Bayer Schering Pharma AG announces the kick-start of the TALENT study, a multicenter "STudy EvALuating the Efficacy of Nifedipine GITS - Telmisartan Combination in Blood Pressure Control", which will examine two of its major antihypertensive brands in combination with each other. With the first patient enrollment, this multicenter, randomized, double blind trial will examine alternative therapy regimes with Adalat GITS (nifedipine) and Pritor/Kinzal (telmisartan) in 400 hypertensive patients in Italy and Spain over 16 weeks. The primary study endpoint will be the 24 hour mean systolic blood pressure (SBP) at 16 weeks compared to baseline.
"TALENT will give us valuable information about the benefits of different antihypertensive therapy approaches", said Prof. Giuseppe Mancia, Chairman of the Department of Clinical Medicine, Prevention and Applied Biotechnologies of the University of Milan-Bicocca, Italy, and principal investigator of the study together with Prof. Luis Ruilope, President of the Spanish Hypertension Society, Madrid. In addition to being hypertensive, all patients enrolled in TALENT will have additional risk factors such as type 2 diabetes, target organ damage or excess weight. "The type of patient we will be looking at, is a very typical patient for practitioners today, so the results will be very relevant for daily practice", said Prof. Mancia. The data collection is expected to be completed by the end of 2008 and the results of the TALENT study are expected to be available in early 2009.
Combination Therapies are Needed
In order to achieve target blood pressure levels, it is often necessary for physicians to prescribe more than one antihypertensive medication. Reaching target blood pressure within the first months appears to have therapeutic advantages. This is especially true for patients with target organ damage
or existing cardiovascular disease. Several studies have already shown that the long acting form of the dihydropyridine calcium channel blocker Adalat® GITS is effective in combination with other antihypertensive agents. "Nifedipine is effective in reducing the risk of stroke and in combination
with an angiotensin II receptor blocker like telmisartan, it appears to have beneficial effects on the progression of vascular disease", said Professor Ruilope. "TALENT will provide evidence as to whether it is better to start with a monotherapy with one of these drugs before switching to the combination or to prescribe the combination from the very start".
"Major outcome trials like INSIGHT have demonstarted that nifedipine GITS is a very effective antihypertensive", said Dennis Kvesic, Global Brand Head for Adalat. "We expect TALENT to demonstrate that Adalat® GITS and Pritor®/Kinzal® are ideal partners to meet the growing demand for more effective combination therapies."
The recently published guidelines from the European Society of Cardiology (ESC) and the European Society of Hypertension (ESH) also stressed the importance of combination therapies. In particular, the guidelines recommend that patients with grade 2 or 3 hypertension or with high or very high total cardiovascular risk should be given a 2-drug combination as initial treatment. Dihydropyridine calcium channel blockers like nifedipine GITS are widely recognized as an ideal combination partner with several classes of antihypertensive drugs.
About TALENT
TALENT is a multicenter, prospective, randomized, double blind trial. 40 centers in Italy and Spain will enroll 400 hypertensive patients who will be randomized to three arms. Patients will initially be assigned to one of three groups, receiving either 20mg of Adalat®GITS (nifedipine GITS), 80mg
of Pritor®/Kinzal® (telmisartan) or a combination of both. After eight weeks, all groups will receive the combination therapy. Among the inclusion criteria for patients are: untreated or poorly controlled hypertension (systolic blood pressure, SBP, > 135mmHg); presence of type 2 diabetes or target organ damage; presence of at least two defined indicators of metabolic syndrome. The objective of the trial is to evaluate the efficacy in blood pressure control when antihypertensive therapy is initiated with a combination of low dose nifedipine GITS and telmisartan compared to a regimen starting with monotherapy before adding the other drug after eight weeks. The primary study endpoint is the mean 24 hour SBP at 16 weeks compared to baseline using an ambulatory blood pressure measurement.
Secondary endpoints include the decrease in SBP at 8 and 16 weeks; the percentage of patients achieving a blood pressure under 125/80 mmHg; changes in day and night average blood pressures and the presence of selected metabolic parameters.
About the Gastro-Intestinal Therapeutic System (GITS)
The GITS-delivery system used in Adalat®GITS allows for a slow, controlled release of nifedipine over 24 hours. GITS consists of a drug reservoir and osmotic push system surrounded by a semi-permeable membrane, which has a single precision-laser drilled pore. Upon entry into the gastrointestinal system, the tablet begins to absorb water which leads to the active agent
being pushed through the pore at a constant rate. Clinical trials such as INSIGHT and ACTION, which have been conducted with Adalat® GITS, demonstrate that this formulation provides a controlled onset of action and has a significantly lower incidence of side effects compared with the short-acting formulations. Fewer side effects and the ease of once-daily dosing aim to improve patient compliance and maximize the therapeutic effect.
Bayer HealthCare
Bayer HealthCare, a subsidiary of Bayer AG, is one of the world's leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Diabetes Care and Pharmaceuticals
divisions. The pharmaceuticals business operates under the name Bayer Schering Pharma and as Bayer HealthCare Pharmaceuticals in the US and Canada. Bayer HealthCare's aim is to discover and manufacture products that will improve human and animal health worldwide.
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Bayer Schering Pharma
Bayer Schering Pharma is a worldwide leading specialty pharmaceutical company. Its research and business activities are focused on the following areas: Diagnostic Imaging, Hematology/Cardiology, Oncology, Primary Care, Specialized Therapeutics and Women's Healthcare. With innovative products,
Bayer Schering Pharma aims for leading positions in specialized markets worldwide. Using new ideas, Bayer Schering Pharma aims to make a contribution to medical progress and strives to improve the quality of life.
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