Amlodipine + Olmesartan + Hydrochlorothiazide

Essential hypertension in adults whose BP is not controlled on a dual combination. Per the Spanish label (CIMA 73437, section 4.1) it replaces Olmesartan + Amlodipine when BP is not controlled on that pair, or the same three components that a patient with controlled BP already takes as two tablets: one tablet instead of two for adherence. ESH 2023 and ESC 2024 place the triple combination of a RAS blocker + dihydropyridine CCB + thiazide at step two of the algorithm: start with a dual single-pill combination, and if BP is not controlled move to triple, ideally also in one pill. The label advises titrating the components first; a direct switch from dual to triple is acceptable when clinically appropriate. If BP stays at 140/90 or higher on triple therapy at maximally tolerated doses, that is resistant hypertension: check adherence and out-of-office BP, exclude secondary causes (renovascular hypertension, primary aldosteronism, pheochromocytoma) and add Spironolactone with potassium and creatinine monitoring. Target per SEH-LELHA 2022 and ESH 2023: <130/80 in most patients if well tolerated; ESC 2024 is stricter: systolic 120–129. The combination itself has an RCT, TRINITY (12 weeks, moderate to severe hypertension, triple combination vs dual combinations of the same components). Strengths (Amlodipine/Olmesartan/HCTZ): 5/20/12.5, 5/40/12.5, 5/40/25, 10/40/12.5, 10/40/25 mg once daily at the same time, with or without food; maximum 10/40/25. Safety (label 4.3–4.6): Hydrochlorothiazide raises the risk of non-melanoma skin cancer with cumulative dose – protect the skin from the sun, check it regularly, and reconsider the drug in patients with a history of skin cancer. Olmesartan very rarely causes sprue-like enteropathy: severe chronic diarrhea with weight loss months or years after starting; stop the drug if confirmed. Monitor potassium, sodium, calcium, uric acid and creatinine; HCTZ can cause choroidal effusion, acute myopia and angle-closure glaucoma. Contraindicated with CrCl <30 mL/min, refractory hypokalemia, hypercalcemia, hyponatremia, symptomatic hyperuricemia, severe hepatic impairment or cholestasis, sulfonamide allergy, shock, severe hypotension, high-grade aortic stenosis, hemodynamically unstable heart failure after myocardial infarction, and together with Aliskiren in diabetes or eGFR <60. With CrCl 30–60 mL/min or moderate hepatic impairment the maximum is 5/20/12.5 with potassium and creatinine monitoring; over 65, monitor BP more often; over 75, data are very limited. Pregnancy: contraindicated in the 2nd and 3rd trimesters, not recommended in the 1st; switch to another drug when planning pregnancy and stop at once if pregnancy occurs. Not recommended during breastfeeding. Interactions: Lithium (combination not recommended), NSAIDs (weaker effect, kidney function may worsen), potassium-sparing diuretics and potassium supplements, ACE inhibitors and Aliskiren (dual RAS blockade), CYP3A4 inhibitors (higher Amlodipine levels), Simvastatin no more than 20 mg per day.

ICD-10: I10 · ICD-11: BA00