbeda dengan yang dipelajari dalam uji klinis, seperti usia yang lebih tua, yang membuat mereka lebih rentan terhadap kejadian buruk serta berpotensi memengaruhi respons glikemik sehingga, besarnya penurunan HbA1c selama penelitian lebih rendah dengan bertambahnya usia. 11 Moon et al 13 melakukan penelitian terhadap 3368 pasien Korea dengan dosis empagliflozin 10 mg dan 25 mg. Pengobatan empagliflozin secara bermakna mengurangi tingkat HbA1c rerata selama masa studi sebesar -0,68%±1,39% (P<0,0001). Selain itu, 44,10% pasien mencapai target kontrol glikemik (HbA1c <7%) dan lebih dari setengahnya (51,23%) menunjukkan penurunan HbA1c lebih besar dari 0,5%.…”

Section: Bahasanunclassified

“…Akibatnya, durasi diabetes yang lebih pendek, tingkat HbA1c awal yang lebih tinggi, dan tidak adanya dislipidemia merupakan faktor klinis yang terkait dengan penurunan kadar HbA1c yang lebih besar dan secara bermakna terkait dengan kemanjuran glikemik empagliflozin pada pasien Korea, sehingga empagliflozin akan lebih menguntungkan pada pasien di Korea dengan DMT2 yang tidak terkontrol dengan baik pada fase awal diagnosis. 13 Berdasarkan penelitian Okada et al 14 pada 131 pasien DMT2 dengan hipertensi noktrunal yang berusia <75 dan 75 tahun dan kontrol glikemik rerata HbA1c 6,6%. Pada awal penelitian, 44 peserta berusia ≥75 tahun dan 87 peserta berusia <75 tahun.…”

Section: Bahasanunclassified

Efektivitas Penggunaan Empagliflozin terhadap Nilai HbA1c pada Pasien Diabetes Melitus Tipe 2

Rawung,

Posangi,

Nangoy

2023

MSJ

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Type 2 diabetes mellitus (T2DM) is the most common type of diabetes today. Lifestyle changes are one of the causes of DM problems. Patients with T2DM are usually treated with oral hypoglycemic drugs. The sodium glucose cotransporter 2 (SGLT-2) group is a type of oral hypoglycemic drug groups that plays a role in reducing HbA1c level. Empagliflozin is a drug included in the SGLT-2 group. Previous clinical trials showed that empagliflozin could lead to a reduction in HbA1c level. This study aimed to determine the effectiveness of using empagliflozin on HbA1C values in T2DM patients. This was a literature review study with data searching using three databases namely, Pubmed, Google Scholar, and Science Direct. The results obtained 10 literatures to be reviewed. All literatures showed that there was a significant effect of empagliflozin on HbA1c value of T2DM patients. In conclusion, type 2 diabetes mellitus patients using empagliflozin show significant decreases in HbA1c values. Keywords: type 2 diabetes mellitus; empagliflozin; HbA1c; sodium glucose cotransporter 2 Abstrak: Diabetes melitus tipe 2 (DMT2) merupakan jenis diabetes yang paling umum ditemukan saat ini. Perubahan gaya hidup menjadi salah satu penyebab timbulnya masalah DM. Penyandang DMT2 biasanya diterapi dengan obat hipoglikemik oral (OHO). Golongan obat sodium glucose cotransporter 2 (SGLT-2) merupakan salah satu jenis golongan obat OHO yang berperan dalam menurunkan kadar HbA1c, salah satunya ialah empagliflozin. Penelitian sebelumnya menunjukkan peran empaglifozin dalam uji klinis dapat menyebabkan penurunan kadar HbA1c. Penelitian ini bertujuan untuk mengetahui efektivitas penggunaan empagliflozin terhadap nilai HbA1C pada pasien DMT2. Jenis penelitian ini ialah suatu literature review dengan pencarian data menggunakan tida sumber basis data yaitu, Pubmed, Google Scholar dan Science Direct. Hasil penelitian mendapatkan sebanyak 10 literatur yang dilakukan review. Kesepuluh artikel memperlihatkan adanya pengaruh bermakna dari penggunaan empagliflozin terhadap nilai HbA1c dari pasien DMT2. Simpulan penelitian ini ialah penggunaan empagliflozin pada pasien diabetes melitus tipe 2 menunjukkan terjadinya penurunan nilai HbA1c yang bermakna. Kata kunci: diabetes melitus tipe 2; empagliflozin; HbA1c; sodium glucose cotransporter 2

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“…Moreover, a previous study on post-marketing surveillance of empagliflozin in South Korea reported that the three most frequent ADRs of empagliflozin in patients with T2DM were frequent urination, vulvovaginal pruritus, and weight decrease, however, these ADRs were not observed in the present study. 39 The small sample size in this study limited the extrapolation of drug safety conclusions to the entire population. In addition, although this study confirmed the bioequivalence, safety and tolerability of two empagliflozin formulations, the potential issues associated with the cocrystal formulation should be further studied in more subjects.…”

mentioning

confidence: 92%

Comparison of the Pharmacokinetics, Safety, and Tolerability of Two Empagliflozin Formulations in Healthy Korean Subjects

Jiang¹,

Bae²,

Yoon³

et al. 2023

DDDT

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Empagliflozin is a sodium-glucose cotransporter 2 inhibitor that is commonly used for the treatment of type 2 diabetes mellitus. As cocrystal formulation can improve the chemical properties of drugs, CKD-370 was newly developed as a cocrystal formulation of empagliflozin with solvate L-proline. This study aimed to compare the pharmacokinetics, safety, and tolerability of these two empagliflozin formulations in healthy Korean subjects. Methods: A randomized, open-label, two-sequence, two-period crossover study was conducted on healthy Korean participants. The subjects received a single oral 25 mg dose of either test (CKD-370) or reference treatment (Jardiance ® ) tablet at each period. Plasma empagliflozin concentrations were determined using liquid chromatography with tandem mass spectrometry. Pharmacokinetic (PK) parameters were analyzed using non-compartmental methods. The primary PK parameters included the maximum concentration (C max ) and the area under the concentration-time curve from 0 to last (AUC last ). The safety of both formulations was monitored and evaluated. Results: A total of 28 healthy Korean adult subjects were randomized, and 27 subjects were included in the PK analysis. The mean ± standard deviation values of the primary PK parameters, C max and AUC last after administration of the test treatment, were 442.02 ± 103.37 μg/L and 3131.08 ± 529.30 μg•h/L, respectively, and those after administration of the reference treatment were 436.29 ± 118.74 μg/L and 3006.88 ± 514.21 μg•h/L, respectively. The geometric mean ratio and its 90% confidence interval of test to reference treatment for C max and AUC last were 1.0221 (0.9527-1.0967) and 1.0411 (1.0153-1.0677), respectively, which were within the commonly accepted bioequivalence criteria of 0.80 to 1.25. Both treatments were well-tolerated. Conclusion:The two formulations of empagliflozin showed similar PK characteristics and were generally well tolerated in healthy subjects.

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

Cited by 5 publications

References 30 publications

Comparative safety of different sodium-glucose transporter 2 inhibitors in patients with type 2 diabetes: a systematic review and network meta-analysis of randomized controlled trials

Comparative safety of different sodium-glucose transporter 2 inhibitors in patients with type 2 diabetes: a systematic review and network meta-analysis of randomized controlled trials

Efektivitas Penggunaan Empagliflozin terhadap Nilai HbA1c pada Pasien Diabetes Melitus Tipe 2

Comparison of the Pharmacokinetics, Safety, and Tolerability of Two Empagliflozin Formulations in Healthy Korean Subjects

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