Archive for May 2, 2013

Cardiovascular Risks with Azithromycin and Other Antibacterial Drugs

N Engl J of Medic May 2, 2013 V.368:1665-68


Andrew D. Mosholder, M.D., M.P.H., Justin Mathew, Pharm.D., John J. Alexander, M.D., M.P.H., Harry Smith, Ph.D., and Sumathi Nambiar, M.D., M.P.H.

From the Office of Surveillance and Epidemiology, Division of Epidemiology II (A.D.M., J.M.), the Office of Antimicrobial Products, Division of Anti-Infective Products (J.J.A., S.N.), and the Office of Communications, Division of Health Communications (H.S.), Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD.

In 2011, approximately 40.3 million people in the United States (roughly one eighth of the population) received an outpatient prescription for the macrolide azithromycin, according to IMS Health. During that year, we at the Food and Drug Administration (FDA) reviewed the labels of azithromycin and other approved macrolide antibacterials in view of cardiovascular risks that had become evident from published studies and reports emerging through postmarketing surveillance. On the basis of its review, the FDA approved revisions to azithromycin product labels regarding risks of QT-interval prolongation and the associated ventricular arrhythmia torsades de pointes. The revised labels advise against using azithromycin in patients with known risk factors such as QT-interval prolongation, hypokalemia, hypomagnesemia, bradycardia, or use of certain antiarrhythmic agents, including class IA (e.g., quinidine and procainamide) and class III (e.g., dofetilide, amiodarone, and sotalol) — drugs that can prolong the QT interval. In March 2013, the FDA announced that azithromycin labels had been further revised to reflect the results of a clinical study showing that azithromycin can prolong the corrected QT interval…..



N Engl J of Medic May 2, 2013 V.368:1704-1712

Use of Azithromycin and Death from Cardiovascular Causes

Henrik Svanström, M.Sc., Björn Pasternak, M.D., Ph.D., and Anders Hviid, Dr.Med.Sci.


Azithromycin use is associated with an increased risk of death from cardiovascular causes among patients at high baseline risk. Whether azithromycin confers a similar risk in the unselected general population is unknown.


We conducted a nationwide historical cohort study involving Danish adults (18 to 64 years of age), linking registry data on filled prescriptions, causes of death, and patient characteristics for the period from 1997 through 2010. We estimated rate ratios for death from cardiovascular causes, comparing 1,102,050 episodes of azithromycin use with no use of antibiotic agents (matched in a 1:1 ratio according to propensity score, for a total of 2,204,100 episodes) and comparing 1,102,419 episodes of azithromycin use with 7,364,292 episodes of penicillin V use (an antibiotic with similar indications; analysis was conducted with adjustment for propensity score).


The risk of death from cardiovascular causes was significantly increased with current use of azithromycin (defined as a 5-day treatment episode), as compared with no use of antibiotics (rate ratio, 2.85; 95% confidence interval [CI], 1.13 to 7.24). The analysis relative to an antibiotic comparator included 17 deaths from cardiovascular causes during current azithromycin use (crude rate, 1.1 per 1000 person-years) and 146 during current penicillin V use (crude rate, 1.5 per 1000 person-years). With adjustment for propensity scores, current azithromycin use was not associated with an increased risk of cardiovascular death, as compared with penicillin V (rate ratio, 0.93; 95% CI, 0.56 to 1.55). The adjusted absolute risk difference for current use of azithromycin, as compared with penicillin V, was −1 cardiovascular death (95% CI, −9 to 11) per 1 million treatment episodes.


Azithromycin use was not associated with an increased risk of death from cardiovascular causes in a general population of young and middle-aged adults. (Funded by the Danish Medical Research Council.)


May 2, 2013 at 9:08 pm

Changes in and shortcomings of control strategies, drug stockpiles, and vaccine development during outbreaks of avian influenza A H5N1, H1N1, and H7N9 among humans.

Biosci Trends. 2013 Apr;7(2):64-76.

Mei L, Song PP, Tang Q, Shan K, Tobe RG, Selotlegeng L, Ali AH, Cheng YY, Xu LZ.


Department of Health Care Management and Maternal and Child Health, Shandong University, Ji’nan, Shandong, China.


The purpose of this review is to provide a reference for the future prevention and control of emerging infectious diseases by summarizing the control strategies, the status of drugs and vaccines, and shortcomings during three major outbreaks of avian influenza among humans (H5N1 in 2003, H1N1 in 2009, and H7N9 in 2013). Data on and documents regarding the three influenza outbreaks have been reviewed. Results indicated that the response to pandemic influenza outbreaks has improved markedly in terms of control strategies, stockpiles of antivirals, and vaccine development. These improvements also suggest advances in disease surveillance, transparency in reporting, and regional collaboration and cooperation. These trends also foreshadow better prospects for prevention and control of emerging infectious diseases. However, there are shortcomings since strategies failed to focus on high-risk groups, quantitative and measurable results (both direct and indirect) were unclear, and quantitative assessment is still lacking.


May 2, 2013 at 9:07 pm

Immunotherapy of human papilloma virus induced disease.

Open Virol J. 2012;6:257-63.

van der Burg SH.


Department of Clinical Oncology, Leiden University Medical Center, Leiden, The Netherlands.


Immunotherapy is the generic name for treatment modalities aiming to reinforce the immune system against diseases in which the immune system plays a role. The design of an optimal immunotherapeutic treatment against chronic viruses and associated diseases requires a detailed understanding of the interactions between the target virus and its host, in order to define the specific strategies that may have the best chance to deliver success at each stage of disease. Recently, a first series of successes was reported for the immunotherapy of Human Papilloma Virus (HPV)-induced premalignant diseases but there is definitely room for improvement. Here I discuss a number of topics that in my opinion require more study as the answers to these questions allows us to better understand the underlying mechanisms of disease and as such to tailor treatment.


May 2, 2013 at 9:05 pm

Biology and pathogenesis of Acanthamoeba.

Parasit Vectors. 2012 Jan 10;5:6.

Siddiqui R, Khan NA.


The Aga Khan University, Karachi, Pakistan.


Acanthamoeba is a free-living protist pathogen, capable of causing a blinding keratitis and fatal granulomatous encephalitis. The factors that contribute to Acanthamoeba infections include parasite biology, genetic diversity, environmental spread and host susceptibility, and are highlighted together with potential therapeutic and preventative measures. The use of Acanthamoeba in the study of cellular differentiation mechanisms, motility and phagocytosis, bacterial pathogenesis and evolutionary processes makes it an attractive model organism. There is a significant emphasis on Acanthamoeba as a Trojan horse of other microbes including viral, bacterial, protists and yeast pathogens.


May 2, 2013 at 9:03 pm

Canadian guidelines for rhinosinusitis – practical tools for the busy clinician.

BMC Ear Nose Throat Disord. 2012 Feb 1;12:1.

Kilty S.


Department of Otolaryngology-Head and Neck Surgery, The Ottawa Hospital, University of Ottawa, ON, Canada.


Acute bacterial rhinosinusitis (ABRS) and chronic rhinosinusitis (CRS) frequently present in clinical practice. Guidelines for management of these conditions have been published extensively in the past. However, a set of guidelines that addressed issues specific to the Canadian environment while offering clear guidance for first-line clinicians was needed, and resulted in the recent publication of Canadian clinical practice guidelines for ABRS and CRS. In addition to addressing issues specific to Canadian physicians, the presented guidelines are applicable internationally, and offer single algorithms for the diagnosis and management of ABRS and CRS, as well as expert opinion in areas that do not have an extensive evidence base. This commentary presents major points from the guidelines, as well as the intended impact of the guidelines on clinical practice.

See guidelines at:


May 2, 2013 at 12:56 pm

New treatments for bacterial keratitis.

J Ophthalmol. 2012;2012:831502.

Wong RL, Gangwani RA, Yu LW, Lai JS.


Eye Institute, The University of Hong Kong, Room 301, Level 3, Block B, 100 Cyberport Road, Cyberport 4, Hong Kong.


Purpose. To review the newer treatments for bacterial keratitis. Data Sources. PubMed literature search up to April 2012.

Study Selection. Key words used for literature search: “infectious keratitis”, “microbial keratitis”, “infective keratitis”, “new treatments for infectious keratitis”, “fourth generation fluoroquinolones”, “moxifloxacin”, “gatifloxacin”, “collagen cross-linking”, and “photodynamic therapy”. Data Extraction. Over 2400 articles were retrieved. Large scale studies or publications at more recent dates were selected.

Data Synthesis. Broad spectrum antibiotics have been the main stay of treatment for bacterial keratitis but with the emergence of bacterial resistance; there is a need for newer antimicrobial agents and treatment methods. Fourth-generation fluoroquinolones and corneal collagen cross-linking are amongst the new treatments. In vitro studies and prospective clinical trials have shown that fourth-generation fluoroquinolones are better than the older generation fluoroquinolones and are as potent as combined fortified antibiotics against common pathogens that cause bacterial keratitis. Collagen cross-linking was shown to improve healing of infectious corneal ulcer in treatment-resistant cases or as an adjunct to antibiotics treatment.

Conclusion. Fourth-generation fluoroquinolones are good alternatives to standard treatment of bacterial keratitis using combined fortified topical antibiotics. Collagen cross-linking may be considered in treatment-resistant infectious keratitis or as an adjunct to antibiotics therapy.


May 2, 2013 at 12:54 pm

Epidemiology of Streptococcus pneumoniae Serogroup 6 Isolates from IPD in Children and Adults in Germany.

PLoS One. 2013 Apr 9;8(4):e60848.

van der Linden M, Winkel N, Küntzel S, Farkas A, Perniciaro SR, Reinert RR, Imöhl M.


National Reference Center for Streptococci, Department of Medical Microbiology, University Hospital (RWTH), Aachen, Germany.


This study presents serogroup 6 isolates from invasive pneumococcal disease (IPD) before and after the recommendation for childhood pneumococcal conjugate vaccination in Germany (July 2006). A total of 19,299 (children: 3508, adults: 15,791) isolates were serotyped. Serogroup 6 isolates accounted for 9.5% (children) and 6.7% (adults), respectively. 548 isolates had serotype 6A, 558 had serotype 6B, 285 had serotype 6C, and 4 had serotype 6D. Among children, serotype 6B was most prevalent (7.5% of isolates) before vaccination, followed by 6A and 6C. After the 7-valent pneumococcal conjugate vaccine (PCV7), the prevalence of serotype 6B significantly decreased (p = 0.040), a pattern which continued in the higher-valent PCV period (PCV10, PCV13). Serotype 6A prevalence showed a slight increase directly after the start of PCV7 vaccination, followed by a decrease which continued throughout the PCV10/13 period. Serotype 6C prevalence remained low. Serotype 6D was not found among IPD isolates from children. Among adults, prevalence of both 6A and 6B decreased, with 6B reaching statistical significance (p = 0.045) and 6A showing a small increase in 2011-2012. Serotype 6C prevalence was 1.5% or lower before vaccination, but increased post-vaccination to 3.6% in 2011/12 (p = 0.031). Four serotype 6D isolates were found post-PCV7 childhood vaccination, and two post-PCV10/13. Antibiotic resistance was found mainly in serotype 6B; serotype 6A showed lower resistance rates. Serotype 6C isolates only showed resistance among adults; serotype 6D isolates showed no resistance. Multilocus sequence typing showed that sequence type (ST) 1692 was the most prevalent serotype 6C clone. Thirty-two other STs were found among serotype 6C isolates, of which 12 have not been previously reported. The four serotype 6D isolates had ST 948, ST 2185 and two new STs: 8422 and 8442. Two serogroup 6 isolates could not be assigned to a serotype, but had STs common to serogroup 6.


May 2, 2013 at 12:52 pm

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