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CIBA INTRODUCES NEW HYPERTENSION THERAPY; First in New Category.


SUMMIT, NJ--(BUSINESS WIRE)--August 7, 1995--Ciba Pharmaceuticals today announced the introduction of Lotrel(TM) (amlodipine and benazepril hydrochloride be·na·ze·pril hydrochloride
n.
An ACE inhibitor drug used in the treatment of hypertension, congestive failure, and other cardiovascular disorders.
), a new approach to the treatment of hypertension positioned as the physician's next choice when a patient's response to treatment with some of the market's leading therapies is not satisfactory.

Approximately 50 million Americans have hypertension (NHLBI NHLBI,
n.pr See National Heart, Lung, and Blood Institute.
, January, 1993). Of those who are treated, one out of two patients are prescribed either a calcium channel blocker calcium channel blocker
n.
Any of a class of drugs that inhibit movement of calcium ions across a cell membrane, used in the treatment of cardiovascular disorders.
 (CCB CCB Calcium channel blocker, see there ) or an angiotensin converting enzyme Noun 1. angiotensin converting enzyme - proteolytic enzyme that converts angiotensin I into angiotensin II
angiotensin-converting enzyme, ACE

peptidase, protease, proteinase, proteolytic enzyme - any enzyme that catalyzes the splitting of proteins into
 (ACE) inhibitor (Arch. Int. Med., April 24, 1995). Despite the proven efficacy of these and other treatments, nearly half of all treated hypertensive hypertensive /hy·per·ten·sive/ (-ten´siv)
1. characterized by increased tension or pressure.

2. an agent that causes hypertension.

3. a person with hypertension.
 patients do not achieve adequate blood pressure control (JNC JNC Joint National Committee
JNC Japan Nuclear Cycle Development Institute
JNC Judicial Nominating Commission
JNC Jet Navigation Chart
JNC Journal of Nuclear Cardiology
JNC JNet Consultancy (Netherlands) 
 V, January, 1993).

"Lotrel provides a unique new approach that simplifies the next choice by providing full 24-hour blood pressure control with a response in up to 87 percent of patients, often with fewer side effects Side effects

Effects of a proposed project on other parts of the firm.
, as well as convenient dosing and reasonable cost," said Malcolm MacNab, M.D., vice president of cardiovascular drug development, Ciba Pharmaceuticals.

New Approach Yields Advantages

Lotrel works through a dual mechanism of action that provides the benefits of both CCBs and ACE inhibitors. Clinical trials in nearly 1,100 hypertensive patients prove that Lotrel produces blood pressure reduction superior to the dihydropyridine (DHP DHP Department of Health Professions
DHP Dean Health Plan
DHP Documentary Heritage Program
DHP Dark Horse Presents (comic)
DHP David Hyde Pierce (actor) 
) CCB amlodipine (Norvasc(R), Pfizer) or the ACE inhibitor benazepril HCl (Lotensin(R), Ciba). In non-African-American patients, the blood-pressure lowering effects were additive and in some cases synergistic. In African-American patients, virtually all of the antihypertensive antihypertensive /an·ti·hy·per·ten·sive/ (-ten´siv) counteracting high blood pressure, or an agent that does this.

an·ti·hy·per·ten·sive
adj.
Reducing high blood pressure.

n.
 effect of Lotrel could be attributed to the CCB component.

Lotrel also has an excellent tolerability and safety profile across all strengths, regardless of race, gender, or age. In particular, it provides a protective effect from the edema edema (ĭdē`mə), abnormal accumulation of fluid in the body tissues or in the body cavities causing swelling or distention of the affected parts.  associated with the DHP CCB amlodipine. Edema -- swelling of the ankles, feet, hands and face -- is one of the most common dose-dependent side effects associated with the DHP CCBs, particularly among female patients. Like all ACE inhibitors, Lotrel should be discontinued as soon as pregnancy is detected. Angioedema and cough have been reported in patients receiving ACE inhibitors.

Lotrel is indicated when blood pressure control is inadequate with either a DHP CCB or an ACE inhibitor, or when a patient experiences unacceptable edema with the DHP CCB amlodipine but blood pressure control is achieved. Substituting the corresponding strength of one-capsule/once a day Lotrel for patients on two-drug therapy with the DHP CCB amlodipine and the ACE inhibitor benazepril provides comparable therapeutic benefits while reducing the inconvenience and cost of multiple medications.

First in New Category

Lotrel represents the first entry in a new antihypertensive therapy category that will compete against all others as the next choice when therapy with ACE inhibitors or DHP CCBs is unsatisfactory. Lotrel is not indicated for initial therapy.

The ACE inhibitor and CCB segments are fueling the growth of the hypertension market and represent $2 billion and $3.2 billion respectively, with the dihydropyridines accounting for about half of new prescriptions in the CCB category. Currently, Lotensin is the most prescribed of the newer ACE inhibitors and the fastest-growing, and Norvasc is the third most-prescribed branded CCB and also growing rapidly. Both were among the top 50 U.S. drugs.

"Lotrel offers a new alternative to increasing dosages, switching to different classes, or progressing to two-drug therapy when patients do not adequately respond to dihydropyridine CCBs or ACE inhibitors," said Dr. MacNab.

Other DHP CCBs include Procardia XL(R) (nifedipine nifedipine /ni·fed·i·pine/ (ni-fed´i-pen) a calcium channel blocking agent used as a coronary vasodilator in the treatment of coronary insufficiency and angina pectoris; also used in the treatment of hypertension. , Pfizer), Adalat CC(R) (nifedipine, Bayer), Cardene(R) (nicardipine, Syntex), and Plendil(R) (felodipine, Astra-Merck). Other ACE inhibitors include Vasotec(R) (enalapril, Merck), Zestril(R) (lisinopril, Stuart) Prinivil(R) (lisinopril, Merck), Capoten(R) (captopril captopril /cap·to·pril/ (kap´to-pril) an angiotensin-converting enzyme inhibitor used in the treatment of hypertension, congestive heart failure, and post–myocardial infarction left ventricular dysfunction. , Bristol-Myers Squibb), Accupril(R) (quinapril hydrochloride, Parke-Davis), and Altace(R) (ramipril, Hoechst).

Lotrel is available in three strengths -- amlodipine/benazepril HCl 2.5mg/10mg, 5mg/10mg, and 5mg/20mg, in bottles of 100. Lotrel will be launched in August by the 1,200 members of the CibaGeneva field force.

Lotrel is manufactured and marketed by Ciba Pharmaceuticals, Summit, NJ, maker of Lotensin(R) (benazepril hydrochloride). Ciba has a patent license in the U.S. from Pfizer Inc. to use amlodipine with benazepril in Lotrel, a dual-acting product. Pfizer manufactures and markets amlodipine for the treatment of hypertension and angina under the trade name Norvasc(R).

CONTACT: Gloria Martini, Ciba

908/277-5563

or

Richard Chamberlain

212/684-6102
COPYRIGHT 1995 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1995, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Date:Aug 7, 1995
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