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Biovail Comments On Filing Of Lawsuit
Sun, 12 Oct 2008 00:00:00 -0700
Biovail Corporation (NYSE, TSX: BVF) today announced that it has been notified that a proposed securities class action lawsuit has been filed in the U.S. District Court Southern District of New York against the Company, its Chairman and two former officers. The complaint has been filed on behalf of all persons and entities that purchased Biovail securities from December 14, 2006 through July 19, 2007.
Phase III Study Showed Rituxan In Combination With Chemotherapy Improved Progression-Free Survival In Patients With Relapsed Chronic Leukemia
Sat, 11 Oct 2008 01:00:00 -0700
Genentech, Inc. (NYSE: DNA) and Biogen Idec (Nasdaq: BIIB) today announced that a global Phase III study of RituxanŽ (rituximab) in combination with fludarabine and cyclophosphamide chemotherapy met its primary endpoint of improving progression-free survival (PFS), as assessed by investigators, in patients with previously treated CD20-positive chronic lymphocytic leukemia (CLL) compared to chemotherapy alone. There were no new or unexpected safety signals reported in the study.
Early Data Show Potential For Imatinib To Treat Life-threatening Form Of Pulmonary Artery Disease
Sat, 11 Oct 2008 01:00:00 -0700
An early proof-of-concept study presented shows promising results for imatinib in the treatment of pulmonary arterial hypertension (PAH), a severe, incurable blood vessel disorder.
Boston Scientific To Release Broad Range Of Clinical Trial Data On The Performance Of TAXUS(R) Coronary Stent Systems At TCT 2008
Sat, 11 Oct 2008 00:00:00 -0700
Boston Scientific Corporation (NYSE: BSX) announced the schedule of the Company's major events and press announcements at the Cardiovascular Research Foundation's (CRF) twentieth annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, which runs from October 12 to 17 in Washington, D.C.
FDA Continues Review Of Takeda's New Drug Application For Alogliptin (SYR-322), A DPP-4 Agent For Type 2 Diabetes
Sat, 11 Oct 2008 00:00:00 -0700
Takeda Pharmaceutical Company Limited ("Takeda") announced that Takeda Global Research and Development Center, Inc., a wholly owned United States (U.S.) subsidiary, received notification that the U.S. Food and Drug Administration (FDA) will not be able to complete its review of the alogliptin New Drug Application (NDA) by the Prescription Drug User Fee Act (PDUFA) date of October 27, 2008.
A Forecast Insight Report Into The Antidiabetics Market - Switching To New Molecule Antidiabetics Drives Market Growth
Fri, 10 Oct 2008 05:00:00 -0700
Research and Markets has announced the addition of the "Forecast Insight: Antidiabetics - Switching to New Molecule Antidiabetics Drives Market Growth" report to their offering. The antidiabetics market is expected to reach $29 billion, across the seven major markets, by 2017.

Annals of Pharmacotherapy PAP Articles

Emerging Therapies for the Treatment of Helicobacter pylori Infections (November) (CE)
Jodlowski, T. Z, Lam, S., Ashby Jr., C. R Thu, 09 Oct 2008 00:00:00 -0000
OBJECTIVE: To describe emerging therapies, such as levofloxacin, moxifloxacin, rifabutin, rifaximin, tinidazole, doxycycline, minocycline, lactoferrin, and plaunotol for the eradication of Helicobacter pylori infection. DATA SOURCES: Relevant information was identified through a search of MEDLINE (1966-July 2008), PubMed (1955-July 2008), American Search Premier (1975-July 2008), International Pharmaceutical Abstracts (1960-2008), Science Citation Index Expanded (1996-2008), Cochrane Databases (publications archived until July 2008), and various tertiary sources using the terms Helicobacter pylori, fluoroquinolones, levofloxacin, moxifloxacin, rifabutin, rifaximin, lactoferrin, plaunotol, tinidazole, doxycycline, minocycline, faropenem, new treatments, refractory, and salvage alone or in combination. STUDY SELECTION AND DATA EXTRACTION: Relevant information was identified and selected based on clinical relevance and value of information. In vitro and in vivo data were included if available. DATA SYNTHESIS: Data exist supporting the use of levofloxacin or rifabutin as salvage therapies for H. pylori infection. Levofloxacin triple therapy has been recommended in the current treatment guideline, but more data are needed, especially from studies conducted in the US. A rifabutin-based regimen is better tolerated than conventional quadruple therapy, but its use is limited due to cost, hematologic adverse effects, drug interactions, and predicted development of resistance. Tinidazole appears to be an option, particularly as sequential therapy when combined with other agents; however, its use is limited by the high prevalence of nitroimidazole-resistant H. pylori strains in the US. Moxifloxacin data are limited. Data supporting the use of rifaximin, doxycycline, and minocycline are lacking or do not show benefit of these drugs over standard treatments. CONCLUSIONS: H. pylori infection remains one of the most significant infections worldwide, and treatment failure rate with the current standard therapy continues to rise. Other treatment options should be explored to meet the emerging challenge.
Comment: Tigecycline for the Treatment of Acinetobacter Infections: A Case Series (November)
Curcio, D. Tue, 30 Sep 2008 00:00:00 -0000

Comparison of the Impact of the Atrial Fibrillation Follow-Up Investigation of Rhythm Management Trial on Prescribing Patterns: A Time-Series Analysis (November)
Choudhry, N. K, Zagorski, B., Avorn, J., Levin, R., Sykora, K., Laupacis, A., Mamdani, M. Tue, 30 Sep 2008 00:00:00 -0000
BACKGROUND: The AFFIRM (Atrial Fibrillation Follow-Up Investigation of Rhythm Management) trial demonstrated that rate control and rhythm control strategies result in similar survival and quality of life for patients with atrial fibrillation (AF). Because of superior safety and lower cost, rate control is now the recommended strategy for the management of most elderly, high-risk AF patients. OBJECTIVE: To determine the extent to which the AFFIRM trial results have been adopted into actual practice. METHODS: We conducted a time-series analysis of 3 population-based cohorts of patients with AF who were 66 years of age or older in Pennsylvania and Ontario. We stratified patients in Ontario by socioeconomic status (SES) and examined changes in quarterly prescription rates for rate control and rhythm controlling medications as well as cardioversion procedures before and after publication of the AFFIRM trial. RESULTS: The publication of the AFFIRM trial resulted in statistically significant reductions in the use of rhythm controlling medications in all 3 cohorts (p < 0.01). The magnitude of these changes in the non-low SES Canadian cohort was approximately 1% per quarter and was greater than the magnitude observed in the other cohorts (p < 0.001). The use of cardioversion procedures also decreased in all study regions (p < 0.01). In contrast, AFFIRM publication was also associated with a small increase in the use of rate controlling medications in Canada (p < 0.01) but not in the US (p = 0.23). CONCLUSIONS: Publication of the AFFIRM trial resulted in small but statistically significant changes in the care of patients with AF.
Authors' Reply: (November)
Gallagher, J. C, Rouse, H. M Tue, 30 Sep 2008 00:00:00 -0000

Blood Pressure Control with Amlodipine Add-on Therapy in Patients with Hypertension and Diabetes: Results of the Amlodipine Diabetic Hypertension Efficacy Response Evaluation Trial(November)
Kloner, R. A, Neutel, J., Roth, E. M, Weiss, R., Weinberger, M. H, Thakker, K. M, Schwartz, B., Shi, H., Gregg, A.-M. Tue, 30 Sep 2008 00:00:00 -0000
BACKGROUND: Attainment of blood pressure (BP) goals in patients with diabetes is critical both to reduce the risk of cardiovascular events and to delay the progression of renal disease. While therapeutic guidelines advise initial therapy with an angiotensin-converting enzyme inhibitor or angiotensin receptor blocker, monotherapy with these agents may not be sufficient to attain target BP. OBJECTIVE: The ADHT (Amlodipine Diabetic Hypertension Efficacy Response Evaluation Trial) evaluated the efficacy and safety of adding amlodipine to the treatment regimen of patients with hypertension and diabetes who were already receiving either quinapril or losartan as monotherapy METHODS: ADHT was a double-blind, double-dummy, 22-week trial conducted in the US. After a washout period of 7-13 days, patients (aged 30-75 y) with hypertension and diabetes were randomized to receive quinapril 20 mg/day plus placebo or losartan 50 mg/day plus placebo for 4 weeks, titrated to 40 mg or 100 mg (if required), respectively, for an additional 4 weeks to achieve their BP goals (<130/80 mm Hg). At week 8, either amlodipine 5 mg/day or placebo was added for an additional 12 weeks, with titration to 10 mg at week 14 if the BP goal was not achieved. RESULTS: Efficacy of add-on therapy was evaluated in 411 patients (amlodipine 211, placebo 200). BP goal was reached by 27.5% of patients when amlodipine was added to quinapril or losartan monotherapy, compared with 12.5% when placebo was added (OR 2.73; 95% CI 1.61 to 4.64; p < 0.001). When added to quinapril or losartan monotherapy, amlodipine reduced BP by 8.1/5.4 mmHg, compared with a 1.6/0.7 mm Hg decrease with add-on placebo (p < 0.001). Amlodipine, quinapril, and losartan were well tolerated. CONCLUSIONS: Amlodipine is safe and effective when added to quinapril or losartan monotherapy to help lower BP toward therapeutic targets in patients with hypertension and diabetes.
Pharmacokinetic Interaction Between Everolimus and Antifungal Triazoles in a Liver Transplant Patient (November)
Pea, F., Baccarani, U., Tavio, M., Cojutti, P., Adani, G. L., Londero, A., Baraldo, M., Franceschi, L., Furlanut, M., Viale, P. Tue, 23 Sep 2008 00:00:00 -0000
OBJECTIVE: To describe the management of a pharmacokinetic interaction between azole antifungals (fluconazole and voriconazole) and everolimus in a patient who underwent an orthotopic liver transplant. CASE SUMMARY: A 65-year-old male who received an orthotopic liver transplant experienced an iatrogenic retroperitoneal duodenal perforation on postoperative day 55. His condition was subsequently complicated by severe sepsis and acute renal failure. Intravenous fluconazole 400 mg, followed by 100 mg every 24 hours according to impaired renal function, was immediately started; to avoid further nephrotoxicity, immunosuppressant therapy was switched from cyclosporine plus mycophenolate mofetil to oral everolimus 0.75 mg every 12 hours. Satisfactory steady-state minimum concentration (Cmin) of everolimus was achieved (~5 ng/mL). On day 72 posttransplant, because of invasive aspergillosis, antifungal therapy was switched to intravenous voriconazole 400 mg every 12 hours on the first day, followed by 200 mg every 12 hours; to prevent drug toxicity, the everolimus dosage was promptly lowered to 0.25 mg every 24 hours. At that time, the everolimus Cmin averaged approximately 3 ng/mL. The concentration/dose ratio of everolimus (ie, Cmin reached at steady-state for each milligram per kilogram of drug administered) was markedly lower during fluconazole versus voriconazole cotreatment (mean ± SD, 3.49 ± 0.29 vs 11.05 ± 0.81 ng/mL per mg/kg/daily; p < 0.001). Despite intensive care, the patient's condition continued to deteriorate and he died on day 84 posttransplant. DISCUSSION: Both azole antifungals were considered probable causative agents of an interaction with everolimus according to the Drug Interaction Probability Scale. The interaction is due to the inhibition of CYP3A4-mediated everolimus clearance. Of note, prompt reduction of the everolimus dosage since the first azole coadministration, coupled with intensive therapeutic drug monitoring, represented a useful strategy to prevent drug overexposure. CONCLUSIONS: Our data suggest that during everolimusazole cotreatment, a dose reduction of everolimus is needed to avoid overexposure. According to the different inhibitory potency of CYP3A4 activity, the reduction should be lower during fluconazole than during voriconazole cotreatment.

Clinical Pharmacology & Therapeutics

In This Issue
In This Issue Clinical Pharmacology & Therapeutics 84, 431 (October 2008). doi:10.1038/clpt.2008.173
Imaging as a Biomarker for Therapy Response: Cancer as a Prototype for the Creation of Research Resources
G McLennanL ClarkeRJ Hohl Imaging as a Biomarker for Therapy Response: Cancer as a Prototype for the Creation of Research Resources Clinical Pharmacology & Therapeutics 84, 433 (October 2008). doi:10.1038/clpt.2008.171 Authors: G McLennan, L Clarke & RJ Hohl
Highlights
Highlights Clinical Pharmacology & Therapeutics 84, 438 (October 2008). doi:10.1038/clpt.2008.175 Author:
ASCPT News
ASCPT News Clinical Pharmacology & Therapeutics 84, 440 (October 2008). doi:10.1038/clpt.2008.176
Imaging Guiding Therapy Development in Lymphoma
BK Link Imaging Guiding Therapy Development in Lymphoma Clinical Pharmacology & Therapeutics 84, 443 (October 2008). doi:10.1038/clpt.2008.167 Author: BK Link
The PharmD Investigator in Clinical Pharmacology: Supply and Demand
JL Cohen The PharmD Investigator in Clinical Pharmacology: Supply and Demand Clinical Pharmacology & Therapeutics 84, 445 (October 2008). doi:10.1038/sj.clpt.6100475 Author: JL Cohen

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