Rationality, Efficacy, Tolerability of Empagliflozin plus Linagliptin Combination for the Management of Type 2 Diabetes Mellitus: A Systematic review of randomized controlled trials and observational studies.

2021 ◽  
Vol 17 ◽  
Author(s):  
Santenna Chenchul ◽  
Shoban Babu Varthya ◽  
Padmavathi R.

Background: Treatment of diabetes mellitus includes more than one drug of different groups, which may lead to high pill burden and non-adherence to drugs. We have aimed to systematically analyze the clinical efficacy, safety and pharmacoeconomic cost-effectiveness of the fixed-dose combination of empagliflozin plus a linagliptin in Type-2 Diabetes mellitus (T2DM) patients. Methods: A literature search of PubMed/MEDLINE, SCOPUS, Google Scholar and EMBASE was performed using the MeSH terms and/or keywords“((Single-pill combination) OR ((Fixed-dose combination) OR (Combination therapy)) AND (Empagliflozin add on-to Linagliptin) OR (Empagliflozin combined with Linagliptin) OR ((Combination of Empagliflozin and Linagliptin)” from the inception to February2021. Results: Search results were found a total of 13 clinical studies. After removing duplicates and studies not according to inclusion criteria a total of eight clinical studies (Randomized controlled trials: 7; Observational cohort studies: 1) were included (n=7491). A significant reduction in the primary endpoint, the mean changes in baseline HbA1c at the end of 24 weeks and/or 52 weeks of the was found in the empagliflozin plus a linagliptin combination group in all included studies. In addition, significant efficacy was seen in decreasing the secondary endpoints such as, the mean change in the fasting plasma glucose, systolic and diastolic blood pressure (DBP) and body weight with less number of adverse events than the adverse effects with either drug alone. Conclusion: After reviewing findings from the available clinical studies of the combination of empagliflozin plus linagliptin we conclude that, the combination is effective, safe, tolerable and rationale cost effective combination compared to placebo and either drug alone for the management of T2DM in patients with inadequate glycemic control with metformin alone, patients with intoleratance to metformin, increased baseline HbA1c, patients with overweight or obesity and diabetic hypertensive, CHF, atherosclerotic cardiovascular disease and renal dysfunction patients. We suggest for more number of future randomized controlled studies in more number of T2DM patients with or without CHF and renal failure patients.

Author(s):  
Ganapathi Bantwal ◽  
Vageesh Ayyar ◽  
Rajiv Kovil ◽  
Manoj Chawla ◽  
Tejas Shah ◽  
...  

Introduction: Poor adherence of patients to the polypharmacy approach is a crucial challenge in the management of Type 2 Diabetes Mellitus (T2DM) and use of triple Fixed-Dose Combination (FDC) of metformin, glimepiride, and voglibose is effective in achieving glycaemic control and would aid in improved drug adherence. Aim: To analyse clinical profile and treatment patterns of FDC of glimepiride, metformin, and voglibose with or without other antidiabetic therapy in patients with T2DM. Materials and Methods: A retrospective, observational, multi- centric study conducted during August 2019 to March 2020. Included patients of either sex, ≥18 years of age with T2DM and who had received treatment with FDC of glimepiride, metformin, and voglibose of varying strengths with or without other antidiabetic therapy. Data extracted from medical records included demographic characteristics, duration of disease, co- morbidities, concomitant medications and dosage pattern. Data were analysed using Chi-square test and Mann-Whitney U test. Results: A total of 2650 patients with T2DM were included, of which 1689 (63.7%) were males. The mean (standard deviation {SD}) age was 54.2 (11.4) years. The average Body Mass Index (BMI) was 27.2 (4.3) kg/m2 and hypertension 1656 (62.5%) and dyslipidaemia 1109 (41.9%) were the most common co-morbidities. Dipeptidyl peptidase-4 inhibitors 908 (34.3%) and antihypertensives 1601 (60.4%) were the most common concomitant diabetic and non diabetic medications received, respectively. Glimepiride (2 mg)+metformin (500 mg)+voglibose (0.2 mg) FDC twice-a-day 878 (33.1%) was a common triple FDC. A total of 2449 (92.4%) patients were compliant and 2585 (97.9%) achieved glycaemic goal with triple FDC treatment. During the therapy, the majority of patients had decreased weight 1106 (67.2%). The mean Haemoglobin A1c (HbA1c) levels significantly decreased post-treatment (mean change 1.45%; p-value <0.001). Family history of diabetes mellitus, obesity, sedentary lifestyle were the most common risk factors and smoking being prevalent in males. Conclusion: Overall results demonstrate that triple FDC of glimepiride, metformin, and voglibose was effective in reducing HbA1c and weight and was well tolerated. Also, it improves compliance in Indian patients with T2DM.


Diabetes ◽  
2020 ◽  
Vol 69 (Supplement 1) ◽  
pp. 135-OR
Author(s):  
ELENI PAPPA ◽  
CHRISTINA KOSTARA ◽  
CONSTANTINOS TELLIS ◽  
ALEXANDROS D. TSELEPIS ◽  
ELENI BAIRAKTARI ◽  
...  

Author(s):  
Najla Shamsi

Type 2 Diabetes Mellitus is a prevalent chronic disease with several macrovascular and microvascular complications. Cardiovascular diseases including coronary artery disease and stroke are common macrovascular complication that reduces the quality of life and lead to early mortality. Additionally, they pose enormous socioeconomic burden on the societies and the governments. Therefore, any intervention that reduces the cardiovascular events in patients with diabetes will have positive impact of the patients and the society. Thus, this systematic review aimed to evaluate the cardiovascular events after metabolic surgery in comparison with the new classes of glucose lowering agents in patients with type 2 diabetes mellitus. The review included 11 randomized controlled trials to both GLP-1 RA and SGLT-2 i groups. It also included 7 metabolic surgery studies, 2 of these are randomized controlled trials and the other 5 are observational studies. These studies were the most relevant studies to the research question. The results revealed different baseline demographic and clinical characteristics between the medication trials and metabolic surgery studies. Moreover, it revealed significant reduction in cardiovascular events in metabolic surgery studies when compared to medication trials. It also showed significant HbA1c and weight reduction in the metabolic surgery group. The remission of diabetes was very high in the metabolic surgery group while none of medication trials accomplished diabetes recovery. However, both medication and surgery groups had adverse events. In conclusion, the review is consistent with previous literature. It suggests that metabolic surgery is more effective than medical therapy in reducing cardiovascular events. Although this conclusion should be interpreted with caution due to the differences in baseline characteristics between studies. In general, the review recommends younger adult diabetic patients with obesity and history of established cardiovascular diseases to undergo metabolic surgery. Whereas, older patients with history of cardiovascular disease should be advised to take one of the medications that has been proved to reduce cardiovascular events. Future studies that compare metabolic surgery and the new classes of the glucose lowering agents is recommended to confirm the findings in this review.


2016 ◽  
Vol 129 (3) ◽  
pp. 382-392 ◽  
Author(s):  
R. Devi ◽  
Ghanshyam Mali ◽  
Indrani Chakraborty ◽  
Mazhuvancherry Kesavan Unnikrishnan ◽  
Suhaj Abdulsalim

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