Tokyo Japan, May 31, 2013 - Nippon Boehringer Ingelheim Co., Ltd. (headquartered in Shinagawa-ku, Tokyo; president, Yoshiaki Aono; hereinafter referred to as “Nippon Boehringer Ingelheim”) and Astellas Pharma Inc. (Tokyo:4503, headquartered in Chuo-ku, Tokyo; president, Yoshihiko Hatanaka; hereinafter referred to as “Astellas”) announced today’s launch of “Micamloâ Combination Tablets BP,” a combination drug of telmisartan 80 mg, a long-acting angiotensin II type 1 (AT1) receptor blocker (ARB), and amlodipine 5 mg, a long-acting calcium channel blocker (CCB), following its drug price listing today.
Micamloâ Combination Tablets BP is Japan’s first combination of high-dose ARB and long-acting CCB. While the previously launched Micamloâ Combination Tablets AP is a combination drug of telmisartan 40 mg and amlodipine 5 mg, the amount of telmisartan in Micamloâ Combination Tablets BP is increased to 80 mg. This is, therefore, expected to maintain a more potent antihypertensive effect for 24 hours compared to existing ARB/CCB combination tablets.
The medicine expert of the domestic clinical studies of Micamloâ Combination Tablets BP, Dr. Jitsuo Higaki of the Department of Cardiology, Pulmonology, Hypertension and Nephrology at Ehime University Graduate School of Medicine, made a following comment: Unlike other ARBs, Micardisâ contained in “Micamloâ Combination Tablets BP contains Micardisâ has a special feature of providing powerful antihypertensive effect due to the delta-lock1 structure which binds with the stronger affinity to three points of AT1 receptor. It is also long-acting, with an effect that is sustained for 24 hours. Moreover, since the selective PPARγ-activating action of Micardis has a salutary effect upon metabolism, this drug is sometimes referred to as Metabo-sartan, and it is regarded as the first choice for hypertensive patients with metabolic syndrome or risk factors for it.
Micamloâ Combination Tablets BP combines the highest available dosage of Micardis with amlodipine, the most prescribed hypertension drug in the world, which, like Micardisâ, is backed by evidence that it prevents cardiovascular events. While we generally get the impression that it is more difficult to obtain antihypertensive effect by increasing the dosage of ARB, compared to increasing the dosage of CCB, it is noteworthy that powerful antihypertensive effect represented by reduction of 6.9 mmHg in systolic blood pressure was obtained by switching to Micamlo® Combination Tablets BP in a Japanese phase-III long-term administration study involving hypertensive patients who had not met their blood pressure targets when taking Micamlo ® Combination Tablets AP®.
There are also survey results indicating that approximately 60 percent of hypertensive patients have still not met their target blood pressure, and since many of the patients we see in clinical practice have hypertension that is inadequately controlled with the existing medications. Therefore, the advent of Micamloâ Combination Tablets BP, with its powerful and long-acting antihypertensive effect, can be expected to contribute to the treatment of a great many patients.”
With the existing telmisartan drugs, “Micardisâ Tablets 20 mg/40 mg/80 mg,” “Micombiâ Combination Tablets AP/BP” (combining telmisartan with hydrochlorothiazide diuretic of the thiazide class), and “Micamlo® Combination Tablets AP” (combining telmisartan with long-acting CCB amlodipdine), Micamlo® Combination Tablets BP to be launched constitutes the Micardisâ family.
As in the previous cases for the telmisartan drugs, Micamloâ Combination Tablets BP will be manufactured by NBI, distributed by Astellas, and co-promoted by two companies. They remain committed to continuously maximising the value of the Micardisâ family products and further contributing to hypertension treatment.