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Type 2 diabetes mellitus (T2DM) frequently requires multidrug therapy, and complex dosing schedules can escalate pill burden and potentially compromise treatment adherence, particularly among those with multiple comorbidities.
Once-daily vildagliptin 100 mg sustained-release is well tolerated and effectively improves glycemic parameters, with no clinically meaningful renal or hepatic safety concerns over 24 weeks.
Type 2 diabetes mellitus (T2DM) frequently requires multidrug therapy, and complex dosing schedules can escalate pill burden and potentially compromise treatment adherence, particularly among those with multiple comorbidities. Reducing dosing frequency may improve convenience and support medication compliance.
The 100 mg sustained-release (SR) formulation of vildagliptin, given once a day, provides an alternative to the conventional twice a day 50 mg regimen. This prospective post-marketing surveillance study determined the safety, tolerability, and glycemic outcomes associated with vildagliptin.
In this open-label study, adults aged ≥18 years with a clinical diagnosis of T2DM were recruited. Participants received vildagliptin 100 mg SR once per day. Safety and tolerability were assessed primarily through the rate of adverse drug reactions (ADRs). At baseline and at weeks 12 and 24, alterations in serum creatinine, serum amylase, serum lipase, glycated hemoglobin (HbA1c), fasting plasma glucose (FPG), postprandial glucose (PPG), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) were checked.
The study included 210 volunteers (129 males and 81 females) with a mean age of 52.63 years. Glycemic parameters improved significantly during follow-up, with progressive reductions in HbA1c, FPG, and PPG. No clinically significant changes were noted in AST or serum creatinine, while ALT, amylase, and lipase levels dropped markedly, supporting the treatment’s overall metabolic and biochemical tolerability (Table 1).
In total, 9 ADRs were reported in 7 patients (3.3%), corresponding to an overall ADR incidence of 4.3%. All events were mild, non-serious, and considered to have a probable or likely relationship with vildagliptin.
Over 24 weeks, vildagliptin 100 mg SR administered once daily demonstrated favorable safety and tolerability in adults with T2DM while providing significant improvements in HbA1c, FPG, and PPG.
Cureud
Safety and Tolerability of Vildagliptin 100 mg Sustained-Release Formulation in Type 2 Diabetes Mellitus: Results From a Prospective, Multicenter, Single-Arm, Post-marketing Surveillance Study
Pravin Soni et al.
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