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Bayer Schering Pharma was granted European marketing authorization for its new antihypertensive fixed dose combination drug PritorPlus® 80/25 and Kinzalkomb® 80/25 (80 mg telmisartan/25 mg hydrochlorothiazide) by the European Commission. The new formulation will be launched in Germany later this month, to be followed soon by selected countries in the EU.
The product is indicated for the treatment of essential hypertension in patients whose blood pressure is not adequately controlled on PritorPlus® 80/12.5 and Kinzalkomb® 80/12.5 (80 mg telmisartan/12.5 mg hydrochlorothiazide), or patients who have been previously stabilized on telmisartan and hydrochlorothiazide separately at the same dosages.(1,2)
"For physicians and patients, it is often very challenging to reach the recommended blood pressure targets with the available treatments. PritorPlus® 80/25 and Kinzalkomb® 80/25 offer physicians a new therapeutical strategy to treat their hypertensive patients", said Dr. Rahul Agrawal, Global Clinical Leader Cardiology, Bayer HealthCare.
European approval of PritorPlus® 80/25 and Kinzalkomb® 80/25 follows the submission of efficacy and safety data from 12 clinical trials performed in patients with mild to moderate hypertension. The core clinical development program consisted of two consecutive trials. The superiority of the fixed dose combination, 80 mg telmisartan/25 mg hydrochlorothiazide (T80/H25), versus 80 mg telmisartan/12.5 mg hydrochlorothiazide (T80/H12.5) was demonstrate.(1)
971 patients(1), who were inadequately controlled for their blood pressure (BP) on existing antihypertensive treatment, were enrolled in the program. Treatment with T80/H25 provided superior trough systolic and diastolic blood pressure lowering power??? (*) after 8 weeks treatment(1) compared to T80/H12.5. In the consecutive follow-up trial, 639 patients (633 patients evaluated for efficacy) were treated with the T80/H25 for a further 6 months. At the end of this treatment interval, the proportion of patients achieving DBP control had increased from 52.4% to 71.4%.(2) No clinically meaningful differences in the adverse event profiles of T80/H25 and T80/H12.5 were detected. No specific increased incidence was identified for all adverse events. No additional specific safety issues have been identified. (1,2)
Other studies considered by the EMEA showed that T80/H25-based treatment led to a significant greater lowered trough systolic and diastolic blood pressure than treatment with 160 mg valsartan /25 mg hydrochlorothiazide, the market-leading ARB’s high-strength combination.(3)
About Telmisartan
Telmisartan was discovered and developed by Boehringer Ingelheim. The company markets telmisartan in 84 countries around the world, including the United States, Japan and European countries, under the trademarks Micardis® and MicardisPlus® (in combination with HCTZ). Bayer Schering Pharma promotes telmisartan under the brand names Pritor®, PritorPlus® (in combination with HCTZ) and Kinzalmono®, Kinzalkomb® (in combination with HCTZ) in markets across Europe.
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About 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. www.bayerhealthcare.com
About 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.
Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at Buy viagra pills The company assumes no liability whatsoever to update these forward-looking statements or to conform them/b to future events or developments.
References
(1) Trials.Boehringer-Ingelheim.com. Boehringer Ingelheim Trial Number 502.480
(2) Trials.Boehringer-Ingelheim.com. Boehringer Ingelheim Trial Number 502.491
(3) White WB, Murwin D, Chrysant SG, Koval SE, Davidai G, Guthrie R. Blood Press Monit. 2008 Feb;13(1):21-27
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Perching on an exam table with arms and legs dangling is not the most accurate (nor medically recommended) position for a blood pressure check, according to a study released in the April 2008 issue of MEDSURG Nursing.
In an eye-opening report on the most common diagnostic test patients receive in the doctor’s office, researcher Melly Turner and her colleagues write that patients who were in the proper position - sitting in a chair, back supported, feet on the floor, with arm at heart level - had blood pressure readings consistently and significantly lower than the usual exam table option. The chair position is recommended by the American Heart Association (AHA) Guidelines for Blood Pressure Assessment and the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC-7).
Turner tested 100 patients (male and female) visiting an ambulatory cardiology clinic, comparing the exam table readings with those taken from a chair the proper way. Systolic pressure readings taken in timed intervals in the chair ranged an average of 12.5% - 14.2% lower than the table. Diastolic readings were 4.4% - 7.6% lower.
During the study, researchers discovered the majority of staff were unaware of the JNC-7 and AHA recommendations, many saying that they were never trained on the chair position technique.
Recognizing the importance of the findings, the authors quickly disseminated the results in newsletters and reports and at meetings.
Requests from other facilities on how to implement the findings are flowing in as providers hear the news, and Turner adds that nurses have a key role as front-line providers in ensuring proper techniques.
comprare levitra mastercard Measuring Blood Pressure Accurately in an Ambulatory Cardiology Clinic Setting: Do Patient Position and Timing Really Matter?
Melly Turner, BSN, RN-BC et al.
MEDSURG Nursing April 2008 -
About MEDSURG Nursing - The Journal of Adult Health
MEDSURG Nursing, The Journal of Adult Health, is the official journal of the Academy of Medical-Surgical Nurses (AMSN). The journal provides its readers with the multidisciplinary information they need to provide clinically excellent patient care and to enhance their nursing practice. MEDSURG Nursing supports adult health/medical-surgical nurses as they strive for excellence in patient care, private practice, and outpatient health care settings in urban, suburban, and rural locations. Each peer-reviewed issue of MEDSURG Nursing features a comprehensive discussion and description of today’s clinical issues in adult health/medical-surgical nursing. MEDSURG Nursing and AMSN are committed to the advancement of adult health/medical-surgical nursing practice. The journal is published six times a year.
MEDSURG Nursing
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ORLANDO, FL (UroToday.com) - In this presentation, the group reported on the incidence and predictors of erectile dysfunction after plaque incision and grafting (PIG).
56 patients undergoing PIG were analyzed with pre and 6-month postoperative IIEF questionnaires. Mean duration of PD at the time of surgery was 23 months, mean plaque area was 4.7 cm2 and mean pre-op curvature was 52 degrees. 52 patients had grafting with Tutoplast, 4 with Surgisis. Baseline and postoperative IIEF scores 23 and 17 respectively - 46% experienced a greater than 6 point reduction.
Predictors of this drop proved to be degree of pre-operative curvature, the type of plaque incision (Egydio was worse then an H-type incision), age greater than 55 years, and those that showed pre-op venous leak on cavernosometry.
Kaufen cialis soft pillen mastercard Presented by Judy M. Choy, MD, et al. at the Annual Meeting of the American Urological Association (AUA) - May 17 - 22, 2008. Orange County Convention Center - Orlando, Florida, USA.
Reported by UroToday.com Contributing Editor Michael J. Metro, MD
UroToday - the only urology website with original content written by global urology key opinion leaders actively engaged in clinical practice.
To access the latest urology news releases from UroToday, go to:
www.urotoday.com
Copyright © 2008 - UroToday
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Men’s Health News
Eating one or more portions of broccoli every week can reduce the risk of prostate cancer, and the risk of localised cancer becoming more aggressive.
For the first time, a research group at the Institute of Food Research led by Professor Richard Mithen has provided an explanation of how eating broccoli might reduce cancer risk based upon studies in men, as opposed to trying to extrapolate from animal models.
Prostate cancer is the most common non-skin cancer for males in western countries. The research has provided an insight into why eating broccoli can help men stay healthy.
For the study to be published in PLoS ONE on 2nd July, men who were at risk of developing prostate cancer ate either 400g of broccoli or 400g of peas per week in addition to their normal diet over 12 months. Tissue samples were taken from their prostate gland before the start of the trial and after 6 and 12 months, and the expression of every gene measured using Affymetrix microarray technology.
kaufen viagra Ohne Rezept It was found that there were more changes in gene expression in men who were on the broccoli-rich diet than on the pea diet, and these changes may be associated with the reduction in the risk of developing cancer, that has been reported in epidemiological studies.
Previous studies have suggested that the fifty percent of the population who have a GSTM1 gene gain more benefit from eating broccoli than those who lack this gene. The study showed that the presence of the GSTM1 gene had a profound effect on the changes in gene expression caused by eating broccoli.
This study fills the gap between observational studies and studies with cell and animal models. While observational studies have shown that diets rich in cruciferous vegetables may reduce the risk of prostate cancer and other chronic disease, they do not provide an explanation of how this occurs. Evidence from animal and cell models has sought to provide an explanation, but these studies are usually based on high doses that would not normally be experienced as part of the diet.
The results of the study suggested that relatively low amounts of cruciferous vegetables in the diet - a few portions per week - can have large effects on gene expression by changing cell signalling pathways. These signalling pathways are the routes by which information is transmitted through a molecular cascade which amplifies the signal to the nucleus of the cell where gene expression occurs.
The Norwich team are currently planning a larger study with men with localised prostate cancer, and will compare the activity of standard broccoli with the special variety of high glucosinolate broccoli used in the current study.
Designer studies for health promotion
"Other fruits and vegetables have been shown to also reduce the risk of prostate cancer and are likely to act through other mechanisms," says Professor Mithen.
"Once we understand these, we can provide much better dietary advice in which specific combinations of fruit and vegetable are likely to be particularly beneficial. Until then, eating two or three portions of cruciferous vegetable per week, and maybe a few more if you lack the GSTM1 gene, should be encouraged."

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Men’s Health News
A simple blood test screening for a panel of biomarkers can accurately predict whether a patient who has had prostate cancer surgery will have a recurrence or spread of the disease.
Generique cialis soft pilules bon marche Calling their findings a major step forward in prostate cancer care, Texas researchers report in the June 15 issue of Clinical Cancer Research, a journal of the American Association for Cancer Research, that the presence of seven of these biomarkers can predict prostate cancer risk with 86.6 percent reliability. This is at least 15 percentage points higher than standard clinical measures currently in use, the researchers say.
"We have been looking at these biomarkers for the past 10 to 15 years in the laboratory, but now we can translate these findings into progress for the individual patient," said Shahrokh F. Shariat, M.D., chief resident in urology at the University of Texas Southwestern Medical Center.
Clinicians need this information to decide whether to take a "watchful waiting" approach with their prostate cancer patients or to move to more aggressive additional therapy such as hormone therapy, chemotherapy or radiation, Shariat says. Urologists currently use a risk predictor that includes variables like stage, Gleason score and serum levels of prostate-specific antigen. "However, this method is only accurate about 70 percent of the time, which is not optimal," Shariat said.
Shariat and colleagues enrolled 423 patients who were surgically treated for prostate cancer with either radical prostatectomy or bilateral lymphadenectomy.
Using commonly available blood tests, they measured levels of the following seven biomarkers: transforming growth factor-â1, interleukin-6, interleukin-6 soluble receptor, vascular endothelial growth factor, vascular cell adhesion molecule-1, endoglin, urokinase plasminogen activator.
"We reviewed background literature over 60 separate biomarkers and determined that these were the optimal seven that would have predictive value," Shariat said.
Patients were followed for approximately four years, and researchers noted cancer recurrence in 17.7 percent of patients. Elevated levels of the seven biomarkers were associated with increased risk of relapse. For example, the presence of urokinase plasminogen inhibitor-1 increased risk by 37 percent, while the presence of vascular endothelial growth factor increased risk by 47 percent.
The combination of all seven biomarker variables accurately predicted risk 86.6 percent of the time in this study.
"This is a large and unique improvement for patient care. Neither preoperative MRI nor any of the clinical features we have used before even comes close to this level of accuracy," Shariat said.

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