BACKGROUND AND OBJECTIVES<p>Pelargonium sidoides DC. Root (PELARGO) 20 mg capsule is approved by the Philippine Food and Drug Administration (FDA) for the symptomatic treatment of common cold. In compliance with FDA, this post-authorization safety study was conducted to determine the incidence of signs and symptoms of liver injury with PELARGO intake. It also aimed to look at symptom improvement and the incidence of other adverse events.p>METHODS<p>This non-interventional post-authorization safety study enrolled 300 adult patients with common cold, pre- scribed with Pelargonium sidoides DC. 20 mg capsule three times a day for seven days during routine clinical care from May 2023 to December 2023 in Cavite, Philippines. Demographic, clinical, and physical exam data were collected at baseline. Physical exam data, signs and symptoms of liver injury, symptom improvement, and other adverse events were determined post-treatment. Descriptive statistics were computed to characterize the participants at baseline (day 0) and end-study visit (day 8).p>RESULTS<p>There were 300 enrolled patients, 53% female and 60% single. The mean age was 36 years and the mean BMI was 26 kg/m2. Vital signs at baseline were mostly within normal limits and most had respiratory f indings. Two hundred ninety-eight (298) completed the study. Only a few had respiratory findings at end-study visit. There were no signs and symptoms of liver toxicity nor serious adverse events after seven days of PELARGO intake. Reported adverse effects with 2.0% to 1.3% incidence in seven days include dizziness, drowsiness, headache, and polyphagia. Others wereCONCLUSION<p>There is no evidence of liver toxicity after seven days of PELARGO intake for common cold among Filipino adults. The drug was well tolerated, and most patients experienced significant symptom improvement. Results should be interpreted with caution in the light of study limitations.p>
Human ; Pelargonium ; Common Cold

Objectives: Bioequivalence studies provide evidence that generic drugs can produce the same blood levels as the innovator, suggesting similar efficacy and safety and indicating interchangeability without the need to titrate dosing. This study aimed to compare the rate and extent of absorption of two simvastatin 20 mg tablets of Pascual Laboratories, Inc. with two Zocor 20 mg tablets of Merck Sharp & Dohme (I.A.) Corp. in healthy Filipinos. The study also monitored the safety and tolerability of the medications, under the same conditions. Proof of bioequivalence is required by FDA Philippines to establish the interchangeability of generic products and their innovators. Methods: Twenty-four healthy participants were administered with a single oral dose of two 20 mg simvastatin tablets under fasting conditions, in a randomized, open-label, blind-endpoint analysis, two-way crossover study, with a washout period of one week. Pharmacokinetic blood sampling was done up to 24 h post-dose. Simvastatin was measured using Liquid Chromatography-Tandem Mass Spectrometry with a validated method. The geometric mean ratios for maximum plasma concentration (Cmax) and area under the plasma-concentration-time curve from time zero to the last observed concentration at time 24 h (AUC0-24) were used for bioequivalence. Results: All 24 participants, 12 males and 12 females, completed the study. Mean age was 24.21 years, mean weight was 58.81 kg, and mean BMI was 23.16 kg/m2. The ratios of Cmax and AUC0-24 were 102.17% (90% CI: 89.19-117.03), and 101.29% (90% CI: 86.87-118.10), respectively, and were both within the bioequivalence limits of 80% to 125%. No adverse event was reported and both formulations were well-tolerated. Conclusions Simvastatin 20 mg tablet of Pascual Laboratories, Inc. and the innovator Zocor 20 mg tablet are bioequivalent. Single two-tablet doses of both products are safe and well tolerated.
Simvastatin ; Hydroxymethylglutaryl-CoA Reductase Inhibitors

Objectives: Vitex negundo is an endemic shrub in the Philippines which has been clinically tested for the symptomatic treatment of cough in syrup and tablet formats. However, the effectiveness and safety of the capsule have not been formally documented in a clinical trial setting. Therefore, in compliance with the Philippine FDA directive, this study compared the efficacy and safety of the capsule and tablet formats after three days of treatment among Filipinos with acute uncomplicated cough. Methods: This is a Phase 3b randomized, open-label, parallel-group non-inferiority study with 335 subjects using improvement based on Global Rating of Change Scale scores as primary efficacy endpoint and several secondary endpoints. Descriptive and inferential analyses were performed. The Farrington-Manning Method of Z-test with -10% non-inferiority margin was used for the primary outcome. Appropriate inferential tests were used for the secondary outcomes. Results: Of 335 enrolled subjects, 170 were randomized to the capsule group and 165 to the tablet group with comparable baseline characteristics. The proportion of success based on the Global Rating of Change Scale rated by patients was 95.71% and 91.19% for the capsule and tablet groups, respectively. Based on doctors’ ratings, they were 96.93% and 94.34%, respectively. In addition, the Farrington-Manning Method of Z-test revealed the capsule was not inferior to the tablet based on patients’ and doctors’ ratings (90% Confidence Intervals: -0.0086 to 0.0988 and -0.0228 to 0.0747, respectively). The intention-to-treat analysis also showed non-inferiority, indicating robust results. Significant and similar improvements in cough severity and quality of life were observed in both groups based on Cough Severity Diary scores and Leicester Cough Questionnaire for acute cough, respectively. There were also improvements in the Forced Expiratory Volume at 1 second [FEV1] (capsule group) and Peak Expiratory Flow Rate [PEFR] (both groups), but these were not clinically significant. The safety profiles were also comparable (p= 0.4437) with 1.23% and 2.52% incidence of adverse events, respectively, all of which were mild and assessed as not related to the drug. Conclusion In terms of efficacy, Ascof® Forte capsule was non-inferior to Ascof® Forte tablet in treating acute uncomplicated cough among Filipinos based on Global Rating of Change Scale scores as rated by patients and doctors. Both treatments showed significant and similar improvements in cough severity and quality of life. They were also comparable in safety with few adverse events in both groups, all mild and assessed unrelated to drug intake.
Capsules

<p style="text-align: justify;">Objective. Proof of bioequivalence is important for the interchangeability of pharmaceutically equivalent drug products. This study aimed to compare the rate and extent of absorption of meloxicam 15 mg tablet of Pascual Laboratories, Inc. (Test) with meloxicam 15 mg tablet (Mobic) of Boehringer Ingelheim (Reference) in healthy Filipino men. In addition, the study also determined the safety and tolerability of single doses of the said medications, under the same conditions.p><p style="text-align: justify;">Methods. This was a randomized, open label, blind-endpoint analysis, truncated, crossover study with single drug doses administered in the fasting condition in each of the two treatment periods, separated by a two-week washout period. Pharmacokinetic blood sampling was performed up to 72 h post-dose. Plasma samples were analyzed using a validated liquid chromatography with tandem mass spectrometry technology. The primary endpoints were: area under plasma-concentration-time curve from time zero to the last observed concentration at time 72 h (AUC0-72) and maximum plasma concentration (Cmax) for meloxicam.p><p style="text-align: justify;">Results. Eighteen men (mean age 21.5 years; mean body mass index 22.9 kg/m2) completed the study. When administered one meloxicam 15 mg tablet, the ratios of the geometric means of the primary endpoints AUC0-72 and Cmax, were within the established bioequivalence limits of 80% to 125% compared with Mobic 15 mg tablet: 104.07% (90% Confidence Interval [CI]: 100.26, 108.03), and 103.34% (90% CI: 96.22, 110.97), respectively. No adverse event was reported.p><p style="text-align: justify;">Conclusion. Meloxicam 15 mg tablet of Pascual Laboratories, Inc. and the innovator Mobic 15 mg tablet are bioequivalent. Single doses of both products were safe and well tolerated.p>
Meloxicam

<p style="text-align: justify;">OBJECTIVE: This study aimed to assess the safety and effectiveness of subcutaneous (SC) Epoetin alfa in the treatment of Filipino patients with anemia associated with chronic renal failure.
METHODS: This is a prospective, observational, multicenter study on chronic renal failure patients with anemia for whom Epoetin alfa SC is indicated. Each patient was followed-up according to the frequency deemed appropriate by the physician for a period of 6 months. Data were collected using a case-report form which is filled-up by the investigator based on available data in the patient records. Patient characteristics were analyzed descriptively. The frequency and description of adverse events were obtained. Baseline and endstudy hemoglobin and hematocrit levels were compared inferentially. Monitoring for antibody-mediated pure red cell aplasia (PRCA) was given special focus.
RESULTS: A total of 458 patients were enrolled in the study with an average age 52.8 ± 16.9 years and a slight male predominance (57.8% male). Among patients with primary renal diseases, the most common diagnosis was chronic glumerulonephritis (31.0%), followed by diabetic nephropathy (14.4%) and hypertension (10.0%). Around two-thirds (66.2%) of the patients were on dialysis, while the rest were in the pre-dialysis stage. Most patients had concomitant disease conditions with hypertension (57.9%) and diabetes mellitus (27.1%) being the most common. Most patients also had multiple concomitant medications. Significant improvements inhemoglobin (mean increase 0.8 ± 2.3 mg/dL from 9.66 at baseline; p value at < 0.0001) and hematocrit (mean increase 2.4 ± 6.9% from 28.91% at baseline; p value at <0.0001) levels were observed. A total of 16.6% of the patients experienced non-serious adverse events, with fatigue being the most common, and all of these were resolved during the study. Less than 5% of the patients had serious adverse events leading to mortality, which were all assessed by the investigators as not related to Epoetin alfa. There was no reported suspected loss ofeffect among the subjects indicating no incident PRCA.
CONCLUSION: Subcutaneously administered Epoetin alfa was effective in significantly increasing hemoglobin and hematocrit in chronic kidney disease patients with anemia. The drug is also safe and well tolerated, with no new safety issue identified, and no incident case of PRCA.p>
Human ; Male ; Female ; Middle Aged ; Adult ; Anemia ; Kidney Failure, Chronic ; Diabetic Nephropathies ; Epoetin Alfa ; Hematocrit ; Hypertension ; Renal Dialysis ; Renal Insufficiency, Chronic ; Erythropoietin