INTRODUCTION: GUARD (vildaGliptin clinical Use in reAl woRlD) was  a  multinational,  prospective,  observational  study that assessed the effectiveness,safety  and  tolerability of vildagliptin and vildagliptin+metformin in patients with type 2 diabetes mellitus (T2DM) under real-world conditions across four  geographical  regions  (Asia,  the  Middle  East,  Central  America and Africa). The current paper discusses the results of patients with T2DM enrolled in the Philippines.
METHODS: Patients  with  T2DM  who  were  prescribed vildagliptin or vildagliptin+metformin combination therapy were enrolled and followed as per routine clinical practice for 24 ± six weeks. Primary endpoint was the change in HbA1c from  baseline  to  study  end  (week  24±6).  Key  secondary endpoints included proportion of patients reaching target HbA1c ?7.0%, incidence of hypoglycemic events, adverse events (AEs) and serious AEs (SAEs).
RESULTS: A total of 1,117 patients were included in the final analysis, 280 on vildagliptin (of these, eight patients received additional oral antidiabetes medications) and 837 on vildagliptin+metformin. At baseline, the mean (±SD) age of the enrolled population was 54.1±11.5 years, BMI 26.3±4.7 kg/m2, HbA1c 8.0±1.2% and T2DM duration 2.3±4.0 years.At  study  end,  significant  mean  (±SE)  reductions  in  HbA1c of -1.2±0.1% (p<0.0001) and -1.5±0.1% (p<0.0001) from a baseline of 7.6±1.1% and 8.1±1.2% were observed for the vildagliptin and vildagliptin+metformin group, respectively.A similar proportion of patients achieved HbA1c ?7.0% in the vildagliptin (66.1%) and vildagliptin+metformin group(62.7%). Changes in body weight and BMI from baseline to week 24±6 were statistically significant (p<0.0001) in both the vildagliptin (-1.5±0.3 kg; -0.6±0.1 kg/m2) and the vildagliptin+metformin group (-1.4±0.2 kg; -0.5±0.1 kg/m2).The incidence of hypoglycemia was low--six patients reported hypoglycemia in the vildaglipti metformin group and  none  in  the  vildagliptin  group.  Incidence  of  adverse events was also low in both the groups (vildagliptin, 8.6% and vildagliptin+metformin, 5.3%).
CONCLUSION: Vildagliptin  and  vildagliptin+metformin significantly  reduced  HbA1c  with  good  weight  control and low incidence of hypoglycemia in patients with T2DM under real-world conditions in Philippines

Human ; Male ; Female ; Aged ; Middle Aged ; Adult ; Metformin ; Vildagliptin ; Diabetes Mellitus, Type 2 ; Adamantane ; Pyrrolidines ; Hypoglycemic Agents ; Nitriles ; Hypoglycemia ; Body Weight ; Asia ; Africa ; Central America

Introduction: Allergic rhinitis (AR) is a highly prevalent chronic disease affecting up to 30% of the population worldwide.1 Although AR is not life-threatening, it greatly impacts patients’ health-related quality of life and furthermore, if left untreated, it may be complicated by other respiratory co-morbidities.2 Intranasal corticosteroids are one of the several classes of medications recommended to manage AR. Fluticasone furoate nasal spray is a novel enhancedaffinity glucocorticoid for the management of AR.2 This study assessed the safety profile of Fluticasone furoate nasal spray in the treatment of Filipino patients with AR. Methods: This is a multicenter, prospective, post-marketing surveillance study aimed at documenting adverse events, their frequency and severity as assessed by the investigators among Filipino patients with AR administered with Fluticasone furoate nasal spray from August 2010 to January 2013. Results: Four hundred thirty-nine (439) patients were enrolled in the study. Among these, 421 patients were included in the safety analysis population. Eighteen patients were excluded from the safety analysis population due to protocol violation and lack of post-baseline safety assessment. Of the total eligible population, 10 patients (2.4%) experienced adverse events (AEs) with a total of 10 and no serious adverse events (SAEs) were reported. Eight of these 10 AEs resolved while two AEs had unknown outcome. One patient (0.2%) experienced an AE suspected to be related to study medication. The most common AE occurring in eight patients was respiratoryrelated which were nasal dryness (3 events), rhinorrhea (2 events), epistaxis (1 event), nasal discomfort (1 event) and rhinalgia (1 event). Conclusion Fluticasone furoate nasal spray, among indicated patients with AR showed AEs which approximate AE of other similar post-marketing studies with incidence of less than 1% for each event.[21] Neither SAEs nor drugrelated deaths were reported throughout the study.
Rhinitis, Allergic