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insufficiency in Medical Technology

Arena Pharmaceuticals Announces Lorcaserin Data Demonstrating Highly Significant Categorical and Absolute Weight Loss and Improvements in Secondary Endpoints Associated with Cardiovascular Risk

... valvulopathy (moderate or greater mitral insufficiency and/or mild or greater aortic insufficiency) were ... In addition, similar numbers of mitral insufficiency shifts and aortic insufficiency shifts in Year 1 and Year 2 were reported for ...

Positive Mid-Term Results on CryoValve(R) SG Pulmonary Human Heart Valve Presented at Western Thoracic Meeting

... SG versus 55 percent for CryoValve) and valvular insufficiency (48 percent of patients with trivial or less valvular insufficiency at last follow-up for CryoValve SG versus 30 ... a statistically significant reduction in valvular insufficiency in patients who received the CryoValve SG as part ...

Schering-Plough Announces U.S. Filing of Mometasone Furoate/Formoterol Fumarate Combination for the Maintenance Treatment of Asthma

... that hypercorticism (an excess level of steroids in your body) or adrenal insufficiency (your adrenal gland cannot produce enough steroids) may appear in a small ... and the oral steroids should be reduced slowly. Deaths due to adrenal insufficiency have occurred during and after switching from oral steroids to inhaled ...

ASMANEX(R) (Mometasone Furoate Dry Powder Inhaler) Now Approved in Japan for the Treatment of Bronchial Asthma in Adult Patients

... that hypercorticism (an excess level of steroids in your body) or adrenal insufficiency (your adrenal gland cannot produce enough steroids) may appear in a small ... and the oral steroids should be reduced slowly. Deaths due to adrenal insufficiency have occurred during and after switching from oral steroids to inhaled ...

First Swiss Patients Treated with the Percutaneous MitraClip(R) System

... (MR). Mitral regurgitation is the most common type of heart valve insufficiency in Europe and the United States, affecting millions of people worldwide. ... they have already had heart surgery, or presented with important renal insufficiency or lung disease, all of which significantly increase the risk of a second ...

Long-Term Soliris(R) Therapy Improved or Stabilized Kidney Function in Patients With PNH

... presentations titled, "High Incidence of Progression to Chronic Renal insufficiency in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH)" and "Sustained ... during hemolysis. (10) High Incidence of Progression to Chronic Renal insufficiency in Patients with PNH and Impact of Long-Term Soliris Therapy Among 195 ...

MitraClip(R) Therapy Data Demonstrate Clinical Benefit in High-Risk Patients With Mitral Regurgitation

... official congress of the European Association of Percutaneous Cardiovascular Interventions (EAPCI). MR is the most common type of heart valve insufficiency in Europe and the United States, affecting millions of people worldwide. Significant MR affects more than eight million people in the US and Europe, ...

TYRX Presents Early Clinical Results from AIGISRX(TM) Antibacterial Envelope Retrospective Registry

... n % n % CHF 218 55.5 152 59.8 Chronic Renal insufficiency 93 23.7 56 22.1 Chronic Renal Failure 41 10.4 24 9.5 Oral anti-coagulant ...

Hyperion Therapeutics Receives Orphan Drug Designation for HPN-100 for the Treatment of Urea Cycle Disorders

... insufficiency, and in clinical states where there is sodium retention with edema. Use caution when administering to patients with hepatic or renal insufficiency or inborn errors of beta oxidation. The safety or efficacy of doses in excess of 20 grams (40 tablets) per day has not been established. About ...

Hyperion Therapeutics Announces Results for Phase II Study in Urea Cycle Disorders

... insufficiency, and in clinical states where there is sodium retention with edema. Use caution when administering to patients with hepatic or renal insufficiency or inborn errors of beta oxidation. The safety or efficacy of doses in excess of 20 grams (40 tablets) per day has not been established. About ...

ViroPharma Submits Comments on Vancocin(R) Draft Bioequivalence Guidance

... systemic and renal clearance of vancomycin are reduced in the elderly. Monitoring of serum concentrations may be appropriate in patients with renal insufficiency and/or colitis. About C. difficile Infection C. difficile is a bacterium, which under certain circumstances, typically after ...

First U.S. Patients Enrolled in the REALISM Continued Access Study

... valve surgery, successfully completed enrollment in 2008. MR affects millions of people worldwide and is the most common type of heart valve insufficiency in the United States and Europe. The vast majority of patients with significant MR are untreated, which leaves their hearts affected by the chronic ...

AstraZeneca Responds to FDA Joint Advisory Committees' Recommendation on SYMBICORT(R)

... of asthma. Particular care is needed for patients who are transferred from systemically active corticosteroids. Deaths due to adrenal insufficiency have occurred in asthmatic patients during and after transfer from systemic corticosteroids to less systemically available inhaled corticosteroids. ...

Two-Year Follow-Up Data Demonstrates Preservation of Adequate Mitral Valve Area in Patients Treated with the MitraClip(R) System

... in late stage clinical trials in the United States. MR affects millions of people worldwide and is the most common type of heart valve insufficiency in Europe and in the United States. The vast majority of patients with significant MR are untreated, which leaves their hearts affected by the ...

Evalve Announces Enrollment Completion of the EVEREST Randomized Study

... MitraClip(R) system as a non-surgical repair option for patients suffering from mitral regurgitation (MR). MR is the most common type of heart valve insufficiency in the United States, affecting millions of people worldwide. "The completion of enrollment in the randomized trial is an important milestone for ...

First European Patients Treated With the Percutaneous MitraClip(R) System

... a non-surgical option for patients suffering from the effects of mitral regurgitation (MR). MR is the second most common type of heart valve insufficiency in Europe, and the most common in the United States, affecting millions of people worldwide. Both in Europe and the United States, the vast ...

NIH Funds New Wellstone Research Center for Muscular Dystrophy at Boston Biomedical Research Institute

... down to the abdominal and foot-extensor muscles. In the worst cases, all skeletal muscles are lost, hearing and vision are involved, and respiratory insufficiency can cause severe disability and even death. In addition to Emerson, Kunkel and Perez, the center's network of collaborators includes Kathryn ...

Hyperion Therapeutics Completes Enrollment in Phase 1/2 Clinical Trial in Patients With Urea Cycle Disorders

... insufficiency, and in clinical states where there is sodium retention with edema. Use caution when administering to patients with hepatic or renal insufficiency or inborn errors of beta oxidation. The safety or efficacy of doses in excess of 20 grams (40 tablets) per day has not been established. About ...

Two DOXIL(R) Studies to be Presented at American Society of Clinical Oncology (ASCO) Annual Meeting

... studies will be presented: -- The Effect of Pegylated Liposomal Doxorubicin Plus Bortezomib in Multiple Myeloma Patients with Renal insufficiency (Abstract 8562) Presentation: Saturday, May 31, 8:00 am - 12:00 pm CST, General Poster Session: Lymphoma and Plasma Cell Disorders, S ...

Myocor Receives Approval for Percutaneous Trial

... feasibility study will evaluate the safety and feasibility of the percutaneously implanted iCoapsys(TM) system in treating patients with mitral valve insufficiency caused by left ventricular dysfunction and coronary artery disease (CAD). "Percutaneous valve repair is a new frontier of patient care," said ...

Hyperion Therapeutics Announces Enrollment of First Patient in Phase 1/2 Clinical Trial of GT4P in Patients With Urea Cycle Disorders

... insufficiency, and in clinical states where there is sodium retention with edema. Use caution when administering to patients with hepatic or renal insufficiency or inborn errors of beta oxidation. The safety or efficacy of doses in excess of 20 grams (40 tablets) per day has not been established. AMMONUL(R) ...

Studies Suggest Key Correlation Between Lung Cancer Subtype and Treatment Outcomes

... prior to ALIMTA administration. Caution should be used when administering ibuprofen concurrently with ALIMTA to patients with mild to moderate renal insufficiency (creatinine clearance from 45 to 79 mL/min). Patients with mild to moderate renal insufficiency should avoid taking NSAIDs with short elimination ...

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

... that dose adjustments are necessary. Patients with hepatic and renal impairment: Gemcitabine should be used with caution in patients with hepatic insufficiency or with impaired renal function. Clinical studies have not provided sufficient information to allow clear dose recommendation for this patient ...

Advanced Life Sciences to Present Data on Selected Cethromycin Therapeutic Studies at the 47th Interscience Conference on Antimicrobial Agents and Chemotherapy

... and Pharmacokinetics of Cethromycin Following Administration of Single and Multiple Doses to Subjects with Mild or Moderate Chronic Hepatic insufficiency About ICAAC The American Society for Microbiology (ASM) is hosting the 47th Interscience Conference on Antimicrobial Agents and Chemotherapy ...

CuraGen Provides Update on Velafermin, Belinostat and CR011-vcMMAE Clinical Development Programs

... for Injection in patients with advanced, refractory MM, two out of four patients enrolled developed acute deterioration in already existing renal insufficiency (ARI) in the first cycle of combination treatment. ARI is a common complication in the treatment of MM patients due to deposition of myeloma protein ...

DuoCort AB: DuoCort announces Phase I Data Presentation at the European Congress of Endocrinology

... tablets for patients with chronic adrenal insufficiency were granted an Orphan Medicinal Product ... cortisol serum profile. About adrenal insufficiency Recent research on adrenal insufficiency patients taking currently available ...

Late Breaking Data Released at ADA Showed that the Investigational Use of Januvia and Metformin as Initial Combination Therapy Provided Significant Glucose Lowering Efficacy over 54 Weeks in Patients with Type 2 Diabetes

... for patients with mild to moderate hepatic insufficiency or in patients with mild renal insufficiency (CrCl greater than or equal to 50 mL/min). To ... is 50 mg once daily. For those with severe renal insufficiency (CrCl less than 30 mL/min) or with ESRD requiring ...

An Investigational Study Released at ADA Showed that Initial Combination Therapy with Januvia (sitagliptin) and Metformin Led to Improvement in Markers of Beta Cell Function in Patients with Type 2 Diabetes

... for patients with mild to moderate hepatic insufficiency or in patients with mild renal insufficiency (CrCl =>50 mL/min). To achieve plasma ... patients with moderate and severe renal insufficiency as well as in end-stage renal disease (ESRD) ...

Eurand Announces Positive Phase III Clinical Study Results

... Zentase(TM), formerly EUR-1008, for the treatment of Exocrine Pancreatic insufficiency (EPI). The US Food and Drug Administration (FDA) granted fast track status ... such statements. (1) Guidance for Industry Exocrine Pancreatic insufficiency Drug Products -Submitting NDAs U.S. Department of Health ...

Eurand to Present Zentase Phase III Data

... . -- Exocrine pancreatic insufficiency (EPI) is a deficiency of digestive enzymes normally produced ... Young Cystic Fibrosis (CF) Patients with Exocrine Pancreatic insufficiency (EPI) 3. Child friendly dosing options for PEPs 4. ...

Eurand's Zentase Effective in Treating Exocrine Pancreatic Insufficiency, Studies Show

... fat, protein and nutrients in patients suffering from Exocrine Pancreatic insufficiency (EPI). Absorption levels were measured by coefficient of fat (CFA) and ... (2000; 2 : 205-22) (2) Guidance for Industry Exocrine Pancreatic insufficiency Drug Products - Submitting NDAs. U.S. Department of Health and ...

Mircera Effective in Stabilising Haemoglobin Levels in Elderly Patients With Kidney Disease on Dialysis

... Current Opinion in Nephrology and Hypertension. 2002; 11:337-341 (viii) Hsu C.Y., et al Epidemiology of anemia associated with chronic renal insufficiency among adults in the United States: Results from the Third National Health and Nutrition Examination Survey. Journal of the American Society of ...

Lilly Studies Try to Shed Light on Impact of Race on Lung Cancer Treatment

... ALIMTA to patients with mild to moderate renal insufficiency (creatinine clearance from 45 to 79 mL/min). Patients with mild to moderate renal insufficiency should avoid taking NSAIDs with short elimination half-lives for a period of 2 days before, the day of, and 2 days following administration of ....

Phase 2 Clinical Results of Ganite Plus Standard Therapy in Patients with Relapsed/Refractory Lymphoma Presented at ASCO

... use of Ganite with other potentially nephrotoxic drugs like aminoglycosides and amphotericin B may increase the risk for developing severe renal insufficiency in patients with cancer-relapsed hypercalcemia. If use of a potentially nephrotoxic drug is indicated during Ganite therapy, Ganite should be ...

Phase 2 Clinical Results of Ganite Plus Standard Therapy in Patients with Relapsed/Refractory Lymphoma Presented at ASCO

... use of Ganite with other potentially nephrotoxic drugs like aminoglycosides and amphotericin B may increase the risk for developing severe renal insufficiency in patients with cancer-relapsed hypercalcemia. If use of a potentially nephrotoxic drug is indicated during Ganite therapy, Ganite should be ...

Cytochroma Reports Positive Phase I Clinical Data for CTA018 Injection

... to the National Kidney Foundation, more than nine million North American patients suffer from moderate to severe CKD. Many develop Vitamin D insufficiency and secondary hyperparathyroidism which, if untreated, can cause debilitating bone diseases and increased patient morbidity and mortality. ...
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