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Long-term Follow Up Interim Data Show Nplate(TM) Increased and Sustained Platelet Counts in Adult Chronic ITP Patients

... a platelet response defined as a platelet count of 50,000 platelets per microliter and doubling of the baseline platelet count (median:17,000 platelets per microliter). A ... -- Platelet counts maintained: Platelet count increases of 50,000 platelets per microliter were ...

GSK Reports PROMACTA(R) (eltrombopag) Significantly Increased Platelet Counts and Reduced Bleeding in Long-Term Study of Patients With Chronic ITP

... or less frequently. The baseline median platelet count in both the placebo and the PROMACTA groups ... Throughout the study, the median platelet count in the placebo group never exceeded ... arm experienced a rise in their median platelet count to 36,000/microliters, with median platelet ...

Soyfoods Do Not Impact Sperm Count

... known that of all semen parameters, variation in count (#s of sperm/cc seminal fluid) is highly variable ... when one considers the "range" of "normal" sperm count accepted in our field (20-200,000 million.)" ... fluid volume with equivalent amounts of sperm count as those with lower intakes, neither the volume ...

Long-Term Safety and Efficacy Data on Promacta(TM) (Eltrombopag) Presented at American Society of Hematology Annual Meeting

... that of the patients with a baseline platelet count of less than 30,000/microliters, 73% achieved a platelet count of greater than or equal to 50,000/microliters. ... time after 3 weeks) in order to reach a platelet count of greater than or equal to 50,000/microliters ...

Lilly Files for European Approval of ALIMTA(R) (pemetrexed for injection) for First-Line Treatment of Non-Small Cell Lung Cancer

... cell count, including a differential white cell count and platelet count. Absolute neutrophil count should be > or = 1,500 cells/mm(cubed) and ... Patients should have an absolute granulocyte count of at least 1,500 (x 106/l) prior to initiation ...

IMPACT Study Showed Longer Valcyte(R) (valganciclovir hydrochloride tablets) Treatment Demonstrated Better Protection Against Cytomegalovirus (CMV) Disease One Year Post-Transplant

... Valcyte tablets should not be administered if the absolute neutrophil count is less than 500 cells/micro liter, the platelet count is less than 25,000/micro liter, or the hemoglobin is less than 8 g/dL. ...

New Weight Loss Hope for People with Diabetes

... meal program does not require members visit centers to weigh-in or count carbs, calories or points. "People with diabetes have to perform ... approaches, like featuring low glycemic foods and eliminating the need to count calories, carbs or points. These factors make it easy to stay with the ...

CIMZIA(R) (Certolizumab Pegol) Provides Rapid and Sustained Relief from Signs and Symptoms of Rheumatoid Arthritis for Two Years

... response scores measure improvement in the tender and swollen joint count and also include assessment of the following five parameters: patient's ... is achieved when there is 20% improvement in the tender and swollen joint count as well as a 20% improvement in at least three of the five parameters. ...

Long-Term Study Evaluates Boosted PREZISTA(R) Vs. Lopinavir/Ritonavir as Part of HIV Combination Therapy in Treatment-Naive Adults

... ( arm, (p=not significant). -- Of patients with baseline CD4+ cell count less than 200 cells per cubic millimeter, 79 percent of patients in ... the lopinavir/r arm, (p=0.009). -- Of patients with baseline CD4+ cell count greater than 200 cells per cubic millimeter, 79 percent of patients ...

Abbott's Kaletra(R) Tablet Dosed Once-Daily or Twice-Daily Demonstrated Similar Clinical Results Across Race and Gender Lines

... HIV viral loads (less than 50 copies/mL) at 48 weeks. CD4+ cell count mean increases over 48 weeks were similar for females and males, ... mean increases in CD4+ cell counts than males. In addition, CD4+ cell count mean increases over 48 weeks were similar for whites and non-whites. At 48 ...

Positive Phase I/II Data of IDX899 Confirm Potent Antiviral Activity and Favorable Safety Profile in Treatment-Naive HIV-Infected Patients

... eligibility criterion for enrollment in the study was that patients' CD4+ count (or T-cell count) had to be greater than or equal to 200 cells/mm3. The mean CD4+ count change from baseline increased by at least 60 cells/mm3 for each of the ...

Sequential R-CHOP and Ibritumomab Tiuxetan (Zevalin(R)) Regimen Produces Impressive Survival Rates in High Risk Elderly Patients With Untreated Aggressive Diffuse Large B-cell Lymphoma

... response (PR) to a CR/CRu. The side effects reported included blood count suppression: 26 percent and 36 percent grade 3/4 neutropenia, 15 percent ... and 31 percent grade 3/4 thrombocytopenia. Six patients had delayed blood count recovery for more than 12 weeks. One patient developed myelodysplasia and ...

AstraZeneca Submits sNDA for SEROQUEL XR(TM) for the Treatment of Generalized Anxiety Disorder - a First for the Atypical Antipsychotic Class of Medicines

... of drug induced leukopenia/neutropenia should have their complete blood count monitored frequently during the first few months of therapy. In these ... XR should be discontinued in any patient if the absolute neutrophil count is less than 1000 per cubic millimeter. Warnings and Precautions also ...

New Data on SEROQUEL XR(TM) in Treatment of Both Major Depressive Disorder and Generalized Anxiety Disorder Presented at APA Annual Meeting

... of drug induced leukopenia/neutropenia should have their complete blood count monitored frequently during the first few months of therapy. In these ... XR should be discontinued in any patient if the absolute neutrophil count is less than 1000/mm3. Warnings and Precautions also include the risk of ...

New 48-Week Efficacy and Safety Data Presented for INTELENCE(TM) (etravirine) as Part of HIV Combination Therapy

... placebo arm [p<0.0001]. -- In DUET-1, the mean increase in CD4+ cell count from baseline was 103 cells/mm3 in the INTELENCE arm compared with 74 ... placebo arm [p=0.0025]. -- In DUET-2, the mean increase in CD4+ cell count from baseline was 94 cells/mm3 in the INTELENCE arm compared with 72 ...

CASTLE Study Showed Similar Efficacy Between Once-Daily REYATAZ(R) (atazanavir sulfate)/ritonavir and Twice-Daily lopinavir/ritonavir at 48 Weeks in Previously Untreated HIV-Infected Adult Patients

... load of greater than or equal to 5,000 copies/mL; there was no CD4+ cell count restriction for study entry. The primary endpoint for the study was the ... lopinavir/r arm. Immunologic Response * The mean increase in CD4+ count from baseline at 48 weeks was 203 cells/mm3 in patients in the ...

AstraZeneca Submits sNDAs for SEROQUEL XR(TM) for the Treatment of Bipolar Mania and Bipolar Depression

... of drug induced leukopenia/neutropenia should have their complete blood count monitored frequently during the first few months of therapy. In these ... XR should be discontinued in any patient if the absolute neutrophil count is < 1000/mm. Warnings and Precautions also include the risk of ...

Boehringer Ingelheim Initiates NEwArT Study Comparing Viramune(R) (nevirapine) to a Ritonavir-Boosted Atazanavir-based Regimen in Treatment-Naive HIV Patients

... 18 years and older. At screening, male patients must have a CD4+ cell count of <400 cells/mm3 and female patients must have a CD4+ cell count of <250 cells/mm3. Patients will have no prior NRTI or NNRTI use of more ...

SEROQUEL XR(TM) Receives Approval From FDA for Maintenance Treatment of Schizophrenia

... of drug induced leukopenia/neutropenia should have their complete blood count monitored frequently during the first few months of therapy. In these ... XR should be discontinued in any patient if the absolute neutrophil count is Warnings and Precautions also include the risk of ...

CIMZIA(R) (certolizumab pegol), Significantly Reduces Structural Damage and Rheumatoid Arthritis Signs & Symptoms for Up to One Year

... response scores measure improvement in the tender and swollen joint count and also include assessment of the following five parameters: ... when there is 20% improvement in the tender and swollen joint count as well as a 20% improvement in at least three of the five ....

Abbott's m2000(TM) Molecular Diagnostic Instrument and RealTime HIV-1 Test Win Chicago Innovation Award

... are guided by monitoring plasma HIV-1 levels or viral load, CD4-T cell count and the patient's clinical condition. The goal of antiretroviral therapy ... at the DNA level. Using fluorescent colors and a microscope, physicians count the actual number of HER-2 genes present in the cell nucleus. Results from ...

New Phase 3 Study in Treatment-Naive Adults with HIV Evaluates Efficacy and Safety of Once-Daily PREZISTA(TM)/ritonavir vs. KALETRA(R) as Part of HIV Combination Therapy

... baseline viral load of 4.85 log10 copies per mL and a median CD4+ cell count of 225 cells per cubic millimeter. Patients were randomized to receive ... viral load ( lopinavir/r arm. -- The median change in CD4+ cell count from baseline was similar between the PREZISTA/r and lopinavir/r arms ...

Rigel's R788 Significantly Improves Rheumatoid Arthritis in Phase 2b Clinical Trial

... whom month 6 data were unavailable, was considered a treatment failure (ACR non-responder). Disease Activity Scores are based on a 28 joint count and CRP or an ESR at week 24 (depending on which was the qualifying biomarker). Safety Results The most common clinically ...

SUNY Youth Sports Institute Convenes Top Experts in NYC Next Week to Present Research & Analysis on Energy Drink Health Impacts

... educators, young athletes, and youth sports coaches, according to Timothy Donovan, Executive Director, SUNY Youth Sports Institute. "At a recent count there were nearly 500 energy drink brands. Classified as supplements and aggressively marketed, they have a special allure with young people. This ...

CDC Foundation Partners with Amgen, CDC to Reduce Infections Among Cancer Patients

... published in Cancer , 60,000 cancer patients in the United States are hospitalized for chemotherapy-related neutropenia - or low white blood cell count - which is a risk for serious infection, and a patient dies every two hours from this complication. Healthcare professionals are highly ...

RISPERDAL(R) CONSTA(R) (Risperidone) Long-Acting Treatment Delayed the Time to Relapse in Patients with Bipolar I Disorder

... Neutropenia and Agranulocytosis have been reported with antipsychotics, including risperidone. Patients with a pre-existing low white blood cell count (WBC) or a history of leukopenia/neutropenia should have frequent complete blood cell counts during the first few months of therapy. At the first ...

New Studies Show Popular Heartburn Medications Moderate the Effect of Taking Widely Prescribed Heart Drug

... for about 96 percent of PPI use in the study. Other PPI's, including rabeprazole (Aciphex(R)), were not included in the study due to the patient count for these agents being insufficient to yield reliable results. Clopidogrel is one of the world's most prescribed drugs, and ranked third in US ...

Schering-Plough Announces Results of the Early ACS Trial

... dependent upon renal dialysis (please see dosing guidelines); caution should be exercised when administering INTEGRILIN to patients with a platelet count <100,000/mm3. Bleeding is the most common complication encountered during INTEGRILIN therapy. The majority of excess major bleeding events were ...

Terumo Heart, Inc. Reports Clinical Progress in the DuraHeart(TM) U.S. Pivotal Trial as NewYork-Presbyterian Hospital/Columbia University Medical Center Implants First Patient

... trials in the U.S.," said Dr. Naka, who serves as co-principal investigator of the DuraHeart Trial. "It is extremely gratifying for us to count Dr. Naka's team among those elite institutions who are investigating Terumo Heart's DuraHeart System and building the empirical body of evidence to ...

Hana Biosciences Announces New Positive Interim Efficacy Results in Pivotal rALLy Clinical Trial of Marqibo in Acute Lymphoblastic Leukemia

... analysis revealed that nine patients, or 31 percent, of the first 29 evaluable subjects achieved a complete response (CR) or CR without full blood count recovery (CRi). The estimated median overall survival (OS) in responders was 10.5 months compared to 5.1 months in non-responders at the time of the ...

Hana Biosciences Announces Successful Planned Independent Safety Analysis Supports Ability to Complete Pivotal rALLy Clinical Trial of Marqibo, Its Lead Novel Anti-Cancer Compound

... Marqibo treatment. Safety was assessed in the context of efficacy defined as the achievement of a complete response with or without full blood count recovery. Susan O'Brien, M.D., professor in the leukemia department at the University of Texas MD Anderson Cancer Center in Houston, and ...

Hope for 14 Million Rosacea Sufferers: Pyratine-XR(TM) Study to be Presented at South Beach Symposium

... participated in a 48-week study at the University of California, Irvine , and were evaluated through physician assessments of inflammatory lesion count (papules and pustules), severity of erythema (redness) and telangiectasia (spider veins) and overall clinical improvement, as well as through patient ...

US Testing Proves Glyc'n Go(TM) Increases NO in the Blood Stream

... and HFL, the world's largest sports regulatory and research lab. Glyc'n Go(TM) is available from leading supplement retailers in 60 count and 16-count individual serving packets. For more detailed information visit www.glycngo.com or call toll free 1-877-GLYCNGO. Hi resolution ...

Study Finds DOXIL(R) Combination Therapy Delays Disease Progression for Patients With Metastatic Breast Cancer

... of DOXIL - In patients with recurrent ovarian cancer or AIDS-related Kaposi's sarcoma, hematologic toxicity (based on platelet count or absolute neutrophil count) may require dose reduction or delay in administration of DOXIL - In patients with ...

Dacogen(R) (decitabine for injection) Data Presented on a Phase II Clinical Trial in Elderly Patients with Acute Myeloid Leukemia (AML)

... response rate in the intent-to-treat (ITT) population was 26 percent, with morphologic CR in 24 percent of patients and CR with incomplete blood count recovery (CRi) in 2 percent. The median time to response was three months, and responses were seen in all subgroups of patients, including patients ...

Sunesis Pharmaceuticals Announces Presentation of Voreloxin Clinical Data in Patients with Acute Myeloid Leukemia at the 50th Annual Meeting of the American Society of Hematology

... activity has been maintained. To date, of 18 evaluable patients, one achieved a CRp and five are hypoplastic and are awaiting hematologic count recovery. Three additional patients with bone marrow blast reductions are undergoing second induction cycles of treatment. Patients on Schedule B ...

Studies Examine Quality of Care for Hospitalized Sickle Cell Disease Patients and Effective Methods for Detecting Risk of Stroke in Children With This Disorder

... each patient, analysis of the TCD blood-flow speeds in the main arteries of the brain, age at the time of TCD screening, and the most recent blood count and hemoglobin saturation were analyzed. The study found that patients who had lower hemoglobin saturations had higher TCD blood-flow ...

Novel Therapeutic Approaches May Transform Treatment and Improve Patient Outcomes in Several Platelet Disorders

... six months from the beginning of therapy) between the two treatment groups. Secondary objectives included overall safety, initial response (platelet count of 50 x 10^9/L after 30 days of treatment), activity of the salvage therapy (dexamethasone/rituximab) in patients not responding to dexamethasone ...

FDA Approves Promacta(R) (Eltrombopag), the First Oral Medication to Increase Platelet Production for People With Serious Blood Disorder

... do not use PROMACTA in an attempt to normalize platelet counts. Follow the dose adjustment guidelines to achieve and maintain a platelet count of > / = 50 x 10(9)/L. Malignancies and Progression of Malignancies: Stimulation of the TPO receptor on the surface of hematopoietic ...

Analysis of Long-Term Vicriviroc Data Provides Evidence of Sustained Viral Suppression, Increased CD4 Cell Counts and Tolerability in Treatment-Experienced HIV-Infected Patients

... viral load (HIV RNA) was -2.1, -2.2, -2.3, -2.3 (log10) at weeks 48, 96, 144 and 168, respectively. Mean change from baseline CD4 (cells/microliter) count was +121, +144, +158 and +143 at the same time points. Key Safety Findings Safety analyses were performed on data from all patients who ...
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