telmisartan and amlodipine
Fuentes regulatorias consultadas
Indicaciones aprobadas
- Hipertensión esencial en adultos como combinación cuando el control es insuficiente o como sustitución de telmisartán y amlodipino administrados por separado a las mismas dosis.
Contraindicaciones
Absolutas
- Hipersensibilidad a telmisartán, amlodipino o cualquier componente.
- Segundo o tercer trimestre del embarazo.
- Aliskireno concomitante en pacientes con diabetes o TFG inferior a 60 ml/min/1,73 m².
- Trastorno obstructivo biliar o insuficiencia hepática grave.
- Choque, incluido el cardiogénico; obstrucción grave del tracto de salida del ventrículo izquierdo; o insuficiencia cardiaca hemodinámicamente inestable tras un infarto agudo de miocardio.
Advertencias clínicas
- Advertencia destacada (boxed warning) · Toxicidad fetal: interrumpir inmediatamente cuando se diagnostique embarazo. — DailyMed telmisartan/amlodipine set ID ca60a4d5-ace7-4889-94ee-e2265fd63811
- Advertencia mayor · Corregir la depleción de volumen o sodio y vigilar hipotensión; controlar periódicamente función renal, creatinina y potasio. — CIMA registro 10648023
Interacciones medicamentosas
- SeveraLitio
Mecanismo: Telmisartán puede aumentar de forma reversible la concentración y toxicidad del litio.
Recomendación: Evitar si es posible; si se usa, monitorizar estrechamente la lithemia.
https://cima.aemps.es/cima/dochtml/ft/10648023/FT_10648023.html
- ModeradaAINE
Mecanismo: Pueden reducir el efecto antihipertensivo y aumentar el deterioro renal.
Recomendación: Hidratar y vigilar periódicamente la función renal.
https://cima.aemps.es/cima/dochtml/ft/10648023/FT_10648023.html
- ModeradaPomelo o zumo de pomelo
Mecanismo: Puede aumentar la biodisponibilidad de amlodipino y potenciar la hipotensión.
Recomendación: No se recomienda la administración conjunta.
https://cima.aemps.es/cima/dochtml/ft/10648023/FT_10648023.html
- ModeradaPotasio, suplementos de potasio, sustitutos de sal con potasio o diuréticos ahorradores de potasio
Mecanismo: La combinación puede aumentar el potasio sérico y el riesgo de hiperpotasemia.
Recomendación: Usar con precaución y monitorizar el potasio sérico.
https://cima.aemps.es/cima/dochtml/ft/10648023/FT_10648023.html
- SeveraIECA, ARA II o aliskireno
Mecanismo: El bloqueo dual del SRAA aumenta hipotensión, hiperpotasemia y deterioro renal, incluida insuficiencia renal aguda.
Recomendación: No se recomienda; si fuera imprescindible, usar bajo supervisión especializada y monitorizar presión arterial, función renal y electrolitos. Aliskireno está contraindicado con diabetes o TFG inferior a 60 ml/min/1,73 m².
https://cima.aemps.es/cima/dochtml/ft/10648023/FT_10648023.html
- ModeradaDigoxinaC01AA05
Mecanismo: Telmisartán puede aumentar las concentraciones plasmáticas máximas y mínimas de digoxina.
Recomendación: Monitorizar las concentraciones de digoxina al iniciar, ajustar o suspender telmisartán.
https://cima.aemps.es/cima/dochtml/ft/10648023/FT_10648023.html
- ModeradaInhibidores moderados o potentes de CYP3A4
Mecanismo: Pueden aumentar de forma significativa la exposición a amlodipino.
Recomendación: Monitorizar estrechamente hipotensión y edema; puede ser necesario ajustar amlodipino.
https://cima.aemps.es/cima/dochtml/ft/10648023/FT_10648023.html
- ModeradaSimvastatinaC10AA01
Mecanismo: Amlodipino aumenta la exposición a simvastatina.
Recomendación: Limitar la dosis de simvastatina a 20 mg al día durante el uso concomitante.
https://cima.aemps.es/cima/dochtml/ft/10648023/FT_10648023.html
Eventos adversos
Comunes (≥1%)
Edema periférico · Mareo · Dolor de espalda
Raros pero graves
Angioedema o anafilaxia · Insuficiencia renal aguda · Síncope o hipotensión grave
Embarazo y lactancia
No se recomienda en el primer trimestre y está contraindicado en el segundo y tercero; suspender al diagnosticar embarazo. Amlodipino pasa a la leche y no se recomienda la combinación durante la lactancia; se prefiere una alternativa mejor establecida.
Bibliografía reciente (PubMed)
Systemic arterial hypertension is a health condition causing target organ damage (TOD) in dogs. Early and effective treatment is essential to prevent hypertensive emergencies and to reduce the risk of TOD. This study investigated the diseases underlying hypertension and compared the short-term efficacy of antihypertensive drugs in dogs. We evaluated the medical records of client-owned dogs treated with antihypertensive drugs between 2017 and 2018. The study included 75 dogs diagnosed with systemic arterial hypertension (systolic blood pressure ≥150 mmHg). The dogs were classified based on treatment with the following antihypertensive drugs: calcium channel blocker amlodipine, angiotensin-converting enzyme inhibitor ramipril, and angiotensin receptor blocker telmisartan, either as monotherapy or combination therapy (telmisartan + amlodipine or ramipril + amlodipine). Systolic blood pressure was measured using an indirect Doppler method over 4 weeks. Naturally acquired hyperadrenocorticism was the most common disorder to be diagnosed in conjunction with systemic hypertension. In the telmisartan group, the systolic blood pressure decreased more rapidly for 3 weeks compared to ramipril. The combination of telmisartan and amlodipine showed the greatest decrease in systolic blood pressure throughout the 4-week treatment period. This study is meaningful as it suggests guidelines for the use of various antihypertensive drugs in dogs.
Hypertension is a major cause of cardiovascular disease and death worldwide. Low-dose combination therapy is a promising approach for managing hypertension due to its safety and efficacy. This systematic review evaluates the safety and efficacy of a single-pill, low-dose combination of amlodipine, telmisartan, and chlorthalidone for essential hypertension based on evidence from randomized controlled trials (RCTs). We followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines and searched the Cochrane, Scopus, PubMed, and Web of Science databases until July 01, 2024, using the following search string: (telmisartan) AND (amlodipine) AND (chlorthalidone) AND (randomized OR randomly). The quality of the RCTs was assessed using the revised Cochrane risk of bias tool. The primary endpoint was the mean change in sitting systolic blood pressure (BP), with secondary endpoints including BP target achievement rates, BP response rates, and serious treatment-related adverse events. Overall, three RCTs met the inclusion criteria and exhibited a low risk of bias. The doses in the combination pill ranged from 2.5 to 5 mg of amlodipine, 20 to 80 mg of telmisartan, and 4.167 to 25 mg of chlorthalidone. Control groups varied, including usual care, amlodipine 10 mg, and dual therapy of telmisartan and amlodipine. Results showed significant reductions in mean sitting systolic and diastolic BP, improved BP control and response rates, and a generally safe profile with no significant differences in serious adverse events. Despite encouraging data, results should be interpreted with caution due to heterogeneity in doses and control groups. Further research should address the long-term effects and explore predictors of response to this therapy.
There is lacking evidence that telmisartan can improve insulin resistance in patients on high-intensity statins. This study compared the effects of telmisartan and amlodipine on glucose metabolism in hypertensive atherosclerotic cardiovascular disease (ASCVD) patients with impaired fasting glucose (IFG) requiring high-intensity rosuvastatin therapy. Ninety-nine patients were randomly assigned to 2 groups [telmisartan-statin group (n=48) and amlodipine-statin group (n=51)] as add-on therapy to high-intensity rosuvastatin therapy (20 mg). The primary endpoint was to assess insulin resistance using the homeostatic model assessment (HOMA-IR) value at week 24. The secondary endpoint was the change in glucose metabolism indices from baseline to week 24. The HOMA-IR at week 24 (2.4 [interquartile range, 1.8-3.8] versus 2.7 [1.7-3.7]; P = .809) and changes in the HOMA-IR from baseline to week 24 (-7.0 [-29.0 to 21.0] versus -5.5 [-53.3 to 27.3]; P = .539) were not significantly different between 2 groups. However, the fasting glucose level at week 24 was significantly lower in the telmisartan-statin group than in the amlodipine-statin group (107.7 ± 13.4 mg/dL versus 113.3 ± 12.4 mg/dL; P = .039) and significantly decreased in the telmisartan-statin group (-3.2 ± 8.6% versus 3.8 ± 13.2%; P = .003). The proportion of patients with fasting glucose ≥100 mg/dL (71.1% versus 89.6%; P = .047) or new-onset diabetes mellitus (12.5% versus 31.4%, P = .044) at week 24 was also significantly lower in the telmisartan-statin group than in the amlodipine-statin group. In comparison to amlodipine, telmisartan did not decrease the HOMA-IR. However, telmisartan preserved insulin secretion, led to a regression from IFG to euglycemia and prevented new-onset diabetes mellitus in ASCVD patients with IFG requiring high-intensity statins.