scholarly journals Regulatory and clinical perspective on patient access to antidiabetic medicines in Slovenia

2021 ◽  
pp. 58-58
Author(s):  
Spela Zerovnik ◽  
Nika Mardjetko ◽  
Igor Locatelli ◽  
Mitja Kos

Introduction/Objective. Three novel classes of antidiabetic medicines have been introduced to the market in the last decade, namely dipeptidyl peptidase-4 inhibitors, glucagon-like peptide-1 analogues and sodium-glucose co-transporter 2 inhibitors. There are many factors that influence patient access to these medicines and their utilization in clinical practice that need to be explored. The aim of the study was to gain an insight into patient access to antidiabetic medicines in Slovenia from a regulatory and clinical point of view. Methods. A focus group with five Slovenian experts (representatives of regulatory bodies and prescribers of antidiabetic medicines) was performed in January 2019. The discussion was audiotaped upon obtaining written consent from the experts and transformed into a verbatim transcript. Two researchers independently analyzed the content of the discussion, using NVivo 11 to identify main themes and subthemes. Results. Slovenia provides satisfactory patient access to antidiabetic medicines; however, prescribing restrictions and unequal access to diabetologists in the Slovenian regions may limit patient access to novel antidiabetic medicines. Prescribing restrictions should be aligned with the new evidence on cardiovascular benefit of some antidiabetic medicines. A national registry of patients with diabetes should be established in order to obtain reliable data on patient outcomes and improve the quality of patient care. Conclusion. Patient access to antidiabetic medicines not only in Slovenia but also in other countries could be improved by changing prescribing restrictions, establishment of national registries of patients with diabetes and involvement of multidisciplinary teams in diabetes care.

2022 ◽  
pp. 1-13
Author(s):  
Juraj Secnik ◽  
Hong Xu ◽  
Emilia Schwertner ◽  
Niklas Hammar ◽  
Michael Alvarsson ◽  
...  

Background: The effectiveness of glucose-lowering drugs (GLDs) is unknown among patients with dementia. Objective: To analyze all-cause mortality among users of six GLDs in dementia and dementia-free subjects, respectively. Methods: This was a longitudinal open-cohort registry-based study using data from the Swedish Dementia Registry, Total Population Register, and four supplemental registers providing data on dementia status, drug usage, confounders, and mortality. The cohort comprised 132,402 subjects with diabetes at baseline, of which 11,401 (8.6%) had dementia and 121,001 (91.4%) were dementia-free. Subsequently, comparable dementia – dementia-free pairs were sampled. Then, as-treated and intention-to-treat exposures to metformin, insulin, sulfonylurea, dipeptidyl-peptidase-4 inhibitors, glucagon-like peptide-1 analogues (GLP-1a), and sodium-glucose cotransporter-2 inhibitors (SGLT-2i) were analyzed in the parallel dementia and dementia-free cohorts. Confounding was addressed using inverse-probability weighting and propensity-score matching, and flexible parametric survival models were used to produce hazard ratios (HR) and 95% confidence intervals (CI) of the association between GLDs and all-cause mortality. Results: In the as-treated models, increased mortality was observed among insulin users with dementia (HR 1.34 [95%CI 1.24–1.45]) as well as in dementia-free subjects (1.54 [1.10–1.55]). Conversely, sulfonylurea was associated with higher mortality only in dementia subjects (1.19 [1.01–1.42]). GLP-1a (0.44 [0.25–0.78]) and SGLT-2i users with dementia (0.43 [0.23–0.80]) experienced lower mortality compared to non-users. Conclusion: Insulin and sulfonylurea carried higher mortality risk among dementia patients, while GLP-1a and SGLT-2i were associated with lower risk. GLD-associated mortality varied between dementia and comparable dementia-free subjects. Further studies are needed to optimize GLD use in dementia patients.


2020 ◽  
Vol 11 ◽  
Author(s):  
Xiaohui Pan ◽  
Shishi Xu ◽  
Juan Li ◽  
Nanwei Tong

Patients with type 2 diabetes (T2D) have a higher risk of heart failure (HF) than healthy people, and the prognosis of patients with diabetes and current or previous HF is worse than that of patients with only diabetes. We reviewed the HF outcomes in recently published cardiovascular outcome trials (CVOTs) of three new classes of anti-diabetic agents, namely, dipeptidyl peptidase-4 inhibitors (DPP-4is), glucagon-like-peptide 1 receptor agonists (GLP-1RAs), and sodium glucose cotransporter-2 inhibitors (SGLT-2is) or SGLT-2 and SGLT-1 dual inhibitors and divided the patients into two groups based on the history of HF (with or without) and analyzed their risks of HHF based on the receipt of the aforementioned anti-diabetes drug types. Since the follow-up period differed among the trials, we expressed the rate of HHF as events/1,000 person-years to describe the HF outcome. At last we pooled the data and analyzed their different effects and mechanisms on heart failure outcomes. Although DPP-4is did not increase the risk of HHF in T2D patients with a history of HF, they were associated with a significantly higher risk of HHF among patients without history of HF. Some GLP-1RAs reduced the risk of macrovascular events, but none of these drugs reduced the risk of HHF in patients with T2D irrespective of their HF history. It was not clarified whether SGLT-1/2is can improve the prognosis of macrovascular events in patients with T2D, but these drugs reduced the risk of HHF regardless of patients’ histories of HF. This information may be useful or referential for the “precise” selection of hyperglycemic medications. Further researches still needed to clarify the mechanisms of these anti-diabetic medications.


2016 ◽  
Vol 30 (2) ◽  
pp. 238-244 ◽  
Author(s):  
Oluwaranti F. Akiyode ◽  
Adebola A. Adesoye

The increasing number of newer type 2 diabetes therapies has allowed providers an increased armamentarium for the optimal management of patients with diabetes. In fact, these newer agents have unique benefits in the management of type 2 diabetes. However, they are also associated with certain adverse effects. This review article aims to describe the notable adverse effects of these newer antidiabetic therapies including the glucagon-like peptide 1 receptor agonists, dipeptidyl peptidase-4 inhibitors, and the sodium-glucose cotransporter 2 inhibitors. The adverse effects reviewed herein include pancreatitis, medullary thyroid carcinoma, heart failure, gastrointestinal disturbances, renal impairment, and genitourinary infections. More clinical data are necessary to solidify the association of some of these adverse effects with the newer diabetes agents. However, it is important for health care practitioners to be well informed and prepared to properly monitor patients for these adverse effects.


2021 ◽  
Vol 22 (17) ◽  
pp. 9504
Author(s):  
María Sofía Martínez ◽  
Alexander Manzano ◽  
Luis Carlos Olivar ◽  
Manuel Nava ◽  
Juan Salazar ◽  
...  

Type 2 Diabetes Mellitus (T2DM) is one of the most prevalent chronic metabolic disorders, and insulin has been placed at the epicentre of its pathophysiological basis. However, the involvement of impaired alpha (α) cell function has been recognized as playing an essential role in several diseases, since hyperglucagonemia has been evidenced in both Type 1 and T2DM. This phenomenon has been attributed to intra-islet defects, like modifications in pancreatic α cell mass or dysfunction in glucagon’s secretion. Emerging evidence has shown that chronic hyperglycaemia provokes changes in the Langerhans’ islets cytoarchitecture, including α cell hyperplasia, pancreatic beta (β) cell dedifferentiation into glucagon-positive producing cells, and loss of paracrine and endocrine regulation due to β cell mass loss. Other abnormalities like α cell insulin resistance, sensor machinery dysfunction, or paradoxical ATP-sensitive potassium channels (KATP) opening have also been linked to glucagon hypersecretion. Recent clinical trials in phases 1 or 2 have shown new molecules with glucagon-antagonist properties with considerable effectiveness and acceptable safety profiles. Glucagon-like peptide-1 (GLP-1) agonists and Dipeptidyl Peptidase-4 inhibitors (DPP-4 inhibitors) have been shown to decrease glucagon secretion in T2DM, and their possible therapeutic role in T1DM means they are attractive as an insulin-adjuvant therapy.


2021 ◽  
Vol 12 ◽  
Author(s):  
Xiaocui Qin ◽  
Xia Zhang ◽  
Pinyu Li ◽  
Min Wang ◽  
Li Yan ◽  
...  

Background: Diabetes mellitus (DM) increases the risk of Parkinson's disease (PD). However, whether DM medications play a part on that increased PD risk is unclear. We designed this meta-analysis to assess the influence of different oral DM medications on the PD risk in patients with DM.Methods: We searched PubMed, Embase, and CENTRAL databases for relevant studies up until January 2021. We pooled adjusted outcomes to assess the PD risk in patients using different DM medications including sulfonylurea, metformin, glitazones (GTZ), dipeptidyl peptidase-4 inhibitors (DPP4i), and glucagon-like peptide-1 agonists (GLP1a).Results: We included 10 studies in our analysis. Our results indicate a lack of significant association between the PD risk and the use of sulfonylureas (three studies; HR, 1.26; 95% CI, 0.95 to 1.66; I2, 70%; p = 0.11), DPP4i (three studies; HR, 0.69; 95% CI, 0.35 to 1.38; I2, 88%; p = 0.30), metformin (five studies; HR, 1.23; 95% CI, 0.98 to 1.78; I2, 84%; p = 0.13), and GTZ (six studies; HR, 0.88; 95% CI, 0.66 to 1.16; I2, 92%; p = 0.35). After exclusion of a single study in the GTZ analysis, our results indicate a significantly reduced PD risk with GTZ use (HR, 0.78; 95% CI, 0.65 to 0.93; I2, 59%; p = 0.06). Similarly, after the exclusion of a single study, our results indicate a significantly increased PD risk with the use of metformin (HR, 1.50; 95% CI, 1.11 to 2.02; I2, 80%; p = 0.008). We also found a significantly reduced PD risk with the use of GLP1a (two studies; HR, 0.41; 95% CI, 0.19 to 0.87; I2, 0%; p = 0.02).Conclusion: The role of different DM medications on the PD risk remains unclear, and the quality of studies is low. While our analysis suggests a lack of association between the use of metformin, GTZ, DPP4i, and sulfonylureas and the PD risk, metformin (to a higher degree) and GTZ may still increase the risk. Limited data suggest a protective effect of GLP1a on the PD risk.


Author(s):  
Hsin-Hung Chen ◽  
Shang-Yi Li ◽  
Weishan Chen ◽  
Chia-Hung Kao

In this retrospective study, we attempted to evaluate the association between dipeptidyl peptidase-4 (DPP-4) inhibitors and allergic rhinitis in patients with diabetes. We analyzed the Longitudinal Health Insurance Database 2000 subdatabase. Our study population included patients with type 2 diabetes (ICD-9-CM 250) between 2009 and 2012, and the study groups were DPP-4 inhibitor users and nonusers. Propensity scores were estimated in a multivariable logistic regression model for the analysis of allergic rhinitis (ICD-9-CM 477.9). Each group consisted of 6204 patients. DPP-4 inhibitor users had a reduced risk of allergic rhinitis (aHR = 0.74, 95% confidence interval (CI) = 0.61–0.90) in all stratifications. Among women, DPP-4 inhibitor users had a lower risk of allergic rhinitis (aHR = 0.67, 95% CI = 0.50–0.90). Among patients aged older than 40 years, DPP-4 inhibitor users had a decreased risk of allergic rhinitis (those aged 40–59: aHR = 0.75, 95% CI = 0.56–0.99; those aged ≧60: aHR = 0.73, 95% CI = 0.54–0.97). Among patients with comorbidities, the risk of allergic rhinitis for DPP-4 inhibitor users was 0.73 (95% CI = 0.60–0.90). High-dose (cumulative defined daily dose ≧648mg) DPP-4 inhibitor users had a decreased risk of allergic rhinitis (aHR = 0.23, 95% CI = 0.15–0.35). Our study revealed that Asian patients with diabetes who used DPP-4 inhibitors had decreased risk of allergic rhinitis, especially for DPP-4 inhibitor treatment in patients who were women, were older than 40 years, had higher diabetes severity scores, were taking higher doses of DPP-4 inhibitors, and had diabetes with comorbidities.


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