Drug Safety - Brand Institute, inc.



			Drug Safety Brand 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 Altace associated with lower risk of type 2 diabetes than are Norvasc, Toprol-XL in high-risk black patients, study finds Black patients with hypertensive kidney disease who are treated with King Pharmaceuticals Inc.'s Altace (ramipril) have a significantly lower risk of developing type 2 diabetes than do those treated with Pfizer Inc.'s Norvasc (amlodipine besylate) or AstraZeneca Plc's Toprol-XL (metoprolol succinate), according to a new analysis of a recent trial. Researchers compared the incidence of type 2 diabetes and the composite outcome of impaired fasting glucose or diabetes (IFG/diabetes) for patients in the AASK study, a multicenter trial that involved patients who had kidney disease due to hypertension, but who did not have a history of type 1 or type 2 diabetes. The double-blind trial was designed to study the effects of hypertension drugs on the progression rate of hypertensive nephrosclerosis. Black patients (aged 18 to 70 years) were randomized to one of two blood pressure goals (mean arterial pressure of 102 mm Hg to 107 mm Hg or mean arterial pressure of no more than 92 mm Hg) and to initial treatment with ACE inhibitor Altace, beta blocker Toprol-XL or calcium channel blocker Norvasc. Investigators evaluated the association between the different treatment groups and the relative risk of diabetes and IFG/diabetes. They also used several pre-randomization characteristics to determine the relative risk of diabetes and IFG/diabetes. Overall, 147 (14.5 percent) of 1,017 trial participants developed diabetes and 333 (42.9 percent) of 776 participants developed IFG/diabetes. Diabetes event rates per patient-year were 2.8 percent, 4.4 percent and 4.5 percent in the Altace, Norvasc and Toprol-XL groups, respectively. Patients who received Altace were 47 percent less likely to develop diabetes than were those who received Toprol-XL and 51 percent less likely than were those who received Norvasc. IFG/diabetes event rates per patient-year were 11.3 percent, 13.3 percent and 15.8 percent in the Altace, Norvasc and Toprol-XL groups, respectively. The Altace group had a 36 percent reduced risk of IFG/diabetes as compared with the Toprol-XL group and a 24 percent reduced risk when compared with the Norvasc group. "In summary, [Altace]-based therapy was associated with a significantly lower incidence of diabetes and IFG/diabetes among a group of subjects at high risk for these disorders compared with [Norvasc]-based or [Toprol-XL]-based therapy," the researchers said. "Further studies are indicated to determine the mechanisms and long-term consequences of the effect associated with this ACE inhibitor," they concluded. The study appeared in the April 10 issue of the Archives of Internal Medicine. Drug Safety Enbrel associated with clinically meaningful improvement in fatigue in patients with recent-onset, established RA, data show In a study that included individuals with recent-onset rheumatoid arthritis as well as those with established RA, researchers found that treatment with Amgen Inc. and Wyeth's Enbrel (etanercept) was associated with clinically meaningful reductions in fatigue among patients in both groups. The study included participants of open-label extensions of two previously published Enbrel trials. Specifically, 304 patients with recent-onset RA (mean duration, 11 months) comprised one trial in which subjects were randomized to receive either Enbrel 25 mg twice weekly or methotrexate once weekly for 12 months, then open label for 12 months. All patients then received open-label Enbrel. The second trial included 131 subjects with established RA (mean duration, 12 years) who received Enbrel 25 mg or placebo twice weekly for six months, then open-label Enbrel (the current analysis includes 40-month data for this open-label phase). Fatigue was measured regularly using the Health Assessment Questionnaire (HAQ) vitality domain, a measure the researchers noted consists of four questions from the Short Form-36 health survey vitality domain that ask about the patient's energy level during the previous four weeks. For patients with recent-onset RA, both Enbrel treatment and methotrexate treatment were associated with significantly reduced fatigue relative to baseline. However, the reduction of fatigue was more rapid in the Enbrel group as compared with the methotrexate group, with significant differences in fatigue observed at weeks two, four and eight. After these time points, the patients in the Enbrel group consistently reported a greater reduction in fatigue of 23 percent to 29 percent compared with the 17 percent to 24 percent reduction in patients who started on methotrexate. For patients with established RA, those who received Enbrel had significantly greater reductions in fatigue than did those who initially received placebo. After at least four weeks of Enbrel treatment, mean reduction in fatigue score was 25 percent to 36 percent in patients who initially received Enbrel and 20 percent to 27 percent in patients who initially received placebo. Further analysis revealed that reduction in fatigue strongly correlated with reduced pain and HAQ disability scores. Additionally, patients who achieved clinically meaningful improvement in fatigue were more likely to meet the American College of Rheumatology improvement criteria. "The ability of [Enbrel] to improve patients' long-term fatigue status may have important implications for quality of life, resource utilization and both direct and indirect costs of care for those with RA," title="branding company" the study authors suggested. The study appeared in the April 15 issue of the journal Arthritis Care & Research. Drug Safety Shire's Fosrenol helps control phosphate levels in patients with hyperphosphatemia, Phase IV study results show A Phase IV study revealed that switching to Shire Plc's noncalcium phosphate binder, Fosrenol (lanthanum carbonate), from other phosphate binder therapies provides continued mean serum phosphorus control for patients with end-stage renal disease and hyperphosphatemia. Since diet alone usually cannot adequately control phosphorus levels, hyperphosphatemia is managed with a combination of diet restriction and phosphorus-binding agents; these agents absorb phosphorus in the gastrointestinal tract before it can be absorbed into the blood. The open-label trial included 2,520 patients and was designed to evaluate efficacy, patient and physician satisfaction, as well as tablet burden and daily dose, of Fosrenol compared with previous phosphate-binder therapy. After 12 weeks of treatment with Fosrenol, 84 percent of physicians expressed overall satisfaction with the drug compared with 52 percent of those at baseline who were satisfied with their phosphate-binder therapies. Of the 1,862 patients who completed 12 weeks of Fosrenol treatment, 84 percent expressed overall satisfaction compared with 67 percent at baseline. According the study results, patients experienced a 30 to 40 percent reduction in tablet burden overall, and up to a 56 percent reduction in tablet burden compared with combination therapy. Shire noted that a higher dosage formulation of the drug became available earlier this year. The new formulation offers a reduced tablet size, which may provide an additional 50 percent reduction in tablet burden as compared with the Fosrenol doses used in the study; patients may be able to take one tablet per meal, based on a three meal per day schedule. "Successfully managing hyperphosphatemia is a challenge for most ESRD patients due to the exceedingly restrictive diet they must follow and the high tablet burden associated with traditional phosphate-binder therapies," said Dr. Nirupama Vemuri of the South Florida Nephrology Group. "By significantly reducing phosphate-binder tablet burden, Fosrenol may help improve patient compliance, as well as clinical outcomes for patients with hyperphosphatemia." These data were presented at the National Kidney Foundation 2006 Spring Clinical Meetings in Chicago. Drug Safety Final analysis of CHOIR trial supports current hemoglobin target levels for Procrit-treated patients with anemia, CKD Final data from the CHOIR trial support the current hemoglobin target levels for Ortho Biotech Products L.P.'s Procrit (epoetin alfa). Investigators sought to determine if Procrit-treated patients with anemia and chronic kidney disease who were not on dialysis had improved mortality and cardiovascular outcomes when they were treated to an investigational target hemoglobin level of 13.5 g/dL of blood versus a target hemoglobin level of 11.3 g/dL, a level that is consistent with the product's current product label. The composite endpoint of the 1,432-patient trial was a combination of mortality, myocardial infarction, stroke and hospitalization because of congestive heart failure. A total of 222 composite endpoint events occurred before the study was terminated in May 2005 on the recommendation of its Data Safety Monitoring Board. Statistically significantly more events occurred in the 13.5 g/dL arm than in the 11.3 g/dL arm (125 vs. 97), Ortho Biotech said. During the trial and its 90-day follow-up period, 128 patients died. More patients died in the 13.5 g/dL arm than in the 11.3 g/dL arm, but the difference was not statistically significant (72 vs. 56). Ortho Biotech has reported the trial's results to regulatory authorities. "The results of this study reinforce the guidance in the approved product label not to exceed the recommended target hemoglobin of 12 g/dL in anemic patients with CKD not on dialysis," Ortho Biotech said. The firm added that Procrit's label currently recommends target hemoglobin levels of 10 g/dL to 12 g/dL in patients with CKD and anemia who are not on dialysis, and the National Kidney Foundation guidelines recommend target hemoglobin levels of 11 g/dL to 12 g/dL. These data were presented at the National Kidney Foundation 2006 Spring Clinical Meetings in Chicago. Drug Safety Beta blocker therapy appears to improve survival among Japanese patients following first MI Using beta blockers to treat Japanese patients who have experienced a first myocardial infarction appears to improve survival following hospital discharge, according to findings published in the April 14 issue of the International Journal of Cardiology. Researchers conducted the study because "after a[n] [MI], a higher prevalence of coronary vasospastic response has been reported in the Japanese population than in the Caucasian population. Beta blockers may exacerbate coronary vasospasm." To determine the mortality benefit of beta blockers administered to Japanese patients following MI, researchers prospectively assessed patients admitted to a coronary care unit of a university hospital in Osaka, Japan. Patients who survived their first MI without the need for a coronary artery bypass graft were included in the study. All participants were followed for an average of two years and were admitted to the care unit at some point from May 1994 to December 2001. Of the 546 patients admitted, 400 subjects received beta blockers at the time of discharge. During the follow-up period, 46 patients (8.4 percent) died. The study findings showed that beta blocker therapy was an independent predictor for survival following hospital discharge. Additional independent predictors of mortality included older age, male gender and serum creatinine level. The authors also found that receiving a beta blocker (versus no beta blocker) at the time of discharge was associated with a mortality difference that continued to widen until the end of the second year. "[C]ontrary to the concern that beta blocker therapy might induce coronary vasospasm and reduce survival in Japanese patients, beta blocker therapy was found to improve survival after discharge in Japanese patients with a first [MI]," the investigators concluded. Drug Safety Wyeth's Q1 earnings beat forecasts Wyeth reported positive first-quarter results, including a 6 percent increase in net revenue compared with the first quarter of last year. Net income for the quarter was $1.12 billion, or $0.82 per diluted share, compared with $1.08 billion, or $0.80 per diluted share, in the corresponding quarter of 2005. Adjusted net income for the quarter was $1.14 billion, or $0.84 per diluted share. The company surpassed Reuters Estimates analysts' predicted earnings per share of $0.73. Revenue was $4.84 billion in the first quarter, a 6 percent increased from the first quarter of 2005, in which net revenue was $4.58 billion. The company said its depression drugs, Effexor (venlafaxine hydrochloride) tablets and Effexor XR extended-release capsules, were the highest selling antidepressant globally and generated $945 million in net revenue in the first quarter of 2006, a 9 percent increase from the same quarter of 2005. Sales of Wyeth's arthritis drug, Enbrel (etanercept), also contributed to the company's revenue growth, generating net revenue of $335 million in the 2006 first quarter, a 42 percent increase from the 2005 quarter. Wyeth shares closed at $47.50, up $0.73, or 1.6 percent, in heavy trading on the New York Stock Exchange. Drug Safety Drug Safety Abbott Abbott completed its acquisition of Guidant Corp.'s vascular business, which Abbott said will offer "a broad line of leading coronary and endovascular products, a pre-eminent sales force and global manufacturing operations, as well as a state-of-the-art [research and development] organization." title="branding company" As a result of the acquisition, Abbott lowered its full-year earnings guidance for 2006 from $2.46 to $2.52 per share, to $2.39 to $2.45 per share. The company lowered its guidance for the second quarter from $0.58 to $0.60 per share, to $0.55 to $0.57 per share. Drug Safety Drug Safety Teva Pharmaceutical Industries Ltd. Teva Pharmaceutical Industries Ltd.'s Abbreviated New Drug Application for its generic version of Wyeth's Protonix (pantoprazole sodium) delayed-release tablets (20 mg and 40 mg) has been tentatively approved by the Food and Drug Administration. Protonix, which had U.S. sales of approximately $2.4 billion for the 12 months ended December 2005, is approved for short-term treatment of erosive esophagitis associated with gastroesophageal reflux disease, maintenance of healing of erosive esophagitis and for treating hypersecretory conditions. Teva is currently involved in patent litigation for the drug. Drug Safety Drug Safety Endo Pharmaceuticals Holdings Inc. Endo Pharmaceuticals Holdings Inc. and SkyePharma Plc terminated their agreement to jointly develop Propofol IDD-D, an injectable sedative and anesthetic that Endo licensed in December 2002. Under the 2002 agreement, SkyePharma would have been responsible for the cost of the product's Phase III development and could have received up to $45 million in milestone payments from Endo, pending the product's approval by the Food and Drug Administration with a label that met pre-specified criteria. SkyePharma would also have shared Propofol IDD-D's sales with Endo. Now that the agreement is terminated, SkyePharma said it is strategically reviewing the product and evaluating its options. Drug Safety Drug Safety Actavis Group Actavis Group increased its takeover offer for Pliva d.d. by 10.5 percent in an effort to reinitiate stalled talks. Actavis noted that if Pliva does not respond to the offer in a timely fashion, Actavis will withdraw it. Pliva previously declined Actavis' initial offer of $1.6 billion in cash, stating that it was inadequate. In related news, Actavis entered into a cooperation agreement with Quaestus Private Equity Partners Ltd., a private merchant banking and asset management firm that supports Actavis' offer for Pliva. Drug Safety


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