Nippon Boehringer Ingelheim Co., Ltd. (Head Office: Tokyo; President and Representative Director: Yoshiaki Aono, hereafter “Nippon Boehringer Ingelheim”) and Astellas Pharma Inc. (Head Office: Tokyo; President and CEO: Yoshihiko Hatanaka, hereafter “Astellas”) announced that manufacturing and marketing approval for “Micatrio® Combination Tablets,” a combination of “Micardis® Tablets” (AT1 receptor blocker [ARB]), long-acting calcium channel blocker (CCB) amlodipine besylate and the thiazide diuretic hydrochlorothiazide (HCTZ) was obtained on September 28.
“Micatrio® Combination Tablets” is the first combination drug in Japan to contain the three ingredients of a renin-angiotensin inhibitor, a CCB and small dose diuretic. Compared to ARB/CCB combination formulations and ARB/HCTZ combination formulations, it is expected to have a strong antihypertensive effect that lasts for 24 hours. In addition, hypertension is a major risk factor for cardiovascular death, yet the rate of the patient undergoing treatment and keeping their blood pressure under control remains at approximately 30% for men and approximately 40% for women. By increasing the medication adherence, a combination drug in general has a superior antihypertensive effect to the concomitant use of the respective drugs alone, and is expected to improve the rate to achieve target blood pressure values.1
“Micatrio® Combination Tablets” which obtained manufacturing and marketing approval, constitute the Micardis® family along with “Micardis® 20mg/40mg/80mg Tablets”, “Micombi® Combination Tablets AP/BP”, a combination drug with HCTZ and “Micamlo® Combination Tablets AP/BP,” a combination drug with the long-acting CCB amlodipine besylate.
“Micatrio® Combination Tablets,” like the other telmisartan formulations, will be manufactured by Nippon Boehringer Ingelheim, distributed by Astellas and co-promoted by both companies. Nippon Boehringer Ingelheim and Astellas remain committed to further contribute to hypertension treatment through the Micardis family.
Date of Approval: September 28, 2016
Brand Name: Micatrio® Combination Tablets
Generic Name: Telmisartan/amlodipine besylate/hydrochlorothiazide
Dosage Form/Content: Film-coated tablet containing 80 mg, 5 mg and 12.5 mg of telmisartan, amlodipine, and hydrochlorothiazide per tablet, respectively
Precautions with related to indication
Since patients may experience hypotension, this fixed dose combination is not indicated for initial therapy of hypertension.
Dosage and Administration: For adults, one tablet (80 mg/ 5 mg/ 12.5 mg of telmisartan/ amlodipine/ hydrochlorothiazide) to be administered orally once daily. This drug is not to be used as a first-line drug in the treatment of hypertension.
Precautions with related to dosage and administration
In principle, switching to Micatrio® Combination Tablet should be considered in patients who are receiving both telmisartan 80 mg, amlodipine 5mg and hydrochlorothiazide 12.5 mg for a certain period continuously with same dosage and administration and have maintained stable blood pressure control.
Telmisartan is a drug that was discovered and developed by Boehringer Ingelheim, and it has been approved in over 100 countries including Japan, the US, and Europe. In Japan, telmisartan is available as Micardis® Tablets 20 mg / 40 mg / 80 mg, Micombi® Combination Tablets AP/BP, a combination drug with HCTZ, and Micamlo® Combination Tablets AP/BP, a combination drug with the long-acting CCB amlodipine besilate. These drugs comprise the Micardis® family of products including Micatrio. They are number one in terms of sales in the ARB family in Japan2. In ONTARGET3, the largest ARB clinical study published in 2008, it was reported to have effectiveness for suppressing cardiovascular events equivalent to ACE inhibitor Ramipril (unapproved in Japan).