BACKGROUND: Insulin glulisine  is a  new  rapid-acting insulin  analogue.  Currently,  few  data   are   available on its safety and tolerability among patients in the Asia-Pacific   region.
OBJECTIVES:
Primary Objective: To assess the safety and tolerability of insulin glulisine as part of an insulin treatment   regimen   in   Filipinos   with   diabetes
Secondary  Objectives:
1.    To compare the change in glycosylated hemoglobin (HbA1c), fasting blood glucose (FBG) and post-prandial blood glucose (PPBG) levels at baseline and after  three  and  six months on an insulin treatment regimen with insulin  glulisine
2.    To measure patients' level of  satisfaction  in  using   the   Insulin   glulisine  pen
METHODS: This was a multicenter, observational, post- marketing  surveillance  study   of   adult   patients   (18   to Results: Among 1,805 patients included, 132 (7.31%) experienced hypoglycemia. The overall incidence of adverse events other than hypoglycemia was 0.78%. There  was  a  significant  reduction  in   baseline  levels   of HbA1c,  FBG  and  PPBG  during  the  follow-up  visits  at third and sixth months (all p<0.0001). Patient satisfaction  with  using  the  pen  was  good  to    excellent.
CONCLUSION: This post-marketing surveillance study demonstrates the safety and tolerability of  insulin  glulisine  when  used   as   part   of   an   insulin   regimen in an actual clinical setting for the management of diabetes among Filipino  patients.  Insulin  glulisine  as  part of  a   diabetes  treatment  regimen  was   effective  in improving glycemic  parameters.  The  glulisine  pen  was   also   well   tolerated   and   accepted   by patients.

Human ; Male ; Female ; Aged ; Middle Aged ; Adult ; Hemoglobin A, Glycosylated ; Insulin Glulisine ; Diabetes Mellitus, Type 2 ; Insulin, Short-acting ; Excipients ; Fasting ; Insulin ; Hypoglycemia

Introduction: Diabetes in the Philippines is a major and growing health issue. From its prevalence of 2.8 million in 2000, it was projected by the World Health Organization to reach 7.8 million by 2030. Glimepiride has been found to be effective and well-tolerated, as monotherapy and in combination with metformin, in managing glycemic levels among type II diabetes mellitus (T2DM) patients. This study aimed to assess the safety and efficacy of a sustained release (SR) fixed-dose combination (FDC) preparation of glimepiride and metformin in the treatment of Filipino patients with T2DM. Methods: This open-label, observational, multicenter, post-marketing study, conducted from April 2012 to December 2013, included 20 to 75-year-old patients with T2DM, presenting with 7% to 11% HbA1c or 110-250 mg/dL fasting blood sugar, insulin-naive, and in consideration for management with a glimepiride-metformin FDC. Baseline data were collected. Patients were prescribed with glimepiride-metformin FDC SR 2/500 mg/tab for a six-month treatment period. Follow-up data were collected on the third and the sixth month of treatment. Patients who missed one follow-up were included in population for safety analysis. Patients who completed both follow-up schedules make up the per-protocol population for efficacy analysis. Adverse events (AEs) were reported in frequencies and percentages. Repeated measures analysis of variance (ANOVA) was used for efficacy analysis on HbA1c and FBG data. Results: From 1,052 enrollees, 795 patients had sufficiently filled data forms and attended at least one follow-up schedule; this is the population whose data was analyzed for this study. Fifty-nine AEs were reported; only 21 incidents of hypoglycemia were assessed to be definitely, probably, or possibly related to the study drug. Repeated measure ANOVA showed that the mean ± SD HbA1c at month three (7.15 ± 1.22%) and month six (6.80 ± 1.17%) were significantly lower than baseline (8.67 ± 1.10%). The mean ± SD FBG at month three (133.20 ± 35.46 mg/dL) and month six (122.47 ± 29.34 mg/dL) were also significantly lower than baseline (176.85 ± 41.24 mg/dL). The differences in HbA1c and FBG changes between those with concomitant OAD and those without were non-significant. Conclusion Fixed-dose combination of glimepiridemetformin is a drug with a tolerable profile and favorable benefits in treating patients with T2DM.
Metformin

Introduction: Resistant hypertension (RH) is defined as a blood pressure (BP) reading that remains above goal despite concurrent use of three optimally dosed antihypertensives of different classes, including a diuretic. Spironolactone, a mineralocorticoid receptor antagonist, has shown significant benefit in reduction of BP in recent trials and is used empirically as an add-on therapy for RH. The researchers’ objective is to evaluate the BP-lowering efficacy of spironolactone in patients with resistant hypertension. Methods: A meta-analysis was performed on randomized controlled trials (RCTs) comparing office or home BP reduction using spironolactone with placebo or an alternative drug regimen on top of standard-triple drug therapy among patients with RH. The study was conducted in reference to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). Results: Five RCTs were included comprising a total of 662 patients. Three of these studies were found to have low risk of bias while two had unclear risk of bias. Compared to placebo, the addition of spironolactone significantly decreased office systolic BP (weighted mean difference [WMD]= -16.33, 95% confidence interval [CI]=-24.68 to -7.97, P=0.0001) and office diastolic BP (WMD=-6.12, 95% CI= -9.35 to -2.89, P=0.0002). Compared to an alternative drug regimen, additional spironolactone resulted in a significantly greater reduction in office systolic BP (WMD=-4.58mmHg, 95% CI=-7.19, -1.97, P= 0.0006) and home systolic BP (WMD= -4.33, 95% CI= 5.55, -3.12, P< 0.00001); while the addition of spironolactone had no significant difference compared to an alternative drug regimen in reducing office diastolic BP (WMD=-3.35, 95% CI=-12.08 to +5.38, P=0.45) and home diastolic BP (WMD= 0.00, 95 % CI=-0.73 to 0.73, P=1.0). Conclusion Spironolactone, when added to triple-drug anti-hypertensive therapy, showed significant reduction of systolic office and home BP. It should be considered as the add-on medication of choice for BP reduction in patients with RH.
Antihypertensive Agents ; Spironolactone ; Blood Pressure

Pheochromocytoma, a rare cause of hypertension, is potentially fatal if left untreated. Definitive treatment is resection of the mass. Preoperative blockade is important to improve intraoperative hemodynamic stability and reduce morbidity during resection. Phenoxybenzamine, a non-selective alpha adrenergic blocker, has been widely used as preoperative blockade, but is unavailable in the Philippines. Terazosin, a selective alpha 1 antagonist and is widely available as treatment for benign prostatic hypertrophy, has been documented in reports as a suitable preoperative drug in reducing blood pressure in pheochromocytoma patients. The objective is to present four cases of Filipino pheochromocytoma patients who were treated with terazosin as first line preoperative blockade. Four Filipino patients from the Philippine General Hospital were diagnosed with pheochromocytoma based on biochemical and imaging studies. They were started on different doses of terazosin, the maximum dose as high as 4 mg per day. One patient experienced orthostatic hypotension at this dose, but was resolved after reducing the dose to 3 mg per day. A beta blocker (metoprolol on 3 cases, carvedilol) was added for reduction of the symptoms. One patient was also diagnosed with diabetic ketoacidosis, and was treated as such. Two patients experienced labile changes with blood pressure during resection but were resolved with the use of intravenous nicardipine for elevated blood pressure, and crystalloids during bouts of hypotension. All of the patients' blood pressure returned to normal after resection of the mass. Terazosin, a selective alpha 1 antagonist, at a maximum dose of 4 mg per day, may be safely given to Filipino patients diagnosed with pheochromocytoma as first line preoperative blockade.
Pheochromocytoma ; Hypertension

Dyslipidemia is a cardiovascular risk factor that is increasing in prevalence in the country. The need to treat and manage elevated cholesterol levels, both pharmacologic and non-pharmacologic, is of utmost importance. Different medical societies and groups bonded together to formulate the 2020 Philippine Clinical Practice Guidelines for dyslipidemia. The group raised nine clinical questions that are important in dyslipidemia management. A technical working group analyzed the clinical questions dealing with non-pharmacologic management, primary prevention for both non-diabetic and individuals with diabetes, familial hypercholesterolemia, secondary prevention, adverse events of statins and the use of other lipid parameters as measurement of risk for cardiovascular disease. Randomized controlled trials and meta-analyses were included in the GRADE-PRO analysis to come up with the statements answering the clinical questions. The statements were presented to a panel consisting of government agencies, members of the different medical societies, and private institutions, and the statements were voted upon to come up with the final statements of the 2020 practice guidelines. The 2020 CPG is aimed for the Filipino physician to confidently care for the individual with dyslipidemia and eventually lower his risk for cardiovascular disease.
Dyslipidemias ; Hyperlipoproteinemia Type II ; Diabetes Mellitus

Background: The COVID-19 pandemic continues to afflict nations worldwide. The Philippines is no exception which has recorded more than 3 million cases as of December 2021 with children comprising 12% of total cases. Since the start of the pandemic, the Pediatric Infectious Disease Society of the Philippines (PIDSP) has been collecting data nationwide, through an online pediatric COVID-19 registry (SALVACION registry), to provide a better understanding of COVID-19 in children in the local setting. Methods: This was an ambispective cohort study of pediatric COVID-19 cases in the Philippines reported from March 2020 to December 2021. Data on clinical features, laboratory findings, disease severity, and treatment outcomes were voluntarily reported by physicians across the country. This study was approved by the Department of Health Single Joint Research Ethics Board. Results: As of December 30, 2021, there were 2,127 cases reported in the registry, with a median age of 5 years (interquartile range: 1-13 years) and mostly mild (41.9%) or moderate (24.5%) in severity. The top symptoms reported were fever (57.9%), cough (42.7%), coryza/colds (29.4%), anorexia (25.2%), and difficulty of breathing (23.1%). The most common comorbidities were hematologic-oncologic diseases (7.4%), neurologic diseases (7.0%) and surgical conditions (4.4%), while the most common coinfections were sepsis (6.3%), dengue fever (4.8%) and healthcare-associated pneumonia (2.1%). Significantly higher median CRP, procalcitonin, D-dimer, ferritin, transaminases and lactate dehydrogenase were seen among severe/critical cases compared to non-severe cases. There was a high frequency of antibiotic use (58%). Most cases recovered, although 172 deaths were reported with an 8.6% case fatality rate. The most common comorbidities in those who died were neurologic (15.7%), cardiac (12.8%) and hematologic (11.6%) diseases. Conclusion Children across all age groups are susceptible to COVID-19 and most cases are mild or moderate in severity. Among severe and critical cases, the most common comorbidities were neurologic, hematologic-oncologic and cardiac diseases. Most patients recovered with supportive management.
COVID-19 ; SARS-CoV-2 ; Child ; Registries ; Philippines