Approximately 50 million Americans have hypertension (NHLBI, January, 1993). Of those who are treated, one out of two patients are prescribed either a calcium channel blocker (CCB) or an angiotensin converting enzyme (ACE) inhibitor (Arch. Int. Med., April 24, 1995). Despite the proven efficacy of these and other treatments, nearly half of all treated hypertensive patients do not achieve adequate blood pressure control (JNC 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, 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) 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 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 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, 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, 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
