Abstract:
:A parallel-group, randomized, double-blind, forced-titration, multicenter study was done to compare the efficacy and safety of once-daily nifedipine coat-core (NIF CC) and once-daily nifedipine gastrointestinal therapeutic system (NIF GITS) dosed in the fasting state in patients with mild-to-moderate essential hypertension. Both formulations have been shown to effectively and safely lower blood pressure in placebo-controlled trials. After a 4-week placebo run-in period, 228 patients were randomized to 4 weeks of treatment with either NIF CC 30 mg daily or NIF GITS 30 mg daily. This period was followed by a forced-titration period to nifedipine 60 mg daily for an additional 4 weeks of double-blind therapy. After the 30-mg treatment period (the primary time point), there were no statistically significant differences between treatment groups in mean change from baseline in trough supine diastolic blood pressure, the primary efficacy variable (NIF CC patients, -7.0 mm Hg; NIF GITS patients, -8.4 mm Hg; P = 0.139). Also, because the upper bound of the treatment difference confidence interval was < 3.0 mm Hg, equivalence--as defined in the protocol--was established. After the 60-mg treatment period, the change from baseline in trough supine diastolic blood pressure was significantly greater for patients treated with NIF GITS than for patients treated with NIF CC (NIF GITS patients, -12.0 mm Hg; NIF CC patients, -8.4 mm Hg; P < 0.001). Because the upper bound of the confidence interval was > 3 mm Hg, equivalence cannot be claimed. No statistically significant differences were noted for the comparison of mean 24-hour ambulatory blood pressure monitoring changes. Both formulations were well tolerated.
journal_name
Clin Therjournal_title
Clinical therapeuticsauthors
Glasser SP,Ripa SR,Allenby KS,Schwartz LA,Commins BM,Jungerwirth Sdoi
10.1016/0149-2918(95)80028-xsubject
Has Abstractpub_date
1995-03-01 00:00:00pages
296-312issue
2eissn
0149-2918issn
1879-114Xpii
014929189580028Xjournal_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 study aims to investigate glycosylated hemoglobin (HbA1c), between-laboratory imprecision (%CV), and pass rates from 2012 to 2015 in Nanjing to provide evidence for improving the HbA1c measurement. METHODS:This was a retrospective, descriptive analysis of HbA1c levels obtained from participating hospitals...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2016.11.013
更新日期:2017-01-01 00:00:00
abstract::A four-week crossover study to compare the efficacy of an acne cleanser containing 2% salicylic acid with that of a 10% benzoyl peroxide wash was conducted in 30 patients with acne vulgaris. The results demonstrated that only patients treated with the salicylic acid cleanser had a significant reduction in comedones. P...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:
更新日期:1989-03-01 00:00:00
abstract:PURPOSE:Multidrug-resistant bacterial pathogens are becoming a significant problem worldwide. Acinetobacter baumannii and Pseudomonas aeruginosa are problematic multidrug-resistant pathogens. This multicenter study in Vietnam determined the level of resistance to antimicrobial agents used to treat A baumannii and P aer...
journal_title:Clinical therapeutics
pub_type: 杂志文章,多中心研究
doi:10.1016/j.clinthera.2016.07.172
更新日期:2016-09-01 00:00:00
abstract:BACKGROUND:Clarithromycin is a semisynthetic macrolide that exhibits broad-spectrum activity against gram-positive, gram-negative, and atypical respiratory tract and skin/skin structure pathogens, Mycobacterium species, and Helicobacter pylori. It is indicated for the treatment of a wide variety of respiratory and derm...
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(01)80060-6
更新日期:2001-04-01 00:00:00
abstract::The added hypotensive effect of bevantolol, a new cardioselective beta-blocker, was studied in 244 patients with mild to moderate essential hypertension following prior treatment with hydrochlorothiazide or placebo. After four weeks of monotherapy with 50 mg/day or 100 mg/day of hydrochlorothiazide or placebo, the mea...
journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章
doi:
更新日期:1985-01-01 00:00:00
abstract:OBJECTIVE:This study assessed the cost-effectiveness of escitalopram for the treatment of depression in the Netherlands from a societal perspective. METHODS:A decision tree model was constructed using decision analytical techniques. Data sources included published literature, clinical trials, official price/tariff lis...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2012.04.006
更新日期:2012-06-01 00:00:00
abstract:BACKGROUND:On February 3, 2006, the US Food and Drug Administration (FDA) approved a live, oral, pentavalent (G1-G4, P1[8]) human-bovine reassortant rotavirus vaccine for the prevention of rotavirus gastroenteritis (RVGE) in infants in the United States. The Advisory Committee of Immunization Practices of the Centers f...
journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
doi:10.1016/j.clinthera.2007.12.018
更新日期:2007-12-01 00:00:00
abstract:INTRODUCTION:Acute generalized exanthematous pustulosis (AGEP) is a clinical reaction pattern that is principally drug induced and is characterized by acute, extensive formation of nonfollicular sterile pustules on an erythematous and edematous substrate. Hydroxychloroquine (HHCQ), an antimalarial drug widely used to t...
journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
doi:10.1016/j.clinthera.2008.05.014
更新日期:2008-05-01 00:00:00
abstract:PURPOSE:Chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C) are common functional gastrointestinal disorders. The prevalence of constipation-related issues tends to increase with age. This analysis pooled data from Phase III trials in CIC and IBS-C to assess the safety and effic...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2020.05.012
更新日期:2020-07-01 00:00:00
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journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:
更新日期:1993-01-01 00:00:00
abstract:PURPOSE:The information that is available when marketing authorizations are approved is limited. Pharmacovigilance has an important role during the postauthorization period, and alerts published by national authorities allow health care professionals to be informed about new data on safety profiles. This study therefor...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2015.07.015
更新日期:2015-09-01 00:00:00
abstract:BACKGROUND:New targeted therapeutics for metastatic renal cell carcinoma (mRCC) enable an increment in progression-free survival (PFS) ranging from 2 to 6 months. Compared with best supportive care, everolimus demonstrated an additional PFS of 3 months in patients with mRCC whose disease had progressed on sunitinib and...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2013.10.004
更新日期:2013-12-01 00:00:00
abstract:PURPOSE:Neuromodulation holds great promise for the treatment of drug-resistant epilepsy. This article reviews the most common types of neuromodulation as well as potential future applications of preclinical techniques such as optogenetics. This review serves as a reference for treating neurologists on the latest scien...
journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
doi:10.1016/j.clinthera.2020.05.017
更新日期:2020-07-01 00:00:00
abstract:PURPOSE:Megestrol acetate oral suspension is an appetite stimulant indicated for cachexia. It is available in a conventional formulation and as a nanocrystal dispersion. The aim of this study was to compare the tolerability and pharmacokinetics of these formulations under fed conditions in healthy Korean volunteers. M...
journal_title:Clinical therapeutics
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.clinthera.2014.09.022
更新日期:2015-02-01 00:00:00
abstract:PURPOSE:We examined the safety profile and usability of an integrated advanced robotic device and telecare system to promote medication adherence for elderly home-care patients. METHODS:There were two phases. Phase I aimed to verify under controlled conditions in a single nursing home (n = 17 patients) that no robotic...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2017.03.020
更新日期:2017-05-01 00:00:00
abstract:BACKGROUND:Eperisone hydrochloride, a centrally acting muscle relaxant, is a calcium antagonist that causes vasodilation and antispastic actions. Aceclofenac, an anti-inflammatory analgesic and antipyretic drug, has similar efficacy and improved gastrointestinal tolerance compared with other nonsteroidal anti-inflammat...
journal_title:Clinical therapeutics
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.clinthera.2013.08.012
更新日期:2013-10-01 00:00:00
abstract::Healing rates were examined retrospectively in 124 outpatients with peptic ulcer who had received cimetidine for at least four weeks. Treatment was unsuccessful in 73 patients. A statistical analysis of the factors involved in treatment failure revealed that in patients with duodenal ulcers 60.6% of the treatment succ...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:
更新日期:1984-01-01 00:00:00
abstract:PURPOSE:Phenylephrine is a commonly used vasopressor for the treatment of spinal-induced hypotension in obstetric patients, but it is associated with reflex bradycardia and a corresponding decrease in cardiac output. This study aims to assess the effectiveness of continuous epinephrine versus phenylephrine infusion in ...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2020.08.004
更新日期:2020-10-01 00:00:00
abstract:BACKGROUND:Sirolimus, a new immunosuppressive agent, has recently been approved in the United States for use in combination with cyclosporine and corticosteroids in renal allograft transplantation. Therapeutic drug monitoring (TDM) of sirolimus is advocated by the drug's manufacturer in certain patient populations. Giv...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/s0149-2918(00)89019-0
更新日期:2000-01-01 00:00:00
abstract:BACKGROUND:Rufinamide is indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome in patients aged ≥4 years. OBJECTIVES:The primary purpose of this study was to compare the relative bioavailability and other pharmacokinetics of rufinamide administered as a 400-mg tablet formulation (r...
journal_title:Clinical therapeutics
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.clinthera.2011.01.016
更新日期:2011-01-01 00:00:00
abstract::This multicenter, randomized, double-blind study compared the efficacy and tolerability of ondansetron 8 mg twice daily for 3 days with placebo in preventing nausea and vomiting in 81 patients receiving cyclophosphamide-doxorubicin-based chemotherapy. The first dose of study drug was administered 30 minutes before the...
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:10.1016/0149-2918(95)80087-5
更新日期:1995-11-01 00:00:00
abstract:BACKGROUND:Tetanus-diphtheria-acellular pertussis (Tdap) was licensed in the United States in 2005 to be given in place of tetanus-diphtheria (Td) for single use in adolescents. OBJECTIVES:This analysis was conducted to determine vaccination coverage with Td and Tdap among adolescents in the United States aged 13 to 1...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2010.07.016
更新日期:2010-08-01 00:00:00
abstract::The effect of leuprorelin acetate depot on the endocrine system and on lipid metabolism was evaluated in a multicentre, noncomparative study. During the first month of treatment, suppression of serum oestradiol levels to below 20 pg/ml was achieved and luteinising hormone and follicle-stimulating hormone levels were r...
journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章,多中心研究
doi:
更新日期:1992-01-01 00:00:00
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journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/s0149-2918(00)83032-5
更新日期:2000-11-01 00:00:00
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journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2015.11.021
更新日期:2016-02-01 00:00:00
abstract:BACKGROUND:Tapentadol hydrochloride is a centrally acting oral analgesic approved by the US Food and Drug Administration in November 2008 for the treatment of moderate to severe acute pain. It is available as immediate-release 50-, 75-, and 100-mg tablets. OBJECTIVE:The purpose of this article is to review animal stud...
journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
doi:10.1016/j.clinthera.2009.12.003
更新日期:2009-12-01 00:00:00
abstract:PURPOSE:Pain in the neonate is often challenging to assess but important to control. Physicians often must balance the need for optimal pain control with the need to minimize oversedation and prolonged opioid use. Both inadequate pain control and overuse of opioids can have long-term consequences, including poor develo...
journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
doi:10.1016/j.clinthera.2019.07.014
更新日期:2019-09-01 00:00:00
abstract::A study was undertaken to determine the usefulness of ubidecarenone in pulmonary rehabilitation in exercise training programs in the management of chronic obstructive pulmonary disease (COPD). The subjects were 20 patients with COPD who had been participating in an exercise training program for at least four weeks. Th...
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:1991-11-01 00:00:00
abstract:BACKGROUND:Technologies in which a remote trigger is used to release drug from an implanted or injected device could enable on-demand release profiles that enhance therapeutic effectiveness or reduce systemic toxicity. A number of new materials have been developed that exhibit sensitivity to light, ultrasound, or elect...
journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
doi:10.1016/j.clinthera.2012.09.012
更新日期:2012-11-01 00:00:00
abstract:BACKGROUND:Communicating potential benefits and harm to patients and payers is essential for high-quality care. However, there are no published guidelines or consensuses on how to communicate potential benefits and harm to patients and payers. OBJECTIVE:The goal of this review was to identify key elements for communic...
journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
doi:10.1016/j.clinthera.2011.11.013
更新日期:2011-12-01 00:00:00