Olmesartan
Regulatory sources consulted
- openfda-label-48bfa982-5678-139d-e063-6294a90adbfa
- aemps-cima-ft-65498
- ansm-bdpm-rcp-68573412
- PubMed PMID:38861046 ↗
- PubMed PMID:40434761 ↗
- PubMed PMID:38771738 ↗
- PubMed PMID:39412629 ↗
- OpenFDA · C09CA08
- RxNorm rxcui 321064 ↗
Approved indications
- Treatment of essential hypertension in adults.
Contraindications
Absolute
- Hypersensitivity to the active substance.
- Second and third trimesters of pregnancy.
- Biliary obstruction.
- Concomitant use with aliskiren in patients with diabetes or renal impairment (GFR < 60 ml/min/1.73 m2).
Clinical warnings
- Boxed warning · Fetal Toxicity: When pregnancy is detected, discontinue olmesartan as soon as possible. Drugs that act on the renin-angiotensin system can cause injury and death to the developing fetus. — FDA
- Major warning · Sprue-Like Enteropathy: Severe, chronic diarrhea with substantial weight loss has been reported in patients taking olmesartan months to years after drug initiation. Discontinue treatment if no other etiology is identified. — FDA
- Hypotension in Volume- or Salt-Depleted Patients: Symptomatic hypotension may occur, particularly after the first dose. Correct volume depletion before initiating treatment. — FDA
Drug interactions
- HighAliskirenC09XA02
Mechanism: Dual blockade of the renin-angiotensin-aldosterone system (RAAS), increasing the risk of hypotension, hyperkalemia, and renal impairment.
Recommendation: Contraindicated in patients with diabetes or renal impairment (GFR < 60 mL/min). Not recommended in other patients.
FDA labelANSM RCP
- ModerateNSAIDs (Nonsteroidal anti-inflammatory drugs)M01A
Mechanism: May attenuate the antihypertensive effect and increase the risk of worsening renal function, including acute renal failure.
Recommendation: Monitor blood pressure and renal function periodically, especially in the elderly, volume-depleted, or patients with compromised renal function.
FDA labelANSM RCP
- HighLithiumN05AN01
Mechanism: Decreased renal clearance of lithium, leading to increased serum concentrations and risk of lithium toxicity.
Recommendation: Concomitant use is not recommended. If necessary, monitor serum lithium levels closely.
FDA labelANSM RCP
- ModerateColesevelamC10AC04
Mechanism: Colesevelam, a bile acid sequestrant, reduces systemic exposure and peak concentration of olmesartan by binding to it in the GI tract.
Recommendation: Administer olmesartan at least 4 hours before the colesevelam dose to minimize the interaction.
FDA labelANSM RCP
Adverse events
Common (≥1%)
dizziness · headache · upper respiratory tract infection · flu-like symptoms · hyperuricemia · nausea
Rare but serious
sprue-like enteropathy · acute renal failure · rhabdomyolysis · angioedema · severe hyperkalemia
Pregnancy and lactation
FDA category: D
Pregnancy: Contraindicated in the second and third trimesters. Discontinue as soon as pregnancy is detected due to risk of fetal (reduced renal function, oligohydramnios, skull hypoplasia) and neonatal toxicity. Lactation: Avoid use; an alternative drug is preferred, especially while nursing a newborn or preterm infant.
Recent literature (PubMed)
Esta meta-análisis en red de 193 estudios encontró que olmesartán tuvo la mayor eficacia en reducir la presión arterial sistólica y diastólica de consulta. Olmesartán y telmisartán demostraron el mejor equilibrio entre eficacia antihipertensiva y eventos adversos mínimos.
Meta-análisis en red que compara azilsartán con otros antihipertensivos, incluido olmesartán. Aunque azilsartán 80 mg mostró el ranking más alto, olmesartán demostró una reducción de presión arterial significativamente mejor que el placebo, posicionándolo como un comparador eficaz.
Ensayo de fase 2 que evalúa zilebesiran añadido a un antihipertensivo estándar. En el cohorte de olmesartán 40 mg, añadir zilebesiran logró una reducción adicional de la PAS media ambulatoria de 24h de -4.5 mmHg en comparación con placebo, demostrando el uso de olmesartán como terapia de base en ensayos modernos.
Revisión que destaca la falta de información sobre el uso de olmesartán durante la lactancia. Recomienda que se prefiera un fármaco alternativo, especialmente al amamantar a un recién nacido o a un lactante prematuro.