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Synopsis Amgen has issued a letter to all healthcare professionals regarding important changes to the safety information of the product labeling for Aranesp darbepoetin alfa ; for the treatment of chemotherapy-induced anaemia in patients with non-myeloid malignancies. The changes in the prescribing information are based on the results of 2 recent investigational studies with other erythropoietin products where doses required to achieve haemoglobin levels of greater than 12 grams per decilitre were used. An increased frequency of adverse patient outcomes, including increased mortality and thrombotic vascular events were reported in these studies. Although these studies were conducted with other erythropoietin products, Amgen has incorporated this information in the Aranesp prescribing information. This new information does not change the Dosage and Administration section of the Aranesp prescribing information; Amgen continues to recommend that the target haemoglobin should not exceed 12 grams per decilitre in men or women as indicated in the Aranesp prescribing information, for example, aspirin.
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Table 3. Proportion of patients with individual National Cholesterol Education Program NCEP ; Adult Treatment Panel III ATP III ; Metabolic Syndrome criteria at baseline that normalised by study end and
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To mimic prostate cancer progression, we established a cell culture system with an androgen-dependent LNCaP clonal cell line, LNCaP 104-S. After long-term culture in androgen-depleted medium, LNCaP 104-S cells progress to androgen-independent LNCaP 104-R1 and 104-R2 cells 5, 6 ; . Using our progression model, we analyzed the expression levels of genes that play important roles in cholesterol and lipid homeostasis in the androgen-dependent 104-S and androgenindependent 104-R1 and 104-R2 cells. We report that the expression levels of ATP-binding cassette transporter A1 ABCA1 ; , which functions as a cholesterol exporter 7 ; , is altered during prostate cancer progression, is regulated by androgens, and can regulate cell proliferation. Materials and Methods and
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Q. What are generic drugs? A. A generic drug is a copy that is the same as a brand name drug in dosage, safety, strength, how it is taken, quality, performance and intended use. Q. Are generic drugs as safe as brand name drugs? A. Yes. FDA requires that all drugs be safe and effective. Since generics use the same active ingredients and are shown to work the same way in the body, they have the same risks and benefits as their band name counterparts. Q. Are generic drugs as strong as brand name drugs? A. Yes. FDA requires generic drugs to have the same quality, strength, purity and stability as brand name drugs. Q. Do generic drugs take longer to work in the body? A. No. Generic drugs work in the same way and in the same amount of time as brand name drugs. Q. Why are generic drugs less expensive? A. Generic drugs are less expensive because generic manufacturers don't have the investment costs of the developer of a new drug. Because those manufacturers don't have the same research and development costs, they can sell their product at substantial discounts. Q. Are brand name drugs made in more modern facilities than generic drugs? A. No. Both brand name drugs and generic drug facilities must meet the same standards of good manufacturing practices. FDA won't permit drugs to be made in substandard facilities. Q. If brand name drugs and generic drugs have the same active ingredients, why do they look different? A. In the United States, trademark laws do not allow a generic drug to look exactly like the brand name drug. However, a generic drug must duplicate the active ingredient. Colors, flavors, and certain other inactive ingredients may be different. Q. Does every brand name drug have a generic counterpart? A. No. Brand name drugs are generally given patent protection for 20 years from the date of submission of the patent. This provides protection for the innovator who laid out the initial costs to develop the new drug. However, when the patent expires, other drug companies can introduce competitive generic versions, but only after they have been thoroughly tested by the manufacturer and approved by the FDA. Q. What is the best source of information about generic drugs? A. Contact your physician, pharmacist, or insurance company for information on your generic drugs. You can also visit the FDA website at : fda.gov cder ogd index for more information and
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A total of 78 women were enrolled in the study using non-probability purposive sampling. They were given letrozole at a dose of 2.5 mg per orem once a day. The primary endpoint of efficacy was the overall objective tumor response rate assessed for visceral lesions and bone metastases. The efficacy of letrozole was also based on the performance status using the Karnofsky scale, Study Population Women were eligible if they were less than 80 years of age with histologically or cytologically confirmed breast cancer with locally advanced stage IIIB by American Joint Committee on Cancer Criteria, 1992 ; or locoregionally recurrent disease not amenable to treatment by surgery or radiotherapy with metastatic disease; patients treated with one regimen of chemotherapy for advanced disease provided that.
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BACKGROUND AND RATIONALE 1 26 04 ; There will be approximately 12, 200 new patients with invasive cervical cancer diagnosed in the United States in 2003 with about 4, 100 deaths from this disease.1 This accounts for approximately 17% of all deaths due to gynecologic cancers. Radiation has been the primary treatment modality for locoregionally advanced cervical cancer. Recent trials of concomitant systemic cisplatin chemotherapy and radiation have shown high response rates RR ; with improvements in durable remissions and overall survival among women with primary untreated disease.2 Single-agent cisplatin chemotherapy has also been used for nearly three decades to treat recurrent and metastatic cervical cancer with a RR of approximately 20%.3 Unfortunately, the impact of cisplatin alone on survival or quality of life among these incurable patients is unproven. However, the addition of paclitaxel to cisplatin GOG protocol 169 ; has shown a statistically significant improvement in RR without significant toxicity making this combination the new standard of care for treating women with recurrent or advanced cervical cancer.4 Disappointingly however, the survival rates still did not change in this study. Recently, the survival data from GOG protocol 179 have been analyzed. Although, the quality of life data are still immature, there is an adjusted covariates: performance status, age, disease status at entry and time from diagnosis to study entry ; survival relative risk of 0.713 [95% confidence interval 0.542, 0.936] with a two tailed P value of p 0.015 for the topotecan and cisplatin regimen compared to cisplatin alone. In contrast to protocol 169, protocol 179 was completed after chemotherapy and radiation became standard in the upfront management of advanced disease. Thus, the response rates to cisplatin alone and the overall survival in 179 are vastly inferior to the previous study 169 ; investigating paclitaxel and cisplatin. Although intriguing, comparing these two protocols 169 and 179 ; to each other is impossible especially since they were completed in two very different eras. For the patients treated on 179, chemotherapy for their recurrent disease was frequently "second line" chemotherapy rather than "first line" as in 169 since those on 179 frequently received cisplatin with radiation as part of their initial therapy. In an attempt to improve the response rates and survival even further as well as to settle the issues regarding the addition of paclitaxel or topotecan to cisplatin, we propose to study the effect of adding vinorelbine or gemcitabine to cisplatin and comparing these combinations to cisplatin plus paclitaxel or topotecan in a four arm study. Vinorelbine has demonstrated a promisingly high RR with cisplatin in phase II GOG studies and gemcitabine and cisplatin have shown promise outside of the GOG.
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117Petras RE In Practical Reviews in Pathology 1993: 17 No. 12 118Owen DA, Kelly JK: Atlas of gastrointestinal pathology, Philadelphia, 1994, Saunders, p149-50 119Am J Surg Pathol 1996; 20: 1102-9 : cdc.gov health disease htm 121Haggitt RC, presentation at San Antonio Society of Pathologists Annual Seminar.
INTRODUCTION No doubt you are familiar with the nerve-sparing technique developed by Dr. Patrick Walsh at Johns Hopkins. Having trained at Hopkins, I had the opportunity to seek out Dr. Walsh very early in the development of that technique. In 1985 I probably performed the first radical prostatectomy in the city using the Walsh technique. The nerve-sparing radical prostatectomy is likely the most common procedure that I do. Nevertheless, I have a large cohort of patients that I haven't touched with a scalpel. It is my opinion that we operate on many men with prostate cancer who don't need surgery. The only problem is that we can't be sure beforehand who really needs it. Prostate cancer--to treat or not to treat--that is the question, and my topic for tonight. Let's talk about watchful waiting. Watchful waiting or expectant management of prostate cancer isn't "watchful ignoring." It involves close observation of the patient. During the observation process I essentially an advisor. If his condition changes, I would offer him the appropriate treatment consistent with his overall health, age, medical condition, and personal preferences. In effect, watchful waiting is a means of deferring treatment. My objective tonight is to help you understand the implications of watchful waiting by discussing which men are candidates; what is the so-called "natural" history of prostate cancer; and what is used most frequently to determine the aggressiveness of prostate cancer. Any cancer that occurs in us is result of a genetic change--the cells are no longer normal. The interaction of that genetic change within the host can vary considerably. To put it another way, your prostate cancer is yours! Within your support group, you, for example, ibuprofen.
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PREVALENCE OF HYPERTRIGLYCERIDEMIA IN HEALTHY MINIATURE SCHNAUZERS. PG Xenoulis, MD Levinski, JS Suchodolski, and JM Steiner. Gastrointestinal Laboratory, Texas A&M University, College Station, TX. There are anecdotal reports of a high prevalence of hypertriglyceridemia in Miniature Schnauzers MS ; . However, studies investigating the true prevalence of this condition, the effects of age and gender on serum triglyceride sTG ; concentrations, and the mode of inheritance of hypertriglyceridemia in large populations of MS are lacking. The aim of this study was to determine the prevalence of hypertriglyceridemia in a large population of healthy MS and to compare sTG concentrations between MS and healthy dogs of other breeds. Serum samples were collected after food had been withheld for at least 12 hours ; from 192 MS and 38 healthy control dogs of various.
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As a result, three primary health groups situated in Wellington, Porirua and Christchurch undertook the local adaptation or `localisation' ; process. Despite difficulties with the timing of the project and the support required to achieve the project tasks, the three groups found they generated a process that has potential to be an effective implementation strategy. Contact Eileen McKinlay or Deborah McLeod for more information Development of NZGG guidelines for screening for prostate cancer A current practice review has been completed. John Durham has completed a systematic review of the evidence of the benefits of population based screening for prostate cancer. The current practice review and the systematic review will inform the development of guidelines by the NZGG. Educational material for GPs and patients is being developed and evaluated. Contact John Durham, Deborah McLeod or Eileen McKinlay for more information. HIV screening in pregnancy A review of scientific evidence on antenatal HIV screening has been completed. Helen Moriarty prepared a background report for the National Advisory Committee on Health and Disability. The National Health Committee distributed a discussion document on HIV screening in pregnancy to coincide with the release of this scientific report in October 2003. Both documents are based on the new NHC criteria to assess screening programmes. Antenatal HIV screening has been the first health screening issue to apply NHC decisionmaking criteria. Contact Helen Moriarty for more information.
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