telmisartan and amlodipine
Sources réglementaires consultées
Indications approuvées
- Hypertension artérielle essentielle chez l’adulte en association lorsque le contrôle est insuffisant ou en remplacement du telmisartan et de l’amlodipine administrés séparément aux mêmes doses.
Contre-indications
Absolues
- Hypersensibilité au telmisartan, à l’amlodipine ou à tout composant.
- Deuxième ou troisième trimestre de la grossesse.
- Aliskirène concomitant chez les patients diabétiques ou ayant un DFG inférieur à 60 ml/min/1,73 m².
- Trouble obstructif biliaire ou insuffisance hépatique sévère.
- Choc, y compris cardiogénique ; obstruction sévère de la voie d’éjection du ventricule gauche ; ou insuffisance cardiaque hémodynamiquement instable après un infarctus aigu du myocarde.
Mises en garde cliniques
- Mise en garde encadrée · Toxicité fœtale : arrêter immédiatement lorsque la grossesse est diagnostiquée. — DailyMed telmisartan/amlodipine set ID ca60a4d5-ace7-4889-94ee-e2265fd63811
- Mise en garde majeure · Corriger la déplétion volémique ou sodée et surveiller l’hypotension ; contrôler périodiquement la fonction rénale, la créatinine et le potassium. — CIMA registro 10648023
Interactions médicamenteuses
- SévèreLithium
Mécanisme: Le telmisartan peut augmenter de façon réversible la concentration et la toxicité du lithium.
Recommandation: Éviter si possible ; en cas d’utilisation, surveiller étroitement la lithémie.
https://cima.aemps.es/cima/dochtml/ft/10648023/FT_10648023.html
- ModéréeAINS
Mécanisme: Peuvent réduire l’effet antihypertenseur et augmenter l’altération rénale.
Recommandation: Assurer une hydratation adéquate et surveiller périodiquement la fonction rénale.
https://cima.aemps.es/cima/dochtml/ft/10648023/FT_10648023.html
- ModéréePamplemousse ou jus de pamplemousse
Mécanisme: Peut augmenter la biodisponibilité de l’amlodipine et majorer l’hypotension.
Recommandation: L’administration concomitante n’est pas recommandée.
https://cima.aemps.es/cima/dochtml/ft/10648023/FT_10648023.html
- ModéréePotassium, suppléments potassiques, substituts de sel contenant du potassium ou diurétiques épargneurs de potassium
Mécanisme: L’association peut augmenter la kaliémie et le risque d’hyperkaliémie.
Recommandation: Utiliser avec prudence et surveiller la kaliémie.
https://cima.aemps.es/cima/dochtml/ft/10648023/FT_10648023.html
- SévèreIEC, ARA II ou aliskirène
Mécanisme: Le double blocage du SRAA augmente l’hypotension, l’hyperkaliémie et l’altération rénale, y compris l’insuffisance rénale aiguë.
Recommandation: Association non recommandée ; si elle est indispensable, l’utiliser sous surveillance spécialisée et contrôler la pression artérielle, la fonction rénale et les électrolytes. L’aliskirène est contre-indiqué en cas de diabète ou de DFG inférieur à 60 ml/min/1,73 m².
https://cima.aemps.es/cima/dochtml/ft/10648023/FT_10648023.html
- ModéréeDigoxineC01AA05
Mécanisme: Le telmisartan peut augmenter les concentrations plasmatiques maximales et minimales de digoxine.
Recommandation: Surveiller les concentrations de digoxine lors de l’instauration, de l’ajustement ou de l’arrêt du telmisartan.
https://cima.aemps.es/cima/dochtml/ft/10648023/FT_10648023.html
- ModéréeInhibiteurs modérés ou puissants du CYP3A4
Mécanisme: Ils peuvent augmenter significativement l’exposition à l’amlodipine.
Recommandation: Surveiller étroitement l’hypotension et l’œdème ; un ajustement de la dose d’amlodipine peut être nécessaire.
https://cima.aemps.es/cima/dochtml/ft/10648023/FT_10648023.html
- ModéréeSimvastatineC10AA01
Mécanisme: L’amlodipine augmente l’exposition à la simvastatine.
Recommandation: Limiter la simvastatine à 20 mg par jour pendant l’utilisation concomitante.
https://cima.aemps.es/cima/dochtml/ft/10648023/FT_10648023.html
Effets indésirables
Communs (≥1%)
Œdème périphérique · Étourdissements · Douleur dorsale
Rares mais graves
Angio-œdème ou anaphylaxie · Insuffisance rénale aiguë · Syncope ou hypotension sévère
Grossesse et allaitement
L’utilisation n’est pas recommandée au premier trimestre et est contre-indiquée aux deuxième et troisième trimestres ; arrêter dès le diagnostic de grossesse. L’amlodipine passe dans le lait et l’association n’est pas recommandée pendant l’allaitement ; une alternative mieux établie est préférable.
Bibliographie récente (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.