Biovail Corporation announced that a major cardiovascular study has shown that Teveten (eprosartan), an angiotensin II receptor blocker (ARB) marketed in the United States by Biovail, offers protection against cerebrovascular and cardiovascular events in hypertensive patients with a previous stroke, over and above that offered by blood-pressure reduction alone.
The results of the MOSES study (Morbidity and Mortality After Stroke - Eprosartan Compared with Nitrendipine in Secondary Prevention) in more than 1,400 patients were released late Monday at the European Society of Cardiology Congress in Munich, release from Biovail said.
Initial results from the study showed that blood pressure was equally well controlled when hypertensive patients with a history of stroke were treated with either Teveten-based or nitrendipine-based therapies. There was a 20 per cent greater reduction in the primary endpoint (total mortality and total cardiovascular and cerebrovascular events), a 25 per cent greater reduction in the recurrence of stroke and associated disease, and a 30 per cent greater reduction in first-time cardiovascular events in the Teveten group vs. the nitrendipine group. All of these differences were statistically significant.
Biovail acquired United States marketing rights for Teveten and Teveten HCT (eprosartan mesylate and hydrochlorothiazide combination), both of which are patent-protected through 2010, from Solvay Pharmaceuticals Marketing & Licensing AG in March 2002. Teveten and Teveten HCT compete in the US$4-billion angiotensin receptor blocker market, the fastest-growing class of anti-hypertensive drugs; for the 12 months ended June 30, 2004, the ARB market grew 27 per cent. Approximately 62.6 million total prescriptions were written for ARBs during the same period. The Teveten line provides Biovail with multiple treatment options for cardiovascular disease.
According to the release, MOSES study was designed to compare the efficacy of the two agents in secondary stroke prevention and reduction of cardiovascular and cerebrovascular morbidity and mortality. It is the first study to specifically compare the outcomes of alternative anti-hypertensive treatment in patients with a history of stroke. Nitrendipine was chosen as the comparator agent because of its success in the Syst-Eur study where treatment reduced the risk of stroke by 42 per cent in elderly patients with systolic hypertension. Although not marketed in the United States, nitrendipine is a member of the dihydropyridine calcium channel blocker class, which includes amlodipine, nifedipine and felodipine.
In the MOSES study, both nitrendipine and Teveten produced impressive reductions in blood pressure, with approximately 75 per cent of patients in each group reaching the target blood pressure as determined by ambulatory blood-pressure monitoring. Since both agents produced similar reductions in blood pressure, the reduced incidence of cerebrovascular and cardiovascular events in patients receiving Teveten suggests that these benefits are achieved independently of blood-pressure reductions.
Teveten (eprosartan) is an antihypertensive agent in the angiotensin II receptor blocker (ARB) class that treats hypertension in a broad range of patients, including older patients, African Americans, and individuals with severe hypertension.