AHypertension
First line
Hypertension
First line
Essential hypertension in adults. Per 2024 (Class I), ESH 2023 and the Spanish SEH-LELHA 2022 guideline, most patients with confirmed hypertension start treatment with two drugs in a single pill; a renin-angiotensin-aldosterone system blocker (RAAS blocker, here olmesartan) with a dihydropyridine calcium channel blocker (here amlodipine) is one of the two preferred starting pairs. Monotherapy is reserved for specific groups (very old or frail patients, orthostatic hypotension and, per ESH 2023, low-risk grade 1 hypertension). The Spanish SmPC (AEMPS) indicates the combination for adults whose blood pressure is not controlled on olmesartan or amlodipine monotherapy and allows a direct switch from monotherapy when clinically appropriate. ESC 2024 target: systolic BP 120–129 mmHg if well tolerated. In Spain the tablets are 20/5, 40/5 and 40/10 mg (olmesartan/amlodipine) once daily with or without food; the maximum effect is reached within the first 2 weeks. With creatinine clearance 20–60 mL/min and in moderate hepatic impairment olmesartan is capped at 20 mg/day; with clearance <20 mL/min the combination is not recommended. Contraindicated in the second and third trimesters of pregnancy (not recommended in the first), in severe hepatic impairment and biliary obstruction, severe hypotension, shock, severe aortic stenosis, unstable heart failure after acute myocardial infarction, and with aliskiren in diabetes or eGFR <60 mL/min/1.73 m²; not recommended during breastfeeding. Potassium and creatinine are monitored, especially in chronic kidney disease, heart failure and with potassium supplements or potassium-sparing diuretics; combination with lithium and dual RAAS blockade are not recommended. Olmesartan carries a risk of its own: very rare sprue-like enteropathy (SmPC warning, 2013), severe chronic diarrhoea with weight loss after months or years of use; olmesartan is stopped and not restarted.
Sources
- ESC: 2024 ESC Guidelines for the management of elevated blood pressure and hypertension. (2024)
- AEMPS: Ficha técnica BALZAK 20mg/5mg COMPRIMIDOS RECUBIERTOS CON PELICULA (2025)
- J Hypertens: 2023 ESH Guidelines for the management of arterial hypertension The Task Force for the management of arterial hypertension of the European Society of Hypertension: Endorsed by the International Society of Hypertension (ISH) and the European Renal Ass (2023)
- Hipertension y riesgo vascular: [2022 Practice guidelines for the management of arterial hypertension of the Spanish Society of Hypertension]. (2022)
- Clinical therapeutics: The combination of olmesartan medoxomil and amlodipine besylate in controlling high blood pressure: COACH, a randomized, double-blind, placebo-controlled, 8-week factorial efficacy and safety study. (2008)
- Mayo Clinic proceedings: Severe spruelike enteropathy associated with olmesartan. (2012)
- FDA: FDA Drug Safety Communication: FDA approves label changes to include intestinal problems (sprue-like enteropathy) linked to blood pressure medicine olmesartan medoxomil (2013)
- ESC: 2024 ESC Guidelines for the management of elevated blood pressure and hypertension (2024)
ICD-10: I10 · ICD-11: BA00