BACKGROUND: Diabetes mellitus (DM) is a major cause of morbidity and mortality in the Philippines. Improvement in hemoglobin A1c (HbA1c) remains below recommended targets for Filipino patients. Safe and effective therapies are needed for this population.
OBJECTIVE: To investigate treatment-emergent adverse events (TEAEs) and change in HbA1c among Filipino patients with DM treated with insulin lispro mix 25/75 in a real-world setting.
MATERIALS AND METHODS: This was a prospective, non-interventional, post-marketing surveillance study among 459 Filipinos aged 18 years or older with type 1 or 2 DM. Patients were treated with insulin lispro mix 25/75 according to the approved label, as prescribed by the investigators, and observed for 12 weeks. Occurrence of all TEAEs and change in HbA1c from baseline to final visit were reported.
RESULTS: Mean (SD) treatment duration was 12.93 (5.7) weeks, and mean total daily dose was 0.62 (0.29) units/kg. Eighteen patients (3.9%) experienced 23 TEAEs, the majority of which were mild. None were reported to be related to treatment. No serious TEAEs or hypoglycemic episodes were reported. Mean (95% confidence interval) HbA1c was significantly reduced by -2.03% (-2.19%, -1.87%), and 36.3% of patients achieved HbA1c <7.0% at 12 weeks.
CONCLUSION: In this observational study, no treatmentrelated safety signals using insulin lispro mix 25/75 were detected among Filipino diabetic patients. HbA1c was significantly reduced in Filipino patients with DM at 12 weeks.

Human ; Male ; Female ; Middle Aged ; Adult ; Insulin Lispro ; Hemoglobin A, Glycosylated ; Hypoglycemia ; Diabetes Mellitus ; Hypoglycemic Agents

To establish reference values for lung function test in Filipinos, 283 (130 males and 153 females) normal non-smoking (< 0.5 pack years), adults were studied using a body plethysmograph (Jaeger, West Germany). Spirometric indices were integrated from a pneumotachograph (linear at flows between 0-20 1/sec with ± 2% error). Spirometric performance and measurements followed the ATS Snowbird Workshop recommendations. Lung volumes and airway resistance (Raw) were taken from the average of three plethysmographic determinations.

Multiple linear regressions with backward elimination was done. The data obtained was regressed against independent variables of age height, weight, and body surface area for each sex.

Analysis of variance (ANOVA) of the regression equations for most parameters were significant at = 0.01. In a few parameters were significance was = 0.05. Only in Raw was the regression model not significant. The coefficient of determination (R) of our regression equations were low (<0.50). However, such low R have been observed in other predictions equations which have gained widespread acceptance, attesting to their clinical usefulness. Ninety five percent confidence interval was used to determine the lower limit of normal for FEV1 and FVC. Since the other parameters showed greater individual variability, cumulative percentiles of % of predicted were determine instead (Knudson 1977). For performance test, the 5th percentiles of % of predicted was computed. For lung volumes, the 5th and 95th percentiles were determined. For Raw, the 95th percentiles of the actual values was used. Since there were fewer subjects above the age of 60 years, the use of these equations is subject to this limitation.

Human ; Male ; Female ; Smoking ; Lung ; Analysis Of Variance ; Population