Clinical Drug Investigation (CLIN DRUG INVEST)

Publisher: Springer Verlag

Journal description

Clinical Drug Investigation gives you rapid access to the best designed, peer reviewed clinical and pharmacoeconomic studies worldwide, allowing you to keep up to date with the latest original research in this exciting area. The Journal's aim is rapid publication of original research covering all phases of clinical drug development and therapeutic use of drugs. This includes clinical trials, outcomes research, clinical pharmacoeconomic studies, pharmacoepidemiology studies with a strong link to optimum prescribing practice for a drug or group of drugs, clinical pharmacodynamic and clinical pharmacokinetic studies with a strong link to clinical practice and, in some instances, pharmacodynamic or pharmacokinetic studies in healthy volunteers, but in which some established or purported implications for clinical prescribing are discussed. In addition, short communications and case study reports that meet these criteria are also encouraged, as are letters to the editor.

Current impact factor: 1.56

Impact Factor Rankings

2015 Impact Factor Available summer 2016
2014 Impact Factor 1.557
2013 Impact Factor 1.704
2012 Impact Factor 1.915
2011 Impact Factor 1.822
2010 Impact Factor 1.622
2009 Impact Factor 1.414
2008 Impact Factor 1.301
2007 Impact Factor 0.602
2006 Impact Factor 0.559
2005 Impact Factor 0.707
2004 Impact Factor 0.77
2003 Impact Factor 0.709
2002 Impact Factor 0.914
2001 Impact Factor 0.846
2000 Impact Factor 0.888
1999 Impact Factor 0.651
1998 Impact Factor 0.71
1997 Impact Factor 0.913

Impact factor over time

Impact factor

Additional details

5-year impact 1.61
Cited half-life 4.90
Immediacy index 0.61
Eigenfactor 0.00
Article influence 0.45
Website Clinical Drug Investigation website
ISSN 1179-1918
OCLC 31920475
Material type Periodical, Internet resource
Document type Journal / Magazine / Newspaper, Internet Resource

Publisher details

Springer Verlag

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  • Classification

Publications in this journal

  • [Show abstract] [Hide abstract]
    ABSTRACT: Background and objectives: Ramucirumab is a fully immunoglobulin G (lgG) monoclonal antibody targeting vascular endothelial growth factor receptor type 2 (VEGFR2). Previous clinical trials suggested ramucirumab could improve the survival and increase the risk of adverse effects. Here, we aimed to assess the efficacy and safety of ramucirumab in the treatment of advanced solid tumors. Methods: Publications were searched from Pubmed, Embase database and Hazard ratio (HR) and 95 % confidence interval (95 % CI) were calculated to evaluate efficacy, and the risk ratio (RR) for adverse effects. Results: Ten relevant studies were included. Ramucirumab resulted in significant benefit in overall survival [OS, HR and 95 % CI 0.87 (0.82-0.93), I (2): 0.0 %] and progression-free survival [PFS, HR and 95 % CI 0.74 (0.66-0.82), I (2): 67.4 %]. Also the difference of time to progression (TTP) and objective response rate (ORR) between two groups were also significant [0.70 (0.57-0.88) and 1.78 (1.40-2.25), respectively]. Ramucirumab could increase the risk of total adverse effects (TAEs, of any grade) by 1 % (from 0 to 2 %) and severe adverse effects (SAEs, grade > 2) by 17 % (from 9 to 26 %). The most frequently occurring TAEs were fatigue (54.71 %), neutropenia (42.74 %), bleeding (37.55 %), nausea (34.63 %) and stomatitis (33.74 %). Most frequently occurring SAEs (grade ≥3) were neutropenia (33.43 %), fatigue (12.08 %), leukopenia (10.59 %), hypertension (8.99 %) and liver injury (8.74 %). Conclusion: Ramucirumab could improve OS and PFS for patients suffering from advanced solid tumors. Ramucirumab could increase the risk of TAEs and SAEs.
    Clinical Drug Investigation 11/2015; DOI:10.1007/s40261-015-0355-x
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    ABSTRACT: Background: Patients with chronic obstructive pulmonary disease (COPD) are at elevated risk of pneumococcal infection. A 13-valent pneumococcal conjugate vaccine (PCV13) was approved for protection against invasive disease and pneumonia caused by Streptococcus pneumoniae in adults. This study estimated the incremental cost-effectiveness ratio (ICER) of vaccinating COPD patients ≥50 years old with PCV13 compared with current vaccination policy (CVP) with 23-valent pneumococcal polysaccharide vaccine. Methods: A Markov model accounting for the risks and costs for all-cause non-bacteremic pneumonia (NBP) and invasive pneumococcal disease (IPD) was developed. All parameters, such as disease incidence and costs (€; 2015 values), were based on published data. The perspective of the analysis was that of the Spanish National Healthcare System, and the horizon of evaluation was lifetime in the base case. Vaccine effectiveness considered waning effect over time. Outcomes and costs were both discounted by 3 % annually. Results: Over a lifetime horizon and for a 629,747 COPD total population, PCV13 would prevent 2224 cases of inpatient NBP, 3134 cases of outpatient NBP, and 210 IPD extra cases in comparison with CVP. Additionally, 398 related deaths would be averted. The ICER was €1518 per quality-adjusted life-year (QALY) gained for PCV13 versus CVP. PCV13 was found to be cost effective versus CVP from a 5-year modelling horizon (1302 inpatient NBP and 1835 outpatient NBP cases together with 182 deaths would be prevented [ICER €25,573/QALY]). Univariate and probabilistic sensitivity analyses confirmed the robustness of the model. Conclusions: At the commonly accepted willingness-to-pay threshold of €30,000/QALY gained, PCV13 vaccination in COPD patients aged ≥50 years was a cost-effective strategy compared with CVP from 5 years to lifetime horizon in Spain.
    Clinical Drug Investigation 11/2015; DOI:10.1007/s40261-015-0345-z
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    ABSTRACT: Background and objective: Metered-dose inhalers require patients to coordinate inhalation with actuation. The present albuterol multi-dose dry-powder inhaler (mDPI) does not require patients to coordinate inspiration with actuation, thereby simplifying delivery of albuterol to the lungs. The aim of the present study was to compare the efficacy, pharmacokinetics, pharmacodynamics, extrapulmonary pharmacodynamics, and safety of albuterol (salbuterol) delivered via a ProAir® hydrofluoroalkane (HFA) metered-dose inhaler and an mDPI. Methods: Two double-blind, randomized, double-dummy, crossover, multicenter, placebo-controlled studies in persistent asthma patients were conducted. Study 1: 47 adult patients were treated with cumulative doses of albuterol mDPI or ProAir HFA (90 µg/inhalation; 1 + 1 + 2 + 4 + 8 inhalations) or placebo. Study 2: 71 patients aged ≥12 years were randomly assigned to receive 90 or 180 μg of albuterol mDPI or ProAir HFA, or placebo. Primary efficacy endpoints were baseline-adjusted forced expiratory volume in 1 s (FEV1) at 30 min (30-min FEV1) after each cumulative dose (Study 1) and FEV1 area under the effect curve over 6 h (FEV1 AUEC0-6) after dosing (Study 2). Results: Study 1: differences, with corresponding 90 % confidence intervals, between albuterol mDPI and ProAir HFA in FEV1 after each cumulative dose and in FEV1 AUEC0-6 after the final dose were within pre-established equivalence limits. The difference in FEV1 at high vs. low doses was significant for both active treatments (p < 0.0001). Active treatments were similar in systemic exposure, extrapulmonary pharmacodynamics, and safety. Study 2: mean FEV1 AUEC0-6 was significantly greater than for placebo for both doses of albuterol mDPI and ProAir HFA (p < 0.0001). Albuterol mDPI was comparable to ProAir HFA at 90 and 180 µg. Both study treatments were generally well tolerated. Conclusion: The bronchodilatory efficacy and pharmacokinetic/pharmacodynamic profiles of albuterol mDPI and ProAir HFA are comparable, with a safety profile consistent with that of inhaled albuterol.
    Clinical Drug Investigation 11/2015; DOI:10.1007/s40261-015-0346-y
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    ABSTRACT: Background and objective: Concerns that antiepileptic brand-to-generic interchange results in disruption of seizure control are widespread. The objective of this study was to evaluate the safety and tolerability of the brand-to-generic levetiracetam switch in patients with focal or generalized epilepsy. Methods: A prospective study in patients with primary, cryptogenic or symptomatic epilepsy, who were taking branded levetiracetam and were switched to generic levetiracetam. Patients were consecutively recruited from January 2013 to January 2015. We evaluated efficacy, tolerability and compliance before switching (T0) and after 6 months of therapy (T1). Evaluations were scheduled as follows: baseline, 7 and 15 days, 1, 3 and 6 months. At each visit clinical diary seizures, physical and neurological examination, laboratory parameters and electroencephalogram were evaluated. Results: Fifty-nine patients, equally mixed by sex, were included in the study. Mean age was 26.1 years. Forty-seven per cent of the patients enrolled received levetiracetam as monotherapy. One patient was lost during the follow-up: so at T1 we had 58 patients (28 monotherapy and 30 polytherapy). At T0 and at T1, there was no statistically significant difference in terms of seizure frequency and intensity, occurrence of adverse events, laboratory parameters and electroencephalographic features. Two patients stopped treatment with the generic (both at 3 months after the switch) and restarted therapy with brand levetiracetam because of seizure increase. At the end of the study, the switchback rate was 3.4 %. Conclusions: No increase of seizures and adverse effects were observed when branded levetiracetam was interchanged to a generic equivalent. More studies should be conducted with a larger series of patients to confirm these results.
    Clinical Drug Investigation 10/2015; DOI:10.1007/s40261-015-0351-1
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    ABSTRACT: Background and objectives: A fixed-dose combination (FDC) of aspirin and clopidogrel bisulfate may improve medication adherence. However, the absence of data on the relative antiplatelet efficacy of FDC and separate dual pills (SDP) of aspirin and clopidogrel in real-world patients with stable coronary artery disease is a major factor retarding clinical introduction of such an FDC. Methods: This was a single-centre, randomized, open-label, parallel-group, non-inferiority trial. Patients who maintained a regimen of separate aspirin and clopidogrel pills for at least 1 year after drug-eluting stent implantation without adverse events were enrolled. Patients were randomly assigned to either the FDC group or the SDP group. Antiplatelet efficacy and tolerability were assessed at baseline and at 4 weeks. Results: Of the 93 enrolled patients, 83 (FDC group: n = 42; SDP group: n = 41) completed the study. The difference in the changes in P2Y12 percentage inhibition did not exceed the predetermined value for inferiority [mean difference -1.7; 95 % confidence interval (CI) -6.9 to 4.5, p < 0.001 for non-inferiority]. The changes from baseline to 4 weeks in P2Y12 reaction units (PRU) (mean difference 9.7 PRU, p = 0.46), maximal platelet aggregation (mean difference 2.0 %, p = 0.44) and aspirin reaction units (ARU) (mean difference -2.3 ARU, p = 0.88) did not differ significantly between the treatment groups. The tolerability of the FDC formulation was similar to that of SDP therapy (p = 0.68). Conclusion: In patients with prior percutaneous coronary intervention, the antiplatelet efficacy of the aspirin/clopidogrel FDC was non-inferior to that of SDP and the tolerability of the two regimens was similar after 4 weeks of treatment.
    Clinical Drug Investigation 10/2015; DOI:10.1007/s40261-015-0350-2
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    ABSTRACT: Background and objectives: Oxidative stress in drug-induced thrombocytopenia (TP) has been discussed. This study was carried out to assess the oxidative stress in patients with normal platelet count (NPC) and TP after linezolid (LZD) treatment and to evaluate if TP caused by LZD is associated with a reduction in antioxidation ability and an increase in lipid peroxidative product in platelets. Methods: After LZD treatment for 20 days, 44 patients with TP and 73 patients with NPC were included in this study. Blood samples were collected on the day before medicine treatment and day 7, 14, and 20 after LZD therapy. Levels of reactive oxygen species (ROS), malondialdehyde (MDA), and cholesterol as well as the activities of antioxidative enzyme were estimated. In addition, we identified 37 patients with TP caused by low-dose methotrexate (7.5-25 mg/week) therapy as a positive control group. Results: In total, 37.60 % of cases presented with TP on the 20th day of LZD administration. Individuals with TP had significantly elevated levels of ROS and MDA, low levels of superoxide dismutase (SOD) and catalase (CAT), significantly decreased high-density lipoprotein-cholesterol, low-density lipoprotein (LDL)-cholesterol levels, and increased oxidized-LDL levels in comparison to individuals with NPC. However, no significant changes in the levels of glutathione-peroxidase were found in the course of time. In all cases with LZD, significant increases in levels of ROS, MDA, and ox-LDL were found in the 20-day samples compared with their respective samples before LZD treatment. Correlation analysis revealed a positive association between platelet count and levels of SOD on day 20 and CAT on days 14 and 20 in plasma, a negative association between platelet count and level of MDA and ROS on days 14 and 20 in patients with LZD-induced TP. Conclusions: The oxidative stress markers were increased in LZD-induced TP, suggesting that oxidative damage might be the underlying mechanism.
    Clinical Drug Investigation 10/2015; DOI:10.1007/s40261-015-0352-0
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    ABSTRACT: Background and objective: Breakthrough pain (BTP) is highly prevalent in patients with cancer and is strongly associated with adverse outcomes related to health status, mood, anxiety and depression. However, studies on the effect of BTP medication on quality of life (QOL) are lacking. The purpose of this study was to provide a qualitative evaluation of the effect of sublingual fentanyl tablets (SFT), a therapy specifically developed for BTP, on the QOL of cancer pain patients. Methods: We conducted a multicentre, prospective observation post-authorisation, open-label study between March and December 2013. The study consisted of a screening visit and four assessment points at 3, 7, 15 and 30 days. Pain intensity (PI), frequency of BTP, onset of pain relief and adverse events (AEs) were assessed at each visit. Anxiety and depression were evaluated using the validated Hospital Anxiety and Depression Scale (HADS) and health status using the Short Form 12, version 2 (SF-12v2) Health Survey. Results: Of the 102 patients considered eligible, 81 (79.4 %) were enrolled; of these, 69 (85.1 %) completed the study. Significant pain reduction was achieved for average PI (p < 0.001) compared with baseline. At the end of the observational period, HADS scores showed significant improvement in the depression subscale (p = 0.005) and the anxiety subscale (p < 0.001). Similarly, SF-12 scores showed significant improvement, both in the mental component score (p < 0.001) and the physical component score (p = 0.002). SFT was well-tolerated and only one patient withdrew from the study due to drug-related AEs. Conclusion: SFT represents an effective, well-tolerated treatment for cancer BTP. Results provide consistent evidence for the positive impact of SFT on health-related QOL and physical functioning as well as other co-morbidities of cancer BTP such as anxiety and depression.
    Clinical Drug Investigation 10/2015; DOI:10.1007/s40261-015-0344-0
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    ABSTRACT: Oral teneligliptin [Teneglucon(®) (Argentina)], a dipeptidyl peptidase-4 inhibitor, is indicated for the treatment of adults with type 2 diabetes (T2DM). This article reviews the pharmacology, therapeutic efficacy and tolerability of teneligliptin in the treatment of adults with T2DM. In 12- or 16-week, placebo-controlled phase 2 and 3 trials, oral teneligliptin 20 or 40 mg once daily, as monotherapy or in combination with metformin, glimepiride or pioglitazone improved glycaemic control, including in patients with end-stage renal disease, and was generally well tolerated. Most treatment-emergent adverse events were of mild intensity and relatively few patients discontinued treatment because of these events. Improvements in glycaemic control observed in short-term trials were maintained at 52 weeks in extension phases of these trials and in 52-week interventional studies, with no new safety concerns identified during this period. In the absence of direct head-to-head clinical trials, the position of teneligliptin relative to other antidiabetic agents in the management of T2DM remains to be determined. In the meantime, teneligliptin is a useful treatment option for adults with T2DM who have not responded adequately to diet and exercise regimens, or the addition of antidiabetic drugs.
    Clinical Drug Investigation 10/2015; DOI:10.1007/s40261-015-0348-9
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    ABSTRACT: Background and objectives: Desloratadine, the major active metabolite of loratadine, is a non-sedating long-acting antihistamine that is widely used in the treatment of allergic rhinitis and chronic idiopathic urticaria. This study aimed to investigate the prevalence of desloratadine slow-metabolizer (DSM) phenotype and the effects of food on the pharmacokinetics of desloratadine and its active metabolite 3-OH-desloratadine in healthy Chinese volunteers. Methods: A total of 46 healthy Chinese male volunteers were included in this investigation. All subjects received a single dose of a 5-mg desloratadine tablet under fasting or fed conditions and the plasma concentrations of desloratadine and 3-OH-desloratadine were measured by liquid chromatography-tandem mass spectrometry. The pharmacokinetic profiles were analyzed using a non-compartmental method in the Phoenix WinNonlin program. The individuals with a 3-OH-desloratadine-to-desloratadine exposure ratio lower than 10 % or a desloratadine half-life (t 1/2) of ≥50 h were supposed to be DSM. Results: There was only one DSM among the 46 volunteers, with a prevalence of 2.2 %. Moreover, administration in a fed state resulted in 34.07 and 32.06 % decreases in maximum plasma concentration and area under the concentration-time curve from time zero to infinity for desloratadine and 47.26 and 48.46 % for 3-OH-desloratadine compared with those values under fasting conditions. Conclusions: Taken together, these results indicated that the incidence of the DSM phenotype in the Chinese population was low and that food intake could significantly decrease the absorption rate and extent of desloratadine.
    Clinical Drug Investigation 10/2015; DOI:10.1007/s40261-015-0343-1
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    ABSTRACT: Background and objectives: We studied the effect of achieving sustained virological response (SVR) on the risk of developing hepatocellular carcinoma (HCC) in patients with hepatitis C receiving anti-hepatitis C virus treatment. Avoiding HCC is considered the main long-term benefit of successful antiviral treatment. Methods: Our literature search extended up to June 2015. We identified all studies that assessed the risk of HCC in patients achieving or not achieving SVR. Meta-analysis was based on a standard random-effect model. The end-point was occurrence of HCC compared between patients with and without SVR; this end-point was expressed as an odds ratio and percent reduction in risk and was also presented separately for patients with and without cirrhosis. All results estimates presented with 95 % confidence intervals (CIs). The presence of any temporal trend in these indexes was investigated by standard meta-regression. Results: Our search identified 25 observational studies (19,822 patients). The odds ratio of HCC for SVR versus no-SVR was 0.19 (95 % CI 0.15-0.24) in the overall series of 25 studies. The difference in this index between patients with any stage of fibrosis/cirrhosis and those with cirrhosis was small. With regard to risk difference, the 25 studies indicated an overall reduction of 10 % (95 % CI 8.00-12.0); this effect was much less pronounced in the group with any stage of fibrosis/cirrhosis (risk difference 6.7 %) than in the selected group with cirrhosis (risk difference 22 %). Meta-regression showed no temporal trend. Conclusion: Our analysis was successful in providing an updated overview on this controversial topic. Some pharmacoeconomic assessments are also presented to interpret the clinical results of our analysis.
    Clinical Drug Investigation 10/2015; DOI:10.1007/s40261-015-0338-y
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    ABSTRACT: Intra-articular administration of hyaluronic acid is a valuable therapeutic tool for the management of patients with osteoarthritis. However, in recent years numerous formulations containing hyaluronic acid administrable by oral route have entered the market. Even if there are some data in the literature that have shown their effectiveness, systemic administration may expose a greater risk in certain situations. In fact, although hyaluronic acid is not considered a drug it is certain that it can interact with specific receptors and promote cell proliferation. This interaction may be potentially hazardous in cancer patients for which these oral formulations should be contraindicated.
    Clinical Drug Investigation 09/2015; 35(11). DOI:10.1007/s40261-015-0339-x
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    ABSTRACT: Background and objective: Long-term adverse effects of oral glucocorticoids are frequent and serious. Large between-patient variability in the pharmacokinetics of prednisolone might explain why drug dose is a poor predictor of drug-related toxicity. The aim of the study was to investigate relationships between prednisolone exposure and adverse effects. Methods: Male kidney transplant recipients were recruited for serial blood sampling and assessment of glucocorticoid-related adverse effects including dyslipidaemia, abnormal body fat distribution, Cushingoid appearance and impaired quality of life. Total and free prednisolone plasma concentrations were determined using ultra-high-performance liquid chromatography with tandem mass spectrometric detection. Prednisolone exposure was estimated using a limited sampling strategy. Results: Fifty-six patients were recruited. Patients had a mean age of 54 years and median time post-transplantation of 75 months. Median prednisolone dose was 5 mg. Mean area under the plasma concentration-time curve was 2390 nmol h/L (±580) (SD) and 175 nmol h/L (±78) for total and free prednisolone, respectively. Waist to upper arm circumference ratio was positively associated with free prednisolone plasma exposure with a Spearman correlation coefficient of 0.30 (p value 0.02). The correlation coefficient was 0.24 (p value 0.08) for neck to upper arm circumference ratio and free prednisolone plasma exposure. The clinical Cushingoid phenotype as determined by the Visual Assessment of Cushing's Severity (VACS) score was associated with a reduced score relating to physical functioning on the SF-12, but there was no significant relationship between free prednisolone plasma exposure and quality-of-life scores. Lipid levels and haemoglobin A1c (HbA1c) were not associated with total or free prednisolone exposure. Conclusions: There is a positive correlation between free prednisolone plasma exposure and waist to upper arm circumference ratio in adult male kidney transplant recipients on low maintenance prednisolone doses. There is no significant association between total or free prednisolone plasma exposure and plasma glucose and lipid levels in the low prednisolone dose range.
    Clinical Drug Investigation 09/2015; 35(11). DOI:10.1007/s40261-015-0334-2
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    ABSTRACT: Background and objective: Patients with bipolar I disorder and schizophrenia have an increased risk of obstructive sleep apnea. The effects of armodafinil, a weak cytochrome P450 (CYP) 3A4 inducer, on pharmacokinetics and safety of risperidone, an atypical antipsychotic used to treat major psychiatric illness, were investigated. Methods: Healthy subjects received 2 mg risperidone alone and after armodafinil pretreatment (titrated to 250 mg/day). Pharmacokinetic parameters were derived from plasma concentrations of risperidone and its active metabolite, 9-hydroxyrisperidone (formed via CYP2D6 and CYP3A4), collected before and over 4 days after risperidone administration, and from steady-state plasma concentrations of armodafinil and its circulating metabolites, R-modafinil acid and modafinil sulfone. Safety and tolerability were assessed. Results: Thirty-six subjects receiving study drug were evaluable for safety; 34 were evaluable for pharmacokinetics. Risperidone maximum plasma concentration (C max) decreased from mean 16.5 ng/mL when given alone to 9.2 ng/mL after armodafinil pretreatment (geometric mean ratio [90 % CI] 0.55 [0.50-0.61]); area under the plasma concentration-time curve from time 0 to infinity (AUC0-∞) decreased from 92.3 to 44.5 ng·h/mL (geometric mean ratio [90 % CI] 0.51 [0.46-0.55]). C max and AUC0-∞ for 9-hydroxyrisperidone were also reduced (geometric mean ratios [90 % CI] 0.81 [0.77-0.85] and 0.73 [0.69-0.77], respectively). Adverse events were consistent with known safety profiles. Conclusion: Consistent with CYP3A4 induction, risperidone and 9-hydroxyrisperidone systemic exposure was reduced in the presence of armodafinil. Concomitant armodafinil and risperidone use may necessitate risperidone dosage adjustment, particularly when starting or stopping coadministration of the two drugs. However, any such decision should be based on patient disease state and clinical status.
    Clinical Drug Investigation 09/2015; 35(11). DOI:10.1007/s40261-015-0330-6
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    ABSTRACT: Objectives: The aim of this work was to investigate the efficacy and safety of loading-dose rosuvastatin therapy in elderly patients with non-ST-segment elevation acute coronary syndromes (NSTEACS) undergoing elective percutaneous coronary intervention (PCI). Methods: A total of 126 patients (≥70 years old) with NSTEACS were randomly divided into two groups: (1) loading-dose rosuvastatin-treated group, treated with rosuvastatin 20 mg 12 h prior to PCI, with a second dose administered just before PCI (n = 62), and (2) control-treated group, treated with the standard method according to ACC/AHA guidelines in UAP/NSTEMI 2007 (n = 64). All patients were required to take rosuvastatin 10 mg once a day starting 24 h after the surgery irrespective of the initial randomization assignment. The serum soluble lectin-like oxidized low-density lipoprotein receptor-1 (sLox-1), high-sensitivity C-reactive protein (hs-CRP), creatinine kinase (CK)-MB, cardiac troponin I (cTnI), and brain natriuretic peptide (BNP) levels were measured prior to PCI and at 24 h and 30 days after PCI in both groups. The left ventricular ejection fraction (LVEF) levels were recorded prior to PCI and 30 days after PCI in both groups. Results: Compared to pre-PCI, the serum sLox-1, hs-CRP, CK-MB, and cTnI levels were increased at 24 h after PCI (all p < 0.05) in both groups. However, the increased sLox-1, hs-CRP, CK-MB, and cTnI values were significantly lower in the loading-dose rosuvastatin-treated group than in the control-treated group (p < 0.05). In addition the serum sLox-1 and hs-CRP levels were lower in the loading-dose rosuvastatin-treated group than in the control-treated group at 30 days after PCI. However, the decreased values of sLox-1and hs-CRP from 24 h after PCI to 30 days after PCI did not show any significant difference between the two groups. No significant difference was found in the serum ALT and Scr levels between the two groups before and after PCI. Compared to the control-treated group, the serum BNP level decreased (p < 0.05) and LVEF (p < 0.05) increased in the loading-dose rosuvastatin-treated group at 30 days after PCI. Conclusion: The loading-dose rosuvastatin therapy in elderly patients with non-ST-segment elevation acute coronary syndromes undergoing elective PCI can attenuate the increase in serum hs-CRP, sLox-1, CK-MB, and cTnI levels, reduce myocardial injury and inflammatory reaction caused by PCI, and improve the LVEF level at 30 days after PCI, ensuring an effective and safe therapy.
    Clinical Drug Investigation 09/2015; DOI:10.1007/s40261-015-0335-1