No abstract available.
Metformin

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

BACKGROUND AND OBJECTIVES

The in vitro bioequivalence assessment using a dissolution apparatus, as specified by the United States Pharmacopeia (USP), is a critical parameter in the formulation and development of generic pharmaceutical products. This study is crucial for evaluating the interchangeability of generic drugs with their reference innovator counterparts. Post-market surveillance of generic drugs ensures consistent quality after distribution in the market. Metformin hydrochloride, a widely prescribed oral hypoglycemic agent for managing type 2 diabetes, is among the most utilized medications globally.

In the Philippines, there is a growing need to assess the bioequivalence of various generic formulations of metformin HCl f ilm coated tablets to ensure compliance with regulatory requirements. The Philippine Food and Drug Administration (FDA) mandates in vivo or in vitro bioequivalence including, dissolution profile comparison, as a prerequisite for the registration of generic drugs. This study aims to evaluate the quality and in vitro bioequivalence of metformin HCl f ilm-coated tablets available in the Philippine market by comparing their dissolution profiles against the innovator, Glucophage. This research seeks to provide insights into the interchangeability, therapeutic equivalence, and overall quality of these generic formulations, thus contributing to public health and regulatory standards.

Generic metformin HCl film-coated tablets were subjected to quality control tests, including weight variation, thickness and diameter, hardness, friability, and disintegration tests, in accordance with USP guidelines. To assess in vitro bioequivalence, dissolution testing was performed, and the concentration of the dissolved drug was determined using a microplate assay reader to measure absorbance. Dissolution profiles of the generic metformin HCl film-coated tablets were compared to that of the innovator drug, Glucophage to evaluate bioequivalence.

All tested generic metformin HCl film-coated tablets complied with USP specifications for quality control tests, except for the hardness test, where three brands failed to meet the required standards. While for dissolution testing, five out of six generic brands demonstrated acceptable dissolution profiles and were bioequivalent to the innovator drug Glucophage. However, one brand (Brand A) failed to meet the bioequivalence criteria, exhibiting a dissolution profile outside the acceptable limits.

This study demonstrates that most generic metformin HCl film-coated tablets available in the Philippine market meet the United States Pharmacopeia (USP) quality control requirements and exhibit in vitro bioequivalence with the innovator drug. However, the failure of three brands to meet the hardness specifications and the lack of bioequivalence in one brand highlight the need for stringent quality assurance and  regulatory oversight. Ensuring compliance with these standards is critical to maintaining the safety, efficacy, and therapeutic interchangeability of generic drugs. These findings emphasize the importance of continuous post-market surveillance to uphold the quality of generic medications in the market, to safeguard public health.

No abstract available.
Humans ; Metformin*

No abstract available.
Humans ; Metformin*

No abstract available.
Humans ; Metformin*

INTRODUCTION: Acne vulgaris has multifactorial causes. Prolonged systemic antibiotics are often necessary because relapse of lesions occurs upon its discontinuation. Currently, antimicrobial resistance is a growing concern. Androgen inhibitors like metformin may decrease need for antibiotics and maintain adequate control of the disease. OBJECTIVE: To determine the efficacy and safety of metformin versus placebo as an adjunct to lymecycline and adapalene+benzoyl peroxide gel in the treatment of moderate to severe acne vulgaris METHODS: Patients with moderate to severe acne vulgaris received either metformin or placebo tablets, together with lymecycline and adapalene+benzoyl peroxide gel. Lymecycline was taken for six weeks. The rest were given for 18 weeks. Evaluation was done biweekly using the mean reduction rates of non-inflammatory, inflammatory and total lesion count, modified global severity score, subjective self-assessment score, Dermatology life quality index (DLQI) score, and cutaneous and systemic adverse events. RESULTS: Forty patients were selected for the trial. Mean reduction rates of the non-inflammatory lesion counts of the two groups were comparable (p>0.05). Mean reduction rates of the inflammatory and total lesion count in the metformin group were higher than the placebo group (p<0.05). The mean modified global severity score of the metformin group was lower than the placebo group (p=0.034). Mean DLQI scores decreased in both groups (p<0.0001). Subjective self-assessment scores improved in both groups with comparable results. Cutaneous adverse events (erythema, pain, scaling, and dryness) were tolerable. Systemic adverse events (diarrhea, flatulence, headache, and epigastric pain) were self-limited CONCLUSION: Metformin is an effective and safe adjunct in the treatment of moderate to severe acne vulgaris.
Lymecycline ; Metformin ; Acne Vulgaris

Background and Objective: Type 2 (T2DM) and gestational diabetes mellitus (GDM) among pregnant Filipinos have been increasing over the years because of lifestyle westernization. While insulin has been the safe mainstay when dietary measures fail to maintain normoglycemia during pregnancy, recent studies have suggested oral hypoglycemic agents (OHAs) such as metformin and glibenclamide, may offer cheaper and efficacious alternatives. The problem however, is the passage of these drugs through the placenta which may pose possible danger towards the development of the growing embryo. The proposed study aims to evaluate and compare the embryotoxic and teratogenic potentials of the varying concentrations of the two PhilHealth covered oral hypoglycemic agents in the Philippines, namely metformin (biguanide) and glibenclamide (sulfonylureas). Methodology: In this study, a comparison on embryotoxic potentials of metformin and glibenclamide was conducted using zebrafish embryotoxicity test (ZFET) across concentrations found in fetal (10, 20, 100, 500, 1000, 2000 μg/L) and maternal serum (10, 20, 100, 500, 1000, 2000 mg/L). Results and Conclusions Results revealed that metformin showed no significant (p>0.05) lethal effects, but revealed significant risk for teratogenicity, specifically decreased head and tail lengths and advanced hatching. Conversely, glibenclamide revealed significant potential for lethal (e.g., coagulation) and teratogenic effects including pericardial and yolk sac edema, spinal deformity and increased tail length. Comparative evaluation between the two OHAs reveal that glibenclamide has significantly (p<0.05) higher lethal and teratogenic effects. Together, our results suggest that the use of metformin over glibenclamide is favorable for safety testing in pregnant women suffering T2DM and GDM for the benefit of expanding treatment options for these diseases.
Glyburide ; Metformin ; Teratogenesis ; Zebrafish

No abstract available.
Diabetes Mellitus, Type 2 ; Humans ; Metformin ; Thiazolidinediones

Metformin is a first-line anti-diabetic drug that has been widely used in patients with type 2 diabetes. Many population-based epidemiologic studies have shown that metformin treatment is associated with decreased risk for various cancers. Recent epidemiologic studies showed that the use of metformin was associated with a reduction in gastric cancer risk, especially in patients with type 2 diabetes who used metformin for long periods of time (>2~3 years). Currently, there are no registered clinical trials investigating the anti-cancer effect of metformin in gastric cancer; hence, further well-designed clinical trials are required. Herein, we review the literature regarding the use of metformin for the prevention of gastric cancer.
Chemoprevention* ; Epidemiologic Studies ; Humans ; Metformin* ; Stomach Neoplasms*