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9 "Safety"
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Original Articles
Safety and Effectiveness of Pravastatin in Korean Patients with Dyslipidemia Based on the Cardiovascular Risk Classification: Pooled Analysis of Four Observational Studies
In-Kyung Jeong, Hyuk-Sang Kwon, Dae Jung Kim, Sin Gon Kim
Received October 2, 2024  Accepted February 17, 2025  Published online April 15, 2025  
DOI: https://doi.org/10.3803/EnM.2024.2200    [Epub ahead of print]
  • 526 View
  • 48 Download
AbstractAbstract PDFSupplementary MaterialPubReader   ePub   
Background
Despite their efficacy, statin-related adverse events (AEs) may interfere with statin treatment and contribute to negative outcomes in patients with cardiovascular diseases. In this study, we evaluated the safety and effectiveness of pravastatin in Korea.
Methods
Pooled data were collected from four multicenter prospective observational studies conducted in Korea between 2011 and 2020. Finally, 7,334 and 2,022 participants were included in the safety and effectiveness analyses, respectively. Overall safety, particularly muscle-related, incidence of new-onset diabetes mellitus (DM), changes in fasting plasma glucose and hemoglobin A1c level, achievement of target low-density lipoprotein cholesterol (LDL-C) level, and changes in LDL-C level were analyzed.
Results
At week 24, after 20 or 40 mg pravastatin treatment, safety results showed that AEs and adverse drug reactions (ADRs) were 8.7% and 1.3%, respectively, and that muscle-related AEs and ADRs were 0.5% and 0.3%, respectively, with no statistically significant difference in risk factors for statin-associated muscle symptoms. No patients developed DM during the study period. Additionally, at week 24, the achievement rates of target LDL-C levels were 87.9%, 78.4%, 57.8%, and 11.6% in low-, moderate-, high-, and very high-risk groups, respectively.
Conclusion
This study found that 20 or 40 mg pravastatin had minimal side effects and was safe for use in real-world clinical settings in Korea. Specifically, these doses effectively achieved the target LDL-C levels in patients with dyslipidemia in low-, moderate-, and high-risk groups for atherosclerotic cardiovascular disease (ASCVD). These results demonstrate that pravastatin can be safely administered continuously to patients with low-, moderate-, and high-risk ASCVD in a real-world clinical setting.
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Mineral, bone & muscle
Comparison of the Effectiveness and Hypocalcemia Risk of Antiresorptive Agents in Patients with Hypercalcemia of Malignancy
Sung Hye Kong, Seung Shin Park, Jung Hee Kim, Sang Wan Kim, Se Hyun Kim, Jee Hyun Kim, Chan Soo Shin
Endocrinol Metab. 2025;40(2):289-298.   Published online February 4, 2025
DOI: https://doi.org/10.3803/EnM.2024.2132
  • 863 View
  • 76 Download
AbstractAbstract PDFSupplementary MaterialPubReader   ePub   
Background
Hypercalcemia of malignancy (HCM), a major metabolic complication of cancer, is often managed with bisphosphonates (BP) and, increasingly, with denosumab. We aimed to compare the effectiveness and safety of denosumab with that of BP, with or without calcitonin, in treating HCM.
Methods
This retrospective cohort study was conducted at a tertiary hospital from 2017 to 2022 and included 317 patients treated for HCM. Participants were divided into three treatment groups: denosumab, intravenous (IV) BP only, and IV BP combined with calcitonin. The primary outcomes measured were changes in calcium levels and the incidence of hypocalcemia. Analysis of covariance was used to adjust for age, sex, body mass index, creatinine level, type of malignancy, and the use of furosemide and steroids.
Results
The mean participant age was 65 years, and 37.5% were female. After adjustment, both denosumab and IV BPs were found to effectively lower calcium levels. Denosumab led to a decrease of 2.0 mg/dL (−15.9%), while IV BP alone resulted in a reduction of 1.8 mg/dL (−13.9%). The largest reduction, of 2.7 mg/dL (−20.9%), occurred with IV BP and calcitonin. Both denosumab and IV BP+calcitonin yielded their lowest calcium levels within 48 hours, whereas the IV BP only group reached a nadir within 72 hours. Despite these differences in treatment effectiveness, hypocalcemia occurred significantly less frequently in the denosumab group compared to the other groups.
Conclusion
Denosumab and IV BP were similarly effective in reducing calcium levels. However, IV BP combined with calcitonin yielded a more rapid and pronounced decrease.
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Review Article
Mineral, Bone & Muscle
Long-Term Efficacy and Safety of Denosumab: Insights beyond 10 Years of Use
Jeonghoon Ha, Youn-Ju Lee, Jinyoung Kim, Chaiho Jeong, Yejee Lim, Jeongmin Lee, Ki-Hyun Baek, on Behalf of the Catholic Medical Center Bone Research Group
Endocrinol Metab. 2025;40(1):47-56.   Published online January 13, 2025
DOI: https://doi.org/10.3803/EnM.2024.2125
  • 7,338 View
  • 350 Download
AbstractAbstract PDFPubReader   ePub   
Osteoporosis management in post-menopausal women focuses on fracture prevention, with denosumab as a key therapeutic option. Despite its proven efficacy in reducing fracture risk and increasing bone mineral density (BMD) over 10 years, its long-term impact remains uncertain. We evaluated the literature on its efficacy and safety beyond the initial decade. Clinical trials and real-world studies confirm denosumab’s sustained efficacy, especially in lumbar spine BMD, with hip BMD stabilizing. Concerns about adverse events (AEs) like hypocalcemia and osteonecrosis of the jaw necessitate vigilant monitoring. Risks of atypical femoral fractures and malignancies also require attention, despite unclear links to treatment duration. Clinical guidelines for denosumab beyond 10 years are limited, emphasizing the need for careful monitoring. In certain scenarios, such as advanced chronic kidney disease, prolonged denosumab may be required to balance AE risks with fracture prevention benefits. Denosumab shows potential for long-term efficacy in augmenting BMD; however, monitoring for AEs is crucial to guide clinical decision-making effectively.
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Original Articles
Diabetes, obesity and metabolism
Efficacy and Safety of Omarigliptin, a Novel Once-Weekly Dipeptidyl Peptidase-4 Inhibitor, in Type 2 Diabetes Mellitus: A Systematic Review and Meta-Analysis
A.B.M. Kamrul-Hasan, Muhammad Shah Alam, Samir Kumar Talukder, Deep Dutta, Shahjada Selim
Endocrinol Metab. 2024;39(1):109-126.   Published online January 23, 2024
DOI: https://doi.org/10.3803/EnM.2023.1839
  • 4,190 View
  • 137 Download
  • 14 Web of Science
  • 13 Crossref
AbstractAbstract PDFSupplementary MaterialPubReader   ePub   
Background
No recent meta-analysis has holistically analyzed and summarized the efficacy and safety of omarigliptin in type 2 diabetes mellitus (T2DM). We conducted a meta-analysis to address this knowledge gap.
Methods
Electronic databases were searched to identify randomized controlled trials (RCTs) that included patients with T2DM who received omarigliptin in the intervention arm. The control arm consisted of either a placebo (passive control group [PCG]) or an active comparator (active control group [ACG]). The primary outcome assessed was changes in hemoglobin A1c (HbA1c), while secondary outcomes included variations in glucose levels, achievement of glycemic targets, adverse events (AEs), and hypoglycemic events.
Results
From 332 initially screened articles, data from 16 RCTs involving 8,804 subjects were analyzed. Omarigliptin demonstrated superiority over placebo in reducing HbA1c levels (mean difference, –0.58%; 95% confidence interval, –0.75 to –0.40; P<0.00001; I2=91%). Additionally, omarigliptin outperformed placebo in lowering fasting plasma glucose, 2-hour postprandial glucose, and in the percentage of participants achieving HbA1c levels below 7.0% and 6.5%. The glycemic efficacy of omarigliptin was similar to that of the ACG across all measures. Although the omarigliptin group experienced a higher incidence of hypoglycemic events compared to the PCG, the overall AEs, serious AEs, hypoglycemia, and severe hypoglycemia were comparable between the omarigliptin and control groups (PCG and ACG).
Conclusion
Omarigliptin has a favorable glycemic efficacy and safety profile for managing T2DM.

Citations

Citations to this article as recorded by  
  • Once-Weekly Tirzepatide Versus Once-Daily Basal Insulin in Managing Type 2 Diabetes Inadequately Controlled With Oral anti-Hyperglycemic Drugs: A Systematic Review and Meta-Analysis
    A.B.M. Kamrul-Hasan, Shahjada Selim, Faria Afsana, Lakshmi Nagendra, Rezwana Ahmed, Deep Dutta
    Endocrine Practice.2025; 31(3): 315.     CrossRef
  • Renal effects and safety of tirzepatide in subjects with and without diabetes: A systematic review and meta-analysis
    A B M Kamrul-Hasan, Shinjan Patra, Deep Dutta, Lakshmi Nagendra, AFM Muntahi-Reza, Sanja Borozan, Joseph M Pappachan
    World Journal of Diabetes.2025;[Epub]     CrossRef
  • Tirzepatide and Cancer Risk in Individuals with and without Diabetes: A Systematic Review and Meta-Analysis
    A.B.M. Kamrul-Hasan, Muhammad Shah Alam, Deep Dutta, Thanikai Sasikanth, Fatema Tuz Zahura Aalpona, Lakshmi Nagendra
    Endocrinology and Metabolism.2025; 40(1): 112.     CrossRef
  • Reasons for discontinuing tirzepatide in randomized controlled trials: A systematic review and meta-analysis
    Abul Bashar Mohammad Kamrul-Hasan, Joseph M Pappachan, Deep Dutta, Lakshmi Nagendra, Mohammad Shafi Kuchay, Nitin Kapoor
    World Journal of Diabetes.2025;[Epub]     CrossRef
  • Role of flibanserin in managing hypoactive sexual desire disorder in women: A systematic review and meta-analysis
    A.B.M. Kamrul-Hasan, Mohammad Abdul Hannan, Muhammad Shah Alam, Fatema Tuz Zahura Aalpona, Lakshmi Nagendra, Shahjada Selim, Deep Dutta
    Medicine.2024; 103(25): e38592.     CrossRef
  • Teneligliptin: A potential therapeutic approach for diabetic cardiomyopathy
    Ashraf Al Madhoun
    World Journal of Diabetes.2024; 15(8): 1654.     CrossRef
  • Inhibition of Oxidative Stress and Related Signaling Pathways in Neuroprotection
    Maja Jazvinšćak Jembrek
    Antioxidants.2024; 13(9): 1033.     CrossRef
  • Safety and Efficacy of the Novel RNA Interference Therapies for Hypertriglyceridemia and Mixed Hyperlipidemia Management: A Systematic Review and Meta-analysis
    A.B.M. Kamrul-Hasan, Deep Dutta, Lakshmi Nagendra, Sunetra Mondal, Saptarshi Bhattacharya, Sanjay Kalra
    Endocrine Practice.2024; 30(11): 1103.     CrossRef
  • Hepatobiliary effects and safety of tirzepatide: A systematic review and meta‐analysis
    A. B. M. Kamrul‐Hasan, Deep Dutta, Lakshmi Nagendra, Mohammad Shafi Kuchay, Md. Saiful Islam, Joseph M. Pappachan
    Diabetes, Obesity and Metabolism.2024; 26(12): 6074.     CrossRef
  • Efficacy and Safety of Ertugliflozin Compared to Placebo in Patients With Type 2 Diabetes: An Updated Systematic Review and Meta‐Analysis
    A. B. M. Kamrul-Hasan, Muhammad Shah Alam, Samir Kumar Talukder, Mohammad Abdul Hannan, Deep Dutta, Lakshmi Nagendra, Shahjada Selim, Eusebio Chiefari
    Journal of Diabetes Research.2024;[Epub]     CrossRef
  • Optimal Use of Once-Weekly Basal Insulin Efsitora Alfa in Type 1 and Type 2 Diabetes: A Systematic Review and Meta-Analysis
    Deep Dutta, Lakshmi Nagendra, Manoj Kumar, A.B.M. Kamrul-Hasan, Saptarshi Bhattacharya
    Endocrine Practice.2024;[Epub]     CrossRef
  • Neuropsychiatric Effects of Tirzepatide: A Systematic Review and Meta-Analysis
    A.B.M. Kamrul-Hasan, Sanja Borozan, Deep Dutta, Lakshmi Nagendra, Dina Shrestha, Joseph M. Pappachan
    Endocrine Practice.2024;[Epub]     CrossRef
  • Pancreatic Safety of Tirzepatide and Its Effects on Islet Cell Function: A Systematic Review and Meta‐Analysis
    A. B. M. Kamrul‐Hasan, Sunetra Mondal, Deep Dutta, Lakshmi Nagendra, Mohammed Ruhul Kabir, Joseph M. Pappachan
    Obesity Science & Practice.2024;[Epub]     CrossRef
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Mineral, Bone & Muscle
Real-World Safety and Effectiveness of Denosumab in Patients with Osteoporosis: A Prospective, Observational Study in South Korea
Yumie Rhee, Dong-Gune Chang, Jeonghoon Ha, Sooa Kim, Yusun Lee, Euna Jo, Jung-Min Koh
Endocrinol Metab. 2022;37(3):497-505.   Published online June 3, 2022
DOI: https://doi.org/10.3803/EnM.2022.1427
  • 9,530 View
  • 344 Download
  • 9 Web of Science
  • 11 Crossref
AbstractAbstract PDFPubReader   ePub   
Background
The efficacy and safety of denosumab have been established in a phase 3, randomized, placebo-controlled trial in Korean postmenopausal women with osteoporosis. This postmarketing surveillance study was aimed to investigate the safety and effectiveness of denosumab in Korean real-world clinical practice.
Methods
Patients with osteoporosis who had received denosumab per the Korean approved indications in the postmarketing setting between September 2014 and September 2019 were enrolled. The primary endpoint was the incidence of adverse events (AEs) and adverse drug reactions (ADRs). The secondary endpoint was the percent change from baseline in bone mineral density (BMD) of the lumbar spine, total hip, and femoral neck.
Results
Of the 3,221 patients enrolled, 3,185 were included in the safety analysis set; 2,973 (93.3%) were female, and the mean± standard deviation (SD) age was 68.9±9.9 years. The mean±SD study period was 350.0±71.4 days. AEs, fatal AEs, and ADRs occurred in 19.3%, 0.8%, and 1.6%, respectively. The most frequent AEs, occurring in >0.5% of patients, were dizziness (0.7%), arthralgia (0.7%), back pain (0.6%), and myalgia (0.6%). Hypocalcemia occurred in 0.3% of patients. There were no cases of osteonecrosis of the jaw and atypical femoral fracture. Mean±SD percent change from baseline in BMD of the lumbar spine, total hip, and femoral neck was 7.3%±23.6%, 3.6%±31.4%, and 3.2%±10.7%, respectively.
Conclusion
The safety and effectiveness of denosumab in Korean patients with osteoporosis in this study were comparable with those in the Korean randomized controlled trial, with no new safety findings.

Citations

Citations to this article as recorded by  
  • Long-Term Efficacy and Safety of Denosumab: Insights beyond 10 Years of Use
    Jeonghoon Ha, Youn-Ju Lee, Jinyoung Kim, Chaiho Jeong, Yejee Lim, Jeongmin Lee, Ki-Hyun Baek
    Endocrinology and Metabolism.2025; 40(1): 47.     CrossRef
  • Prevalence of denosumab-induced hypocalcemia: a retrospective observational study of patients routinely monitored with ionized calcium post-injection
    Anna Spångeus, Johan Rydetun, Mischa Woisetschläger
    Osteoporosis International.2024; 35(1): 173.     CrossRef
  • Cost-consequence analysis of continuous denosumab therapy for osteoporosis treatment in South Korea
    Seungju Cha, Minjeong Sohn, Hyowon Yang, Eric J. Yeh, Ki-Hyun Baek, Jeonghoon Ha, Hyemin Ku
    BMC Musculoskeletal Disorders.2024;[Epub]     CrossRef
  • Denosumab and the Risk of Diabetes in Patients Treated for Osteoporosis
    Huei-Kai Huang, Albert Tzu-Ming Chuang, Tzu-Chi Liao, Shih-Chieh Shao, Peter Pin-Sung Liu, Yu-Kang Tu, Edward Chia-Cheng Lai
    JAMA Network Open.2024; 7(2): e2354734.     CrossRef
  • A real-world disproportionality analysis of FDA adverse event reporting system (FAERS) events for denosumab
    Yue He, Rong Zhang, Huarui Shen, Yingqi Liu
    Frontiers in Pharmacology.2024;[Epub]     CrossRef
  • Denosumab in Osteoporosis: Predicting Long-Term Efficacy beyond 10 Years
    Jeongmin Lee, Youn-Ju Lee, Jeonghoon Ha
    Journal of Bone Metabolism.2024; 31(3): 246.     CrossRef
  • Adverse Effects of Denosumab in Kidney Transplant Recipients: A 20-Year Retrospective Single-Center Observation Study in Central Taiwan
    Tsung-Yin Tsai, Zi-Hong You, Shang-Feng Tsai, Ming-Ju Wu, Tung-Min Yu, Ya-Wen Chuang, Yung-Chieh Lin, Ya-Lian Deng, Chiann-Yi Hsu, Cheng-Hsu Chen
    Transplantation Proceedings.2023; 55(4): 837.     CrossRef
  • Persistence with Denosumab in Male Osteoporosis Patients: A Real-World, Non-Interventional Multicenter Study
    Chaiho Jeong, Jeongmin Lee, Jinyoung Kim, Jeonghoon Ha, Kwanhoon Jo, Yejee Lim, Mee Kyoung Kim, Hyuk-Sang Kwon, Tae-Seo Sohn, Ki-Ho Song, Moo Il Kang, Ki-Hyun Baek
    Endocrinology and Metabolism.2023; 38(2): 260.     CrossRef
  • Effect of Denosumab on Bone Density in Postmenopausal Osteoporosis: A Comparison with and without Calcium Supplementation in Patients on Standard Diets in Korea
    Chaiho Jeong, Jinyoung Kim, Jeongmin Lee, Yejee Lim, Dong-Jun Lim, Ki-Hyun Baek, Jeonghoon Ha
    Journal of Clinical Medicine.2023; 12(21): 6904.     CrossRef
  • Denosumab

    Reactions Weekly.2022; 1919(1): 221.     CrossRef
  • Denosumab, an effective osteoporosis treatment option for men
    Sung Hye Kong
    The Korean Journal of Internal Medicine.2022; 37(5): 947.     CrossRef
Close layer
Clinical Study
Efficacy and Safety of the Novel Dipeptidyl Peptidase-4 Inhibitor Gemigliptin in the Management of Type 2 Diabetes: A Meta-Analysis
Deep Dutta, Anshita Agarwal, Indira Maisnam, Rajiv Singla, Deepak Khandelwal, Meha Sharma
Endocrinol Metab. 2021;36(2):374-387.   Published online April 6, 2021
DOI: https://doi.org/10.3803/EnM.2020.818
  • 9,095 View
  • 251 Download
  • 26 Web of Science
  • 35 Crossref
AbstractAbstract PDFSupplementary MaterialPubReader   ePub   
Background
No meta-analysis has holistically analysed and summarised the efficacy and safety of gemigliptin in type 2 diabetes. The meta-analysis addresses this knowledge gap.
Methods
Electronic databases were searched for randomised controlled trials (RCTs) involving diabetes patients receiving gemigliptin in the intervention arm and placebo/active comparator in the control arm. The primary outcome was change in haemoglobin A1c (HbA1c). The secondary outcomes were alterations in glucose, glycaemic targets, lipids, insulin resistance, and adverse events.
Results
Data from 10 RCTs involving 1,792 patients were analysed. Four had an active control group (ACG), with metformin/dapagliflozin/sitagliptin/glimepiride as the active comparator; six had a passive control group (PCG), with placebo/rosuvastatin as controls. HbA1c reduction by gemigliptin at 24 weeks was comparable to ACG (mean difference [MD], 0.09%; 95% confidence interval [CI], –0.06 to 0.23; P=0.24; I2=0%; moderate certainty of evidence [MCE]), but superior to PCG (MD, –0.91%; 95% CI, –1.18 to –0.63); P<0.01; I2=89%; high certainty of evidence [HCE]). Gemigliptin was superior to PCG regarding achieving HbA1c <7% (12 weeks: odds ratio [OR], 5.91; 95% CI, 1.34 to 26.08; P=0.02; I2=74%; 24 weeks: OR, 4.48; 95% CI, 2.09 to 9.60; P<0.01; I2=69%; HCE). Gemigliptin was comparable to ACG regarding achieving HbA1c <7% after 24 weeks (OR, 0.92; 95% CI, 0.52 to 1.63; P=0.77; I2=66%; MCE). Adverse events were similar between the gemigliptin and control groups (risk ratio [RR], 1.06; 95% CI, 0.82 to 1.36; P=0.66; I2=35%; HCE). The gemigliptin group did not have increased hypoglycaemia (RR, 1.19; 95% CI, 0.62 to 2.28; P=0.61; I2=19%; HCE).
Conclusion
Gemigliptin has good glycaemic efficacy and is well-tolerated over 6 months of use.

Citations

Citations to this article as recorded by  
  • Efficacy and safety of the glucagon receptor antagonist volagidemab in type‐1 diabetes: A systematic review and meta‐analysis
    Deep Dutta, A. B. M. Kamrul‐Hasan, Vineet Surana, Rajiv Singla, Deepak Khandelwal, Sameer Aggarwal, Lakshmi Nagendra, Saptarshi Bhattacharya
    Annals of the New York Academy of Sciences.2025; 1543(1): 94.     CrossRef
  • Optimal Use of Once-Weekly Basal Insulin Efsitora Alfa in Type 1 and Type 2 Diabetes: A Systematic Review and Meta-Analysis
    Deep Dutta, Lakshmi Nagendra, Manoj Kumar, A.B.M. Kamrul-Hasan, Saptarshi Bhattacharya
    Endocrine Practice.2025; 31(4): 471.     CrossRef
  • Efficacy and Safety of Tocilizumab in Polymyalgia Rheumatica: A Systematic Review and Meta‐Analysis
    Meha Sharma, Siddharth Kumar Das, Ritin Mohindra, Deep Dutta
    International Journal of Rheumatic Diseases.2025;[Epub]     CrossRef
  • Safety of Rapid Intermittent Bolus versus Slow Continuous Infusion of Hypertonic Saline for Managing Symptomatic Severe Hyponatremia: A Systematic Review and Meta-analysis
    Deep Dutta, Manoj Kumar, Ameya Joshi, Meha Sharma
    Annals of African Medicine.2025; 24(2): 431.     CrossRef
  • Hyperprolactinemia Due to Prolactinoma has an Adverse Impact on Bone Health with Predominant Impact on Trabecular Bone: A Systematic Review and Meta-Analysis
    Lakshmi Nagendra, Deep Dutta, Sunetra Mondal, Nitin Kapoor, Ameya Joshi, Saptarshi Bhattacharya
    Journal of Clinical Densitometry.2024; 27(1): 101453.     CrossRef
  • Impact of early initiation of ezetimibe in patients with acute coronary syndrome: A systematic review and meta-analysis
    Kunal Mahajan, Lakshmi Nagendra, Anil Dhall, Deep Dutta
    European Journal of Internal Medicine.2024; 124: 99.     CrossRef
  • Efficacy and safety of dorzagliatin, a novel glucokinase activators, in the treatment of T2DM: A meta-analysis of randomized controlled trials
    Yuqian Wu, Kai Wang, Jingyang Su, Xin Liu
    Medicine.2024; 103(8): e36916.     CrossRef
  • Glucagon-Like Peptide-1 Receptor Agonists in Post-bariatric Surgery Patients: A Systematic Review and Meta-analysis
    Deep Dutta, Lakshmi Nagendra, Ameya Joshi, Suryashri Krishnasamy, Meha Sharma, Naresh Parajuli
    Obesity Surgery.2024; 34(5): 1653.     CrossRef
  • Orforglipron, a novel non‐peptide oral daily glucagon‐like peptide‐1 receptor agonist as an anti‐obesity medicine: A systematic review and meta‐analysis
    Deep Dutta, Lakshmi Nagendra, Beatrice Anne, Manoj Kumar, Meha Sharma, A. B. M. Kamrul‐Hasan
    Obesity Science & Practice.2024;[Epub]     CrossRef
  • Safety and tolerability of sodium-glucose cotransporter-2 inhibitors in children and young adults: a systematic review and meta-analysis
    Lakshmi Nagendra, Deep Dutta, Harish Bukkasagar Girijashankar, Deepak Khandelwal, Tejal Lathia, Meha Sharma
    Annals of Pediatric Endocrinology & Metabolism.2024; 29(2): 82.     CrossRef
  • Impact of Pheochromocytoma or Paraganglioma on Bone Metabolism: A Systemic Review and Meta-analysis
    Deep Dutta, Lakshmi Nagendra, Manju Chandran, Meha Sharma, Saptarshi Bhattacharya, Satinath Mukhopadhyay
    Journal of Clinical Densitometry.2024; 27(3): 101501.     CrossRef
  • Long-Term Impact on Offspring (5 to 11 Years of Age) of Metformin Use in Pregnancy in Mothers With Diabetes: A Systematic Review and Meta-Analysis
    Deep Dutta, Meha Sharma, Lakshmi Nagendra, Saptarshi Bhattacharya, Ritin Mohindra, Chittaranjan S. Yajnik
    Endocrine Practice.2024; 30(9): 854.     CrossRef
  • Efficacy and Safety of Osilodrostat in Managing Cushing’s Syndrome: A Systematic Review and Meta-Analysis
    Lakshmi Nagendra, Deep Dutta, Nishant Raizada, Vineet Surana, Chitra Selvan, Saptarshi Bhattacharya
    Indian Journal of Endocrinology and Metabolism.2024; 28(3): 232.     CrossRef
  • Efficacy and Safety of Cagrilintide Alone and in Combination with Semaglutide (Cagrisema) as Anti-Obesity Medications: A Systematic Review and Meta-Analysis
    Deep Dutta, Lakshmi Nagendra, BG Harish, Meha Sharma, Ameya Joshi, Basavanagowdappa Hathur, ABM Kamrul-Hasan
    Indian Journal of Endocrinology and Metabolism.2024; 28(5): 436.     CrossRef
  • Gender differences in the management and outcomes of acute coronary syndrome in indians: A systematic review and meta-analysis
    Deep Dutta, Kunal Mahajan, Lokesh Verma, Gunjan Gupta, Meha Sharma
    Indian Heart Journal.2024; 76(5): 333.     CrossRef
  • Efficacy and safety of novel dual glucokinase activator dorzagliatin in type-2 diabetes A meta-analysis
    Deep Dutta, Deepak Khandelwal, Manoj Kumar, Meha Sharma
    Diabetes & Metabolic Syndrome: Clinical Research & Reviews.2023; 17(1): 102695.     CrossRef
  • Efficacy and safety of novel thiazolidinedione lobeglitazone for managing type-2 diabetes a meta-analysis
    Deep Dutta, Saptarshi Bhattacharya, Manoj Kumar, Priyankar K. Datta, Ritin Mohindra, Meha Sharma
    Diabetes & Metabolic Syndrome: Clinical Research & Reviews.2023; 17(1): 102697.     CrossRef
  • Effects of Initial Combinations of Gemigliptin Plus Metformin Compared with Glimepiride Plus Metformin on Gut Microbiota and Glucose Regulation in Obese Patients with Type 2 Diabetes: The INTESTINE Study
    Soo Lim, Minji Sohn, Jose C. Florez, Michael A. Nauck, Jiyoung Ahn
    Nutrients.2023; 15(1): 248.     CrossRef
  • Systematic review and meta-analysis of teneligliptin for treatment of type 2 diabetes
    R. Pelluri, S. Kongara, V. R. Nagasubramanian, S. Mahadevan, J. Chimakurthy
    Journal of Endocrinological Investigation.2023; 46(5): 855.     CrossRef
  • Efficacy and safety of enavogliflozin versus dapagliflozin added to metformin plus gemigliptin treatment in patients with type 2 diabetes: A double-blind, randomized, comparator-active study: ENHANCE-D study
    Kyung-Soo Kim, Kyung Ah Han, Tae Nyun Kim, Cheol-Young Park, Jung Hwan Park, Sang Yong Kim, Yong Hyun Kim, Kee Ho Song, Eun Seok Kang, Chul Sik Kim, Gwanpyo Koh, Jun Goo Kang, Mi Kyung Kim, Ji Min Han, Nan Hee Kim, Ji Oh Mok, Jae Hyuk Lee, Soo Lim, Sang S
    Diabetes & Metabolism.2023; 49(4): 101440.     CrossRef
  • Verapamil improves One-Year C-Peptide Levels in Recent Onset Type-1 Diabetes: A Meta-Analysis
    Deep Dutta, Lakshmi Nagendra, Nishant Raizada, Saptarshi Bhattacharya, Meha Sharma
    Indian Journal of Endocrinology and Metabolism.2023; 27(3): 192.     CrossRef
  • Role of novel sodium glucose co-transporter-2 inhibitor enavogliflozin in type-2 diabetes: A systematic review and meta-analysis
    Deep Dutta, B.G. Harish, Beatrice Anne, Lakshmi Nagendra
    Diabetes & Metabolic Syndrome: Clinical Research & Reviews.2023; 17(8): 102816.     CrossRef
  • Semaglutide and cancer: A systematic review and meta-analysis
    Lakshmi Nagendra, Harish BG, Meha Sharma, Deep Dutta
    Diabetes & Metabolic Syndrome: Clinical Research & Reviews.2023; 17(9): 102834.     CrossRef
  • Efficacy and Safety of Novel Thiazolidinedione Rivoglitazone in Type-2 Diabetes a Meta-Analysis
    Deep Dutta, Jyoti Kadian, Indira Maisnam, Ashok Kumar, Saptarshi Bhattacharya, Meha Sharma
    Indian Journal of Endocrinology and Metabolism.2023; 27(4): 286.     CrossRef
  • Impact of early initiation of proprotein convertase subtilisin/kexin type 9 inhibitors in patients with acute coronary syndrome: A systematic review meta-analysis
    Lakshmi Nagendra, Kunal Mahajan, Gunjan Gupta, Deep Dutta
    Indian Heart Journal.2023; 75(6): 416.     CrossRef
  • Optimal use of once weekly icodec insulin in type-2 diabetes: An updated meta-analysis of phase-2 and phase-3 randomized controlled trials
    Deep Dutta, Lakshmi Nagendra, Sowrabha Bhat, Ritin Mohindra, Vineet Surana, Anoop Misra
    Diabetes & Metabolic Syndrome: Clinical Research & Reviews.2023; 17(10): 102877.     CrossRef
  • Impact of Enhanced External Counter-pulsation Therapy on Glycaemic Control in People With Prediabetes and Type 2 Diabetes Mellitus: A Systematic Review and Meta-analysis
    Lakshmi Nagendra, Deep Dutta, Meha Sharma, Harish Bg
    touchREVIEWS in Endocrinology.2023; 19(2): 8.     CrossRef
  • Role of Novel Glucagon-like Peptide-1 Receptor Analogue Polyethylene Glycol Loxenatide in Type 2 Diabetes: A Systematic Review and Meta-analysis
    Deep Dutta, Subhankar Chatterjee, Priyankar K. Datta, Ritin Mohindra, Meha Sharma
    Indian Journal of Endocrinology and Metabolism.2023; 27(5): 377.     CrossRef
  • Efficacy and Safety of Ultra-rapid Lispro Insulin in Managing Type-1 and Type-2 Diabetes: A Systematic Review and Meta-Analysis
    Deep Dutta, Lakshmi Nagendra, Saptarshi Bhattacharya, Meha Sharma
    Indian Journal of Endocrinology and Metabolism.2023; 27(6): 467.     CrossRef
  • Safety and efficacy of once weekly dipeptidyl-peptidase-4 inhibitor trelagliptin in type-2 diabetes: A meta-analysis
    Deep Dutta, Ritin Mohindra, Vineet Surana, Meha Sharma
    Diabetes & Metabolic Syndrome: Clinical Research & Reviews.2022; 16(4): 102469.     CrossRef
  • Efficacy and safety of hydroxychloroquine for managing glycemia in type-2 diabetes: A systematic review and meta-analysis
    D Dutta, R Jindal, D Mehta, M Kumar, M Sharma
    Journal of Postgraduate Medicine.2022; 68(2): 85.     CrossRef
  • Gemigliptin exerts protective effects against doxorubicin-induced hepatotoxicity by inhibiting apoptosis via the regulation of fibroblast growth factor 21 expression
    Kyeong-Min Lee, Yeo Jin Hwang, Gwon-Soo Jung
    Biochemical and Biophysical Research Communications.2022; 626: 135.     CrossRef
  • Reporting and methodological quality of systematic reviews of DPP-4 inhibitors for patients with type 2 diabetes mellitus: an evidence-based mapping
    Zouxi Du, Tingting Lu, Mingdong Gao, Limin Tian
    Acta Diabetologica.2022; 59(12): 1539.     CrossRef
  • Ranirestat Improves Electrophysiologic but not Clinical Measures of Diabetic Polyneuropathy
    Deep Dutta, Ritin Mohindra, Manoj Kumar, Ashok Kumar, Meha Sharma
    Indian Journal of Endocrinology and Metabolism.2022; 26(5): 399.     CrossRef
  • Efficacy and safety of novel twincretin tirzepatide a dual GIP and GLP-1 receptor agonist in the management of type-2 diabetes: A Cochrane meta-analysis
    Deep Dutta, Vineet Surana, Rajiv Singla, Sameer Aggarwal, Meha Sharma
    Indian Journal of Endocrinology and Metabolism.2021; 25(6): 475.     CrossRef
Close layer
Clinical Study
Efficacy and Safety of Pitavastatin in a Real-World Setting: Observational Study Evaluating SaFety in Patient Treated with Pitavastatin in Korea (PROOF Study)
In-Kyung Jeong, Sung-Rae Kim
Endocrinol Metab. 2020;35(4):882-891.   Published online December 2, 2020
DOI: https://doi.org/10.3803/EnM.2020.723
  • 9,297 View
  • 303 Download
  • 1 Web of Science
  • 3 Crossref
AbstractAbstract PDFSupplementary MaterialPubReader   ePub   
Background
While randomized controlled trials provide useful information about drug safety and efficacy, they do not always reflect the observed results in the real world. The prospective, observational, non-comparative trial in South Korea was designed to evaluate the efficacy and safety of pitavastatin in clinical practice in 28,343 patients.
Methods
This study was conducted in 893 facilities in Korea from April 2, 2012 to April 1, 2017. This study was designed to administer 1, 2, or 4 mg pitavastatin to patients with hyperlipidemia at the age of 20 or older for at least 8 weeks.
Results
For 126 days of mean duration of administration of pitavastatin, the % change of low density lipoprotein cholesterol indicated a dose dependent reduction: –23.4%, –29.1%, and –35.2% in the 1, 2, and 4 mg groups, respectively in patients who have not been treated with lipid lowering medications prior to study. Only 1.74% (492/28,343) of pitavastatin-treated patients experienced adverse events, of which 0.43% (123/28,343) were adverse drug reactions. Less than 1% of patients experienced the grade 2 or more toxicity (Common Terminology Criteria for Adverse Events v4.03) in alanine aminotransferase, aspartate aminotransferase, serum creatinine, and serum creatine phosphokinase. Although there were no rhabdomyolysis in 28,343 patients, 0.04% of patients had been reported pitavastatin-related musculoskeletal disorders.
Conclusion
Overall, this observational study showed that pitavastatin was well tolerated and effectively modified the lipid profile, reducing cardiovascular and cerebrovascular risk in Korean patients with hypercholesterolemia in the real world.

Citations

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    Heekyoung Jeong, Kyungdo Han, Soon Jib Yoo, Mee Kyoung Kim
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Close layer
Clinical Study
Revisiting Rupture of Benign Thyroid Nodules after Radiofrequency Ablation: Various Types and Imaging Features
Sae Rom Chung, Jung Hwan Baek, Jin Yong Sung, Ji Hwa Ryu, So Lyung Jung
Endocrinol Metab. 2019;34(4):415-421.   Published online December 23, 2019
DOI: https://doi.org/10.3803/EnM.2019.34.4.415
  • 8,270 View
  • 121 Download
  • 30 Web of Science
  • 32 Crossref
AbstractAbstract PDFPubReader   ePub   
Background

To evaluate the imaging features, clinical manifestations, and prognosis of patients with thyroid nodule rupture after radiofrequency ablation (RFA).

Methods

The records of 12 patients who experienced thyroid nodule rupture after RFA at four Korean thyroid centers between March 2010 and July 2017 were retrospectively reviewed. Clinical data evaluated included baseline patient characteristics, treatment methods, initial presenting symptoms, imaging features, treatment, and prognosis.

Results

The most common symptoms of post-RFA nodule rupture were sudden neck bulging and pain. Based on imaging features, the localization of nodule rupture was classified into three types: anterior, posterolateral, and medial types. The anterior type is the most often, followed by posterolateral and medial type. Eight patients recovered completely after conservative treatment. Four patients who did not improve with conservative management required invasive procedures, including incision and drainage or aspiration.

Conclusion

Thyroid nodule rupture after RFA can be classified into three types based on its localization: anterior, posterolateral, and medial types. Because majority of thyroid nodule ruptures after RFA can be managed conservatively, familiarity with these imaging features is essential in avoiding unnecessary imaging workup or invasive procedures.

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Close layer
Thyroid
A Comparison of Ultrasound-Guided Fine Needle Aspiration versus Core Needle Biopsy for Thyroid Nodules: Pain, Tolerability, and Complications
Eun Ji Jeong, Sae Rom Chung, Jung Hwan Baek, Young Jun Choi, Jae Kyun Kim, Jeong Hyun Lee
Endocrinol Metab. 2018;33(1):114-120.   Published online March 21, 2018
DOI: https://doi.org/10.3803/EnM.2018.33.1.114
  • 7,491 View
  • 72 Download
  • 24 Web of Science
  • 23 Crossref
AbstractAbstract PDFPubReader   ePub   
Background

To compare pain, tolerability, and complications associated with fine needle aspiration (FNA) versus core needle biopsy (CNB).

Methods

FNAs were performed using 23-gauge needles and CNBs were performed using 18-gauge double-action spring-activated needles in 100 patients for each procedure. Patients were asked to record a pain score using a 10-cm visual analog scale and procedure tolerability. Complications and number of biopsies were recorded.

Results

The median pain scores were similar for the FNA and CNB approaches during and 20 minutes after the biopsy procedures (3.7 vs. 3.6, P=0.454; 0.9 vs. 1.1, P=0.296, respectively). The procedure was tolerable in all 100 FNA patients and in 97 CNB patients (P=0.246). The mean number of biopsies was fewer in the CNB group (1.4 vs. 1.2, P=0.002). By subgroup analysis (staff vs. non-staff), no significant difference was detected in any parameter. There were no major complications in either group, but three patients who underwent CNB had minor complications (P=0.246).

Conclusion

FNA and CNB show no significant differences for diagnosing thyroid nodules in terms of pain, tolerability, or complications.

Citations

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