Telmisartan
Regulatory sources consulted
- openfda-label-53869808-0c5e-754f-e063-6294a90ab5f6
- EMA/H/C/000209
- AEMPS-CIMA-98090002
- PubMed PMID:38861046 ↗
- PubMed PMID:38228033 ↗
- PubMed PMID:37432701 ↗
- PubMed PMID:37146924 ↗
- OpenFDA · C09CA07
- AEMPS CIMA · nº registro 98090002 ↗
- EMA EPAR · EMEA/H/C/000209 ↗
- RxNorm rxcui 73494 ↗
Approved indications
- Treatment of essential hypertension in adults.
- Reduction of cardiovascular morbidity in patients with manifest atherothrombotic cardiovascular disease (history of coronary heart disease, stroke, or peripheral arterial disease) or type 2 diabetes mellitus with documented target organ damage.
- Cardiovascular (CV) risk reduction in patients 55 years of age or older at high risk of developing major cardiovascular events who are unable to take ACE inhibitors.
Contraindications
Absolute
- Hypersensitivity to the active substance or to any of the excipients.
- Second and third trimesters of pregnancy.
- Obstructive biliary disorders.
- Severe hepatic impairment.
- The concomitant use of telmisartan with aliskiren is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2).
Clinical warnings
- Boxed warning · Fetal Toxicity: When pregnancy is detected, discontinue telmisartan as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. — FDA
- Major warning · Hypotension in volume- or salt-depleted patients. Risk of hyperkalemia. Dual blockade of the RAS with ACE inhibitors, ARBs, or aliskiren increases the risk of hypotension, hyperkalemia, and renal failure. — EMA SPC
Drug interactions
- HighAliskirenC09XA02
Mechanism: Dual blockade of the renin-angiotensin system (RAS), increasing the risk of hypotension, hyperkalemia, and renal dysfunction.
Recommendation: Contraindicated in patients with diabetes. Avoid use in patients with renal impairment (GFR < 60 mL/min).
OpenFDA labelEMA SPC
- ModerateNSAIDs (Nonsteroidal anti-inflammatory drugs)M01A
Mechanism: May result in deterioration of renal function, including possible acute renal failure, and may attenuate the antihypertensive effect.
Recommendation: Monitor renal function periodically in patients receiving telmisartan and NSAID therapy, especially in the elderly, volume-depleted, or with compromised renal function.
OpenFDA label
- ModerateLithiumN05AN01
Mechanism: Reversible increases in serum lithium concentrations and toxicity have been reported, likely due to reduced renal clearance of lithium.
Recommendation: Monitoring of serum lithium levels is recommended during concomitant use.
OpenFDA labelEMA SPC
- LowDigoxinC01AA05
Mechanism: Increase in digoxin plasma concentrations (median 49% in peak and 20% in trough). Possible P-gp inhibition.
Recommendation: Monitor digoxin levels when initiating, adjusting, and discontinuing telmisartan.
OpenFDA label
Adverse events
Common (≥1%)
back pain · sinusitis · diarrhea · hyperkalemia · hypotension
Rare but serious
angioedema · acute renal failure · severe hyperkalemia · fetal toxicity · rhabdomyolysis · sepsis
Pregnancy and lactation
FDA category: D
Contraindicated in the second and third trimesters of pregnancy. Discontinue as soon as pregnancy is detected due to fetal toxicity. Do not breastfeed during treatment with telmisartan.
Recent literature (PubMed)
Metaanálisis en red de 193 estudios que compara 6 ARA-II. Concluye que olmesartán y telmisartán demuestran el mejor equilibrio entre eficacia antihipertensiva y mínimos eventos adversos. Telmisartán fue superior en la reducción de la presión arterial diastólica ambulatoria de 24h.
Revisión exhaustiva que destaca las propiedades farmacológicas únicas de telmisartán, incluyendo su larga vida media y su efecto agonista parcial de PPAR-gamma. Estos efectos le confieren beneficios potenciales en los componentes del síndrome metabólico más allá de la hipertensión.
Metaanálisis en red que evalúa combinaciones a dosis fija. La combinación de telmisartán/amlodipino se clasificó como la primera en cuanto a tasas de control de la presión arterial. Demuestra la eficacia de telmisartán como componente de terapias combinadas.
Revisión sobre el papel de los receptores PPAR en la patogénesis de la esteatosis hepática no alcohólica. Aunque no se centra en telmisartán, contextualiza su mecanismo de acción único como agonista parcial de PPAR-gamma, que es relevante para sus efectos metabólicos.