دورية أكاديمية
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Safety of Linagliptin in Patients with Type 2 Diabetes Mellitus: A Systematic Review and Meta-analysis of Randomized Clinical Trials.

التفاصيل البيبلوغرافية
العنوان: Safety of Linagliptin in Patients with Type 2 Diabetes Mellitus: A Systematic Review and Meta-analysis of Randomized Clinical Trials.
المؤلفون: Aljohani H; Drug Safety and Risk Management Department, Executive Directorate of Pharmacovigilance, Drug Sector, Saudi Food and Drug Authority, Riyadh, Saudi Arabia. hialjehani@gmail.com., Alrubaish FS; Drug Safety and Risk Management Department, Executive Directorate of Pharmacovigilance, Drug Sector, Saudi Food and Drug Authority, Riyadh, Saudi Arabia., Alghamdi WM; Drug Safety and Risk Management Department, Executive Directorate of Pharmacovigilance, Drug Sector, Saudi Food and Drug Authority, Riyadh, Saudi Arabia., Al-Harbi F; Drug Safety and Risk Management Department, Executive Directorate of Pharmacovigilance, Drug Sector, Saudi Food and Drug Authority, Riyadh, Saudi Arabia.
المصدر: Therapeutic innovation & regulatory science [Ther Innov Regul Sci] 2024 Jul; Vol. 58 (4), pp. 622-633. Date of Electronic Publication: 2024 Apr 18.
نوع المنشور: Journal Article; Meta-Analysis; Systematic Review
اللغة: English
بيانات الدورية: Publisher: Springer International Publishing Country of Publication: Switzerland NLM ID: 101597411 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2168-4804 (Electronic) Linking ISSN: 21684790 NLM ISO Abbreviation: Ther Innov Regul Sci Subsets: MEDLINE
أسماء مطبوعة: Publication: 2020- : Cham, Switzerland : Springer International Publishing
Original Publication: Thousand Oaks, CA : Sage Publications, [2013]-
مواضيع طبية MeSH: Diabetes Mellitus, Type 2*/drug therapy , Dipeptidyl-Peptidase IV Inhibitors*/therapeutic use , Dipeptidyl-Peptidase IV Inhibitors*/adverse effects , Linagliptin*/therapeutic use , Linagliptin*/adverse effects , Randomized Controlled Trials as Topic*, Humans ; Cardiovascular Diseases/chemically induced ; Hypoglycemic Agents/therapeutic use ; Hypoglycemic Agents/adverse effects
مستخلص: Background: Linagliptin is an oral dipeptidyl peptidase DPP-4 inhibitor, which is indicated for the treatment of Type 2 diabetes mellitus (T2DM) as monotherapy or add-on to therapy with other hypoglycemic drugs.
Objectives: We aimed to summarize the evidence from randomized controlled trials (RCTs) to assess the safety of linagliptin focusing on cardiovascular risks among subjects with type 2 diabetes mellitus.
Methods: We conducted a systematic search across the following databases: Medline, Embase, the Cochrane Central Register of Controlled Trials and ClinicalTrials.gov from inception to November 2021. Randomized controlled trials (RCTs) of linagliptin compared to placebo in patients with Type 2 diabetes were included. The primary safety points were cardiovascular (CV) adverse events including non-fatal stroke, non-fatal myocardial infarction (MI), CV death, MI, stroke, and hospitalization for unstable angina. While, secondary safety points included 17 reported adverse events such as infections, hypoglycemia and abdominal pain. Three reviewers independently screened and reviewed each study to extract relevant information. Any discrepancies were resolved by consensus. We conducted a meta-analysis using the random effects model. Pooled risk ratios (RRs) of targeted adverse events with linagliptin compared to placebo were estimated using the Mantel-Haenszel test.
Results: A total of 24 studies with 19,981 adult patients were included. There was no difference in the incidence of all CV adverse events or individual CV adverse events between linagliptin and the placebo arms. The pooled estimate of the risk of upper respiratory tract infection was reported in twelve trials with a 38% risk reduction among patients treated with the linagliptin group compared to the placebo group (RR = 0.62, 95% CI: 0.45-0.85, and I 2  = 0%), while no difference was found in other infections. For gastrointestinal disorders, the risk of abdominal pain showed a 65% risk reduction among patients treated with the linagliptin group compared to the placebo group (RR = 0.35, 95% CI: 0.16-0.77, and I 2  = 0%).
Conclusion: Our study showed an overall acceptable safety profile of linagliptin in patients with T2DM. Moreover, our study showed a risk reduction of upper respiratory tract infection and abdominal pain when using linagliptin compared to placebo.
(© 2024. The Author(s), under exclusive licence to The Drug Information Association, Inc.)
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فهرسة مساهمة: Keywords: Linagliptin; Safety; T2DM
المشرفين على المادة: 0 (Dipeptidyl-Peptidase IV Inhibitors)
0 (Hypoglycemic Agents)
3X29ZEJ4R2 (Linagliptin)
تواريخ الأحداث: Date Created: 20240418 Date Completed: 20240612 Latest Revision: 20240613
رمز التحديث: 20240613
DOI: 10.1007/s43441-024-00637-2
PMID: 38634983
قاعدة البيانات: MEDLINE
الوصف
تدمد:2168-4804
DOI:10.1007/s43441-024-00637-2