Risks Associated with SGLT2 Inhibitors: An Overview

Singh, Mahakpreet; Kumar, Anoop

doi:10.2174/1574886313666180226103408

Cited by 116 publications

(81 citation statements)

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“…151,152 However, the protective cardiovascular effect of SGLT-2 inhibitors has been shadowed by the results from postmarketing studies which indicate significant adverse effects, such as an increased risk of diabetic ketoacidosis and leg amputations. 153…”

Section: Uricosuric Medicationmentioning

confidence: 99%

<p>Uric Acid and Arterial Stiffness</p>

Albu¹,

Para²,

Porojan³

2020

TCRM

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Hyperuricemia is usually associated with hypertension, diabetes mellitus, metabolic syndrome and chronic kidney disease. Accumulating data from epidemiological studies indicate an association of increased uric acid (UA) with cardiovascular diseases. Possible pathogenic mechanisms include enhancement of oxidative stress and systemic inflammation caused by hyperuricemia. Arterial stiffness may be one of the possible pathways between hyperuricemia and cardiovascular disease, but a clear relationship between increased UA and vascular alterations has not been confirmed. The review summarizes the epidemiological studies investigating the relationship between UA and arterial stiffness and highlights the results of interventional studies evaluating arterial stiffness parameters in patients treated with UA-lowering drugs.

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Section: Uricosuric Medicationmentioning

confidence: 99%

<p>Uric Acid and Arterial Stiffness</p>

Albu¹,

Para²,

Porojan³

2020

TCRM

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“…Because side effects such as urinary tract infections (UTIs), genital tract infections, and diabetic ketoacidosis (DKA) are predicted on the basis of the mechanism of action of SGLT2 inhibitors, it is necessary to conduct ongoing monitoring of such events [12]. To mitigate their likelihood, a committee of experts has issued recommendations for the appropriate use of SGLT2 inhibitors [13].…”

Section: Introductionmentioning

confidence: 99%

Safety and effectiveness of empagliflozin in Japanese patients with type 2 diabetes: interim analysis from a post-marketing surveillance study

Kaku

Chin

Naito

et al. 2019

Expert Opinion on Drug Safety

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Background: Sodium-glucose cotransporter-2 (SGLT2) inhibitors are effective treatments for type 2 diabetes mellitus (T2DM). We present the interim findings of an ongoing post-marketing surveillance (PMS) study in Japanese patients with T2DM receiving empagliflozin. Research design and methods: This 3-year, prospective, observational, multicenter PMS evaluated the safety and effectiveness of empagliflozin in Japanese clinical practice. Patients with T2DM who had not been treated with empagliflozin before enrollment were eligible. Assessments, including the primary endpoint of incidence of adverse drug reactions (ADRs), were based on electronic case report forms (eCRF). Results: Of 8,180 registered patients from 1,103 sites, 7,618 patients had an eCRF including a follow-up visit and were treated (mean age, 58.8 years; 10.5% aged ≥75 years; 63.2% male; mean HbA1c, 8.01%; 41.8% with HbA1c ≥8.0%; 24.8% and 61.8% with at least mild hepatic and renal impairment, respectively). Mean treatment duration was 98.4 weeks; 644 (8.5%) patients had ≥1 ADR, including 8.5% of patients aged ≥75 years. Hypoglycemia, urinary tract infection, genital infections, volume depletion, diabetic ketoacidosis, and lower limb amputation occurred in 0.28%, 0.62%, 0.53%, 0.33%, 0%, and 0.03% of patients, respectively. Conclusions: The reported ADRs were consistent with the known safety profile of empagliflozin. Trial registration: ClinicalTrials.gov identifier: NCT02489942.

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“…Regarding serious ADRs of special interest, the incidence of cerebrovascular disease in elderly patients was significantly higher than that in non-elderly patients and was consistent with that reported in the STELLA-ELDER study (0.4%). Some previously reported risks of treatment with other SGLT2 inhibitors include amputation, fracture and serious infection of the genital area 30 . In a recent retrospective, single-center, case-control study of T2DM patients, the incidence of lower limb amputations were compared between patients with active diabetic foot wounds who were receiving an SGLT2 inhibitor and those who were not 31 .…”

Section: Discussionmentioning

confidence: 99%

Safety and effectiveness of ipragliflozin in elderly versus non-elderly Japanese type 2 diabetes mellitus patients: 12 month interim results of the STELLA-LONG TERM study

Maegawa

Tobe

Nakamura

et al. 2019

Current Medical Research and Opinion

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Objective: STELLA-LONG TERM is an ongoing post-marketing surveillance study examining the safety and effectiveness of ipragliflozin in real-world clinical practice in Japan. This interim report of STELLA-LONG TERM examined the safety and effectiveness of ipragliflozin in non-elderly and elderly Japanese patients with type 2 diabetes mellitus (T2DM) using data up to 12 months. Methods: Data from T2DM patients who were first prescribed ipragliflozin between July 2014 and October 2015 and whose 12 month data were locked by January 2018 were analyzed and compared between non-elderly (<65 years) and elderly patients (!65 years). Results: The safety and efficacy analysis sets included 11,051 and 8788 patients, respectively. Elderly patients accounted for 28.6% (n ¼ 3157) of the study population. The mean body mass index was 29.9 kg/m 2 and 26.8 kg/m 2 , the percentage of patients with glycated hemoglobin (HbA1c) <8.0% was 50.1% and 59.5%, and the percentage of patients with complications was 83.2% and 87.3% in the non-elderly and elderly groups, respectively. Mean HbA1c and body weight decreased significantly from baseline to 12 months in both age groups, regardless of baseline HbA1c and body weight (all p < .05). The incidence of adverse drug reactions (ADRs) was 14.8% and 14.2% and that of serious ADRs was 0.8% and 1.4% in non-elderly and elderly patients, respectively (p ¼ .002 for serious ADRs). Conclusion: The incidence of serious ADRs was higher in elderly patients than non-elderly patients. Ipragliflozin was effective in both non-elderly and elderly patients with T2DM in the real-world clinical setting.

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Risks Associated with SGLT2 Inhibitors: An Overview

Cited by 116 publications

References 0 publications

<p>Uric Acid and Arterial Stiffness</p>

<p>Uric Acid and Arterial Stiffness</p>

Safety and effectiveness of empagliflozin in Japanese patients with type 2 diabetes: interim analysis from a post-marketing surveillance study

Safety and effectiveness of ipragliflozin in elderly versus non-elderly Japanese type 2 diabetes mellitus patients: 12 month interim results of the STELLA-LONG TERM study

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