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Name ServicesBrand Institute is the premier full-service branding agency dedicated to strategic and innovative brand naming and identity solutions. We strive to exceed the expectations of every client by combining leading-edge market research with the highest levels of client service, integrity and brand management ACE inhibitors may decrease odds of death, cardiovascular endpoints in patients with CAD without HF, LVSD ACE inhibitors reduce cardiovascular endpoints and total mortality in patients with coronary artery disease without heart failure or left ventricular systolic dysfunction, a meta-analysis found.Investigators searched the MEDLINE database, the EMBASE database and the Cochrane Controlled Trials Register to find randomized, controlled trials that compared ACE inhibitors with placebo in patients with stable CAD who did not have HF or LVSD. Seven studies, which involved a total of 33,960 patients who were followed up for an average of 4.4 years, met all inclusion criteria. Five of the trials included only patients who had documented CAD; one of the trials included patients with documented CAD or diabetes mellitus and at least one other risk factor; and the last trial involved patients with either CAD, a history of transient ischemic attack or intermittent claudication. The investigators found that treatment with ACE inhibitors decreased the odds of overall mortality by 14 percent, the odds of cardiovascular mortality by 19 percent, the odds of myocardial infarction by 18 percent and the odds of stroke by 23 percent. They noted that other endpoints, such as hospitalization due to HF, resuscitation after cardiac arrest and myocardial revascularization, were also reduced by ACE inhibitor therapy. "These results, along with those previously reported in patients who have CAD with LV dysfunction or heart failure, suggest that ACE inhibitor therapy should be systematically used in all patients with documented CAD and that continued efforts should be made to implement current secondary prevention guidelines," the investigators concluded. The study appeared in the April 10 issue of the Archives of Internal Medicine. Name Services Auris Medical's AM-111 receives orphan drug status The Food and Drug Administration granted orphan drug status to Auris Medical's AM-111, an investigational treatment for acute sensorineural hearing loss (ASNHL). AM-111 is a cell-permeable peptide that selectively blocks the c-Jun N-terminal kinase group of mitogen-activated protein kinases from mediating apoptosis of stress-injured hair cells and neurons in the cochlea. In January, Auris initiated a double-blind, randomized, Phase I/II trial, in which patients who were exposed to excessive noise were treated with the drug administered through transtympanic injections. ASNHL is a condition that can be caused by various inner ear injuries such as exposure to excessive noise, viral or bacterial infections in the inner ear, disturbances of the inner ear blood supply, middle and inner ear surgery or a variety of other incidents. If the injury is not treated within a therapeutic time frame after the incident, damage could be irreversible and result in hearing loss. Name Services Rates of MS relapse similar with Betaseron, Rebif, new study shows Patients who take Berlex Inc.'s Betaseron (interferon beta-1b) every other day or Pfizer Inc. and Serono SA's Rebif (interferon beta-1a) once per week demonstrated comparable annualized rates of multiple sclerosis relapse and times to relapse, according to results from a Danish study. An open-label, 24-month trial compared the efficacy of the two therapies in adults who had relapsing-remitting MS and had experienced at least two relapses in the previous two years. Most were randomized to receive 250 mcg of subcutaneous Betaseron every other day (n=158) or 22 mcg of subcutaneous Rebif once every week (n=143). Another 120 patients who declined randomization followed the same Betaseron regimen. More than 84 percent of the patients in each treatment arm completed one year of therapy, and more than 61 percent completed two years. The primary efficacy endpoint of this unblinded, per-protocol trial was the annualized rate of relapse, time to first relapse and the formation of neutralizing antibodies. With an average difference of -0.009, the annualized relapse rates of 0.71 with Betaseron and 0.70 with Rebif were virtually the same. Also, the Kaplan-Meier plot of time to first relapse showed a hazard ratio that was close to unity when the two randomized therapies were compared. Specifically, 58.7 percent of the Rebif-treated patients relapsed after an average 450 days, while 54.4 percent of the Betaseron arm experienced a first relapse within a mean 431 days. When the two Betaseron groups were compared, the nonrandomized group had a higher annualized rate of relapse (but only significantly so after the first year) and tended to relapse more quickly. Finally, neutralizing antibodies that formed in the randomized patients during the first 12 months increased the relapse rates, but appeared not to bias the results. The prior EVIDENCE and INCOMIN trials have shown that once weekly administration of 30 mcg of Rebif by intramuscular injection shows a lower effect than do other regimens, the researchers explained. But because these and the current study differed in formulation, dose, administration frequency and route of administration, they said it is "impossible to determine which of the factors, if any, are of importance. This question has not yet been solved properly, and the current study, contradicting the other studies with its largely negative results, has added to the uncertainty of the issue." These study findings were published in the April 11 issue of the journal Neurology. Name Services Pacemakers cost effective in increasing Coreg benefits in certain CHF patients, Markov model demonstrates Prophylactic insertion of a pacemaker to facilitate treatment with GlaxoSmithKline Plc's Coreg (carvedilol) may be a cost-effective way to produce clinical benefits in patients with chronic heart failure and low resting heart rates, a recent study found. Researchers used a Markov model to mimic the natural history of a group of clinically stable patients (mean age, 60 years) with CHF who had an ejection fraction of 35 percent or less and resting heart rates of less than 68 beats per minute. The investigators assumed patients received either conventional therapy (ACE inhibitors, diuretics and digoxin) or underwent pacemaker insertion along with atrial pacing and Coreg therapy. In the conventional therapy group, researchers derived the risks for death and hospitalization from the ACE inhibitor arm of the SOLVD trial. For the Coreg/pacemaker group, the risks reductions for death and CHF-related hospitalizations were derived from the U.S. Carvedilol Heart Failure Study. The researchers assumed full Coreg benefits for two years, decreased the benefits for the next three years and assumed no additional benefits after five years. The adverse events and costs associated with the Coreg/pacemaker group, however, were assumed to continue for the entire 20-year follow-up period. Cost estimates in the model came from average wholesale drug prices, Medicare data and the U.S. Carvedilol Heart Failure Study, the authors noted. The model estimated that at one year, the survival rate was 94.8 percent in the Coreg/pacemaker arm and 89.9 percent in the conventional therapy arm. This rate was 70.2 percent and 52.7 percent, respectively, at five years, 31.9 percent versus 22.9 percent at 10 years and 5.5 percent versus 3.9 percent at 20 years. Additionally, hospitalizations were estimated to be 3.7 per 100 patients for the Coreg/pacemaker group compared with 10 hospitalizations per 100 patients in the conventional group at one year. By year 20, there were 205 hospitalizations per 100 patients in the Coreg/pacemaker group and 190 hospitalizations per 100 patients in the conventional group. At the base-case estimates, the Coreg/pacemaker strategy was shown to increase mean survival by 1.3 years at an additional cost of $7,800. This translates to an incremental cost effectiveness of $6,100 per year of life saved, the authors said. "We conclude that pacemakers can be used to extend the benefit of beta blockers to a large and previously excluded group of patients with systolic heart failure," the authors said. The study appeared in the April issue of the American Heart Journal. Name Services Treatment with Kureha's AST-120 reduces serum indoxyl sulfate levels in patients with CKD, study demonstrates Treatment with Kureha Chemical Industry Co. Ltd.'s AST-120, an orally administered adsorbent, reduced serum indoxyl sulfate levels and showed promise in the treatment of U.S. patients with chronic kidney disease, according to a recent study. The drug is already approved in Japan, where it is marketed as Kremezin, for improving uremic symptoms and prolonging time to hemodialysis therapy in patients with CKD. A total of 164 patients, aged 25 to 88 years, who had serum creatinine levels of 3 mg/dL to 6 mg/dL and serum indoxyl sulfate levels of at least 0.5 mg/dL were randomized to receive AST-120 in 0.9 g (group A; n=40), 2.1 g (group B; n=41) or 3 g (group C; n=41) doses or placebo three times daily for 12 weeks to examine the nephroprotective effects of the drug. Patients in groups B and C experienced significant dose-related reductions in serum indoxyl sulfate levels from baseline at week 12, which remained significant when compared with placebo. Patients who received AST-120 exhibited no consistent or dose-related changes in serum creatinine levels, reciprocal or serum creatinine, creatinine clearance or urine protein levels. No changes in uremic symptoms were noted, except for malaise, which improved significantly in groups B and C in a dose-dependent fashion as compared with placebo at week 12. No clinically significant changes in absorption of vitamins D and K were observed, suggesting that AST-120 therapy has no adverse effect on absorption of these fat-soluble vitamins at 12 weeks. Additionally, no significant changes in patient nutritional status, body weight, physical examination findings or electrocardiogram tracings were observed. The researchers concluded that the 3 g dose of AST-120, taken three times a day, may be "an optimal dose for the U.S. population, and it may be useful in the treatment of patients with CKD." "Because AST-120 did not directly affect serum creatinine levels or 24-hour urine creatinine appearance, the composite endpoint of doubling of serum creatinine level, transplantation and dialysis therapy would be appropriate for a confirmatory Phase III therapeutic outcome study," the authors noted. The study appeared in the April issue of the American Journal of Kidney Diseases. Name Services Non-formulary coverage of second-generation anticonvulsants does not decrease off-label use, study shows Data presented at a recent conference indicate that removing second-generation anticonvulsants from formulary coverage does not reduce their off-label use. Hemal Patel, of Coventry Health Care Inc., and colleagues revealed their retrospective study findings at the Annual Meeting and Showcase of the Academy of Managed Care Pharmacy in Seattle. They studied claims data for 10,185 members of a benefit plan from January 2004 to December 2005 who filled a prescription for at least one second-generation anticonvulsant. In 2004, the formulary covered Ortho-McNeil Neurologics Inc.'s Topamax (topiramate), GlaxoSmithKline Plc's Lamictal (lamotrigine), Eisai Inc.'s Zonegran (zonisamide), Pfizer Inc.'s Neurontin (gabapentin), Cephalon Inc.'s Gabitril (tiagabine hydrochloride) and UCB Pharma Inc.'s Keppra (levetiracetam). Eisai licenses Zonegran from what is now Dainippon Sumitomo Pharma Co. Ltd. But beginning on Jan. 1, 2005, the formulary changed so that it covered only Neurontin or its generic versions; the other five drugs were granted non-formulary coverage. This formulary change was implemented to determine how it would affect off-label use of the drugs. During both years, more than 80 percent of the anticonvulsant prescriptions were for off-label uses, particularly for pain other than neuropathy or for other diagnoses, such as symptoms of involuntary movement, nutrition or injuries. A greater proportion of primary care providers (41.3 percent) and physicians other than neurologists and psychiatrists (46.5 percent) prescribed the drugs in the 8,586 cases of off-label uses; Neurontin and its generic forms were prescribed most often for such uses (70 percent). From 2004 to 2005, however, the prevalence of neither off-label nor on-label drug use changed: indicated drug use rose slightly from 15.2 percent to 16.2 percent, while off-label use dropped slightly from 84.8 percent to 83.8 percent, differences which were not statistically significant. By drug, on-label use of Topamax, Gabitril and Zonegran rose in 2005. At the same time, off-label use showed an increase for Neurontin and its generics, Lamictal and Keppra. Overall prescriptions per member per year remained steady throughout the study period, although the average cost per prescription dropped by $30.39, due mostly to the availability of gabapentin at the end of 2004. "As there was no impact in changing off-label use of these drugs, future considerations for controlling off-label use may include requiring prior authorizations, provider education or other controlling interventions," the investigators suggested. Name Services Name Services Centers for Medicare & Medicaid Services The Centers for Medicare & Medicaid Services extended the Medicare Part D enrollment period that had been scheduled to end May 15 for low-income beneficiaries, The Wall Street Journal reported. The agency will allow ongoing enrollment for people who qualify for extra federal subsidies of their drug costs. However, if low-income beneficiaries enroll in Part D in August or later, they will be required to pay higher premiums. Individuals who qualify for the extra help are those who earn an annual income of less than $15,000 and have assets of less than $11,500; the government estimates that 8.2 million beneficiaries fit this criteria. According to The Journal, without the extension, low-income people who miss the May deadline would have to wait until January 2007 to enroll in the drug coverage program. Name Services Name Services Centers for Medicare & Medicaid Services The Centers for Medicare & Medicaid Services proposed a new rule to increase Medicare reimbursements for inpatient services at acute care hospitals by 3.4 percent, or approximately $3.3 billion, in fiscal year 2007, The Henry J. Kaiser Family Foundation reported. The Medicare outlier threshold for hospitals would also increase under the proposed rule to $25,530 in fiscal year 2007. The rule is subject to public comment until June 12. According to The Wall Street Journal, CMS also proposed reimbursement cuts for certain heart devices, such as stents and implantable defibrillators. Name Services Name Services Bausch & Lomb Inc. Bausch & Lomb Inc. asked U.S. retailers to temporarily stop selling its contact lens solution ReNu with MoistureLoc while the firm is investigating reports of fungal keratitis infections. The company said it has "initiated the voluntary market withdrawal in order to eliminate any confusion among contact lens wearers about what to do while the investigation is ongoing." Several retailers had already pulled the product, according to Reuters. Last Monday, the Food and Drug Administration issued a statement alerting health care professionals that 109 cases of suspected keratitis in those who wear soft contact lenses are being investigated. Some of the patients had significant vision loss and required a corneal transplant, the agency said. Name Services Name Services YM BioSciences Inc. YM BioSciences Inc. entered into an agreement to acquire Eximias Pharmaceutical Corp. Under the terms of the agreement, Eximias will operate as YM BioSciences USA Inc. and will function as YM's base of operations in the United States. Eximias has cash resources of more than $30 million. The transaction will consist of part cash and part common shares of YM, with at least $25 million of the merger consideration consisting of YM common shares. The transaction is expected to close in early May. Name Services
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