Glimepiride + Pioglitazone
Drug Related WarningGlimepiride + Pioglitazone
- Certain patients may develop congestive heart failure due to thiazolidinediones (such as pioglitazone) or may already have it.
- Patients should be closely monitored for any signs and symptoms of heart failure, such as excessive, fast weight gain, dyspnea, and/or oedema, following initiation and dose increases.
- Heart failure should be treated per accepted medical practices if these indications or symptoms appear.
- It is necessary to think about stopping or reducing the dosage of thiazolidinedione.
- It is not advised to start thiazolidinediones in individuals with symptomatic heart failure; this is especially not for patients with established NYHA class III or IV heart failure.
Medicine Type :
Allopathy
Allopathy
Prescription Type:
Prescription Required
Prescription Required
Approval :
DCGI (Drugs Controller General of India)
DCGI (Drugs Controller General of India)
Schedule
Schedule H
Schedule H
Pharmacological Class:
Sulfonylureas, Thiazolidinedione, Therapy Class:
Antidiabetic Agent, Approved Countries
India, the United States, the United Kingdom, Canada, Australia, Africa and various European and Asian countries.
Glimepiride + Pioglitazone is an Anti-diabetic Agent belonging to the pharmacological class of Sulfonylureas and Thiazolidinediones.
Glimepiride + Pioglitazone is approved for treating type 2 diabetes mellitus. Together, these drugs can help in blood sugar regulation. Pioglitazone increases insulin sensitivity, and glimepiride enhances insulin release, improving glycemic management in people with type 2 diabetes.
Glimepiride + Pioglitazone is taken orally and adequately absorbed. The liver is where glimepiride is processed, and it takes 5-8 hours to be eliminated. With an elimination half-life of roughly 3–7 hours, pioglitazone is metabolized in the liver. Urine is the primary mechanism by which both drugs are removed from the body.
The common side effects of Glimepiride + Pioglitazone is low blood glucose levels (hypoglycemia).
Glimepiride + Pioglitazone is available as tablets for convenient administration.
Glimepiride + Pioglitazone is available in the United States, India, United Kingdom, Canada, Australia, Africa and various European and Asian countries.
Glimepiride + Pioglitazone is an Anti-diabetic Agent belonging to the pharmacological class of Sulfonylureas and Thiazolidinediones.
Glimepiride: Intracellular ATP and ADP activate pancreatic beta cell ATP-sensitive potassium channels. The channel's hetero-octomeric complex comprises four pore-forming Kir6. 2 subunits and four regulatory sulfonylurea receptor (SUR) subunits. Alternative splicing enables the creation of channels of distinct subunit isoforms expressed at various amounts in different organs. ATP-sensitive potassium channels are critical metabolic sensors and regulators in pancreatic beta cells, coupling membrane excitability with glucose-stimulated insulin secretion (GSIS). When the ATP: ADP ratio decreases, the channels are activated and open, resulting in K+ outflow from the cell, membrane hyperpolarization, and inhibition of insulin secretion.On the other hand, increased glucose uptake into the cell causes an increase in the intracellular ATP: ADP ratio, which causes channel closure and membrane depolarization. Depolarization causes activation and opening of voltage-dependent Ca2+ channels, resulting in an influx of calcium ions into the cell. Increased intracellular calcium levels induce the actomyosin filaments responsible for the exocytosis of insulin granules contained in vesicles to contract. Glimepiride inhibits the ATP-sensitive potassium channel by binding non-specifically to the B sites of the sulfonylurea receptor-1 (SUR1) and sulfonylurea receptor-2A (SUR2A) subunits, as well as the A site of SUR1 subunit of the channel to boost insulin secretion from the beta cell.
Pioglitazone: Pioglitazone is a potent and selective agonist for peroxisome proliferator-activated receptor-gamma (PPARgamma). Activation of nuclear PPARgamma receptors influences the production of several gene products involved in glucose and lipid metabolism. PPAR gamma is abundant in the cells within the renal collecting tubules; fluid retention results from stimulation by thiazolidinediones, increasing sodium reabsorption.
Synergistic Benefits: Glimepiride + Pioglitazone together have synergistic effects on type 2 diabetes management. Glimepiride significantly lowers blood sugar levels by stimulating the release of insulin. Insulin resistance is decreased, and insulin sensitivity is increased by pioglitazone. Combined, they offer complete glycemic control by addressing the secretion and usage of insulin. Individuals with diabetes who need two different modes of action to achieve optimal blood sugar regulation would benefit most from the combination of medications.
Data Onset of action of Glimepiride + Pioglitazone varies but may begin within hours to days, with Glimepiride acting more rapidly.
Data duration of action of Glimepiride + Pioglitazone can last up to 24 hours or more after oral administration.
The Data of Tmax and Cmax Glimepiride + Pioglitazone are typically within 2-4 hours for Glimepiride and 2-3 hours for Pioglitazone.
Glimepiride + Pioglitazone is available in oral tablets.
Tablets: To be swallowed whole with water/liquid. Do not chew, crush or break it.
As the physician recommends, take the medication orally once daily, generally with a meal.
In combination with glimepiride, Pioglitazone is used to treat type 2 diabetes. The combined drug helps control blood sugar levels by enhancing insulin sensitivity and secretion. People with uncontrolled diabetes are prescribed it, mainly when other treatments have not successfully directed their blood sugar levels.
Glimepiride + Pioglitazone is an Anti-diabetic Agent belonging to the pharmacological class of Sulfonylureas and Thiazolidinediones.
- Glimepiride: Glimepiride helps treat type 2 diabetes mellitus by increasing the amount of insulin your body produces (in the pancreas). It works by boosting the amount of insulin the body generates following a meal and prevents excessive glucose (sugar) release into the blood. In doing so, it decreases your body's blood glucose levels. It often only causes a single frequent adverse effect and is taken once each day.
- Pioglitazone: Pioglitazone is an agonist for peroxisome proliferator-activated receptor-gamma (PPARγ). PPAR receptors are found in tissues vital for insulin action, such as fatty tissue, skeletal muscle, and liver. Activation of PPARγ nuclear receptors modulates the transcription of several insulin-responsive genes involved in controlling glucose and lipid metabolism.
Glimepiride + Pioglitazone combination has beneficial effects on type 2 diabetes mellitus. It provides superior glycemic control by combining enhanced insulin sensitivity and secretion mechanisms. As a result, there may be benefits in long-term outcomes, decreased risk of hyperglycemia, and improved blood sugar management. For those who need dual-action medication to obtain the best possible diabetes management, this combination therapy may be beneficial.
Glimepiride + Pioglitazone is indicated as an adjunct to diet and exercise in the adults with type 2 diabetes mellitus who have not responded well to thiazolidinedione and sulfonylurea treatment or who have an insufficient response to thiazolidinedione or sulfonylurea treatment alone in terms of glycemic control.
Limitations of Use
- Only when endogenous insulin is present may pioglitazone reduce blood sugar levels. It is not recommended to use glimepiride and pioglitazone tablets to treat diabetic ketoacidosis or type 1 diabetes as they are ineffective.
- Patients with hepatic problems should exercise caution.
Orally: Glimepiride + Pioglitazone is available as a tablet that can be taken orally. Glimepiride + Pioglitazone should be taken with food, and it is best to take it regularly at a fixed time each day following the physician's prescribed schedule for regular and evenly spaced intervals because the dose and duration of therapy are individualized per specific conditions to achieve the most effective and successful treatment outcome.
The dosage and duration of treatment should be as per the treating physician's clinical judgment.
Glimepiride + Pioglitazone has various strengths, such as 2mg+30 mg and 4 mg+30 mg.
Glimepiride + Pioglitazone is available in the form of Oral tablets.
Dosage Adjustment for Adult Patients
Type 2 Diabetes Mellitus
2mg+30 mg, 4 mg+30 mgPO qDay, with an upper limit of 45 mg/8 mg.
Dosing Considerations
After the patient has been successfully titrated to 30 mg of pioglitazone monotherapy, treat systolic dysfunction (NYHA I/II).
For use in patients with type 2 diabetes who are receiving treatment with pioglitazone and a sulfonylurea combined, in patients whose glycemic control is inadequate with a sulfonylurea alone, or in patients who have responded to pioglitazone initially but need further glycemic control.
Glimepiride + Pioglitazone should be used in treating type 2 diabetes mellitus, along with appropriate dietary restrictions.
Limit or avoid alcohol, especially if consumed with Glimepiride + Pioglitazone, as it can lower blood sugar levels.
While taking this combination, it is advised to stay hydrated, consume a rich-balanced diet low in saturated fats and cholesterol—and drink plenty of vegetables, whole grains, fruits, and lean proteins in meals.
Avoid excessive consumption of grapefruit, grapefruit juice, as it may interact with the medication.
The dietary restriction should be individualized as per patient requirements.
Glimepiride + Pioglitazone may be contraindicated in the following conditions:-
Hypersensitivity
- Diabetes mellitus with or without coma
- Serum transaminase levels elevated, active liver disease
- Not advised in the event of cardiac failure. Those with NYHA III–IV
- Edema: dose-related fluid retention can be caused by thiazolidinediones, peroxisome proliferator-activated receptor (PPAR) gamma agonists, especially when combined with insulin.
- Increased risk of dying from cardiovascular disease.
- When treated with sulfonylurea medications, glucose 6-phosphate dehydrogenase (G6PD) deficiency may result in hemolytic anaemia.
- Fluid retention can happen and make congestive heart failure worse or cause it altogether; usage of insulin in combination with congestive heart failure Risk may rise with NYHA Classes I and II; monitor for symptoms and indicators in patients.
- There could be severe hypoglycemia. A lower insulin dose or an insulin secretagogue may be required when administered with pioglitazone to lessen the risk of hypoglycemia.
- Post marketing reports of angioedema, anaphylaxis, and Stevens-Johnson syndrome have been linked to glimepiride; cease glimepiride as soon as possible, examine for alternative causes, start appropriate therapy and monitoring, and start alternate diabetes medication.
- Postmarketing reports of sometimes deadly hepatic failure following a drug's release; One cannot exclude causation. Upon detection of a liver injury, stop treatment immediately, evaluate the patient for a likely cause, and treat the cause as soon as it can be resolved or stabilized. Do not resume therapy if liver damage is proven and there is no other known cause.
- Dose-related edema could happen.
- Reports of a higher frequency of bone fractures
- Cancer risk: There may be a higher risk of bladder cancer when taking pioglitazone. Those with still active bladder cancer shouldn't be prescribed it. Patients with a history of bladder cancer should take caution when using it, and they should notify their doctor immediately if they see any symptoms, such as blood in the urine, that could indicate bladder cancer.
- There has been evidence of macular edema; all diabetic patients should have routine eye exams in accordance with current guidelines, and any sudden vision changes should be promptly evaluated. No clinical studies show glimepiride/pioglitazone or any other anti-diabetic medication to reduce macrovascular risk conclusively.
- Pioglitazone's effects on fluid retention and fat formation may cause increased weight gain.
Alcohol Warning
It is unsafe to consume Glimepiride + Pioglitazone with alcohol.
Breast Feeding Warning
There is insufficient scientific evidence regarding the use and safety of Glimepiride + Pioglitazone in breastfeeding.
Pregnancy Warning
Safe to use during pregnancy only if the possible benefit outweighs the potential risk to the foetus. Use caution.
Food Warning
Increase intake of fibre-rich foods and minimize the carbohydrate or sugary intake.
The adverse reactions related to Glimepiride + Pioglitazone can be categorized as:-
- Common Adverse Effects: Hypoglycemia, weight gain, peripheral oedema, upper respiratory tract infection.
- Less Common Adverse Effects: Diarrhea, anaemia, pain in the limb, headache, nausea
- Rare Adverse Effects: Cardiovascular-related complications, Liver Function Abnormalities, bone fractures.
Reports on Postmarketing
Thrombocytopenia and thrombocytopenic purpura
The clinically relevant drug interactions of Glimepiride + Pioglitazone are briefly summarized here:
- Strong CYP2C8 Inhibitors
Pioglitazone
There may be a higher risk of bladder cancer when taking pioglitazone. Those with still active bladder cancer shouldn't be prescribed it. Patients with a history of bladder cancer should take caution when using it, and they should notify their doctor immediately if they see any symptoms, such as blood in the urine, that could indicate bladder cancer.
- CYP2C8 Inducers
Pioglitazone
CYP2C8 inducers like rifampin may markedly lower Pioglitazone's exposure (AUC). Pioglitazone's maximum recommended daily dose is 45 mg; hence, if a CYP2C8 inducer is started or stopped while on pioglitazone, adjustments to diabetes therapy may be necessary based on clinical response.
Pioglitazone
When pioglitazone and topiramate were administered together, there was a decrease in the exposure of pioglitazone and its active metabolites. Although the therapeutic significance of this reduction is uncertain, patients taking pioglitazone, glimepiride, and topiramate concurrently should be closely observed to ensure proper glycemic control.
- Drugs Affecting Glucose Metabolism
Glimepiride
When taken with pioglitazone and glimepiride, several drugs can alter how the body uses glucose, so dosage modifications and careful monitoring are necessary. Hypoglycemia could result from certain drugs' heightened glucose-lowering effects. These consist of insulin, pramlintide acetate, ACE inhibitors, H2 receptor antagonists, fibrates, oral anti-diabetic medications, and more. Conversely, some drugs might lessen glucose-lowering's impact, which could worsen glycemic control. Thyroid hormones, glucagon, corticosteroids, and danazol are a few examples. Pioglitazone and glimepiride's ability to reduce blood sugar may be affected differently by beta-blockers, clonidine, and reserpine. The medication's ability to decrease blood sugar can also be unpredictable when there is acute or chronic alcohol consumption. Notably, the symptoms of hypoglycemia may be lessened or nonexistent in patients using sympatholytic medications, such as beta-blockers.
- Miconazole
Glimepiride
According to reports, significant hypoglycemia may result from an oral miconazole and sulfonylurea combination. It is unknown if this interaction also happens with different dose formulations of miconazole.
- Concomitant Administration of Colesevelam
Glimepiride
Colesevelam can lower the maximum plasma concentrations and total exposure when coadministered with glimepiride. However, glimepiride given four hours before colesevelam does not decrease absorption. Consequently, glimepiride and pioglitazone should be given at least four hours before colesevelam.
- CYP2C9 Interactions
Glimepiride
Glimepiride may interact with CYP2C9 inducers (like rifampin) and inhibitors (like fluconazole). Hypoglycemia may result from fluconazole inhibiting glimepiride metabolism, which raises plasma concentrations. Glimepiride metabolism may be induced by rifampin, resulting in lower glimepiride plasma concentrations and poorer glycemic control.
The most common side effects of glimepiride + Pioglitazone include:
- Headache
- Hypoglycemia (low blood glucose level)
- Nausea
- Diarrhea
Glimepiride + Pioglitazone should be prudent in the following group of special populations.
- Pregnancy
Pregnancy Category C: Use with caution if the benefits outweigh the risks.
There is insufficient information about the combination of pioglitazone with glimepiride or pioglitazone in pregnant women to establish a drug-associated risk for severe birth abnormalities or miscarriage. When using glimepiride during pregnancy, there are clinical concerns about the harmful effects on the fetus and newborn and stopping the medication. Inadequately managed diabetes during pregnancy raises risks for both the mother and the fetus.
Clinical Considerations
Disease-Associated Maternal and/or Embryo/Fetal Risk
The risk of diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, stillbirth, and delivery difficulties is higher in mothers with poorly controlled diabetes during pregnancy. The risk of severe birth abnormalities, stillbirth, and morbidity associated with macrosomia increases in a fetus with poorly controlled diabetes.
Fetal/Neonatal Adverse Reaction
Pregnant women with gestational diabetes who receive treatment with sulfonylureas may have a higher risk of being admitted neonates to the critical care unit. Additionally, the neonates may exhibit big size for gestational age, respiratory distress, hypoglycemia, and birth damage. When drugs with a prolonged half-life are used, there has been evidence of persistent severe hypoglycemia, lasting four to ten days, in newborns whose mothers were given a sulfonylurea at delivery. To appropriately manage neonates, monitor for signs of hypoglycemia and respiratory distress.
Dose Adjustments During Pregnancy and the Postpartum Period
Glimepiride and pioglitazone should be stopped at least two weeks before the anticipated birth date due to reports of sustained severe hypoglycemia in newborns born to mothers taking a sulfonylurea at the time of delivery.
Data
Animal Data
Pioglitazone and Glimepiride
Studies using the combination of glimepiride and pioglitazone have yet to be done on animal reproduction.
- Nursing Mothers
Pioglitazone and glimepiride are found in rat milk. Still, animal data may not be a reliable indicator of drug levels in human milk due to species-specific differences in lactation physiology. No information on pioglitazone or glimepiride in human milk, its effects on breastfed infants, or milk production is available.
In addition to the mother's clinical need for therapy and any possible adverse effects on the breastfed child from treatment or an underlying maternal ailment, the developmental and health benefits of nursing should be considered.
- Pediatric Use
As per FDA, safety and effectiveness in the pediatric population have yet to be established.
- Geriatric Use
Pioglitazone and glimepiride should be administered cautiously, with dose increases and maintenance to reduce the risk of hypoglycemia. Elderly individuals should be closely monitored for hypoglycemia during the start of pioglitazone and glimepiride therapy and any subsequent dose adjustments.
Dosage adjustment in geriatric patients
To prevent hypoglycemia, start with 1 mg/day of glimepiride (as monotherapy) before starting glimepiride or pioglitazone. Titrate carefully.
Dose Adjustment in Kidney Impairment Patient:
CrCl <22 mL/min: Administer 1 mg of glimepiride PO daily before starting pioglitazone or glimepiride; titrate carefully to prevent hypoglycemia.
Titrate a base dose based on fasting glucose levels.
30 mg/2 mg or 30 mg/4 mg PO qDay at first if CrCl ≥22 mL/min
Dose Adjustment in Hepatic Impairment Patients:
Before starting pioglitazone or glimepiride, take 1 mg of glimepiride PO daily; titrate carefully to prevent hypoglycemia.
Baseline ALT <2.5 xULN: Continue with caution
ALT baseline ≥2.5 xULN: Avoid starting ALT >3 xULN or jaundice after starting treatment: Discontinue
Signs and Symptoms
The physician should be vigilant about the knowledge pertaining to the identification and treatment of overdosage of Glimepiride + Pioglitazone.
Overconsumption of Glimepiride + Pioglitazone could lead to hypoglycemia symptoms such as shakiness, sweating, confusion, and, in severe cases, seizures or loss of consciousness.
Management
There is no specific antidote or treatment for excessive intake of Glimepiride + Pioglitazone. However, immediate medical attention is essential. Glimepiride + Pioglitazone should be terminated immediately when an overdose is suspected or if any unusual symptoms occur after intake.
Mild episodes of hypoglycemia can be treated with oral glucose, whereas severe hypoglycemia with seizure, coma, or neurological impairment can be treated with glucagon or intravenous (IV) glucose. In Severe hypoglycemic reactions, hospitalization may be necessary to monitor and treat the individual until their blood sugar levels are stable.
Management typically involves supportive measures and symptomatic treatment. The patient will also continue to be monitored for several hours to ensure that blood sugar levels remain stable and that there are no further complications.
Pharmacodynamics
- Glimepiride: Glimepiride enhances insulin granule production from pancreatic beta cells and increases insulin sensitivity in peripheral tissues, increasing peripheral glucose absorption and lowering plasma blood glucose and glycated haemoglobin (HbA1C) levels. A multicenter, randomized, placebo-controlled clinical trial assessed the efficacy of glimepiride (1-8 mg) as monotherapy titrated over ten weeks to placebo in T2DM participants not managed by diet alone. Fasting plasma glucose (FPG) was reduced by 46 mg/dL, post-prandial glucose (PPG) was reduced by 72 mg/dL, and HbA1c was reduced by 1.4% more than the placebo in this trial. In another randomized study of patients with T2DM who received either a placebo or one of three doses (1, 4, or 8 mg) of glimepiride over 14 weeks, all glimepiride regimens significantly reduced FPG, PPG, and HbA1c values (P 0.001) compared to placebo. The 4- and 8-mg doses of glimepiride were more efficacious than the 1-mg dose; however, the 4-mg dose gave almost maximal antihyperglycemic efficacy.
- Pioglitazone: An agonist for peroxisome proliferator-activated receptor-gamma (PPARγ) is pomiglitazone. Tissues crucial for insulin action, including skeletal muscle, the liver, and adipose tissue, contain PPAR receptors. The transcription of several insulin-responsive genes involved in the regulation of glucose and lipid metabolism is modulated by the activation of PPARγ nuclear receptors.
Pharmacokinetics
- Absorption
Glimepiride: Glimepiride is entirely absorbed after oral dosing within 1 hour and has a linear pharmacokinetic profile. Peak plasma concentrations (Cmax) of glimepiride were attained 2-3 hours after a single oral dose in healthy participants and several oral doses in type 2 diabetes patients. Accumulation does not develop after numerous doses. When glimepiride was administered with meals, the duration to attain Cmax rose by 12%, while the mean and AUC (area under the curve) fell by 8 to 9%, respectively. In a pharmacokinetic investigation of Japanese patients with T2DM, Cmax values in once-daily dosages were higher than those in twice-daily doses. Following oral administration, the absolute bioavailability of glimepiride is reported to be complete.
Pioglitazone: Following oral administration of pioglitazone, Tmax of pioglitazone was within two hours. Food delays the Tmax to three to four hours but does not alter the extent of absorption (AUC).
- Distribution
Glimepiride: Following dosage, the volume of distribution in healthy participants was 8.8 L (113 mL/kg). Glimepiride has a plasma protein binding rate of more than 99.5%.
Pioglitazone: After a single dose, the mean apparent volume of distribution (Vd/F) of pioglitazone is 0.63 ± 0.41 (mean ± SD) L/kg of body weight. In human serum, pioglitazone is highly protein bound (>99%), primarily to serum albumin. Although with less affinity, pioglitazone also binds to other serum proteins. Additionally, M-III and M-IV have strong bindings (>98%) to serum albumin.
- Metabolism
Glimepiride: Glimepiride is said to be metabolized in the liver. Following an intravenous or oral dosage, glimepiride undergoes oxidative biotransformation mediated by the CYP2C9 enzyme to create a pharmacologically active primary metabolite, cyclohexyl hydroxymethyl derivative (M1). One or more cytosolic enzymes can further convert M1 to the inactive metabolite carboxyl derivative (M2). M1 preserved roughly one-third of its parent's pharmacologic action in an animal model, with a half-life of 3-6 hours. However, whether M1's glucose-lowering action is therapeutically relevant is still being determined.
Pioglitazone: Pioglitazone undergoes significant hydroxylation and oxidation-based metabolism. Part of the metabolites is converted to glucuronide or sulfate conjugates. The two primary active metabolites in human circulation are M-III and M-IV.
- Elimination
Glimepiride: After seven days, when three healthy male individuals were given 14C-glimepiride orally, nearly 60% of the total radioactivity was restored in the urine. M1 and M2 were responsible for 80-90% of the radioactivity collected in urine. M1:M2 ratio in urine was roughly 3:2 in two participants and 4:1 in one subject. In faeces, around 40% of the total radioactivity was recovered. M1 and M2 accounted for almost 70% of the radioactivity collected in faeces (the M1:M2 ratio was 1:3). No parent medication was found in the urine or faeces. There was no substantial biliary excretion of glimepiride or its M1 metabolite after treatment in subjects.
Pioglitazone: After oral administration, approximately 15% to 30% of the pioglitazone dosage is reabsorbed in the urine. Pioglitazone is eliminated chiefly as metabolites and their conjugates, with very little renal clearance occurring. Most oral doses are thought to be removed in the faeces or excreted into the bile in its original form or as metabolites. Pioglitazone and its metabolites, M-III and M-IV, have respective mean serum half-lives (t1/2) of three to seven hours and sixteen to twenty-four hours. The apparent clearance (CL/F) of pioglitazone is estimated to be five to seven L/hr.
Therapeutic benefits of a combination of Glimepiride + Pioglitazone
Pioglitazone improves peripheral tissues' sensitivity to insulin, while glimepiride, a sulfonylurea, promotes the pancreas' production of insulin. This multifaceted action aids in efficient blood glucose regulation. It offers thorough glycemic control by addressing several facets of glucose regulation.
Hypoglycemia can occur from sulfonylureas such as glimepiride. However, compared to glimepiride alone, the risk of low blood sugar is lower when combined with pioglitazone. For patients who are at risk for hypoglycemia, this increases safety.
This combination typically results in weight loss or is weight-neutral, in contrast to several anti-diabetic drugs that may promote weight gain. This is helpful for obese or overweight diabetic people since it improves glycemic control and helps control weight.
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Published on: 23 Oct 2023 6:36 AM GMT