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PubMedDate not supplied

New drugs of 2003.

OBJECTIVES: To provide information regarding the most important properties of the new therapeutic agents marketed in 2003. DATA SOURCES: Product labeling supplemented selectively with published studies and drug information reference sources. STUDY SELECTION: By the author. DATA EXTRACTION: By the author. DATA SYNTHESIS: The 28 new therapeutic agents marketed in the United States during 2003 are reviewed in this article: adalimumab, agalsidase beta, alefacept, alfuzosin hydrochloride, aprepitant, atazanavir sulfate, atomoxetine hydrochloride, bortezomib, daptomycin, efalizumab, eletriptan hydrobromide, emtricitabine, enfuvirtide, eplerenone, gefitinib, icodextrin, laronidase, memantine hydrochloride, mequinol/tretinoin, miglustat, nitazoxanide, omalizumab, palonosetron hydrochloride, pegvisomant, rosuvastatin calcium, tadalafil, tositumomab and iodine I 131 tositumomab, and vardenafil hydrochloride. Indications and information on dosage and administration for these agents are reviewed, as are the most important pharmacokinetic properties, adverse events, drug interactions, and other precautions. Practical considerations for the use of the new agents are also discussed. When possible, the properties of the new drugs are compared with those of older drugs marketed for the same indications. CONCLUSION: A number of the new therapeutic agents marketed in 2003 have important advantages over older medications. An understanding of the properties of these agents is important for the pharmacist to effectively counsel patients about their use and to serve as a valuable source of information for other health professionals regarding these drugs.

Drug Approval↗
PubMed2003

Novel agents for the treatment of resistant Gram-positive infections.

Bacteria have proved themselves able to develop resistance to every antibiotic used clinically. Traditional agents used for treatment of serious infections caused by Gram-positive species have recently been supplemented with the introduction of linezolid, quinupristin-dalfopristin, several new quinolones and telithromycin. However, resistance to many of these agents has already been reported and, although each currently retains activity against the vast majority of clinical isolates of its target species, their long-term efficacy is uncertain. We must look to develop other compounds to replace and hopefully improve upon existing anti-Gram-positive agents. Daptomycin (a lipopeptide), oritavancin and dalbavancin (both second-generation glycopeptides) and ramoplanin (a glycolipodepsipeptide) are among the agents in advanced stages of development and, at present, many seem likely to proceed to licensing. In addition, it is encouraging that many agents active against novel bacterial targets have been discovered and are in earlier stages of development. In the next two decades, we should be optimistic that a regular flow of new anti-Gram-positive agents will enable us to offset the constant spectre of bacterial resistance.

Animals↗
PubMed2003

Novel antibacterial agents for the treatment of serious Gram-positive infections.

With the continuing development of clinical drug resistance among bacteria and the advent of resistance to the recently released agents quinupristin-dalfopristin and linezolid, the need for new, effective agents to treat multi-drug-resistant Gram-positive infections remains important. This review focuses on agents presently in clinical development for the treatment of serious multidrug-resistant staphylococcal, enterococcal and pneumococcal infections, including methicillin-resistant Staphylococcus aureus, vancomycin-resistant enterococci and penicillin-resistant Streptococcus pneumoniae. Agents to be discussed that affect the prokaryotic cell wall include the antimethicillin-resistant S. aureus cephalosporins BAL9141 and RWJ-54428, the glycopeptides oritavancin and dalbavancin and the lipopeptide daptomycin. Topoisomerase inhibitors include the fluoroquinolones gemifloxacin, sitafloxacin and garenoxacin. Protein synthesis inhibitors are represented by the ketolides telithromycin and cethromycin, the oxazolidinones and the glycylcycline tigecycline. Although each of these compounds has demonstrated antibacterial activity against antibiotic-resistant pathogens, their final regulatory approval will depend on an acceptable clinical safety profile.

Anti-Bacterial Agents↗
PubMed2004

New therapies for pneumococcal meningitis.

The treatment of pneumococcal meningitis remains a major challenge, as reflected by the continued high morbidity and case fatality of the disease. The worldwide increase of penicillin-resistant pneumococci and more recently cephalosporin- and vancomycin-tolerant pneumococci has jeopardised the efficacy of standard treatments based on extended spectrum cephalosporins alone or in combination with vancomycin. This review provides a summary of newly developed antibiotics tested in the rabbit meningitis model. In particular, newer beta-lactam monotherapies (cefepime, meropenem, ertapenem), recently developed quinolones (garenoxacin, gemifloxacin, gatifloxacin, moxifloxacin) and a lipopeptide antibiotic (daptomycin) are discussed. A special emphasis is placed on the potential role of combination treatments with some of the new compounds, which are of interest based on the background of increasing resistance problems due to their often synergistic activity in the rabbit model of pneumococcal meningitis.

Animals↗
PubMed1998

38th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC), September 24-27, 1998, San Diego, CA, USA.

This year's ICAAC meeting was dominated by exciting late-stage development antibiotics that represent breakthroughs in covering pathogens of unmet medical need, including drug-resistant pathogens. There are several exciting antibiotics in late-stage development, among them, linezolid, gatifloxacin, moxifloxacin, SB-265805, HMR 3647, SCH27899 and the resurrected daptomycin. The development of new technology for screening and the cross-application into genomics have led to numerous breakthroughs in techniques and strategies for the identification of novel prokaryotic targets.

Journal Article↗
PubMed2000

SMI's 2nd Annual Superbugs and Superdrugs Conference: innovations in anti-infectives.

The emergence of the 'Superbugs', resistant bacterial pathogens, is being aggressively met by the anti-infective community, both academia and industry, with an assortment of classical and novel approaches to control these resistant pathogens. The launch of improved quinolones (gatifloxacin and moxifloxacin), the launch of a new class of protein synthesis inhibitors (oxazolidinones; linezolid) and the ushering-in of the applied genomics age, all offer hope for the future control of resistant bacteria. The seemingly imminent development and completion of the first lipopeptide, daptomycin, offers great hope for the control of Gram-positive resistant pathogens. The first cationic peptide, IB-367, designed to combat the niche medical need of mucositis and the development of a specific antistaphylococcal glycopeptide. BI-397, all will precede the first wave of genomic-targets-based drug candidates, as the antimicrobial genomics effort remains in the target identification and validation stages of early discovery.

Anti-Bacterial Agents↗
PubMed2000

100th American society for microbiology annual meeting.

The 100th ASM Annual Meeting, attended by approximately 10,000 delegates, continued the trend of concentrating on bacteria and antibacterial therapy, mixed with genomics and a diverse number of additional topics. Of the various marketable drug classes, the quinolones received attention with respect to susceptibility studies and several drug comparison studies. New marketable drugs were also of interest, especially given the reservoirs of resistance presented by several speakers. Drugs in development include the antibacterial daptomycin and protegrins and the antifungal lipodepsinonapeptides and echinocandins, to name a few. It is still unclear whether or not antibiotic treatment regimens for Chlamydia pneumonia will he necessary, as association of this bacteria with several chronic diseases, such as atherosclerosis and asthma, was discussed. The development of novel antibiotics was highlighted and the potential role that microbial genomics technology could play was a recurring theme. In fact, a number of symposia treated the increasingly popular topic of genomics in a variety of themes, including phenotyping arrays, transcriptional profiling, proteomics, expression profiling, genome sequencing, target areas or essentiality of genes via gene knockout systems, the role of genomics in pharmaceutical development and fungal genomics. Similarly, genomics plays a role in developing a deeper appreciation for classical areas of interest in microbial physiology, such as gene regulation, cell division, fatty acid biosynthesis, DNA replication and cell signalling. Even in the bio-inorganic field of study in microbial metabolite activation, genomics plays a role. The sequencing of the large gene clusters of the auxiliary proteins necessary to synthesise or activate the metallo-proteins provided insights into the mechanisms of activation of these microbial enzymes, including the genes for the nif gene cluster in Azotobacter vinelandii, the urease from Kiebsiella aerogenes and the three hydrogenases in Ralstonia eutropha.

Anti-Bacterial Agents↗
PubMed2005

Management of healthcare-associated methicillin-resistant Staphylococcus aureus.

Healthcare-associated methicillin-resistant Staphylococcus aureus is a major cause of nosocomial infections worldwide, with significant attributable morbidity and mortality in addition to pronounced healthcare costs. Treatment results with vancomycin--the current recommended antibiotic for serious methicillin-resistant S. aureus infections--have not been impressive. The recent availability of effective antimicrobial agents other than glycopeptides, such as linezolid and daptomycin, as well as the anticipated approval of newer agents with diverse mechanisms of action, has somewhat ameliorated the threat posed by this organism. However, these drugs are expensive, and there is still no overall satisfactory strategy for reducing the incidence of healthcare-associated methicillin-resistant S. aureus in endemic regions. Although early results with the Society for Healthcare Epidemiology of America guidelines give cause for cautious optimism, long-term experience is lacking, and it is likely that these guidelines will have to be adapted according to local conditions and resources before implementation. Trends to keep in mind when considering the problem of healthcare-associated methicillin-resistant S. aureus include the advent of community-associated methicillin-resistant S. aureus, and the propensity of S. aureus to evolve and acquire resistance determinants over time. This was last vividly demonstrated by the handful of vancomycin-resistant S. aureus isolated recently, which had acquired the vancomycin resistance gene from vancomycin-resistant enterococci.

Animals↗
PubMed2006

Epidemiology and treatment of community-associated methicillin-resistant Staphylococcus aureus in children.

Similar to the epidemiology of methicillin-sensitive Staphylococcus aureus, community-associated methicillin-resistant S. aureus infections occur in children in different regions of the USA and throughout the world. Although minor skin and soft-tissue infections predominate, life-threatening invasive disease and death can result. The novel genetic elements, staphylococcal cassette chromosome mec IV and V, explain the narrow antibiotic resistance pattern, and suggest the mechanism of spread among staphylococci. Panton-Valentine leukocidin apparently plays a role in its pathogenesis. Clindamycin therapy is often effective for treatment, but inducible resistance can develop if the isolate exhibits macrolide resistance due to the erm mechanism. Other drugs displaying in vitro activity against community-associated methicillin-resistant S. aureus include trimethoprim-sulfamethoxazole, tetracyclines, quinolones, linezolid and vancomycin. While experience in pediatric patients is limited, daptomycin, ketolides, glycylcyclines, newer glycopeptides and beta-lactamase-stable cephalosporins may be useful in the future. Further research could include well-designed studies of mechanisms of virulence, continued surveillance of changes in pathogenicity and susceptibility, as well as treatment effectiveness.

Anti-Bacterial Agents↗
PubMed2006

Role of linezolid in the treatment of complicated skin and soft tissue infections.

Staphylococcus aureus is the most common cause of complicated skin and soft tissue infections (cSSTIs). Antibiotic choices for these infections continue to evolve. History has seen penicillin progress to antistaphylococcal penicillins and cephalosporins, but these drugs are now giving way to drugs that are effective against methicillin-resistant S. aureus (MRSA). While vancomycin has been the gold standard to treat MRSA infections, newer therapeutic options have been developed over the last 5 years. These include quinupristin-dalfopristin, daptomycin, tigecycline and linezolid, which is the focus for this review. Linezolid is efficacious in the treatment of cSSTIs (including diabetic foot infections) caused by Gram-positive organisms (including MRSA), with a well-defined safety profile and straightforward dosing. It is also approved for nosocomial pneumonia, community-acquired pneumonia and uncomplicated skin and skin structure infections. Linezolid has an oral and parenteral formulation, which are equivalent. The oral formulation has the potential to offer economic benefits as compared with other therapies. Currently, there are only a few new antibiotics in development with MRSA activity. The proper use of all antibiotics, including these newer agents, is increasingly important if we are to slow the evolution of microbial resistance.

Acetamides↗
PubMed2006

Treatment options for multidrug-resistant bacteria.

As a consequence of antibiotic overuse and misuse, nosocomial infections caused by multidrug-resistant bacteria represent a physician's nightmare throughout the world. No newer antimicrobials active against Pseudomonas aeruginosa, the main multidrug-resistant nosocomial pathogen, are available or under investigation. The only exceptions are linezolid, some newer glycopeptides (dalbavancin, oritavancin and telavancin) and daptomycin (a lipopeptide), which are active against methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant Enterococcus (VRE) strains, as well as tigecycline, a potent in vitro glycylcycline against MRSA, VRE, Acinetobacter baumannii and entended-spectrum beta-lactamase (ESBL)+ Enterobacteriaceae. Colistin, an antibiotic of the 1950s has been rediscovered by intensive care unit physicians for use against ESBL+ Enterobacteriaceae, as well as against multidrug-resistant P. aeruginosa and A. baumannii isolates. Although success rates with colistin range between 50 and 73%, almost all studies are retrospective. Immunostimulation efforts against S. aureus are still under development. As antibiotic research and development stagnate, rational policies for prescribing existing antibiotics plus strict infection control are the current mainstay efforts for preventing and combating multidrug-resistant bacterial infections.

Animals↗
PubMed2005

The antimicrobial armamentarium: evaluating current and future treatment options.

The development and introduction of new antibiotics has, unfortunately, not kept pace with the development of bacterial resistance, and the need for new agents is becoming acute. Although some currently marketed agents remain valuable tools in the treatment of infectious diseases, few new drugs have reached the market in the last decade. In recent years, antibiotics with activity against certain problematic resistant bacteria such as methicillin-resistant Staphylococcus aureus, including linezolid and daptomycin, have been approved for clinical practice. Recently, tigecycline, a minocycline derivative, received approval by the United States Food and Drug Administration for treatment of complicated skin and skin structure and intraabdominal infections; the agent is also active against a variety of multidrug-resistant bacteria. Of the other agents in phase III development, ceftobiprole--a cephalosporin, and faropenem and doripenem--both carbapenems, have wide antibacterial spectra. Antimicrobial agents in the pipeline with marked gram-positive activity include dalbavancin, telavancin, and oritavancin.

Anti-Bacterial Agents↗
PubMed2005

Gram-positive resistance: pathogens, implications, and treatment options: insights from the Society of Infectious Diseases Pharmacists.

Despite the advent of new antibiotics, resistance in gram-positive pathogens, including staphylococci and enterococci, continues to increase. This is evident with the recent emergence of vancomycin-resistant Staphylococcus aureus . Newer treatment agents are available, including quinupristin-dalfopristin, linezolid, and daptomycin. In addition, investigational agents are being explored. Clinical trials have been conducted for various infections, such as skin and skin structure infections, pneumonia, and bloodstream infections. Antibacterial activity, site of infection, and potential for adverse effects must be taken into account when making decisions regarding therapy.

Anti-Bacterial Agents↗
PubMed2007

Antimicrobial susceptibility and staphylococcal chromosomal cassette mec type in community- and hospital-associated methicillin-resistant Staphylococcus aureus.

STUDY OBJECTIVE: To differentiate the characteristics of community-associated methicillin-resistant Staphylococcus aureus (MRSA) and hospital-associated MRSA isolates on the basis of their susceptibility profiles, induction of clindamycin resistance, and staphylococcal chromosomal cassette (SCC) mec types. DESIGN: In vitro molecular and susceptibility study of isolates obtained from December 2004-January 2006 as part of a large, ongoing clinical study. SETTING: Level I trauma center in Detroit, Michigan. BACTERIAL STRAINS: Three hundred eight MRSA isolates randomly collected from patients; 130 were classified as community-associated, and 178 were classified hospital-associated by using definitions from the Centers for Disease Control and Prevention (CDC). INTERVENTION: Minimum inhibitory concentrations were tested on the basis of current guidelines from the Clinical and Laboratory Standards Institute. MEASUREMENTS AND MAIN RESULTS: All tested MRSA isolates were susceptible to daptomycin, linezolid, and vancomycin. In addition, community-associated MRSA isolates were significantly (all p < or = 0.05) more susceptible to trimethoprim-sulfamethoxazole (99%), clindamycin (96%), and a fluoroquinolone (76%) than hospital-associated MRSA isolates. Inducible resistance to clindamycin was demonstrated in 8.4% of community-associated MRSA isolates versus 50% of hospital-associated MRSA isolates (p < or = 0.001). Of interest, 35% of the MRSA isolates collected from hospitalized patients (> 48 hrs after admission and according to the CDC definition) possessed SCCmec type IV. CONCLUSION: Overall, inducible clindamycin resistance occurred at significantly higher rates in the hospital-associated MRSA isolates, susceptibility differed significantly between community- and hospital-associated MRSA, and most of the hospital isolates contained SCCmec type IV.

Anti-Bacterial Agents↗
PubMed2002

Treatment options for vancomycin-resistant enterococcal infections.

Serious infection with vancomycin-resistant enterococci (VRE) usually occurs in patients with significantly compromised host defences and serious co-morbidities, and this magnifies the importance of effective antimicrobial treatment. Assessments of antibacterial efficacy against VRE have been hampered by the lack of a comparator treatment arm(s), complex treatment requirements including surgery, and advanced illness-severity associated with a high crude mortality. Treatment options include available agents which don't have a specific VRE approval (chloramphenicol, doxycycline, high-dose ampicillin or ampicillin/sulbactam), and nitrofurantoin (for lower urinary tract infection). The role of antimicrobial combinations that have shown in vitro or animal-model in vivo efficacy has yet to be established. Two novel antimicrobial agents (quinupristin/ dalfopristin and linezolid) have emerged as approved therapeutic options for vancomycin-resistant Enterococcus faecium on the basis of in vitro susceptibility and clinical efficacy from multicentre, pharmaceutical company-sponsored clinical trials. Quinupristin/dalfopristin is a streptogramin, which impairs bacterial protein synthesis at both early peptide chain elongation and late peptide chain extrusion steps. It has bacteriostatic activity against vancomycin-resistant E. faecium [minimum concentration to inhibit growth of 90% of isolates (MIC(90)) = 2 microg/ml] but is not active against Enterococcus faecalis (MIC(90 )= 16 microg/ml). In a noncomparative, nonblind, emergency-use programme in patients who were infected with Gram-positive isolates resistant or refractory to conventional therapy or who were intolerant of conventional therapy, quinupristin/dalfopristin was administered at 7.5 mg/kg every 8 hours. The clinical response rate in the bacteriologically evaluable subset was 70.5%, and a 65.8% overall response (favourable clinical and bacteriological outcome) was observed. Resistance to quinupristin/dalfopristin on therapy was observed in 6/338 (1.8%) of VRE strains. Myalgia/arthralgia was the most frequent treatment-limiting adverse effect. In vitro studies which combine quinupristin/dalfopristin with ampicillin or doxycyline have shown enhanced killing effects against VRE; however, the clinical use of combined therapy remains unestablished. Linezolid, an oxazolidinone compound that acts by inhibiting the bacterial pre-translational initiation complex formation, has bacteriostatic activity against both vancomycin resistant E. faecium (MIC(90) = 2 to 4 microg/ml) and E. faecalis (MIC(90) = 2 to 4 microg/ml). This agent was studied in a similar emergency use protocol for multi-resistant Gram-positive infections. 55 of 133 evaluable patients were infected with VRE. Cure rates for the most common sites were complicated skin and soft tissue 87.5% (7/8), primary bacteraemia 90.9% (10/11), peritonitis 91.7% (11/12), other abdominal/pelvic infections 91.7% (11/12), and catheter-related bacteraemia 100% (9/9). There was an all-site response rate of 92.6% (50/54). In a separate blinded, randomised, multicentre trial for VRE infection at a variety of sites, intravenous low dose linezolid (200mg every 12 hours) was compared to high dose therapy (600 mg every 12 hours) with optional conversion to oral administration. A positive dose response (although statistically nonsignificant) was seen with a 67% (39/58) and 52% (24/46) cure rate in the high- and low-dose groups, respectively. Adverse effects of linezolid therapy have been predominantly gastrointestinal (nausea, vomiting, diarrhoea), headache and taste alteration. Reports of thrombocytopenia appear to be limited to patients receiving somewhat longer courses of treatment (>14 to 21 days). Linezolid resistance (MIC > or = 8 microg/ml) has been reported in a small number of E. faecium strains which appears to be secondary to a base-pair mutation in the genome encoding for the bacterial 23S ribosome binding site. At present a comparative study between the two approved agents for VRE (quinupristin/dalfopristin and linezolid) has not been performed. Several investigational agents are currently in phase II or III trials for VRE infection. This category includes daptomycin (an acidic lipopeptide), oritavancin (LY-333328; a glycopeptide), and tigilcycline (GAR-936; a novel analogue of minocycline). Finally, strategies to suppress or eradicate the VRE intestinal reservoir have been reported for the combination of oral doxycyline plus bacitracin and oral ramoplanin (a novel glycolipodepsipeptide). If successful, a likely application of such an approach is the reduction of VRE infection during high risk periods in high risk patient groups such as the post-chemotherapy neutropenic nadir or early post-solid abdominal organ transplantation.

Acetamides↗
PubMed2006

Antimicrobial agents in orthopaedic surgery: Prophylaxis and treatment.

The pathogenesis of implant-associated infection involves interaction between the microorganisms (biofilm formation), the implant and the host. Despite improvement of perioperative prophylaxis, orthopaedic implants still remain highly susceptible to bacterial or fungal contamination, generally resulting in persistent implant-associated infection. Therefore, perioperative and life-long prevention of infection is important. For perioperative prophylaxis, a first- or second-generation cephalosporin is recommended, which should be administered between 60 and 30 minutes before incision. The duration of prophylaxis should not exceed 1 day. In centres with a low incidence of infection, a single dose is sufficient. Treatment of infections associated with orthopaedic devices usually requires appropriate surgical intervention combined with prolonged antimicrobial therapy. The choice of the antimicrobial regimen depends on the duration and pathogenesis of infection, stability of the implant, antimicrobial susceptibility of the pathogen and condition of the surrounding soft tissue. The role of rifampicin (rifampin), which has excellent activity on adherent staphylococci, in combination with beta-lactams, glycopeptides, fluoroquinolones, minocycline, cotrimoxazole or fusidic acid, in the treatment of staphylococcal infections is outlined. Increasing antimicrobial resistance requires the use of alternative agents, such as quinupristin/dalfopristin, linezolid and daptomycin, but results of clinical trials with these agents are limited. Also reviewed are potential new antimicrobial agents currently undergoing investigation, such as the novel oxazolidinone RWJ-416457, the new glycopeptide dalbavancin, the glycylcycline compound tigecycline, the new carbacephem BP-102 and novel rifamycin derivatives. Vaccination against Staphylococcus aureus with StaphVAX induced specific antibodies potentially preventing bacteraemia; however, there are no studies on efficacy in the prophylaxis of device-associated infections with this vaccine.

Animals↗
PubMed1991

Vancomycin-resistant Enterococcus faecalis in a bone-marrow transplant recipient.

Since 1988 a number of reports on the emergence of vancomycin-resistant enterococci have been published. We describe an additional case of colonization of and subsequent infection with a vancomycin-resistant Enterococcus faecalis in a bone-marrow transplant recipient, who had never before received vancomycin therapy. The strain was resistant to most antibiotics tested, including low-level resistance to gentamicin and cross-resistance to teicoplanin. It was sensitive to amoxicillin and the lipopeptide antibiotic daptomycin. The origin, the mode of acquisition and the incidence of vancomycin-resistant enterococci are still unknown. The clinical and bacteriological features of the cases reported thus far and the genetic and biochemical basis of vancomycin resistance are discussed.

Adult↗
PubMed1999

[ICAA 1999: news in antibiotic therapy].

NEW DERIVATIVES OF OLDER COMPOUNDS: Beta-lactamine derivatives include ne penems and carbapenems as well as beta-lactamase inhibitors and a few cephalosporins. Non-fluoroquinolones without a fluoride atom on position 6 have an antibacterial activity at least equivalent to the most active fluorated products available, suggesting that the contribution of the fluroide atom actually is of limited impact in fluoroquinolones. The clinical importance of these new derivatives remains to be documented. New tetracyclin analogs include glycycyclins. These compounds appear to be active against species resistant to this family of drugs. NEW ANTIBIOTIC CLASSES: A few coumarins have interesting antibacterial activities, essentially against Gram-positive resistant germs. Daptomycin, a glycopeptide-like molecule, gives favorable results for the treatment of Gram-positive infections and yet is comparatively less toxic for the kidney and the auditory system. Oxazolidinones, particularly linezolide, are currently indicated for penicillin and glycopeptide resistant Gram-positive strains. PHARMACOLOGY STUDIES: Recent studies have been conducted on ketolides (14-chain derivatives obtained from erythromycin A) and new fluoroquinolones, gemifloxacin and gatifloxacin, which are active against Gram positive germs (S. pneumoniae) and bactericidal against multiresistant Gram negative.

Anti-Bacterial Agents↗