Manufacturer:Boehringer Ingelheim Pharmaceuticals Pharmacological Class:Antihypertensive (angiotensin II receptor blocker + calcium channel blocker) Active Ingredient(s):Telmisartan 40mg, amlodipine 5mg; tabs. Also:TWYNSTA 40mg/10mg Indication(s):Hypertension, as monotherapy or with other antihypertensives. As initial therapy in patients likely to need multiple drugs to achieve blood pressure goals. Pharmacology:Telmisartan blocks the vasoconstriction and aldosterone-secreting effects of angiotensin II, the main pressor agent of the renin-angiotensin system. Amlodipine inhibits the influx of calcium ions into vascular smooth muscle and, to a lesser extent, cardiac muscle. By inhibiting this process, amlodipine causes a reduction in peripheral resistance and a reduction in blood pressure. Clinical Trials:An 8-week randomized, double-blind, placebo controlled study in 1461 patients with mild to severe hypertension compared Twynsta to either monotherapy component across 16 treatment arms. The four key treatment combinations, including telmisartan 40mg or 80mg and amlodipine 5mg or 10mg, had statistically significant reductions in in-clinic seated trough cuff systolic and diastolic blood pressure (SBP and DBP) compared to the respective individual monotherapies. In an active-controlled study, 1097 patients with mild to severe hypertension who were not adequately controlled on amlodipine 5mg were randomized to either Twynsta (40/5 or 80/5) or amlodipine (5mg or 10mg). In a second active-controlled study, 947 patients with mild to severe hypertension who were not adequately controlled on amlodipine 10mg were randomized to Twynsta (40/10 or 80/10) or amlodipine 10mg. Each of the combination treatments was statistically significantly superior to the respective amlodipine monotherapy doses in the reduction of DBP and SBP after 8-weeks of treatment in both studies. Legal Classification:Rx Adults:Take once daily. Initial therapy: 40/5mg or 80/5mg; may titrate at 2-week intervals to max 80/10mg. Add-on therapy: may be used if not controlled on monotherapy; if dose-limiting adverse reactions with amlodipine 10mg, switch to 40/5mg tab. Replacement therapy: may be substituted for the titrated components. Renal and/or hepatic impairment: titrate slower. ≥75 years, or hepatic impairment: not for initial use (initially use amlodipine alone, or add amlodipine 2.5mg to telmisartan). Children:Not recommended. Precaution(s):Correct hypovolemia before starting therapy or monitor closely. CHF. Biliary obstruction. Hepatic or severe renal dysfunction. Renal artery stenosis. Severe obstructive coronary disease. Pregnancy (Cat.D in 2nd and 3rd trimester; Cat.C in 1st trimester); discontinue ASAP when pregnancy detected. Nursing mothers: not recommended. Interaction(s):Concomitant ramipril: not recommended. Hyperkalemia with K+ supplements, K+ sparing diuretics, K+ containing salt supplements. May potentiate digoxin, lithium. Adverse Reaction(s):Peripheral edema, dizziness, orthostatic hypotension, back pain. How Supplied:Tabs—30, 90 Last Updated:12/3/2009
勃林格殷格翰制药公司
TWYNSTA 80mg/5mg TWYNSTA 80mg/10mg
在主动控制的研究，1097轻度至重度高血压谁没有得到充分的氨氯地平5毫克控制的患者被随机分在Twynsta（40 / 5或80 / 5）或氨氯地平（5毫克或10毫克）。在第二个主动控制的研究，947例轻，重度高血压谁没有得到充分控制在10毫克氨氯地平患者随机Twynsta（40/10或80/10）或氨氯地平10毫克。对合并的处理每一个有统计学显着优于氨氯地平在各自的舒张压和收缩压后8个星期的治疗，在这两项研究减少单药剂量。
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