Liraglutide
Regulatory sources consulted
- EMA/H/C/001026 (Victoza EPAR)
- EMA/H/C/003780 (Saxenda EPAR)
- AEMPS CIMA FT_90096
- PubMed PMID:40466247 ↗
- PubMed PMID:37918631 ↗
- PubMed PMID:39617632 ↗
- PubMed PMID:38450509 ↗
- AEMPS CIMA · nº registro 90096 ↗
- EMA EPAR · EMEA/H/C/001026 ↗
- RxNorm rxcui 475968 ↗
Approved indications
- Treatment of adults, adolescents and children aged 10 years and above with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise, either as monotherapy when metformin is considered inappropriate, or in addition to other medicinal products for the treatment of diabetes.
- Weight management in adults with an initial Body Mass Index (BMI) of ≥30 kg/m² (obesity), or ≥27 kg/m² (overweight) in the presence of at least one weight-related comorbidity, as an adjunct to a reduced-calorie diet and increased physical activity.
Contraindications
Absolute
- Hypersensitivity to the active substance or to any of the excipients.
- Personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
Clinical warnings
- Major warning · Risk of Thyroid C-cell Tumors. Dose-dependent and duration-dependent thyroid C-cell tumors have been observed in rodent studies, but the relevance to humans is unknown. Advise patients of the potential risk and symptoms of thyroid tumors. — EMA SPC
- Major warning · Cases of acute pancreatitis have been reported. Patients should be informed of the characteristic symptoms of acute pancreatitis. If pancreatitis is suspected, treatment should be discontinued. — EMA SPC
Drug interactions
- ModerateSulfonylureas or InsulinA10BB
Mechanism: Additive hypoglycemic effect. Liraglutide stimulates insulin secretion in a glucose-dependent manner, increasing the risk of hypoglycemia when combined with insulin secretagogues.
Recommendation: Consider a dose reduction of the sulfonylurea or insulin to reduce the risk of hypoglycemia. Closely monitor blood glucose, especially at treatment initiation.
EMA SPC
- LowOral medicationsN/A
Mechanism: Liraglutide delays gastric emptying, which may impact the rate and, to a lesser extent, the extent of absorption of concomitantly administered oral medicinal products.
Recommendation: No general dose adjustment is required, but caution should be exercised with drugs requiring rapid absorption or having a narrow therapeutic index. Administer at separate times if necessary.
EMA SPC
Adverse events
Common (≥1%)
nausea · diarrhea · vomiting · constipation · decreased appetite · headache · hypoglycemia
Rare but serious
pancreatitis · acute renal failure · anaphylactic reaction · thyroid C-cell tumors · cholelithiasis · cholecystitis
Pregnancy and lactation
Should not be used during pregnancy. Treatment should be discontinued if a patient plans to or becomes pregnant. Not recommended during breast-feeding due to lack of data, although absorption by the infant is unlikely as it is a large peptide molecule.
Recent literature (PubMed)
Revisión sobre los mecanismos de acción de los fármacos basados en GLP-1 para el tratamiento de la obesidad. Describe cómo estos agonistas afectan la regulación del apetito, la función de los adipocitos, la resistencia a la insulina y otros factores fisiopatológicos, logrando pérdidas de peso de hasta el 24% y abriendo nuevas vías para el tratamiento individualizado.
Estudio aleatorizado que demuestra que la combinación de liraglutida 3.0 mg/día con un programa de educación alimentaria individualizada durante 32 semanas produce una pérdida de peso y de masa grasa significativamente mayor (-9.08% de peso) en comparación con liraglutida sola (-3.45% de peso), subrayando la importancia de un enfoque integral.
Revisión que explora el uso de agonistas de GLP-1 para tratar la obesidad en pacientes con enfermedades cutáneas inmunomediadas como la psoriasis y la hidradenitis supurativa. Sugiere que estos fármacos son una herramienta prometedora para manejar la obesidad en esta población, aunque la experiencia clínica es aún limitada.
Reporte de caso de un paciente con obesidad grado 4 que logró una pérdida de peso del 40% en un año con liraglutida y medidas higiénico-dietéticas. El artículo revisa la literatura sobre la heterogeneidad en la respuesta a los agonistas de GLP-1 y los posibles predictores de una alta respuesta.