Abstract:
OBJECTIVE:Poor quality has been reported for some generics and other copies of original products. We performed a pilot study to compare the disintegration/dissolution profiles of FOSAMAX (alendronate) 70 mg tablets with those of copies of FOSAMAX that were manufactured outside the United States. RESEARCH DESIGN AND METHODS:We used the standard United States Pharmacopeia (USP) disintegration method to evaluate FOSAMAX 70 mg tablets and 13 copies. At least 12 (n = 12) dosage units were tested for each product (except Fosmin, n = 10). The dissolution profiles of FOSAMAX and one representative copy were also compared. RESULTS:Nine copies (Osteomax, Defixal, Fosmin, Endronax, Osteomix, Genalmen, Fixopan, Osteoplus, and Fosval) disintegrated two- to ten-fold faster than FOSAMAX. Three other copies (Neobon, Regenesis, and Ostenan) disintegrated at least five-fold slower than FOSAMAX. Neobon is a softgel capsule, so special consideration was given to this different dosage form. One copy (Arendal) did not fall into either category but exhibited potentially large inter- and intra-lot variability. Dissolution of alendronate from Regenesis lagged behind that from FOSAMAX. CONCLUSION:Slower disintegration may reduce efficacy because bisphosphonates must be taken in the fasting state and contact with food or even certain beverages severely reduces bioavailability. Faster disintegration (or the use of gel-caps or other alterations to the drug formulation) could increase the risk of esophagitis, an adverse event associated with prolonged contact of the esophagus with bisphosphonates. These disintegration and dissolution results suggest that important differences may exist between FOSAMAX and its copies with regard to bioavailability, pharmacokinetics, and clinical efficacy and safety profiles. Additional testing is warranted to evaluate the pharmacokinetics and clinical safety of these copies.
journal_name
Curr Med Res Opinjournal_title
Current medical research and opinionauthors
Epstein S,Cryer B,Ragi S,Zanchetta JR,Walliser J,Chow J,Johnson MA,Leyes AEdoi
10.1185/030079903125002577keywords:
subject
Has Abstractpub_date
2003-01-01 00:00:00pages
781-9issue
8eissn
0300-7995issn
1473-4877journal_volume
19pub_type
杂志文章abstract:OBJECTIVE:To examine medication dosing patterns of duloxetine and pregabalin among patients with fibromyalgia. METHODS:From a large US administrative claims database, commercially insured fibromyalgia patients aged 18-64 who initiated duloxetine or pregabalin in 2006 were selected. Initiation was defined as a 90-day m...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/03007995.2011.605113
更新日期:2011-09-01 00:00:00
abstract::Zolmitriptan is a 5-HT1B/1D receptor agonist for the acute treatment of migraine. This study examined the efficacy of a second dose of zolmitriptan for the treatment of persistent or recurrent headache. Part 1 was a randomised, placebo-controlled, double-blind evaluation of 2.5 mg and 5 mg zolmitriptan for the treatme...
journal_title:Current medical research and opinion
pub_type: 临床试验,杂志文章,多中心研究,随机对照试验
doi:10.1185/03007999909116498
更新日期:1999-01-01 00:00:00
abstract:OBJECTIVES:Epidemiological data support an association between age-related macular degeneration (AMD) and cataract surgery that may be attributed to post-operative blue light exposure. By limiting the retina's blue light exposure, new blue-light filtering intraocular lenses (BLF IOLs) have the potential to reduce the d...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/030079906X115586
更新日期:2006-07-01 00:00:00
abstract:INTRODUCTION:This subanalysis compared the efficacy of betahistine plus piracetam dual therapy versus betahistine monotherapy using data from OSVaLD, a 3 month, open-label, observational study conducted in 2272 patients with peripheral vestibular vertigo. Of the 1898 patients included in the original efficacy populatio...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/03007995.2015.1067193
更新日期:2015-11-01 00:00:00
abstract::In a double-blind study of 102 patients with a mean age of 79 years, zopiclone was compared to flunitrazepam. The patients rated their sleep in a diary. There was no statistically significant difference between the relatively low dose of 5 mg zopiclone and 1 mg flunitrazepam for eleven out of the twelve variables meas...
journal_title:Current medical research and opinion
pub_type: 临床试验,杂志文章,多中心研究,随机对照试验
doi:10.1185/03007999509110492
更新日期:1995-01-01 00:00:00
abstract:BACKGROUND:Resistance to endocrine treatment generally occurs over time, especially in the metastatic stage. In this paper, we aimed to review the mechanisms of cyclin-dependent kinase (CDK) 4/6 inhibition and clinical usage of new agents in the light of recent literature updates. SCOPE:A literature search was carried...
journal_title:Current medical research and opinion
pub_type: 杂志文章,评审
doi:10.1080/03007995.2017.1348344
更新日期:2017-09-01 00:00:00
abstract:OBJECTIVE:Painful physical symptoms are common in patients with major depressive disorder (MDD) and can negatively affect patient outcomes. Duloxetine has demonstrated efficacy in treating MDD and other certain painful conditions; this study specifically evaluated patients with both MDD and MDD-associated pain. METHOD...
journal_title:Current medical research and opinion
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1185/03007995.2011.609540
更新日期:2011-10-01 00:00:00
abstract::Background: Actinic keratosis (AK) is considered an "in situ" non-melanoma skin cancer induced by ultraviolet chronic exposure. Sunscreen and topical anti-inflammatory agents like diclofenac could improve the evolution of this kind of lesions. A topical product containing piroxicam 0.8% and sun filters (50 SPF) (ACTX)...
journal_title:Current medical research and opinion
pub_type: 临床试验,杂志文章,多中心研究
doi:10.1080/03007995.2019.1626227
更新日期:2019-10-01 00:00:00
abstract::Insulin secretion was studied in 12 non-insulin dependent diabetics during middle-term administration of the sulphonylurea gliclazide. Blood sugar, C-peptide and glucagon were also estimated during the intravenous glucose tolerance and arginine tests performed before and after therapy. After 3 months of gliclazide the...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/03007998409109560
更新日期:1984-01-01 00:00:00
abstract::Stress urinary incontinence (SUI) is the involuntary loss of urine associated with physical activities such as running, jumping, or lifting, or with sneezing and coughing. For many patients it can be a very bothersome symptom, causing social isolation, loss of self-esteem, and increased expenses. Although there is cur...
journal_title:Current medical research and opinion
pub_type: 杂志文章,评审
doi:10.1185/030079903125002126
更新日期:2003-01-01 00:00:00
abstract:OBJECTIVE:This study evaluated the long-term cost-effectiveness of atorvastatin 20 mg, rosuvastatin 10 mg and simvastatin 40 mg in primary and secondary prevention of CHD in Finland. RESEARCH DESIGN AND METHODS:The effect of statin therapy on the incidence of CHD and the expected total costs of the disease were descri...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/03007990802144705
更新日期:2008-06-01 00:00:00
abstract:BACKGROUND:Although beta-blocker therapy has been shown to improve survival in patients with chronic heart failure, this class of drugs tends to be underutilized in diabetic patients due to concerns about adverse metabolic effects, especially on glycemic control. No randomized clinical trial has specifically evaluated ...
journal_title:Current medical research and opinion
pub_type: 杂志文章,meta分析
doi:10.1185/030079906X80459
更新日期:2006-02-01 00:00:00
abstract:OBJECTIVE:To further assess the clinically active dose range of etoricoxib, a COX-2 selective inhibitor, in rheumatoid arthritis (RA). METHODS:RA patients were randomized to etoricoxib 10, 30, 60, or 90 mg or placebo in a double-blind, 12-week study. DMARDs (methotrexate, biologics) or low-dose corticosteroids were al...
journal_title:Current medical research and opinion
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1185/03007995.2011.614935
更新日期:2011-10-01 00:00:00
abstract:BACKGROUND:Breast cancer cells can develop resistance to standard hormonal treatment and chemotherapy with the activation of the mTOR pathway; this is supported by results of preclinical and clinical studies. In clinical trials, the addition of everolimus to hormonal treatment or anti-HER2 treatment improved the outcom...
journal_title:Current medical research and opinion
pub_type: 杂志文章,评审
doi:10.1185/03007995.2013.846253
更新日期:2014-01-01 00:00:00
abstract::Anaemia is an important factor in the fatigue experienced by many patients receiving chemotherapy. A recent large-scale, randomised, placebo-controlled trial has shown that treatment with epoetin alfa raises haemoglobin levels, reduces fatigue and improves overall quality of life (QoL). In order to examine the relatio...
journal_title:Current medical research and opinion
pub_type: 临床试验,杂志文章,多中心研究,随机对照试验
doi:10.1185/174234305X13798
更新日期:2005-01-01 00:00:00
abstract::Compatibility of two types of needles with a variety of durable and prefilled injection pens for diabetes medication was tested by attaching the needles according to ISO 11608-2 and verifying penetration into the cartridge using air shots and two-dimensional X-rays. NovoFine* and NovoFine Autocover† attached correctly...
journal_title:Current medical research and opinion
pub_type: 信件
doi:10.1185/03007995.2010.547574
更新日期:2011-03-01 00:00:00
abstract::A double-blind trial was carried out in 37 patients with osteoarthrosis to compare the efficacy and tolerance of 250 mg diflunisal twice daily with that of 400 mg ibuprofen 3-times daily over an 8-week period. Rating scale assessments were made, at the end of a preceding 1-week, wash-out period on placebo and at regul...
journal_title:Current medical research and opinion
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1185/03007997809109001
更新日期:1978-01-01 00:00:00
abstract::In an electropharmacokinetic study, the effects of lormetazepam and flunitrazepam were compared by the means of a sleep EEG and waking EEG during the following daytime. At a 1-week interval, 6 normal subjects received at random either 2 mg lormetazepam or 2 mg flunitrazepam in a double-blind, crossover fashion. Sleep ...
journal_title:Current medical research and opinion
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1185/03007998509109634
更新日期:1985-01-01 00:00:00
abstract::Objective: Health utility estimates for children and adolescents are critical for cost-utility analyses informing health technology assessment (HTA) authorities' decisions governing access to pediatric treatments. However, in a recent review, only 29% of published pediatric cost-utility models used a utility measure v...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1080/03007995.2020.1762553
更新日期:2020-07-01 00:00:00
abstract:BACKGROUND:The validity of opinions expressed in questionnaire surveys diminishes with lower response rates. Recent research suggests that general practitioners (GPs) are more likely to respond to questionnaire surveys if they are motivated to do so because the subject of the survey is perceived as relevant to the prac...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/030079903125002900
更新日期:2004-03-01 00:00:00
abstract:BACKGROUND:Small cell lung cancer (SCLC) patients, who have achieved complete or partial response after chemotherapy, should be followed with prophylactic cranial irradiation (PCI). PCI for extrapulmonary small cell carcinoma (EPSCC) is not routinely recommended. The purpose of this review is to discuss all aspects of ...
journal_title:Current medical research and opinion
pub_type: 杂志文章,评审
doi:10.1185/03007995.2014.904771
更新日期:2014-07-01 00:00:00
abstract:OBJECTIVE:The objectives of this article are to review the pathophysiology of type 2 diabetes mellitus (T2DM), present the rationale for a pathophysiologically based treatment approach for patients with T2DM and discuss the role of the therapeutic combination of pioglitazone and exenatide in the management of T2DM. ME...
journal_title:Current medical research and opinion
pub_type: 杂志文章,评审
doi:10.1185/03007990802390795
更新日期:2008-11-01 00:00:00
abstract:OBJECTIVE:To compare the efficacy and safety of epoetin theta and epoetin beta in anaemic patients with chronic kidney disease, undergoing haemodialysis and previously on stable maintenance therapy with epoetin beta. METHODS:In this multicentre, randomised, controlled, double-blind study 270 haemodialysis patients wer...
journal_title:Current medical research and opinion
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1185/03007995.2010.511084
更新日期:2010-10-01 00:00:00
abstract::A double-blind, parallel group trial of a 1 mg sodium cromoglycate metered dose inhaler, a 5 mg formulation and a placebo aerosol was undertaken in 139 asthmatic patients with extrinsic allergic asthma. None of the patients had previously been treated with sodium cromoglycate and few (15%) were familiar with the use o...
journal_title:Current medical research and opinion
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1185/03007998909110134
更新日期:1989-01-01 00:00:00
abstract::Objective: This economic evaluation aims to provide a preliminary assessment of the cost-effectiveness of radiofrequency ablation (RFA) compared with argon plasma coagulation (APC) when used to treat APC-refractory gastric antral vascular ectasia (GAVE) in symptomatic patients.Methods: A Markov model was constructed t...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1080/03007995.2020.1747997
更新日期:2020-06-01 00:00:00
abstract::A study was carried out to compare a new, unique chemical strip test for the measurement of urine specific gravity with the traditional methods of hydrometry and refractometry, during water concentration/dilution tests in 12 normal subjects. The pattern of specific gravity results during these serial measurements was ...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/03007998309111742
更新日期:1983-01-01 00:00:00
abstract::A study was carried out in 80 mild to moderately depressed patients seen in general practice to assess the relative effectiveness and tolerance of a single night-time dose compared with the usual divided daily dosage regimen of a chlordiazepoxide (5 mg)/amitriptyline (12.5 mg) combination. Patients were assigned at ra...
journal_title:Current medical research and opinion
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1185/03007998009109490
更新日期:1980-01-01 00:00:00
abstract::For over a century, there has been considerable interest in the management of regional lymph node metastasis in patients with primary breast cancer. Since the advent of sentinel lymph node biopsies, there has been renewed interest in the management of patients with metastasis to the internal mammary nodes. The appropr...
journal_title:Current medical research and opinion
pub_type: 社论
doi:10.1185/030079903125002207
更新日期:2003-01-01 00:00:00
abstract::Twenty-seven patients with tennis elbow were treated with triamcinolone acetonide (40 mg/ml) injected locally into the tender area without local anaesthetic. Reduction of pain or complete relief was achieved in 1 to 72 hours, although in 9 cases exacerbation of pain occurred before relief was given. The recurrence rat...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/03007998009109477
更新日期:1980-01-01 00:00:00
abstract:OBJECTIVE:Neurosurgery often requires skull immobilization with a Mayfield clamp, which often causes brief intense nociceptive stimulation, hypertension and tachycardia. Blunting this response may help prevent increased intracranial pressure, cerebral aneurysm or vascular malformation rupture, and/or myocardial stress....
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/03007995.2013.855190
更新日期:2014-02-01 00:00:00