Registry
Alogliptin; Metformin
Alogliptin-metformin is an oral antidiabetic combination for treatment of adult patients (≥18 years) with type 2 diabetes mellitus as an adjunct to diet and exercise, including use as dual therapy with metformin and as triple therapy with pioglitazone or insulin when glycaemic control is inadequate.
Source:
EMA
Active Ingredients:
Alogliptin; Metformin
Indications
Men
Women
Sex Distribution of Population
Men
52.8%
Women
47.2%
Clinical Study Participation
Common
Not reported in available sources.
Sex-Specific Efficacy/Accuracy
Common
No sex- or gender-related differences in efficacy were observed; reductions in HbA1c with alogliptin plus metformin were similar across gender subgroups.
Posology
Common
No sex- or gender-specific dose adjustments are required; gender did not have any clinically relevant effect on the pharmacokinetics of alogliptin, so the same dosing of alogliptin-metformin is used in men and women.
Dose Adjustments
Common
No dose adjustment by sex or gender is required for alogliptin-metformin; dosing is individualised mainly according to renal function and current metformin regimen.
Sex-Specific Differences in Possible Side Effects
Common
No sex-specific differences in adverse reactions were identified in the available sources.
Possible Side Effects
Common
Serious adverse reactions associated with Vipdomet or its components include acute pancreatitis (attributed to alogliptin), serious hypersensitivity reactions including Stevens–Johnson syndrome, anaphylactic reactions and angioedema (attributed to alogliptin), and lactic acidosis (very rare, attributed to metformin; estimated incidence 0.03 cases per 1,000 patient-years). Other serious hepatic reactions include hepatitis, liver function test abnormalities, and hepatic dysfunction including hepatic failure, as well as interstitial nephritis and bullous pemphigoid. Common (≥1/100 to <1/10) adverse reactions attributed to Vipdomet include upper respiratory tract infections, nasopharyngitis, headache, gastroenteritis, abdominal pain, diarrhoea, vomiting, gastritis, gastroesophageal reflux disease, pruritus, rash and hypoglycaemia. Very common or common adverse reactions related to metformin include abdominal pain, diarrhoea, vomiting, loss of appetite, nausea, metallic taste, and vitamin B12 decrease/deficiency. Gastrointestinal symptoms occur most frequently during initiation of therapy and usually resolve spontaneously. Discontinuation of Vipdomet or alogliptin is recommended if lactic acidosis, acute pancreatitis, severe hypersensitivity reactions, bullous pemphigoid or unexplained hepatic dysfunction occur.
Pregnancy and Lactation
Men
Not Applicable
Women
There are no data from the use of alogliptin-metformin in pregnant women and it should not be used during pregnancy. Both alogliptin and metformin are excreted in the milk of lactating rats; metformin is excreted in small amounts into human milk and a risk to the suckling child cannot be excluded. A decision must be made whether to discontinue breast-feeding or discontinue/abstain from alogliptin-metformin therapy, weighing the benefit of breast-feeding for the child against the benefit of therapy for the woman.
Sex/Gender-Specific Nonclinical Findings
Common
In animals, combination treatment with alogliptin plus metformin produced reproductive toxicity in pregnant rats at exposures approximately 5–20 times human exposure, while individual components did not show reproductive toxicity at clinically relevant doses.
Men
Women
Sex Distribution of Population
Men
52.8%
Women
47.2%
Clinical Study Participation
Common
Not reported in available sources.
Sex-Specific Efficacy/Accuracy
Common
No sex- or gender-related differences in efficacy were observed; reductions in HbA1c with alogliptin plus metformin were similar across gender subgroups.
Posology
Common
No sex- or gender-specific dose adjustments are required; gender did not have any clinically relevant effect on the pharmacokinetics of alogliptin, so the same dosing of alogliptin-metformin is used in men and women.
Dose Adjustments
Common
No dose adjustment by sex or gender is required for alogliptin-metformin; dosing is individualised mainly according to renal function and current metformin regimen.
Sex-Specific Differences in Possible Side Effects
Common
No sex-specific differences in adverse reactions were identified in the available sources.
Possible Side Effects
Common
Serious adverse reactions associated with Vipdomet or its components include acute pancreatitis (attributed to alogliptin), serious hypersensitivity reactions including Stevens–Johnson syndrome, anaphylactic reactions and angioedema (attributed to alogliptin), and lactic acidosis (very rare, attributed to metformin; estimated incidence 0.03 cases per 1,000 patient-years). Other serious hepatic reactions include hepatitis, liver function test abnormalities, and hepatic dysfunction including hepatic failure, as well as interstitial nephritis and bullous pemphigoid. Common (≥1/100 to <1/10) adverse reactions attributed to Vipdomet include upper respiratory tract infections, nasopharyngitis, headache, gastroenteritis, abdominal pain, diarrhoea, vomiting, gastritis, gastroesophageal reflux disease, pruritus, rash and hypoglycaemia. Very common or common adverse reactions related to metformin include abdominal pain, diarrhoea, vomiting, loss of appetite, nausea, metallic taste, and vitamin B12 decrease/deficiency. Gastrointestinal symptoms occur most frequently during initiation of therapy and usually resolve spontaneously. Discontinuation of Vipdomet or alogliptin is recommended if lactic acidosis, acute pancreatitis, severe hypersensitivity reactions, bullous pemphigoid or unexplained hepatic dysfunction occur.
Pregnancy and Lactation
Men
Not Applicable
Women
There are no data from the use of alogliptin-metformin in pregnant women and it should not be used during pregnancy. Both alogliptin and metformin are excreted in the milk of lactating rats; metformin is excreted in small amounts into human milk and a risk to the suckling child cannot be excluded. A decision must be made whether to discontinue breast-feeding or discontinue/abstain from alogliptin-metformin therapy, weighing the benefit of breast-feeding for the child against the benefit of therapy for the woman.
Sex/Gender-Specific Nonclinical Findings
Common
In animals, combination treatment with alogliptin plus metformin produced reproductive toxicity in pregnant rats at exposures approximately 5–20 times human exposure, while individual components did not show reproductive toxicity at clinically relevant doses.
Men
Women
Sex Distribution of Population
Men
52.8%
Women
47.2%
Clinical Study Participation
Common
Not reported in available sources.
Sex-Specific Efficacy/Accuracy
Common
No sex- or gender-related differences in efficacy were observed; reductions in HbA1c with alogliptin plus metformin were similar across gender subgroups.
Posology
Common
No sex- or gender-specific dose adjustments are required; gender did not have any clinically relevant effect on the pharmacokinetics of alogliptin, so the same dosing of alogliptin-metformin is used in men and women.
Dose Adjustments
Common
No dose adjustment by sex or gender is required for alogliptin-metformin; dosing is individualised mainly according to renal function and current metformin regimen.
Sex-Specific Differences in Possible Side Effects
Common
No sex-specific differences in adverse reactions were identified in the available sources.
Possible Side Effects
Common
Serious adverse reactions associated with Vipdomet or its components include acute pancreatitis (attributed to alogliptin), serious hypersensitivity reactions including Stevens–Johnson syndrome, anaphylactic reactions and angioedema (attributed to alogliptin), and lactic acidosis (very rare, attributed to metformin; estimated incidence 0.03 cases per 1,000 patient-years). Other serious hepatic reactions include hepatitis, liver function test abnormalities, and hepatic dysfunction including hepatic failure, as well as interstitial nephritis and bullous pemphigoid. Common (≥1/100 to <1/10) adverse reactions attributed to Vipdomet include upper respiratory tract infections, nasopharyngitis, headache, gastroenteritis, abdominal pain, diarrhoea, vomiting, gastritis, gastroesophageal reflux disease, pruritus, rash and hypoglycaemia. Very common or common adverse reactions related to metformin include abdominal pain, diarrhoea, vomiting, loss of appetite, nausea, metallic taste, and vitamin B12 decrease/deficiency. Gastrointestinal symptoms occur most frequently during initiation of therapy and usually resolve spontaneously. Discontinuation of Vipdomet or alogliptin is recommended if lactic acidosis, acute pancreatitis, severe hypersensitivity reactions, bullous pemphigoid or unexplained hepatic dysfunction occur.
Pregnancy and Lactation
Men
Not Applicable
Women
There are no data from the use of alogliptin-metformin in pregnant women and it should not be used during pregnancy. Both alogliptin and metformin are excreted in the milk of lactating rats; metformin is excreted in small amounts into human milk and a risk to the suckling child cannot be excluded. A decision must be made whether to discontinue breast-feeding or discontinue/abstain from alogliptin-metformin therapy, weighing the benefit of breast-feeding for the child against the benefit of therapy for the woman.
Sex/Gender-Specific Nonclinical Findings
Common
In animals, combination treatment with alogliptin plus metformin produced reproductive toxicity in pregnant rats at exposures approximately 5–20 times human exposure, while individual components did not show reproductive toxicity at clinically relevant doses.
EQUAL CARE® Evaluations
EQUAL CARE® Evaluation
Medication
Source
Source:
EMA
Source URL:
Prevalence Source: