2008 November 07

Where is the supporting evidence for treating mild to moderate chronic obstructive pulmonary disease exacerbations with antibiotics? A systematic review.

Nov 072008

Where is the supporting evidence for treating mild to moderate chronic obstructive pulmonary disease exacerbations with antibiotics? A systematic review.

BMC Med. 2008;6:28

Authors: Puhan MA, Vollenweider D, Steurer J, Bossuyt PM, Ter Riet G

BACKGROUND: Randomised trials comparing different drugs head-to-head are extremely valuable for clinical decision-making. However, it is scientifically and ethically sensible to demand strong evidence that a drug is effective by showing superiority over a placebo before embarking on head-to-head comparisons of potentially ineffective drugs. Our aim was to study the evolvement of evidence from placebo-controlled and head-to-head trials on the effects of antibiotics for the treatment of mild to moderate exacerbations of chronic obstructive pulmonary disease. METHODS: We conducted a historical systematic review. Through electronic databases and hand-searches, we identified placebo-controlled and head-to-head antibiotic trials for the treatment of mild to moderate chronic obstructive pulmonary disease exacerbations. We compared the numbers of patients recruited in placebo-controlled and head-to-head trials between 1957 and 2005. Using cumulative meta-analysis of placebo-controlled trials, we determined when, if ever, placebo-controlled trials had shown convincing evidence that antibiotics are effective in preventing treatment failure in patients with mild to moderate chronic obstructive pulmonary disease exacerbations. RESULTS: The first head-to-head trial was published in 1963. It was followed by another 100 trials comparing different antibiotics in a total of 34,029 patients with mild to moderate chronic obstructive pulmonary disease exacerbations. Over time, the cumulative odds ratio in placebo-controlled trials remained inconclusive throughout with odds ratios ranging from 0.39 (95% confidence intervals 0.04-4.22) to the most recent estimate (1995) of 0.81 (95% confidence intervals 0.52-1.28, P = 0.37). CONCLUSION: Placebo-controlled trials do not support the use of antibiotics in chronic obstructive pulmonary disease patients with mild to moderate exacerbations. Conducting head-to-head trials is, therefore, scientifically and ethically questionable. This underscores the requirement to perform or study systematic reviews of placebo-controlled trials before conducting head-to-head trials.

PMID: 18847478 [PubMed - indexed for MEDLINE]

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Clinical and angiographic follow-up of small vessel lesions treated with paclitaxel-eluting stents (from the TRUE Registry).

Am J Cardiol Start a Discussion »

Nov 072008

Clinical and angiographic follow-up of small vessel lesions treated with paclitaxel-eluting stents (from the TRUE Registry).

Am J Cardiol. 2008 Oct 15;102(8):1002-8

Authors: Godino C, Furuichi S, Latib A, Morici N, Chieffo A, Romagnoli E, Tamburino C, Barbagallo R, Cera M, Antoniucci D, Goktekin O, Di Mario C, Reimers B, Grube E, Airoldi F, Sangiorgi GM, Colombo A

Several randomized trials have shown that sirolimus-eluting stents and paclitaxel-eluting stents (PES) are effective in reducing restenosis in respect to bare-metal stents, including the subset of small vessels. The objective of this study was to evaluate "real world" angiographic and clinical outcomes of a large series of patients enrolled in the TRUE registry and treated with PES for both small vessel and very small vessel lesions. A consecutive series of 675 patients (926 lesions) with reference vessel diameter <2.75 mm measured by quantitative coronary angiography analysis were analyzed. The primary end point was the rate of angiographic in-stent restenosis and 1-year major adverse cardiac events. In this study 390 lesions were identified as small vessel (reference vessel diameter >or=2.25 and <2.75 mm) and 536 lesions as very small vessel (reference vessel diameter <2.25 mm). Overall in-stent restenosis was 15.5% (n = 96). Compared with small vessel, the very small vessel lesions had more in-stent restenosis (21.7% vs 11.4%, p <0.001) and in-segment restenosis (29.3% vs 22.5%, p = 0.055). The majority of the restenotic lesions (n = 125) were focal (57%, n = 71). At 1 year, cardiac death was 1.6% (n = 11), acute myocardial infarction 0.5% (n = 4.), and the target lesion revascularization 12.8% (n = 86). Cumulative major adverse cardiac events rate was 17.3% (n = 119). The rate of definite and probable stent thrombosis was 0.9% (n = 8). In conclusion, in comparison with historical bare-metal stent controls, this large series of small vessel lesions treated with PES confirms previous results reporting the efficacy of PES in small vessels. The rate of subacute and late stent thrombosis was low in this subgroup of patients.

PMID: 18929700 [PubMed - indexed for MEDLINE]

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Impact of mild or moderate renal insufficiency on the intravascular ultrasonic analysis of chronic vascular response to paclitaxel-eluting and bare-metal stents (from the TAXUS IV, V, and VI trials).

Am J Cardiol Start a Discussion »

Nov 072008

Impact of mild or moderate renal insufficiency on the intravascular ultrasonic analysis of chronic vascular response to paclitaxel-eluting and bare-metal stents (from the TAXUS IV, V, and VI trials).

Am J Cardiol. 2008 Oct 15;102(8):1009-16

Authors: Aoki J, Mintz GS, Weissman NJ, Mandinov L, Grube E, Dawkins KD, Ellis SG, Greenberg J, Yu A, Mann JT, Cannon L, Cambier PA, Stone GW

The presence of even mild renal insufficiency is usually associated with an increased rate of cardiovascular events after coronary stenting. The aim of this study was to evaluate the impact of mild to moderate renal insufficiency on the chronic vascular responses to the implantation of paclitaxel-eluting stents (PES; Taxus) and bare-metal stents (BMS). In the TAXUS IV, TAXUS V, and TAXUS VI trials, patients with serum creatinine levels >2.0 mg/dl were excluded. In the present analysis, 816 patients with serum creatinine levels <or=2.0 mg/dl had intravascular ultrasound images acquired after the procedures and/or at 9-month follow-up (406 with PES, 410 with BMS). Patients were stratified by level of creatinine clearance (Ccr; group 1: Ccr <40; group 2: 40 <or=Ccr <60; group 3: 60 or/=Ccr <80; group 4: Ccr >or=80 ml/min/1.73 m(2)). For all levels of Ccr, patients with PES compared with those with BMS had less intimal hyperplasia area (group 1: 0.97 +/- 0.98 vs 2.94 +/- 1.89; group 2: 0.94 +/- 0.86 vs 2.30 +/- 1.21; group 3: 0.99 +/- 1.02 vs 2.53 +/- 1.29; group 4: 0.87 +/- 0.95 vs 2.12 +/- 1.29 mm(2), all p values <0.0001) and greater increases in peristent plaque and media area (group 1: 0.90 +/- 0.98 vs -0.02 +/- 0.98 mm(2), p = 0.03; group 2: 0.57 +/- 1.43 vs 0.20 +/- 1.14 mm(2), p = 0.11; group 3: 1.20 +/- 1.95 vs 0.02 +/- 1.17, p <0.0001; group 4: 0.35 +/- 1.44 vs -0.19 +/- 1.08 mm(2), p = 0.08). Neointimal growth and vessel remodeling were not affected by variations in Ccr after either BMS or PES implantation over the range studied. The incidence of incomplete stent apposition at follow-up was lowest in patients with the greatest renal impairment after BMS and PES implantation. In conclusion, neointimal proliferation was less prominent and expansive vessel remodeling was more prominent after PES than BMS implantation, independent of the severity of renal dysfunction.

PMID: 18929701 [PubMed - indexed for MEDLINE]

Link to Article at PubMed

Daptomycin in endocarditis and bacteraemia: a British perspective.

J Antimicrob Chemother Start a Discussion »

Nov 072008

Daptomycin in endocarditis and bacteraemia: a British perspective.

J Antimicrob Chemother. 2008 Nov;62 Suppl 3:iii25-33

Authors: Warren RE

Assessment of the place of daptomycin in the treatment of endocarditis and bacteraemia requires assimilation of data from one open-label randomized comparative clinical trial sized for equivalence, from registry data and from case reports. Selected relevant animal models and in vitro data are also considered in an effort to produce an integrated assessment of the current place of daptomycin in treatment. The evidence for the use of daptomycin is best in Staphylococcus aureus bacteraemia and endocarditis, but also includes some data on infections due to Enterococcus spp., especially if vancomycin-resistant. The emergence of resistance in a minority of patients on current dose regimens may mean that trials have to be repeated with higher doses, or the drug used in a combined therapy where rifampicin may be the best choice. In general, equivalence to comparator antibiotic regimens and a correlation for in vitro and in vivo findings have been demonstrated, but there are important gaps in the clinical data including a comparative equivalence trial in streptococcal and enterococcal endocarditis. Clinical benefit might be anticipated, but has not been proved, over aminoglycoside-containing regimens, and economic assessments are critical in the decision as to when and how daptomycin is deployed.

PMID: 18829722 [PubMed - indexed for MEDLINE]

Link to Article at PubMed

Clinical experience with daptomycin: bacteraemia and endocarditis.

J Antimicrob Chemother Start a Discussion »

Nov 072008

Clinical experience with daptomycin: bacteraemia and endocarditis.

J Antimicrob Chemother. 2008 Nov;62 Suppl 3:iii35-39

Authors: Levine DP

Serious infections due to Staphylococcus aureus, especially those due to methicillin-resistant S. aureus, have become a major challenge. Vancomycin has long been the drug of choice for treatment of such infections, but failures due to its slow bactericidal activity coupled with increasing MICs have necessitated a search for new, more effective agents. Daptomycin has been studied by a number of investigators and has proved to be effective for bacteraemic infections due to staphylococci as well as vancomycin-resistant enterococci and other Gram-positive organisms. In addition, in a randomized controlled trial comparing daptomycin monotherapy with potentially synergistic therapy with either vancomycin or beta-lactam, both used in combination with an aminoglycoside, daptomycin achieved comparable outcomes but with significantly less nephrotoxicity.

PMID: 18829724 [PubMed - indexed for MEDLINE]

Link to Article at PubMed

Future directions with daptomycin.

J Antimicrob Chemother Start a Discussion »

Nov 072008

Future directions with daptomycin.

J Antimicrob Chemother. 2008 Nov;62 Suppl 3:iii41-iii49

Authors: Livermore DM

Daptomycin is the first new natural-product antibiotic launched in a generation. It was licensed first for skin and soft tissue infections (SSTIs) and, more recently, for staphylococcal bacteraemia and endocarditis. Further clinical trials are in progress, some investigating performance in subsets of SSTIs while others, more interestingly, are evaluating efficacy in enterococcal endocarditis and neutropenic fevers--settings where the compound's bactericidal activity is potentially advantageous. There is a need for further trials in bone and joint infections. On the negative side, there are several reports of mutational resistance emerging during the treatment of methicillin-resistant Staphylococcus aureus (MRSA) infections, mostly in settings with a heavy bacterial load, and there is a need to determine whether higher dosages or combination regimens will reduce this risk. A few patients have already been treated with doses of up to 12 mg/kg. Lastly, daptomycin is entering a market increasingly crowded with new anti-Gram-positive agents. More work is required to establish those settings where daptomycin and other new compounds offer real advantages over established glycopeptides and over each other. There is presently a paradox whereby vancomycin is agreed to be less than ideal, with outcomes impaired against MRSA with modestly raised MICs, but where new agents have yet to demonstrate unequivocal superiority.

PMID: 18829725 [PubMed - indexed for MEDLINE]

Link to Article at PubMed

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