Current Issue : October - December Volume : 2016 Issue Number : 4 Articles : 6 Articles
Background: Guidelines from the American Heart Association/American College of Cardiology recommend a\nhigher dosage of aspirin daily following Percutaneous Coronary Intervention (PCI), whereas guidelines from the\nEuropean Society of Cardiology recommend a lower dosage. This study aimed to compare the adverse clinical\noutcomes associated with a low dose and a high dose of aspirin following PCI.\nMethods: Electronic databases were searched for studies comparing a low dose with a high dose aspirin following PCI.\nAdverse clinical outcomes were considered as the endpoints in this study. We calculated Odds Ratios (OR) with 95 %\nConfidence Intervals (CIs) for categorical variables. The pooled analyses were performed with RevMan 5.3 software.\nResults: A total number of 25,083 patients were included. Results from this analysis showed that the combination of\nCardiovascular (CV) death/Myocardial Infarction (MI) or stroke was not significantly different between a low and high\ndose of aspirin with OR: 1.08, 95 % CI: 0.98ââ?¬â??1.18; P = 0.11. Mortality and MI were also not significantly different between\nthese two treatment regimens following PCI with OR: 0.95, 95 % CI: 0.74ââ?¬â??1.23; P = 0.71 and OR: 1.17, 95 % CI: 0.97ââ?¬â??1.41;\nP = 0.09 respectively. However, a high dose of aspirin was associated with a significantly higher rate of Major Adverse\nCardiac Events (MACEs) with OR: 1.20, 95 % CI: 1.02ââ?¬â??1.41; P = 0.03. Thrombolysis In Myocardial Infarction (TIMI) defined\nminor bleeding was also significantly higher with a high dose aspirin with OR: 1.22, 95 % CI: 1.02ââ?¬â??1.47; P = 0.03. When\nStent thrombosis (ST) was compared, no significant difference was found with OR: 1.28, 95 % CI: 0.59ââ?¬â??2.58; P = 0.53.\nEven if TIMI defined major bleeding favored a low dose of aspirin, with OR: 1.42, 95 % CI: 0.95ââ?¬â??2.13; P = 0.09, or even if\nmajor bleeding was insignificantly higher with a high dose aspirin, with OR: 1.78, 95 % CI: 1.01ââ?¬â??3.13; P = 0.05; I2 = 94 %,\nhigher levels of heterogeneity observed in these subgroups could not be considered significant to any extent. Conclusion: According to the results of this analysis, a high dose of aspirin following PCI was not associated with any\nsignificantly higher rate of CV death/MI/stroke, mortality or MI. However, MACEs significantly favored a low dose of\naspirin. In addition, TIMI defined minor bleeding was significantly higher with a high dose of aspirin whereas the results\nfor the major bleeding outcomes were not statistically significant. However, due to limited data availability and since\nthe subgroups analyzing major bleeding were highly heterogeneous, further studies are recommended to completely\nsolve this issue....
Background: Diagnostic reference levels (DRLs) are optimum range of values or diagnostic standard data for a\nparticular procedure by which other imaging measurements must be compared for purposes of optimizing patient\ndose and radiation safety in medical imaging. This study aimed to compare measured dosimetric parameters of the\nlatest 640-Slice Aquilion ONE CT scanner with established DRLs for adult and pediatric head, chest and abdominal\nexaminations as a quality assurance test in order to recommend appropriate radiological safety solutions if\ndifferences existed.\nMethods: A prospective and retrospective study design was applied in this work. Data of measured CT\ndosimetric parameters (patient administered doses) such as dose length product and CT dose index were\ngenerated for pediatric head, chest and abdominal examinations using the Aquilion ONE CT scanner. The\ngenerated database was compared with established international standard DRLs. SPSS version 16 software\nwas used for data processing and analysis.\nResults: The measured volume weighted CT dose index (CTDIvol) and dose length products (DLPs) were generally\nlower than the ICRP and other internationally recommended DRLs. In particular, the relative deviations from the DRLs\nwere head (CTDIvol = âË?â??57.5 %, DLP = âË?â??33.8 %, p-value = 0.001), chest (CTDIvol = âË?â??94.3 %, DLP = âË?â??86.6 %, p-value = 0.002),\nand abdomen (CTDIvol = âË?â??91.0 %, DLP = âË?â??75.2 %, p-value = 0.001) for pediatric examinations, and head (CTDIvol=+5.\n5 %, DLP=âË?â??4.0 %, p-value = 0.001), chest (CTDIvol = âË?â??80.3 %, DLP = âË?â??56.6 % p-value = 0.001), abdomen (CTDIvol = âË?â??6.\n8 %, DLP=âË?â??54.7 %, p-value = 0.001) for adult examinations respectively.\nConclusion: The CTDIvol and DLP administered doses for both pediatric and adult examinations were lower than their\nrespective DRLs except adult head examination where the measured CTDIvol was 5.5 % higher than the standard\nreference dose. Optimization of practice is needed to reduce dose to head CT examinations when using 640-slice\nAquilion ONE CT scanner....
Background: This study forms part of the first complete characterization of the doseââ?¬â??response curve for glycopyrrolate\n(GP) delivered using Co-Suspensionââ??¢ Delivery Technology via a metered dose inhaler (MDI). We examined the lower\nGP MDI dose range to determine an optimal dose for patients with moderate-to-severe chronic obstructive pulmonary\ndisease (COPD).\nMethods: This randomized, double-blind, chronic-dosing, balanced incomplete-block, placebo-controlled, crossover\nstudy compared six doses of GP MDI (18, 9, 4.6, 2.4, 1.2, and 0.6 Ã?¼g, twice daily [BID]) with placebo MDI BID and openlabel\ntiotropium dry powder inhaler (18 Ã?¼g, once daily [QD]) in patients with moderate-to-severe COPD. Patients were\nrandomized into 1 of 120 treatment sequences. Each sequence included 4 of 8 treatments administered for 14-day\nperiods separated by 7- to 21-day washout periods.\nThe primary efficacy endpoint was change from baseline in forced expiratory volume in 1 s area under the curve from\n0 to 12 h (FEV1 AUC0ââ?¬â??12) on Day 14. Secondary efficacy endpoints included peak change from baseline (post-dose) in\nFEV1 and inspiratory capacity (IC) on Days 1, 7, and 14; change from baseline in morning pre-dose trough FEV1 on\nDays 7 and 14; change from baseline in 12-h post-dose trough FEV1 on Day 14; time to onset of action (ââ?°Â¥10 %\nimprovement in mean FEV1) and the proportion of patients achieving ââ?°Â¥12 % improvement in FEV1 on Day 1;\nand pre-dose trough IC on Days 7 and 14. Safety and tolerability were also assessed.\nResults: GP MDI 18, 9, 4.6, and 2.4 Ã?¼g demonstrated statistically significant and clinically relevant increases in FEV1 AUC0ââ?¬â??12 compared with placebo MDI following 14 days of treatment (modified intent-to-treat populati\nGP MDI 18 Ã?¼g was non-inferior to open-label tiotropium for peak change in FEV1 on Day 1 and morning pre-dose\ntrough FEV1 on Day 14. All doses of GP MDI were well tolerated with no unexpected safety findings.\nConclusions: These efficacy and safety results support GP MDI 18 Ã?¼g BID as the most appropriate dose for evaluation\nin Phase III trials in patients with moderate-to-severe COPD....
Background: Cases of ventilator-associated pneumonia (VAP) due to multidrug-resistant (MDR) gram-negative bacilli\n(GNB) mainly Acinetobacter baumannii, Pseudomonas aeruginosa and enterobacteria are common in hospitalised\npatients of Tunisian intensive care units (ICUs). Parenteral colistin has been used for the therapy of VAP caused by MDR\nGNB at Tunisian hospitals over the past few years with a favourable clinical response. However, its use fell out of favour\nbecause of the reported drug-related nephrotoxicity and neurotoxicity.\nObjectives: To determine whether aerosolised (AS) colistin was beneficial and safe in therapy of gram-negative VAP.\nMethods: This was a randomised, single-blind study, in 149 critically ill adults who developed gram-negative VAP.\nIncluded patients were divided into two groups whether they received AS colistin (intervention group; n = 73) or intravenous\n(IV) colistin (control group; n = 76). AS colistin was given as 4 million units (MU) by nebulisation three times per\n24 h. IV colistin was given as a loading dose of 9 MU followed by 4.5 MU two times per 24 h. Patients were followed during\n28 days. Primary outcome was cure of VAP assessed at day 14 of therapy and defined as resolution of clinical signs\nof VAP and bacteriological eradication. Secondary outcomes were incidence of acute renal failure (ARF), mechanical\nventilation length, ICU length of stay and 28-day mortality. Results were analysed based on intention-to-treat concept.\nResults: The patient�s baseline characteristics and distribution of pathogens VAP in both groups were similar. The clinical\ncure rate was 67.1 % in AS group and 72 % in IV group (p = 0.59). When administered in monotherapy or in combination,\nthe AS regimen was as effective as IV regimen. Patients in AS group had significantly lower incidence of ARF\n(17.8 vs 39.4 %, p = 0.004), more favourable improvement of P/F ratio (349 vs 316 at day 14, p = 0.012), shortened time\nto bacterial eradication (TBE) (9.89 vs 11.26 days, p = 0.023) and earlier weaning from ventilator in ICU survivors with a\nmean gain in ventilator-free days of 5 days. No difference was shown in the length of stay and the 28-day mortality.\nConclusion: Aerosolised colistin seems to be beneficial. It provided a therapeutic effectiveness non-inferior to parenteral\ncolistin in therapy of MDR bacilli VAP with a lower nephrotoxicity, a better improvement of P/F ratio, a shortened\nbacterial eradication time and earlier weaning from ventilator in ICU survivors.\nTrial registration ClinicalTrials.gov Identifier: NCT02683603...
Background: We investigated the pharmacokinetics of etoposide (ETP) to reduce the inter-individual variations of ETP\nconcentrations in patients with acute leukemia who underwent allogeneic hematopoietic stem cell transplantation.\nWe also carried out an in vivo study using rats to verify the dose adjustment.\nMethods: This study included 20 adult patients. ETP was administered intravenously at a dose of 15 mg/kg once\ndaily for 2 days (total dose: 30 mg/kg) combined with standard conditioning of cyclophosphamide and total body\nirradiation. In an in vivo study using rats, ETP was administered intravenously at a dose of 15 mg/kg or an adjusted\ndose. The ETP plasma concentration was determined by using HPLC. The pharmacokinetic parameters were estimated\nby using a 1-compartment model.\nResults: The peak concentration (Cmax) of ETP and the area under the plasma concentration-time curve (AUC) of ETP\ndiffered greatly among patients (range of Cmax, 51.8 - 116.5 �¼g/mL; range of AUC, 870 - 2015 �¼g �· h/mL). A significant\nrelationship was found between Cmax and AUC (R = 0.85, P < 0.05). Distribution volume (Vd) was suggested to be one\nof the factors of inter-individual variation in plasma concentration of ETP in patients (range of Vd, 0.13 - 0.27 L/kg), and\ncorrelated with Alb and body weight (R = 0.56, P < 0.05; R = 0.40, P < 0.05 respectively). We predicted Vd of rats by body\nweight of rats (with normal albumin levels and renal function), and the dose of ETP was adjusted using predicted Vd.\nIn the dose adjustment group, the target plasma ETP concentration was achieved and the variation of plasma ETP\nconcentration was decreased.\nConclusion: The results suggested that inter-individual variation of plasma concentration of ETP could be reduced by\npredicting Vd. Prediction of Vd is effective for reducing individual variation of ETP concentration and might enable a\ngood therapeutic effect to be achieved....
Purpose: Respiratory drug delivery has been attracted great interest for the past decades,\nbecause of the high incidence of pulmonary diseases. However, despite its invaluable\nbenefits, there are some major drawbacks in respiratory drug delivery, mainly due to the\nrelatively high drug deposition in undesirable regions. One way to improve the efficiency of\nrespiratory drug delivery through metered-dose inhalers (MDI) is placing a respiratory\nspacer between the inhaler exit and the mouth. The aim of this study was to assess the effect\nof type and shape of spacer on the aerosolization performance of MDIs.\nMethods: A commercial Beclomethasone Dipropionate (BDP) MDI alone or equipped with\ntwo different spacer devices (roller and pear type) widely distributed in the world\npharmaceutical market was used. The effect of spacers was evaluated by calculating\naerosolization indexes such as fine particle fraction (FPF), mass median aerodynamic\ndiameters (MMAD) and geometric standard deviation (GSD) using the next generation\nimpactor.\nResults: Although one of the spacers resulted in superior outcomes than the other one, but it\nwas not statistically significant.\nConclusion: The results confirmed that the type and shape of spacer did not substantially\ninfluence the aerosolization performance of MDIs....
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