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: There is an ever-increasing prevalence of type 2 diabetes mellitus (T2DM) in the Philippines. This observational study aimed to evaluate the effectiveness and safety of vildagliptin as monotherapy or combination therapy in patients with T2DM in a real-life setting from the Philippines. Methods: This 24-week, non-interventional study enrolled adult T2DM patients, receiving vildagliptin either as monotherapy or dual/triple combination therapy. The primary endpoint was change in HbA1c from baseline to week 24. The secondary endpoints included proportion of patients achieving the glycemic goals HbA1c ≤6.5% and ≤7.0%, and safety assessment at week 24. Results: Of the 385 patients enrolled, 267 (69.35%) completed the study. The mean±standard deviation age was 54.72±11.06 years, HbA1c, body mass index, and diabetes duration were 8.54±1.81%, 27.35±5.58 kg/m2 and 3.04±4.88 years, respectively. Overall, treatment with vildagliptin resulted in HbA1c reduction of 2.02±1.68 (p<0.0001) from baseline to week 24. At week 24, 60.64% and 74.47% of the patients achieved the glycemic target of HbA1c ≤6.5% and ≤7.0% respectively. Seven serious adverse events (AEs) unrelated to the study drug were reported, most of which (24/28) were mild or moderate in severity; 85.71% of the AEs reported were not drug related. One hypoglycemic event (with vildagliptin/metformin single pill combination [SPC]) and one death (with vildagliptin/metformin free dose and SPC, due to severe pneumonia) were reported at week 12. Discussion: This observational study showed that treatment with vildagliptin monotherapy or combination therapy for 24 weeks in patients with T2DM in the Philippines provided statistically significant reductions in HbA1c. Overall, vildagliptin (mono or dual/triple therapy) was well-tolerated and demonstrated a favorable safety profile with no new safety signal. Conclusion Treatment with vildagliptin as monotherapy or in combination with other antihyperglycemic agents resulted in good glycemic control and was well-tolerated in patients with T2DM in the Philippines, under real-world settings.
Diabetes Mellitus, Type 2 ; Observational Study

Background: The dose of levothyroxine (LT4) after total thyroidectomy is usually computed based on actual body weight. However, metabolism through deiodination of thyroid hormones usually occur in the lean body compartment. An optimal dose to reduce delay in achieving target levels is essential to improve quality of life, reduce risk factors and cost. Objectives: Comparison of the efficacy of two methods of computation for the initial levothyroxine dose in patients with differentiated thyroid cancer based on actual body weight vs. lean body mass in achieving thyroid-stimulating hormone (TSH) goals. Methodology: Randomized, single-center, 12-week open label controlled trial among adult patients with differentiated thyroid cancer post total thyroidectomy who underwent radioactive therapy at St. Luke’s Medical Center Quezon City from July-December 2018. Participants were divided into 2 groups - Actual Body Weight (ABW) and Lean Body Mass (LBM). Levothyroxine dose was computed based on ABW vs. LBM and TSH determined at 6th and 12th weeks after. Results: 52 participants (ABW n=26; LBM n=26) were included. ABW group had significantly higher mean LT4 dosage (2.2 mcg/kg) compared to the LBM group (1.4 mcg/kg) (p-value<0.001). ABW group had lower TSH levels at 6th week (5.7 uIU/mL) than LBM group (18.4 uIU/mL) but the difference was not significant. (p-value=0.064). A significantly lower TSH level was observed at week 12 in the ABW group (1.6 uIU/mL) compared to the LBM group (3.8 uIU/mL) (p-value=0.010). However, both methods were not associated with achievement of TSH goal at 6th and 12th week (p-value=0.512 and 0.780, respectively). Conclusion Among patients with differentiated thyroid cancer who underwent 1st time RAI therapy, ABW method of computation for LT4 dosage is better compared to the LBM method due to the lower TSH trend seen at 6th week and statistically significantly lower mean TSH at week 12, although, both method of computations did not achieve target TSH levels at the 6th nor 12th week.

Introduction: This is a case of patient with giant pituitary adenoma (GPA) presenting with acromegalic features, minimal symptoms of mass effect who underwent surgical resection via transcranial approach with minimal surgical morbidity. Case: A 40-year-old female presented with typical acromegalic features over 14 years, occasional mild frontal headaches and blurred vision. She had elevated growth hormone (GH) and insulin-like growth factor-1 (IGF-1). Cranial MRI revealed a 6.4x7x5.5 cm lobulated pituitary mass with cystic degeneration, areas of necrosis with mass effect on several intracranial structures. Excision via craniotomy reduced mass size to 5.9x5.8x4.7 cm. Histopathology revealed a mixed GH- and prolactin-secreting pituitary adenoma. She was maintained on bromocriptine and underwent radiotherapy. Repeat IGF-1 levels remained elevated but symptoms did not progress Conclusion This is a case of a patient with GPA with minimal symptom of mass effect, with no hormonal improvement post-surgery and radiotherapy. Ideally, a multi-staged surgery can be done with optimization of medical management. In the absence of these medications locally and reluctance of patient for re-surgery, the team opted to monitor tumor size, hormone levels and maximize management of co-morbidities.
Acromegaly ; Pituitary Neoplasms