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LOGIC, New 9,000-Patient Study, Demonstrates Patients Switched To Lotrel (Amlodipine/Benazepril Hcl) From Norvasc Experience Better Blood Pressure Control With Less Edema Two Other Studies, ALERT and SHIELD, Evaluate Lotrel Efficacy in Diabetic Hypertension, Arterial Compliance, Left Ventricular Hypertrophy NEW YORK, NY -- May 14, 2002 -- Novartis Pharmaceuticals Corporation today announced that three new studies evaluating the efficacy and safety of Lotrel (amlodipine/benazepril HCl) in a broad range of hypertensive patients will be presented this week during the 17th annual meeting of the American Society of Hypertension (ASH). Lotrel is a single-capsule combination of two antihypertensive medications: amlodipine, the calcium channel blocker (CCB) found in Norvasc®, and the angiotensin converting enzyme (ACE) inhibitor Lotensin® (benazepril). The studies -- LOtrel: Gauging Improved Control (LOGIC), Study of HypertensIon and the Efficacy of Lotrel in Hypertensive Diabetics (SHIELD) and A Lotrel Evaluation of Hypertensive Patients with ARterial Stiffness and Left Ventricular HyperTrophy (ALERT) -- demonstrate Lotrel's effects in treating a broad range of hypertensive patients, including those with diabetes or arterial stiffness and left ventricular hypertrophy. The LOGIC study also demonstrated that Lotrel alleviated a common side effect of Norvasc monotherapy known as pedal edema (swelling of the feet and legs). More than 9,500 patients were involved in these studies. "Physicians are embracing the value of combination therapy with an ACE inhibitor and calcium channel blocker for tough-to-treat hypertensive patients because the combination provides superior blood pressure control with excellent tolerability. The new data will make physicians more confident in prescribing Lotrel for a wide array of hypertensive patients," said William Daley, MD, MPH, Executive Director, Cardiovascular & Metabolism, US Medical Affairs, Novartis Pharmaceuticals Corporation. "Novartis will continue to research ACE/CCB combination therapy. We are currently conducting studies to evaluate the efficacy of Lotrel in African-Americans, patients with diabetes and hypertension and in those with isolated systolic hypertension." Lotrel Studies Presented at American Society of Hypertension Meeting LOGIC (LOtrel: Gauging Improved Control) Patients switched from amlodipine to Lotrel in a practice-based setting experienced better blood pressure control with less pedal edema. LOGIC is a four-week, multi-center, practice-based, open-label study that evaluated the antihypertensive efficacy and tolerability of once-daily Lotrel versus amlodipine in 9,208 patients with mild-to-moderate hypertension. The patients were divided into two groups: patients who did not achieve blood pressure control with amlodipine (Group I) and patients whose blood pressure was controlled, but who experienced unacceptable edema with amlodipine (Group II). The 7,468 patients in Group I whose blood pressures were not adequately controlled with either 5 mg or 10 mg of amlodipine (mean sitting diastolic blood pressures (MSDBP) of greater than or equal to 90 mmHg but less than or equal to 110 mmHg) were switched to either 5 mg/10 mg or 5 mg/20 mg of Lotrel. The decision to switch patients to Lotrel 5 mg/10 mg or 5 mg/20 mg was based on the treating physicians' clinical judgment. An additional 1,739 patients taking amlodipine (Group II) who had controlled blood pressure (greater than or equal to 90 mmHg) but who experienced unacceptable amlodipine-induced pedal edema were also switched to Lotrel. After four weeks of treatment, Group I patients experienced significant reductions in MSDBP of 11.5 mmHg and in mean sitting systolic pressure (MSSBP) of 15.6 mmHg when they were switched from amlodipine to Lotrel (p <0.001). Amlodipine-induced pedal edema improved in 85% of patients in Group II when they were switched to Lotrel (p <0.001). Lotrel was well tolerated. The most commonly occurring side effects were cough (3.66%), dizziness (1.50%), edema (1.46%) and headache (1.23%). The full results of this study will be published in the June edition of the "American Journal of Hypertension." LOGIC presented by: Franz Messerli, MD, Alton Ochsner Medical Foundation, Tulane University, New Orleans, LA, Friday, May 17, 2002. ALERT (A Lotrel Evaluation of Hypertensive Patients with Arterial Stiffness and Left Ventricular HyperTrophy) Low doses of Lotrel showed greater improvements in arterial compliance and greater regression of left ventricular mass than higher doses of amlodipine and benazepril monotherapy. ALERT is a 26-week, prospective, open-label, blinded endpoint, parallel group study involving 106 patients with mild to moderate hypertension (DBP of 95-114 mmHg). The study compared the effects of low-dose Lotrel (5 mg/20 mg) versus high-dose amlodipine (10 mg) and benazepril (40 mg) monotherapy on arterial stiffness and left ventricular mass. Patients taking Lotrel experienced significantly greater improvements in arterial stiffness versus amlodipine and benazepril-treated patients (0.71 plus or minus 0.51% mL/mmHg vs. 0.28 plus or minus 0.69% mL/mmHg and 0.39 plus or minus 0.62% mL/mmHg, respectively; p=0.008, p=0.03). Moreover, patients taking Lotrel had greater regressions in left ventricular mass index as measured by echocardiography than amlodipine-treated patients (-29.9 plus or minus 25.5 g/m(2) vs. -14.1 plus or minus 22.1 g/m(2) respectively; p=0.01). Left ventricular mass index reductions were numerically greater in Lotrel than in benazepril-treated patients (-19.3 plus or minus 20.3 g/m(2)). However, the difference from the ACE inhibitor was not statistically significant. These improvements were seen despite the fact that patients on all three medications achieved similar reductions in systolic and diastolic blood pressure. Lotrel was well tolerated. The most commonly occurring side effects were GI complaints (11.4%), peripheral edema (8.6%), cough (5.7%) and headache (2.8%). Lotrel is not indicated for the treatment of arterial stiffness or left ventricular hypertrophy. ALERT presented by: Joel Neutel, MD, Orange County Heart Institute and Research Center, Orange County, CA, Saturday, May 18, 2002. SHIELD (Study of HypertensIon and the Efficacy of Lotrel in Hypertensive Diabetics) Patients with diabetes and hypertension taking Lotrel reached their target blood pressure goal (<130/85 mmHg) 22% faster than those on Vasotec(R) (enalapril) monotherapy. SHIELD is a 12-week, randomized, multi-center, double-blind, parallel group study that evaluated the safety and efficacy of Lotrel versus enalapril monotherapy in 214 patients with hypertension and type 2 diabetes. ACE inhibitor treatment with an agent like enalapril is the standard of care for patients with diabetes. This study was conducted to determine if Lotrel would provide superior blood pressure control while providing the recommended ACE inhibitor therapy. Patients in the study with average diastolic blood pressures (DBP) between 90 and 109 mmHg were randomized to either Lotrel 5 mg/10 mg or enalapril 10 mg. If patients did not reach the target blood pressure of <130/85 mmHg after four weeks, they were titrated to either Lotrel 5 mg/20 mg or enalapril 20 mg. Patients not reaching goal after eight weeks received 12.5 mg of hydrochlorothiazide on top of their treatment regimen. At the conclusion of the study, patients taking Lotrel reached their target blood pressure approximately 22% faster than those taking enalapril (5.3 weeks versus 6.4 weeks respectively; p=0.0001). Moreover, Lotrel-treated patients experienced significantly greater reductions in systolic blood pressure (SBP) and DBP than those taking enalapril (-20.5/-13.9 mmHg versus -14.5/-9.6 mmHg respectively; p=0.002, p=0.001). A statistically significant difference in reduction in triglyceride levels favoring the Lotrel regimen was also observed (p=0.039). Lotrel-treated patients experienced a mean decrease in triglycerides of 21.7 mg/dL, compared with a mean increase of 14.8 mg/dL among enalapril-treated patients. The changes from baseline in all other lipid levels were comparable across the treatment groups. There was no negative impact on glycemic control with either Lotrel or enalapril. Additionally, a sub-study of 20 SHIELD patients found that Lotrel combination therapy offered a statistically significant improvement in vascular compliance (a measure of the arteries' ability to expand and contract with changes in pressure), over enalapril monotherapy (p<0.05). This improvement occurred despite the absence of a significant difference in blood pressure between the groups. Both Lotrel and enalapril were well tolerated. There were a few reported incidents of bronchitis, dyspnea, congestive heart failure, angina and foot ulcers, but none of these was considered to be the result of the study medication. SHIELD presented by: George Bakris, MD, Rush University Hypertension Center, Rush Presbyterian/St. Luke's Medical Center, Chicago, IL, Thursday, May 16, 2002. SHIELD sub-study presented by: Nathaniel Winer, MD, SUNY Downstate Medical Center, Brooklyn, NY, Saturday, May 18, 2002. Ongoing Lotrel Studies Novartis is conducting clinical studies to further explore the clinical potential of Lotrel. The LEAAD (Lotrel and Enalapril in African-Americans with Hypertension and Diabetes) trial is examining the efficacy of Lotrel versus the ACE inhibitor enalapril on blood pressure reduction and kidney function in African-Americans with diabetes. Another trial, called SELECT (Systolic Evaluation of Lotrel Efficacy and Comparative Therapies), is comparing the effects of Lotrel to amlodipine and benazepril monotherapy on systolic blood pressure, a critical indicator of cardiovascular risk. Lotrel is indicated for hypertension, but not for initial therapy, and was approved for marketing in the U.S. in 1995. Lotrel is one of the fastest-growing branded high blood pressure therapies on the market. Due to its ACE inhibitor component, Lotrel should be discontinued as soon as pregnancy is detected because of concerns over its effect on the unborn child. Also, angioedema, a potentially dangerous swelling of the mouth and throat, has been reported in patients receiving Lotrel. In clinical trials, the most common side effects were cough and headache. For full prescribing information, please consult http://www.pharma.us.novartis.com. This release contains certain "forward-looking statements," relating to the Company's business, which can be identified by the use of forward-looking terminology such as "believes," "expects," "promising," "will," "demonstrate," "alleviated," "superior blood pressure control," "excellent tolerability," "significant reductions," "well tolerated," "significantly greater improvements," "greater regressions" or similar expressions, or by discussions of strategy, plans or intentions. Such statements include descriptions of new products expected to be introduced by the Company and anticipated customer demand for such products. Such forward-looking statements reflect the current views of the Company with respect to future events and are subject to certain risks, uncertainties and assumptions. This outlook could be changed by a variety of factors such as, among other things, uncertainties relating to the results of additional clinical trials, product development, regulatory actions or delays or government regulation generally, the ability to obtain or maintain patent or other proprietary intellectual property protection and competition in general, as well as factors discussed in the Company's Form 20F filed with the Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected. Novartis Pharmaceuticals Corporation researches, develops, manufactures and markets leading innovative prescription drugs used to treat a number of diseases and conditions, including central nervous system disorders, organ transplantation, cardiovascular diseases, dermatological diseases, respiratory disorders, cancer and arthritis. The company's mission is to improve people's lives by pioneering novel healthcare solutions. Located in East Hanover, New Jersey, Novartis Pharmaceuticals Corporation is an affiliate of Novartis AG (NYSE: NVS), a world leader in healthcare with core businesses in pharmaceuticals, consumer health, generics, eye-care, and animal health. In 2001, the Group's businesses achieved sales of CHF 32.0 billion (USD 19.1 billion) and a net income of CHF 7.0 billion (USD 4.2 billion). The Group invested approximately CHF 4.2 billion (USD 2.5 billion) in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ about 72,600 people and operate in over 140 countries around the world. For further information please consult http://www.novartis.com. Vasotec is a registered trademark of Merck & Co. Norvasc is a registered trademark of Pfizer Inc. The amlodipine active ingredient found in Lotrel is supplied to Novartis Pharmaceuticals Corporation by Pfizer Inc. Full prescribing information is available upon request. SOURCE: Novartis Pharmaceuticals Corporation E-mail this page to a friend or colleague! To print, use this version