Abstract:
:The objective of this study was to compare the lipid-altering efficacy and safety of simvastatin with that of gemfibrozil in hypercholesterolemic patients with non-insulin-dependent diabetes mellitus (NIDDM). The study was a 24-week, double-blind, randomized, multicenter trial conducted at clinics and hospitals in the United States, Austria, Germany, Brazil, and New Zealand. The study population included 168 men and women aged 34 to 78 years with NIDDM and primary hypercholesterolemia (low-density lipoprotein cholesterol [LDL-C] level at screening was > or = 4.9 mmol/L with no other risk factor or > or = 4.1 mmol/L with one or more other risk factors). All patients had been under moderate-to-good diabetic control (hemoglobin A1c [HbA1c] < or = 10.0%) for at least 6 months with diet alone, oral hypoglycemic agents, or insulin therapy. Patients meeting eligibility criteria were randomized to receive either simvastatin 10 mg (titrated up to 40 mg to achieve an LDL-C level < 3.4 mmol/L) once in the evening or gemfibrozil 600 mg twice daily. There were 81 patients in the simvastatin group and 87 patients in the gemfibrozil group. After 17 weeks of treatment, simvastatin significantly reduced levels of total cholesterol, LDL-C, and very-low-density lipoprotein cholesterol (VLDL-C) by approximately 25%, 33%, and 20%, respectively (P < or = 0.001), and triglycerides by about 9% (P < or = 0.05). The drug increased high-density lipoprotein cholesterol (HDL-C) levels by about 6% (P < 0.01). Gemfibrozil significantly reduced total cholesterol, VLDL-C, and triglyceride levels by approximately 8%, 38%, and 27%, respectively (P < 0.001); it significantly increased HDL-C values by about 12% (P < 0.001). Gemfibrozil lowered LDL-C levels by 4% but not significantly. The decreases in total cholesterol and LDL-C were significantly greater (P < 0.001) in the simvastatin group, and decreases in VLDL-C and triglycerides were significantly greater in the gemfibrozil group (P < 0.01). The changes in HDL-C were not significantly different between groups. LDL-C values of < 3.4 mmol/L were achieved in 60% of the simvastatin patients and 14% of the gemfibrozil patients. There were no significant between-group differences in fasting serum glucose or HbA1c at any time point. Glycemic profiles (performed at baseline and after 17 weeks of treatment) and glucose area under the curve (at baseline and after 17 weeks of treatment) were not significantly different between treatment groups. Both drugs were generally well tolerated.(ABSTRACT TRUNCATED AT 400 WORDS)
journal_name
Clin Therjournal_title
Clinical therapeuticsauthors
Sweany AE,Shapiro DR,Tate AC,Goldberg RB,Stein EAdoi
10.1016/0149-2918(95)80018-2subject
Has Abstractpub_date
1995-03-01 00:00:00pages
186-203issue
2eissn
0149-2918issn
1879-114Xpii
0149291895800182journal_volume
17pub_type
临床试验,杂志文章,多中心研究,随机对照试验abstract:PURPOSE:This article outlines several important issues regarding the management of patients with gout. The topics discussed include best practices for gout based on the most current guidelines, opportunities for improving gout management, and current and emerging therapies for gout. METHODS:[PubMed and Google Scholar ...
journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
doi:10.1016/j.clinthera.2016.12.011
更新日期:2017-02-01 00:00:00
abstract::A meeting of 14 transplant and pharmacokinetic specialists from Europe and North America was convened in November 2001 to evaluate scientific and clinical data regarding the use of different formulations of cyclosporin A (CsA). The following consensus was achieved. (1) CsA is a critical-dose drug with a narrow therape...
journal_title:Clinical therapeutics
pub_type: 共识发展会议,杂志文章,评审
doi:10.1016/s0149-2918(03)80161-3
更新日期:2003-06-01 00:00:00
abstract:BACKGROUND:Mycophenolate mofetil (MMF) is an immunosuppressant indicated for prophylaxis of acute organ transplant rejection. Generic MMF is less costly than the branded product, but European regulatory authorities require bioequivalence studies for the marketing of generics. OBJECTIVES:The aims of the 2 studies repor...
journal_title:Clinical therapeutics
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.clinthera.2011.04.003
更新日期:2011-03-01 00:00:00
abstract:BACKGROUND:Enzyme replacement therapy (ERT) with imiglucerase is a well-established, effective treatment for Gaucher disease. However, there have been no published reports regarding the excretion of imiglucerase into human breast milk and its effects on the nursing infant. OBJECTIVE:This letter reports on the successf...
journal_title:Clinical therapeutics
pub_type: 信件
doi:10.1016/j.clinthera.2010.11.008
更新日期:2010-11-01 00:00:00
abstract:PURPOSE:It is unclear whether vitamin D provides any benefit against the pro-inflammatory effects of homocysteine in elderly patients with type 2 diabetes mellitus (T2DM). METHODS:We compared lymphocyte counts for CD3, CD19, CD4, and CD8 subsets between elderly (age ≥65 years) T2DM patients (n = 5098) and nondiabetes ...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2020.08.009
更新日期:2020-10-01 00:00:00
abstract::A prospective, multicenter, open-label randomized trial was conducted to compare the efficacy and tolerability of imipenem-cilastatin (I-C) monotherapy with clindamycin+aminoglycoside (C+A) combination therapy. Forty-nine patients were able to be evaluated for clinical efficacy in the treatment of postpartum endometri...
journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章,多中心研究,随机对照试验
doi:
更新日期:1992-01-01 00:00:00
abstract:BACKGROUND:Fenofibrate lowers serum total cholesterol and triglyceride levels while it elevates serum high-density lipoprotein cholesterol (HDL-C) level. OBJECTIVE:The aim of this study was to investigate the effects of fenofibrate on the particle size of high-density lipoprotein (HDL). METHODS:Patients with hyperlip...
journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章,多中心研究,随机对照试验
doi:10.1016/s0149-2918(02)80064-9
更新日期:2002-10-01 00:00:00
abstract:BACKGROUND:Since its implementation in 2006, Medicare Part D has evolved from a program that offered basic access to covered drugs for beneficiaries to one that has the potential to affect patient outcomes. OBJECTIVES:The purpose of this article was to highlight key research findings on Medicare Part D published in 20...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2013.02.024
更新日期:2013-04-01 00:00:00
abstract:PURPOSE:The International Conference on Harmonisation E14 guideline mandates an intensive cardiac safety evaluation in a clinical thorough QT study, typically in healthy subjects, for all new non-antiarrhythmic drugs with systemic bioavailability. This thorough QT study investigated the effects of therapeutic (2 mg) an...
journal_title:Clinical therapeutics
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.clinthera.2015.09.006
更新日期:2015-11-01 00:00:00
abstract::In a previous report of a multicenter study (Kannel et al, 1990), the results of 6 months' treatment with lovastatin in 489 adults with primary hypercholesterolemia were presented. The present report contains the results from the 236 women patients. The intial dose of lovastatin was 20 mg daily and could be increased ...
journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章,多中心研究
doi:
更新日期:1992-05-01 00:00:00
abstract:BACKGROUND:Cefprozil and erythromycin are acceptable alternatives to penicillin in the treatment of pharyngitis/tonsillitis due to group A beta-hemolytic streptococcus (GABHS). OBJECTIVE:The purpose of this trial was to determine the relative efficacy and tolerability of cefprozil and erythromycin in the treatment of ...
journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章,多中心研究,随机对照试验
doi:10.1016/s0149-2918(00)89084-0
更新日期:2001-11-01 00:00:00
abstract:BACKGROUND:Coronary heart disease is the major cause of mortality in individuals with diabetes mellitus (DM). Given the increasingly aggressive low-density lipoprotein cholesterol (LDL-C) goals for patients with DM set by the National Cholesterol Education Program Adult Treatment Panel III and the American Diabetes Ass...
journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章,多中心研究,随机对照试验
doi:10.1016/s0149-2918(04)90033-1
更新日期:2004-03-01 00:00:00
abstract:PURPOSE:Improvement in health behaviors following cancer diagnosis may contribute to better prognosis and well-being. This study examines the prevalence of health behaviors in cervical cancer survivors who have completed treatment, and associations between health behaviors and quality of life (QOL). METHODS:We recruit...
journal_title:Clinical therapeutics
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.clinthera.2016.02.006
更新日期:2016-03-01 00:00:00
abstract:BACKGROUND:The off-label use of beta-blockers might be prevalent, but no studies have provided empiric data on the off-label use based on utilization data. OBJECTIVE:This secondary data analysis was conducted to describe the trends of off-label use of beta-blockers among ambulatory visits made to office-based physicia...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2006.10.015
更新日期:2006-10-01 00:00:00
abstract:PURPOSE:The objective of this study was to evaluate the efficacy and tolerability of a triple combination of amlodipine/losartan/rosuvastatin in patients with hypertension and hypercholesterolemia. METHODS:A randomized, multicenter, double-blind, placebo-controlled study was conducted. Eligible patients with hypertens...
journal_title:Clinical therapeutics
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1016/j.clinthera.2017.10.013
更新日期:2017-12-01 00:00:00
abstract::Calorie/protein malnutrition is a common problem among dialysis patients. A study was designed to determine the value of adding a mixture of amino acids to the diet of 36 patients (mean age, 42 years) who had been receiving triweekly hemodialysis for periods ranging from 1 to 13 years. For 1 month the patients receive...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:
更新日期:1993-07-01 00:00:00
abstract:BACKGROUND:The effectiveness of a drug is significantly influenced by a patient's adherence to the required regimen. OBJECTIVE:The goal of this retrospective database analysis was to determine the factors affecting adherence over a 12-month follow-up period in adults with type 2 diabetes mellitus (DM) initiating once-...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2013.03.021
更新日期:2013-06-01 00:00:00
abstract:BACKGROUND:Patients' preferences for medications may be important in determining their compliance with therapy, particularly in the case of an asymptomatic chronic disease such as osteoporosis. Although preferences for certain attributes of osteoporosis medications, including dosing frequency and tolerability, can be e...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/s0149-2918(07)80087-7
更新日期:2007-03-01 00:00:00
abstract::The causes of past accidental viral transmissions associated with blood derivatives are reviewed briefly, as are the safety procedures instituted in Europe on the basis of viral validation studies. A comprehensive five-class classification system for delineating viral risk according to source material and comparative ...
journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
doi:10.1016/s0149-2918(96)80194-9
更新日期:1996-01-01 00:00:00
abstract:PURPOSE:Our study evaluated adverse events of therapeutic failure (and specifically reduced duration of action) with the use of a branded product, Osmotic Release Oral System (OROS) methylphenidate, which is approved for the treatment of attention deficit/hyperactivity disorder, and a generic product (methylphenidate, ...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2017.08.018
更新日期:2017-10-01 00:00:00
abstract:BACKGROUND:Numerous studies have explored dietary-management strategies for decreasing leukotriene synthesis by inflammatory cells through supplementation with polyunsaturated fatty acids such as gamma-linolenic acid (GLA) and eicosapentaenoic acid (EPA). OBJECTIVES:This study sought to determine the optimal daily int...
journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1016/s0149-2918(03)80116-9
更新日期:2003-03-01 00:00:00
abstract::The acid-neutralizing capacity and sodium content of nine antacid products available in Belgium were evaluated and compared with typical values for Mylanta-II. Liquid and tablets of Mylanta-II have a higher acid-neutralizing capacity per unit dose than do all the other Belgian antacids tested. On a unit dose basis, th...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:
更新日期:1984-01-01 00:00:00
abstract:BACKGROUND:High incidences of cardiovascular events coincide with a surge in blood pressure (BP) that occurs in the early morning hours at the time of arousal. Thus, control of BP at this time of day, using oral fixed-dose combinations (FDCs) as required, is important in reducing cardiovascular risk in hypertensive pat...
journal_title:Clinical therapeutics
pub_type: 杂志文章,meta分析
doi:10.1016/j.clinthera.2005.11.014
更新日期:2005-11-01 00:00:00
abstract::The effects of 4 weeks of treatment with doxazosin or enalapril on diastolic blood pressure (DBP) and plasma lipid levels were studied in 160 patients 18 to 50 years old with mild-to-moderate hypertension. Comparing baseline measurements with measurements taken after 4 weeks, DBP was significantly reduced by 6.8 +/- 7...
journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章,多中心研究,随机对照试验
doi:10.1016/s0149-2918(97)80130-0
更新日期:1997-05-01 00:00:00
abstract:BACKGROUND:Combination therapy with at least 2 antihypertensive agents is usually needed to achieve appropriate blood pressure (BP) control in patients with isolated or predominant systolic hypertension. A currently recommended combination is a diuretic added to an angiotensin-receptor blocker. OBJECTIVE:This was a st...
journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章,多中心研究,随机对照试验
doi:10.1016/j.clinthera.2005.07.010
更新日期:2005-07-01 00:00:00
abstract:BACKGROUND:Seasonal allergic rhinitis (SAR) is an allergen-induced inflammatory reaction that occurs during periods of high pollen count. Current treatments for SAR include allergen avoidance, systemic antihistamines, and steroidal and nonsteroidal intranasal sprays. Olopatadine is a selective antihistamine and an inhi...
journal_title:Clinical therapeutics
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1016/j.clinthera.2009.01.016
更新日期:2009-01-01 00:00:00
abstract:OBJECTIVE:This study was conducted to evaluate data on chemotherapy-associated anemia and thrombocytopenia, and cycle delays in patients with cancer in a community oncology practice. METHODS:Data on adult patients (age > or =18 years) with cancer treated in outpatient oncology clinics throughout the United States betw...
journal_title:Clinical therapeutics
pub_type: 杂志文章,多中心研究
doi:10.1016/j.clinthera.2009.11.020
更新日期:2009-01-01 00:00:00
abstract:BACKGROUND:Cytochrome P450-related drug interactions can lead to adverse effects that may affect health care resource utilization. OBJECTIVE:The purpose of this study was to quantify the impact of drug interactions involving hydroxymethylglutaryl-coenzyme A reductase inhibitors (statins) on health care resource utiliz...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/s0149-2918(02)80102-3
更新日期:2002-12-01 00:00:00
abstract:BACKGROUND:Emergence agitation (EA) after emergence from sevoflurane anesthesia is a common phenomenon in children. The efficacy of prophylactic midazolam or clonidine in preventing EA is controversial. OBJECTIVE:We performed a meta-analysis of clinical trials of the 2 drugs to evaluate their ability to prevent EA in ...
journal_title:Clinical therapeutics
pub_type: 杂志文章,meta分析,评审
doi:10.1016/j.clinthera.2013.08.016
更新日期:2013-10-01 00:00:00
abstract::A double-blind, randomized protocol was used to investigate the activity of a benzodiazepine derivative, chlordesmethyldiazepam, at two different dosages, 1 mg and 2 mg (CDDZ1 and CDDZ2), on mnestic functions and information processing in normal subjects. CDDZ2 significantly impaired short-term shortage of logical and...
journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章,随机对照试验
doi:
更新日期:1981-01-01 00:00:00