Abstract:
OBJECTIVE:This study evaluated the efficacy and tolerability of glimepiride in patients with type 2 diabetes mellitus that was inadequately controlled with a combination of immediate- or extended-release metformin and a thiazolidinedione. METHODS:This was a multicenter, randomized, double-blind, placebo-controlled, parallel-group, 2-arm study consisting of a 4-week stabilization and eligibility period and a 26-week treatment period. Patients with a diagnosis of type 2 diabetes for a minimum of 1 year received glimepiride (titrated sequentially from 2 to 4 to 8 mg/d over 6 weeks, followed by 20 weeks of maintenance therapy) or placebo in combination with an established regimen of immediate- or extended release metformin and rosiglitazone or pioglitazone. The primary efficacy outcome was the change in glycosylated hemoglobin (HbA(1c)) from baseline. The safety analysis was based on the incidence of hypo glycemia, adverse events, and laboratory abnormalities. Changes in lipid levels (high-density lipoprotein cholesterol, total cholesterol, low-density lipoprotein cholesterol, very low density lipoprotein cholesterol, and triglycerides) were evaluated, and health-related quality of life was assessed based on scores on the Diabetes Care Profile (DCP) and Health Utilities Index Mark 3 (HU13). RESULTS:Of 170 randomized patients, 159 were included in the efficacy analysis and 168 were included in the safety analysis. Demographic variables were similar at baseline between the glimepiride and placebo groups (mean age, 56.5 and 56.4 years, respectively; percent men/women, 61.0%/39.0% and 62.3%/37.7%; weight, 100.9 and 96.3 kg). HbA(1c) was significantly improved at end point with glimepiride combination therapy compared with placebo (mean [SE], -1.31% [0.08] vs -0.33% [0.08], respectively; P < 0.001). The majority of patients (62.2%) who received glimepiride achieved an HbA(1c) value of < or =7%, compared with 26.0% of patients receiving placebo (P < 0.001 between groups). At end point, the adjusted mean differences between treatments significantly favored the glimepiride combination in terms of fasting plasma glucose (-37.4 [4.0] mg/dL; P < 0.001), fasting insulin (4.06 [1.69] microIU/mL; P < 0.03), and C-peptide (124.5 [35.9] pmol/L; P < 0.001). The adjusted mean changes in body mass index from baseline to end point were 1.26 (0.16) kg/m(2) with glimepiride and 0.17 (0.16) kg/m(2) with placebo (P < 0.001). Similarly, the mean change in weight was greater with glimepiride than with placebo (3.76 [0.54] vs 0.45 [0.52] kg; P < 0.001). There were no significant differences in lipid levels between groups. Clinically significant adverse events, laboratory abnormalities, and rates of severe hypoglycemia were similar between treatment groups. The overall incidence of hypoglycemia, however, was 51.2% in the glimepiride group and 8.3% in the placebo group (P < 0.001). In general, there was no significant difference between treatment groups with respect to scores on the DCP or HUI3 over the study period. CONCLUSIONS:In these patients with type 2 diabetes that was not adequately controlled by dual combination therapy with metformin and a thiazolidinedione, the addition of glimepiride improved glycemic control compared with placebo with an acceptable tolerability profile. Although there were significantly more episodes of hypoglycemia with triple therapy than with dual therapy and placebo, the risk for severe hypoglycemia was low.
journal_name
Clin Therjournal_title
Clinical therapeuticsauthors
Roberts VL,Stewart J,Issa M,Lake B,Melis Rdoi
10.1016/j.clinthera.2005.10.017subject
Has Abstractpub_date
2005-10-01 00:00:00pages
1535-47issue
10eissn
0149-2918issn
1879-114Xpii
S0149-2918(05)00205-5journal_volume
27pub_type
杂志文章,多中心研究,随机对照试验abstract::Flecainide, a new antiarrhythmic agent, was given to eight healthy men to ascertain plasma drug levels and to assess tolerance for the drug. Each subject received a single intravenous (IV) dose (0.5, 1, 1.5, or 2 mg/kg) of flecainide, and plasma levels of unchanged flecainide were measured by gas-liquid chromatography...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:
更新日期:1984-01-01 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::Encapsulation affects the virulence and survival of anaerobic bacteria and their protection from phagocytosis. More encapsulated Bacteroides strains and anaerobic and facultative gram-positive cocci are isolated from patients with clinical infections than from healthy people. The pathogenicity of Bacteroides, Fusobact...
journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
doi:
更新日期:1987-01-01 00:00:00
abstract::Ketoprofen is a nonsteroidal anti-inflammatory drug (NSAID) of the propionic acid family with demonstrated efficacy in the treatment of rheumatoid arthritis and osteoarthritis; a distinguished safety profile; and good tolerability. This report describes a new extended-release formulation that maintains therapeutic pla...
journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
doi:
更新日期:1994-03-01 00:00:00
abstract::Twenty-seven Escherichia coli test strains that were not susceptible to cephalothin were tested for susceptibility to cefazolin, cefamandole, and ceforanide. By zone-size criteria (greater than or equal to 18 mm), 67% of E coli were susceptible to cefazolin and cefamandole, and 93% were susceptible to ceforanide. By m...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:
更新日期:1985-01-01 00:00:00
abstract:BACKGROUND:Flexibility in the recommended dosing time for a statin may improve patient compliance. OBJECTIVE:This study was designed to compare the efficacy and tolerability of morning and evening doses of controlled-release simvastatin in Korean adults with dyslipidemia. It was carried out as a requirement to obtain ...
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.2013.06.020
更新日期:2013-09-01 00:00:00
abstract:BACKGROUND:Prophylaxis with granulocyte colony-stimulating factor reduces the risk for febrile neutropenia (FN) in patients receiving myelosuppressive chemotherapy. OBJECTIVE:We estimated the incremental cost-effectiveness of primary prophylaxis (starting in cycle 1 of chemotherapy) with pegfilgrastim versus filgrasti...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2009.05.003
更新日期:2009-05-01 00:00:00
abstract:PURPOSE:The effect of peripheral arterial disease (PAD) among young and middle-aged adults can be significant, but no previous study has examined the prognosis and the associated health care cost of the disease in this population. We evaluated the clinical and economic burden of PAD in patients from a large claims data...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2014.06.013
更新日期:2014-08-01 00:00:00
abstract::Chancroid, the third most prevalent venereal disease in Thailand, was treated with a single 2-gm dose of spectinomycin, or two tablets of co-trimoxazole (trimethoprim-sulfamethoxazole) twice daily for seven days. The differences in cure rates between the two groups were statistically significant. The chancroidal ulcer...
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:1990-05-01 00:00:00
abstract::The total cost of administering calcium polycarbophil per unit dose (two tablets) was compared with that of administering psyllium mucilloid (one packet dissolved in 8 oz of water) in 20 elderly nursing-home residents. Times for printing labels, checking and initialing labels, gathering materials needed, and preparing...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:
更新日期:1990-01-01 00:00:00
abstract:BACKGROUND:In this era of evidence-based medicine, clinicians require a comprehensive range of well-designed studies to support prescribing decisions and patient management. In recent years, data from observational studies have become an increasingly important source of evidence because of improvements in observational...
journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
doi:10.1016/j.clinthera.2007.07.004
更新日期:2007-06-01 00:00:00
abstract:BACKGROUND:Linezolid is available in an oral as well as an intravenous formulation. It is an oxazolidinone antibiotic and is effective in treating resistant gram-positive organisms such as methicillin-resistant Staphylococcus aureus and multidrug-resistant Streptococcus pneumoniae. OBJECTIVES:The goals of this study w...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/S0149-2918(10)80027-X
更新日期:2010-12-01 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:PURPOSE:The purpose of this review is to discuss the selection and use of disease- modifying treatments for patients with relapsing forms of multiple sclerosis (MS). METHODS:PubMed was searched (1966-2014) using the terms multiple sclerosis, treatment, interferon, glatiramer acetate, dimethyl fumarate, fingolimod, ter...
journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
doi:10.1016/j.clinthera.2014.08.006
更新日期:2014-12-01 00:00:00
abstract:BACKGROUND:Metastatic bone disease is a serious clinical problem in patients with advanced cancer. Bisphosphonates inhibit the activity of osteoclasts and are the treatment of choice for bone metastases. OBJECTIVE:This article reviews the efficacy and safety data from Phase III trials of ibandronate in metastatic bone...
journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
doi:10.1016/j.clinthera.2004.12.010
更新日期:2004-12-01 00:00:00
abstract::This article reviews the administration, efficacy, and safety of prophylactic intravenous immunoglobulin in patients with secondary immunodeficiency and those undergoing allogeneic bone marrow transplantation. Associated infections in these immunosuppressed patients are examined as they relate to transfusion-associate...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/s0149-2918(96)80204-9
更新日期:1996-01-01 00:00:00
abstract::The long-term tolerability and efficacy of indomethacin were evaluated in a retrospective study of 67 patients with moderate to severe rheumatoid arthritis, osteoarthritis, or ankylosing spondylitis who took the drug daily for periods ranging from three to 20 years. Only patients who had not experienced side effects d...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:
更新日期:1986-01-01 00:00:00
abstract:PURPOSE:We estimated the real-world costs of bleeding-related episodes (BREs) in adults with primary immune thrombocytopenia (ITP). METHODS:This retrospective cohort study used the MarketScan Commercial Claims and Encounters and Medicare Supplemental and Coordination of Benefits databases. We identified adult patients...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2017.01.023
更新日期:2017-03-01 00:00:00
abstract:BACKGROUND:Patients and physicians consider rapid onset of pain relief and pain freedom among the most important attributes of migraine therapy. OBJECTIVE:This study compared the effectiveness of rizatriptan 10 mg and usual-care oral migraine medications in everyday clinical practice settings. METHODS:This was a mult...
journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章,多中心研究
doi:10.1016/j.clinthera.2006.06.006
更新日期:2006-06-01 00:00:00
abstract:BACKGROUND:Etravirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) with activity against both wild-type HIV and viruses harboring NNRTI resistance. Etravirine is mainly eliminated via the hepatobiliary route. OBJECTIVES:This study in HIV- patients with mild or moderate hepatic impairment and healthy mat...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2010.02.013
更新日期:2010-02-01 00:00:00
abstract:PURPOSE:Few studies have determined the benefits of pharmacist-run clinics within a tertiary institution, and specifically on their capability to improve clinical outcomes as well as reduce the cost of illness. This study was designed to investigate the effectiveness of a pharmacist-managed risk factor management clini...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2017.10.009
更新日期:2017-12-01 00:00:00
abstract:PURPOSE:Allergic rhinitis (AR) is a highly prevalent disease, affecting the quality of life of millions of Americans. Intranasal corticosteroids (INCs) are widely recommended as first-line therapy for moderate to severe AR. Although these drugs exhibit similar safety and efficacy, a potentially differentiating factor w...
journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
doi:10.1016/j.clinthera.2019.05.017
更新日期:2019-08-01 00:00:00
abstract:BACKGROUND:The eradication rates of Helicobacter pylori with standard treatments are decreasing worldwide. OBJECTIVES:The primary aim of this study was to compare the eradication success of a 14-day sequential regimen with proton pump inhibitor (PPI)-based triple treatment. The secondary objectives of the study were t...
journal_title:Clinical therapeutics
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.clinthera.2008.03.009
更新日期:2008-03-01 00:00:00
abstract:OBJECTIVE:The aim of this research letter was to describe the use of N-carbamoyl-L-glutamate as first-line treatment of hyperammonemia in a 4-month-old female patient with propionic acidemia (PA). METHODS:A 4-month-old female patient weighing 3.9 kg presented with decompensation with PA and initial hyperammonemia of 4...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2010.04.004
更新日期:2010-04-01 00:00:00
abstract:OBJECTIVE:The objectives of this study were to observe a commercially insured sample diagnosed with a venous thromboembolism (VTE) event and treated postevent with warfarin and to detail the thromboembolic and bleeding outcomes in the time periods during warfarin therapy and after discontinuation of such therapy. METH...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/s0149-2918(04)90187-7
更新日期:2004-07-01 00:00:00
abstract::The increasing worldwide recognition of the deleterious sequelae of Chlamydia trachomatis urogenital tract infections makes rapid, inexpensive diagnostic tests a high priority. Cell culture, still the standard for all other methods, is only 90% sensitive. Direct fluorescent antibody (FA) tests use highly specific mono...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:
更新日期:1986-01-01 00:00:00
abstract:BACKGROUND:Combined therapy with cilostazol, an antiplatelet agent, and probucol, an antihyperlipidemic agent, has been reported to prevent restenosis after percutaneous transluminal coronary angioplasty. However, the potential for pharmacokinetic drug interactions between the 2 agents has not been evaluated. OBJECTIV...
journal_title:Clinical therapeutics
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.clinthera.2009.10.005
更新日期:2009-10-01 00:00:00
abstract::As a result of recent advances in our understanding of the role of nitric oxide and endothelial-derived relaxing factor (EDRF) in vascular control, physicians now have the potential to overcome the loss of EDRF effect by administering nitrates. Nitrates are converted to nitric oxide, resulting in vasodilator effects t...
journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
doi:
更新日期:1994-03-01 00:00:00
abstract:BACKGROUND:Cobalamin (vitamin B12) deficiency, the most common cause of megaloblastic anemia, is treated with intramuscular (IM) cobalamin. It has been suggested by some investigators that oral (p.o.) cobalamin treatment may be as effective in the treatment of this condition, with the advantages of ease of administrati...
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)90096-8
更新日期:2003-12-01 00:00:00
abstract::A total of 128 corticosteroid-independent adults with chronic allergic asthma were treated for six weeks with 400 micrograms/day of beclomethasone dipropionate aerosol. Most patients (114 or 89%) had a good to excellent response, characterized by a marked improvement in the signs and symptoms of asthma. Substantial im...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:
更新日期:1982-01-01 00:00:00