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Also In Global Health News: Congo Security Warnings; Niger Food Crisis; Drug Cost In Developing Countries; Measles Vaccination In China
Fri, 03 Sep 2010 06:00:00 -0700
Congolese Community Leaders Warned U.N. About Security; 240 Rape Victims Now Identified "Congolese community leaders say they begged local U.N. officials and army commanders to protect villagers days before rebels gang-raped scores of people, from a month-old baby boy to a 110-year-old great-great-grandmother," the Associated Press reports...
Celsion Receives SBIR Grant To Expand Its Technology Platform
Fri, 03 Sep 2010 05:00:00 -0700
Celsion Corporation (Nasdaq: CLSN), a biotechnology drug development company, announced that it has been awarded a competitive Phase I Small Business Innovation and Research (SBIR) grant from the National Institutes of Health (NIH), to support the proposal, "New Thermal Sensitive Carboplatin Liposomes for Cancer"...
Egg Recall, Drug Approval Time Raise Questions About FDA Resources
Fri, 03 Sep 2010 05:00:00 -0700
The recent salmonella outbreak/egg recall is raising questions about whether the FDA is fulfilling its regulatory role, PBS' NewsHour reports. "For the past few years, it's been one food safety scare after another. There was E. coli-laced spinach, salmonella-tainted peppers. ... There have also been problems with drugs. The ingredients in a contaminated blood thinner came from China...
Optimer Pharmaceuticals Announces Presentations Of Additional Fidaxomicin Phase 3 Data At Upcoming ICAAC Annual Meeting
Fri, 03 Sep 2010 04:00:00 -0700
Results from studies related to Optimer Pharmaceuticals, Inc.'s (Nasdaq: OPTR) lead developmental product candidate, fidaxomicin, will be presented at the 50th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) to be held at the Boston Convention and Exhibition Center in Boston on September 12-15, 2010...
Cetero Research Launches Seminar Series On Accelerated Proof-of-Concept In Drug Development
Fri, 03 Sep 2010 04:00:00 -0700
Cetero Research, the leading early-stage contract research organization (CRO), is launching a series of scientific seminars, "An Accelerated Path to Proof-of-Concept in Drug Development," designed to help pharmaceutical and biotechnology researchers learn the latest innovations in Phase I and IIa clinical trial designs...
New Research Demonstrates Safety Of Cord-blood-derived Stem Cell Treatments
Fri, 03 Sep 2010 03:00:00 -0700
In a new peer-reviewed article published by the Journal of Translational Medicine, scientists from Beike Biotechnology, China's leading stem cell research and regenerative medicine company, and Medistem, Inc...

Annals of Pharmacotherapy PAP Articles

Hepatotoxicity Associated with Metformin Therapy in Treatment of Type 2 Diabetes Mellitus with Nonalcoholic Fatty Liver Disease (October)
Cone, C. J., Bachyrycz, A. M., Murata, G. H. OBJECTIVE: To report a case of idiosyncratic hepatotoxicity associated with metformin in the treatment of type 2 diabetes with nonalcoholic fatty liver disease (NAFLD). CASE SUMMARY: A 61-year-old obese man presented with jaundice, nausea, fatigue, and an unintentional weight loss 2 weeks following initiation of metformin. Laboratory findings revealed aminotransferase values 10-15 times the upper limit of normal. Potential causative agents, including metformin, simvastatin, and Niaspan (extended-release niacin), were discontinued. Two months later, the patient's signs and symptoms had resolved and aminotransferase values returned to normal. An objective causality assessment revealed that the adverse reaction was probably associated with metformin. DISCUSSION: Since numerous medications and disease states can cause abnormalities in liver enzymes, it is important for providers to be able to distinguish the cause(s) and take appropriate actions. This can take a great deal of time and effort in patients with multiple medications and comorbidities. In this patient's case, viral hepatitis, worsening NAFLD, and the concomitant drugs were highly suspected. As hydroxymethylglutaryl coenzyme A reductase inhibitors offer substantial cardiovascular benefits and as metformin is a first-line agent in helping to lower blood glucose concentrations and to normalize the metabolic profile in type 2 diabetes, reintroduction of metformin and simvastatin would likely be beneficial. CONCLUSIONS: This is a case report of metformin-induced hepatotoxicity. As the prevalence of type 2 diabetes and subsequent metabolic effects increases in the US, metformin use will likewise increase. As potential for increased idiosyncratic hepatotoxicity associated with metformin use is likely to occur, clinicians should be vigilant.
Development of Cephradine-Induced Acquired Factor V Inhibitors: A Case Report (October)
Wu, M.-T., Pei, S.-N. OBJECTIVE: To report a case of cephalosporin-induced factor V inhibitor development, an uncommon but potentially fatal condition characterized by severe hemorrhage. CASE SUMMARY: A 71-year-old Chinese man presented with factor V inhibitors after a 7-day cephradine course for a urinary tract infection, characterized by abnormal prothrombin time (PT) and activated partial thromboplastin time (aPTT), gross hematuria, upper gastrointestinal bleeding, and left groin hematoma. Systemic corticosteroid administration restored his factor V activity levels, PT, and aPTT to within normal limits, and hemorrhagic symptoms resolved. Three weeks after successful treatment of bleeding diathesis, he received another 8-day cephradine course for cellulitis. After another 4 weeks, he suffered from recurrent factor V inhibitors presented with abnormal PT, aPTT, and upper gastrointestinal bleeding. The patient eventually died due to hemorrhagic shock despite a second course of corticosteroids. DISCUSSION: Cephalosporins are known to cause coagulopathy via hypoprothrombinemia. Another pathway seldom mentioned in the literature is factor V inhibitor induction, which may result in factor V deficiency. In our patient, factor V deficiency due to inhibitors developed each time that the patient received repeated cephradine treatment. According to the Naranjo probability scale, the relation between the formation of factor V inhibitors and cephradine treatment was probable. CONCLUSIONS: Because cephalosporins are commonly used for their wide therapeutic index and few adverse effects, iatrogenic complications associated with these drugs may be neglected or underdiagnosed. On the basis of our patient's report, careful review of medical records to avoid reexposure to the offending drug cannot be overemphasized.
The Effect of Topical Arnica on Muscle Pain(October)
Adkison, J. D., Bauer, D. W., Chang, T. BACKGROUND: The herb Arnica montana, in topical formulations, has been reputed to decrease bruising and muscle pain. This claim has been inadequately and incompletely addressed. OBJECTIVE: To determine whether topical A. montana cream could decrease subjective leg pain following calf raises. Secondary outcomes were effects on ankle range of motion and muscle tenderness. METHODS: A randomized, double-blind, placebo-controlled trial was conducted in 53 subjects. Active range of motion was measured in both ankles, and then a series of calf-raises were completed according to a standardized protocol. Each participant received 2 tubes of cream, 1 with active arnica and 1 with placebo. The creams were applied to the lower legs immediately after the exercise, and again at 24 and 48 hours postexercise according to the "RIGHT" or "LEFT" labels. At 48 hours postexercise, subjects had their ankle range of motion and muscle tenderness measured. Subjects used the analog scale to rate pain in each leg at baseline, 24 hours, 48 hours, and 72 hours. RESULTS: No significant differences in pain scores were seen before exercise (arnica: 0.07 vs placebo: 0.09, p = 0.32). Pain scores on legs treated with arnica were higher than scores on those receiving placebo 24 hours after exercise (3.04 vs 2.36, respectively; p < 0.005). Pain scores on day 3 (arnica: 3.44 vs placebo: 3.20, p = 0.66) and day 4 (arnica: 2.36 vs placebo: 2.31, p = 0.62) were not significantly different. There was no difference in muscle tenderness (arnica: 1.05 vs placebo: 1.05, p = 1.0). Ankle range of motion did not differ significantly on either day 1 (arnica: 64.70 degrees vs placebo: 66.15, p = 0.352 or day 3 (arnica: 63.32 degrees vs placebo: 65.94, p = 0.058). CONCLUSIONS: Rather than decreasing leg pain, arnica was found to increase leg pain 24 hours after eccentric calf exercises. This effect did not extend to the 48- hour measurement.
Role of Intrathecal Rituximab and Trastuzumab in the Management of Leptomeningeal Carcinomatosis (October)
Perissinotti, A. J., Reeves, D. J. OBJECTIVE: To review evidence for the use of intrathecal rituximab and trastuzumab in the management of leptomeningeal carcinomatosis. DATA SOURCES: A search of MEDLINE (1966-July 2010) and International Pharmaceutical Abstracts (1970-July 2010) was performed using search terms intrathecal, trastuzumab, rituximab, and monoclonal antibody. Additionally, American Society of Clinical Oncology, San Antonio Breast Conference, American Association for Cancer Research, and American Society of Hematology meeting abstracts were searched. STUDY SELECTION AND DATA EXTRACTION: Publications were reviewed for inclusion. Those reporting use of rituximab and trastuzumab intrathecally are reviewed and include 1 Phase 1 trial, 2 small prospective studies, 1 case series, and 15 case reports. DATA SYNTHESIS: The treatment of leptomeningeal carcinomatosis is challenging due to the presence of the blood-brain barrier. Numerous systemically administered therapies do not readily penetrate into the site of leptomeningeal disease and have been ineffective. Intrathecal administration of 2 monoclonal antibodies (trastuzumab and rituximab) has been investigated in case reports and case series. Additionally, intrathecal rituximab has been investigated in a Phase 1 study. Survival after intrathecal trastuzumab ranged from 39 days to greater than 72 months and the drug was well tolerated, with no adverse events attributed to it. Doses used in these reports ranged from 5 to 100 mg. Survival after intrathecal rituximab ranged from 1.1 weeks to greater than 3.5 years. In the Phase 1 trial, the maximum tolerated rituximab dose was 25 mg and 60% of patients responded. Four of the 6 responding patients experienced a complete response. Intrathecal rituximab exhibited minor toxicities that resolved quickly without longterm effects. CONCLUSIONS: Reports suggest that both trastuzumab and rituximab may be utilized intrathecally. Patients with refractory leptomeningeal carcinomatosis may benefit from a trial of intrathecal trastuzumab or rituximab; however, their use remains investigational, as more data and experience are necessary before intrathecal administration can be considered standard.
Use of Psychostimulants in Patients with Dementia (October)
Dolder, C. R., Davis, L. N., McKinsey, J. OBJECTIVE: To review the efficacy and safety of psychostimulants for negative behavioral symptoms (ie, apathy, excessive daytime sedation) and cognition in patients with dementia. DATA SOURCES: Literature was accessed through PubMed and MEDLINE (1966-June 2010), using the terms stimulant, psychostimulant, methylphenidate, dexmethylphenidate, amphetamine, dextroamphetamine, lisdexamfetamine, atomoxetine, modafinil, armodafinil, dementia, Alzheimer disease, vascular dementia, Lewy body dementia, mixed dementia, frontotemporal dementia, therapy, treatment, and therapeutic. Additional references identified from the initial search were reviewed. STUDY SELECTION AND DATA EXTRACTION: All relevant clinical trials published in English and involving primarily older adults with dementia were included. Case reports, review articles, and other preclinical literature were included as appropriate. DATA SYNTHESIS: Psychostimulants have been employed as a treatment for cognitive and behavioral symptoms in dementia for decades, but the literature has lagged behind this practice. Eight reports on use of psychostimulants as a treatment of apathy in dementia were reviewed. Methylphenidate was the most frequently studied medication and improvements in apathy were consistently noted; however, the magnitude and duration of effect remain unclear. Six studies examining the cognitive effects of a variety of psychostimulants in patients with dementia were reviewed; psychostimulants had little to no effect on cognition. A lack of studies exists to draw conclusions about the use of psychostimulants for the treatment of excessive daytime sedation in dementia. The possibility of psychostimulants to increase blood pressure; elevate heart rate; and lead to irritability, agitation, and psychosis makes careful patient selection critical, especially in older adults with severe cardiovascular disease or other underlying cardiac abnormalities. CONCLUSIONS: Based on limited studies, methylphenidate is a possible treatment for apathy in patients with dementia. Psychostimulants, as a group, do not appear to be broadly effective treatments for behavioral or cognitive symptoms of dementia. The potential utility of psychostimulants must be balanced with careful patient selection.
Intrapericardial Triamcinolone Administration for Autoreactive Pericarditis (October)
Glick Frasiolas, J. A., Cahoon Jr, W. D. OBJECTIVE: To review published literature regarding the safety and effectiveness of intrapericardial triamcinolone for the treatment of autoreactive pericarditis. DATA SOURCES: Searches of MEDLINE (1966-June 2010) and Cochrane Database (1993-June 2010) were conducted. Limits included articles published in English reporting on human subjects. Additional data were identified through bibliographic reviews. STUDY SELECTION AND DATA EXTRACTION: All English-language articles identified from the data sources were evaluated. Trials, studies, and case reports were eligible for inclusion if they evaluated the safety and/or efficacy of intrapericardial triamcinolone for the management of autoreactive pericarditis. DATA SYNTHESIS: Systemic corticosteroids offer an effective treatment option for autoreactive pericarditis; however, their use is limited by adverse effects and they are an independent risk factor for pericarditis recurrence. One case series and 3 open-label trials evaluating intrapericardial triamcinolone for the management of autoreactive pericarditis are reviewed. Included studies were limited by small sample sizes (N = 2-84), lack of control groups, short durations of follow-up (24 h to 12 mo), use of adjuvant agents, omission of patient demographic data, subjective report of symptom relief, and lack of consistent dose of intrapericardial triamcinolone. Despite these limitations, the data suggest symptom resolution and reduced pericarditis recurrence with administration of intrapericardial triamcinolone to patients with autoreactive pericarditis. CONCLUSIONS: There is growing evidence that intrapericardial triamcinolone is safe and effective for the management of autoreactive pericarditis. The appropriate regimen (dose and duration of treatment), adverse effect profile, and specific therapeutic role require further investigation.

Clinical Pharmacology & Therapeutics - Issue - nature.com science feeds

In This Issue
Fri, 20 Aug 2010 00:00:00 -0000
In This Issue Clinical Pharmacology & Therapeutics 88, 277 (September 2010). doi:10.1038/clpt.2010.183
Out of the Medicine Closet: Time to Talk Straight About Prescription Drug Abuse
C HallerL James Fri, 20 Aug 2010 00:00:00 -0000
Out of the Medicine Closet: Time to Talk Straight About Prescription Drug Abuse Clinical Pharmacology & Therapeutics 88, 279 (September 2010). doi:10.1038/clpt.2010.169 Authors: C Haller & L James
Highlights
Fri, 20 Aug 2010 00:00:00 -0000
Highlights Clinical Pharmacology & Therapeutics 88, 284 (September 2010). doi:10.1038/clpt.2010.182 Author:
ASCPT News
Fri, 20 Aug 2010 00:00:00 -0000
ASCPT News Clinical Pharmacology & Therapeutics 88, 286 (September 2010). doi:10.1038/clpt.2010.170
The Case for Limiting Acetaminophen-Related Deaths: Smaller Doses and Unbundling the Opioid–Acetaminophen Compounds
W M Lee Fri, 20 Aug 2010 00:00:00 -0000
The Case for Limiting Acetaminophen-Related Deaths: Smaller Doses and Unbundling the Opioid–Acetaminophen Compounds Clinical Pharmacology & Therapeutics 88, 289 (September 2010). doi:10.1038/clpt.2010.164 Author: W M Lee
Bundle Up: It’s Painful Out There—The Case for Opioid–Acetaminophen Combinations
J D Markman Fri, 20 Aug 2010 00:00:00 -0000
Bundle Up: It’s Painful Out There—The Case for Opioid–Acetaminophen Combinations Clinical Pharmacology & Therapeutics 88, 292 (September 2010). doi:10.1038/clpt.2010.153 Author: J D Markman

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