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| |  Lotrel Produces Less Edema Than Increasing Procardia XL And Norvasc Dose EAST HANOVER, NJ -- November 12, 1997 -- Researchers found that in non-responders to initial doses of Norvasc® (amlodipine) and Procardia XL® (nifedipine) switching to low-dose combination agent Lotrel® (amlodipine/benazapril) provided comparable efficacy, but significantly less edema than increasing doses of these two leading calcium channel blockers. The two studies were presented today at a special symposium held in conjunction with the 70th Scientific Sessions of the American Heart Association held in Orlando, FL. Both studies were randomized, double-blind, parallel trials, each including more than 500 patients, whose primary and secondary endpoints measured changes from baseline in mean sitting diastolic and systolic pressure respectively. One study compared Lotrel 5/10 and 5/20 mg with Procardia XL at 30 and 60 mg; the other compared Lotrel 5/10 and 5/20 mg with Norvasc at 5 and 10 mg. “These studies show that Lotrel lowers blood pressure as effectively as higher doses of Procardia XL or Norvasc,, but with significantly less edema, a common side effect of dihydropyridine calcium channel blockers,” said Franz Messerli, M.D., clinical professor of medicine at Tulane University School of Medicine. “Rather than increasing the dose of Procardia XL or Norvasc and increasing the likelihood of dose-dependent side effects, physicians should consider using low-dose combination therapy such as Lotrel,” he said. “These findings are consistent with the recently released JNC VI guidelines, which recommend low-dose combination therapy that not only confers comparable blood pressure control but also a lower incidence of dose-dependent adverse drug reactions than high doses of monotherapy.” All agents were effective in lowering mean sitting diastolic and systolic blood pressures, Lotrel 5/10 and 5/20 mg provided a comparable reduction in mean sitting diastolic blood pressure to Procardia XL 60 mg (9.59, 9.68 vs. 8.97 mm Hg), and Norvasc 10 mg (8.97, 8.95 vs 8.91). During the course of these two clinical trials, there were no remarkable side effects for any agent other than cough and edema. Patients taking Procardia XL 60 mg, however were significantly more likely to experience edema, dose-dependent side effect, than patients taking Lotrel 5/20 mg (19.4 percent vs. 4.6 percent) or Lotrel 5/10 mg (19.4 percent vs. 3.1 percent). Similarly, patients taking Norvasc 10 mg were significantly more likely to experience edema than patients taking Lotrel 5/20 mg (25 percent vs. 3.6 percent) or Lotrel 5/10 mg (25 percent vs. 2.2 percent). Incidence of cough, a non-dose dependent side effect, was comparable for patients receiving Lotrel 5/10, 5/20 mg and Procardia XL 60 mg and significantly less for patients taking Norvasc 5 mg (one percent vs. seven percent with Lotrel 5/10 mg or 5/20 mg) and Norvasc 10 mg (two percent vs. seven percent with Lotrel 5/10 or 5/20 mg). In 1995, Novartis pharmaceuticals introduced Lotrel (amlodipine/benazapril hydrochloride), which combines in one capsule two widely-prescribed antihypertensive medications: the calcium channel blocker Norvas® (amlodipine) and the ACE inhibitor Lotensin (benazepril). Not indicated for initial
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