Linagliptin 5mg tablets

Abstract Background This study investigated the cardiovascular (CV) safety profile of the dipeptidyl peptidase (DPP)-4 inhibitor linagliptin versus comparator treatments. Methods This was a pre-specified meta-analysis of CV events in linagliptin or comparator-treated patients with type 2 diabetes mellitus (T2DM) from eight Phase 3 studies. All suspected CV events were prospectively adjudicated by a blinded independent expert committee. The primary endpoint was a composite of CV death, stroke, myocardial infarction, and hospitalization for unstable angina. Three secondary composite endpoints derived from the adjudicated CV events were also pre-specified. Risk estimates were calculated using several statistical methods including Cox regression analysis. Results Of 5239 treated patients (mean ± SD HbA1c 65 ± 10 mmol/mol [8.0 ± 0.9%], age 58 ± 10 years, BMI 29 ± 5 kg/m2), 3319 received linagliptin once daily (5 mg, 3159; 10 mg, 160) and 1920 received comparators (placebo, 977; glimepiride 1-4 mg, 781; voglibose 0.6 mg, 162). Cumulative exposure (patient-years) was 2060 for linagliptin and 1372 for comparators. Primary CV events occurred in 11 (0.3%) patients receiving linagliptin and 23 (1.2%) receiving comparators. The hazard ratio (HR) for the primary endpoint showed significantly lower risk with linagliptin than comparators (HR 0.34 [95% confidence interval (CI) 0.16-0.70]) as did estimates for all secondary endpoints (HR ranging from 0.34 to 0.55 [all upper 95% CIs Conclusions These results from a large Phase 3 programme support the hypothesis that linagliptin may have CV benefits in patients with T2DM.</p

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Inhibitors of dipeptidyl peptidase-4 (DPP-4) enzyme are one of the commonly recommended hypoglycemic agents. Although efficient in controlling hyperglycemia, their cardiovascular (CV) safety has been debated for long-term use, particularly in relation to heart failure risk. This review analyzed the cardiovascular safety profile after the consumption of various DPP-4 inhibitors in hyperglycemic patients. The systematic review and meta-analysis was conducted by utilizing widespread empirical research and randomized control trials (RCTs), evaluating sitagliptin, saxagliptin, alogliptin, and linagliptin. Databases searched included PubMed, Embase, Cochrane CENTRAL, and Clinical Trials.gov through September 2025. Outcomes assessed were: HHF, i.e., hospitalization for heart failure, MACE, i.e., major adverse cardiovascular events (CV death, nonfatal myocardial infarction (MI), nonfatal cerebrovascular attack (CVA), all-cause mortality, and cardiovascular mortality. Random-effects metHFa-analyses were conducted, with heterogeneity assessed via I² statistics. Seven large RCTs (n > 70,000 participants) were included, along with supporting observational data. Pooled analysis demonstrated no significant increase in MACE intake of DPP-4 inhibitors when compared to placebo (hazard ratio (HR) 0.99, 95% confidence interval (CI) 0.93-1.05, heterogeneity (I²) = 5%). However, an increased probability of HHF was found (HR 1.14, 95% CI 1.02-1.27, I² = 28%), largely driven by saxagliptin (HR 1.27, 95% CI 1.07-1.51) and, to a lesser extent, alogliptin. While no significant heart failure (HF) risk was observed by the intake of drugs sitagliptin (HR 1.00, 95% CI 0.83-1.20) and linagliptin (HR 1.02, 95% CI 0.89-1.17), no differences were noted in all-cause or CV mortality across the class. DPP-4 inhibitors, as a group of drugs, are safe with respect to MACE, but saxagliptin and possibly alogliptin are linked with an increased risk of HHF. Sitagliptin and linagliptin appear neutral regarding HF risk. These findings highlight the importance of drug-specific evaluation when selecting a DPP-4 inhibitor for type-2 diabetic patients, particularly those having an elevated risk of heart failure.

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