Abstract:
BACKGROUND AND SCOPE:Whether generic drug products are truly therapeutically identical and interchangeable with their innovator counterparts is still a matter of debate. This review discusses the controversies related to the criteria for bioequivalence and therapeutic equivalence. These concerns are illustrated by using the calcium antagonist amlodipine besylate (innovator drug) versus amlodipine maleate (generic), indicated for the treatment of hypertension and angina pectoris, as an example. METHODS:English-language publications were searched in Medline and EMBASE to retrieve all references on amlodipine maleate and literature related to the regulatory guidelines for bioequivalence and therapeutic equivalence to August 2008. Websites from the European and US regulatory authorities were also consulted. FINDINGS:According to regulatory definitions, generic drug products need to be identical to their reference with respect to the active substance, the route of administration as well as quality standards. In contrast to innovator drugs, which have to demonstrate their clinical efficacy and safety, generics are considered therapeutically equivalent based on simple bioequivalence testing. In addition, bioequivalence is established with a disputable study method (single dose in a small group of healthy subjects) and statistics (broad acceptance intervals). Consequently, a potential negative impact of alternative salt forms or excipients on the clinical profile of a drug may remain undetected. To exemplify this, although amlodipine maleate is known to contain (degradation) impurities with (potential) biological activity, it is found per definition bioequivalent to its innovator drug, amlodipine besylate. However, only two clinical studies compared the antihypertensive and safety profiles of both drugs up to 3 months, without CV event endpoints. CONCLUSIONS:The validity of the current criteria for interchangeability of generic and innovator drugs remains controversial and may compromise the response and/or safety of patients. In the case of amlodipine, thorough long-term clinical investigations of commercial amlodipine maleate salt preparations including hard endpoints may be needed to justify their use.
journal_name
Curr Med Res Opinjournal_title
Current medical research and opinionauthors
Meredith PAdoi
10.1185/03007990903116867subject
Has Abstractpub_date
2009-09-01 00:00:00pages
2179-89issue
9eissn
0300-7995issn
1473-4877journal_volume
25pub_type
杂志文章,评审abstract::A trial was carried out in 3 clinics to test the efficacy of and cycle control obtained with a very low dosage oral contraceptive combination of lynesternol (0.75 mg) and ethinyl oestradiol (0.0375 mg). A total of 134 healthy, fertile women, ages ranging from under 19 years to over 40 years, participated and completed...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/03007997609109328
更新日期:1976-01-01 00:00:00
abstract:BACKGROUND:The management of iron-deficiency anaemia in patients with non-dialysis chronic kidney disease (ND-CKD) remains controversial, particularly regarding the use of oral versus intravenous iron supplementation. METHODS:A PubMed search from 1970 to February 2009 was conducted to identify relevant research articl...
journal_title:Current medical research and opinion
pub_type: 杂志文章,评审
doi:10.1185/03007990903512461
更新日期:2010-02-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:Rheumatoid arthritis (RA) is a chronic, debilitating disease affecting an estimated 1.5 million patients in the US. The condition is associated with a substantial health and economic burden. An economic model was developed to evaluate the cost-effectiveness of tofacitinib (a novel oral Janus k...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1080/03007995.2018.1497957
更新日期:2018-11-01 00:00:00
abstract::A double-blind, placebo-controlled trial was carried out to assess the effectiveness of a new synthetic bioflavonoid, hidrosmin, in patients with chronic venous insufficiency of the lower limbs. Fifty-seven patients, showing varicose veins and ankle swelling and suffering from local pain and heaviness of the legs, wer...
journal_title:Current medical research and opinion
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1185/03007999209111529
更新日期:1992-01-01 00:00:00
abstract:OBJECTIVE:Evaluation of the safety and efficacy of insulin detemir (IDet) in the observational and non-interventional PREDICTIVE study. METHODS:A total of 2923 patients with type 1 or 2 diabetes on basal-bolus regimens were followed for 6 months: Group (1) NPH + human insulin (HI) bolus switching to IDet + analogue bo...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/03007990903262885
更新日期:2009-11-01 00:00:00
abstract::The efficacy of trimetazidine, an anti-ischaemic agent, has been largely assessed and presented in the international literature through its metabolic effects, selective and specific fatty acid oxidation inhibition and lack of haemodynamic effects in stable angina pectoris. As such, trimetazidine has opened up a new cl...
journal_title:Current medical research and opinion
pub_type: 杂志文章,评审
doi:10.1185/030079903125002261
更新日期:2003-01-01 00:00:00
abstract::Data from phase III clinical trials suggest that high dose chemotherapy (HDC) is currently not indicated for any stage of breast cancer. Therefore HDC should only be considered within the context of clinical trials. Furthermore, there is no significant evidence to support the routine use of taxanes in women with metas...
journal_title:Current medical research and opinion
pub_type:
doi:
更新日期:2001-01-01 00:00:00
abstract::A double-blind trial was carried out on 116 patients with lower respiratory tract infection and systemic manifestations. One group received co-trimoxazole (480 mg. trimethoprim and 2,400 mg. sulphamethoxazole daily), and the other group received 2 g. tetracycline daily. The trial, as judged by clinical improvements, t...
journal_title:Current medical research and opinion
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1185/03007997509113677
更新日期:1975-01-01 00:00:00
abstract:OBJECTIVE:To determine the characteristics of asthma (A) and allergic rhinitis (AR) among asthma patients in primary care practice. RESEARCH DESIGN AND METHODS:Primary care physicians, pulmonologists, and allergologists were asked to recruit consecutive asthma patients with or without allergic rhinitis from their dail...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/03007990902820733
更新日期:2009-05-01 00:00:00
abstract::In a double-blind, partial cross-over study of 141 patients with mild to moderate hypertension, chlorthalidone 50 mg was compared with chlorthalidone 50 mg/triamterene 50 mg combination treatment. The study assessed clinical efficacy in the reduction of blood pressure, and safety with regard to serum potassium concent...
journal_title:Current medical research and opinion
pub_type: 临床试验,杂志文章
doi:10.1185/03007999609111560
更新日期:1996-01-01 00:00:00
abstract:OBJECTIVES:Previous systematic reviews and meta-analyses of treatments in relapsing-remitting multiple sclerosis (RRMS) derived their findings from either placebo-controlled studies only or separately from head-to-head and comparative studies. The purpose of this study is to compare annualized relapse rates (ARR) of fi...
journal_title:Current medical research and opinion
pub_type: 杂志文章,meta分析
doi:10.1185/03007995.2012.681637
更新日期:2012-05-01 00:00:00
abstract:OBJECTIVE:To understand better the true impact of widespread adoption of adjuvant aromatase inhibitor (AI) therapy on postmenopausal breast cancer patients' risk of bone fracture. METHODS:Data from three different studies were used to estimate the relative risk of bone fracture for each of the following groups of wome...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/030079907x187919
更新日期:2007-05-01 00:00:00
abstract::A study was carried out to compare attitudes, perceptions and experiences of general practitioners and patients who had treated/suffered from herpes zoster, or shingles, in the recent past. Randomized samples of 224 general practitioners and 236 patients were drawn from different locations in Italy, Germany and the Un...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/03007999409110485
更新日期:1994-01-01 00:00:00
abstract:OBJECTIVE:To compare glycemic goal achievement (HbA(1c) < 7%) in type 2 diabetes patients receiving initial metformin plus pioglitazone combination therapy and initial metformin monotherapy augmented with pioglitazone in a cohort follow-up study. RESEARCH DESIGN AND METHODS:Adult patients were identified from the Inge...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/03007995.2010.536755
更新日期:2011-01-01 00:00:00
abstract:OBJECTIVES:Many insulin-treated patients with type 2 diabetes (T2D) do not reach hemoglobin A1c (HbA1c) < 7%, but have clinically relevant HbA1c reductions. Using an integrated database (IDB) of 53 insulin lispro clinical trials and a real-world evidence (RWE) database of T2D patients initiating insulin therapy, an exp...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1080/03007995.2017.1396968
更新日期:2018-02-01 00:00:00
abstract:OBJECTIVE:The best management of patients with femoropopliteal and infrapopliteal artery occlusion disease is not clear. This study aimed to compare the efficacy of drug-coated balloons (DCBs) and drug-eluting stents (DESs) with percutaneous transluminal angioplasty (PTA) in patients with femoropopliteal or infrapoplit...
journal_title:Current medical research and opinion
pub_type: 杂志文章,meta分析,评审
doi:10.1080/03007995.2017.1372114
更新日期:2018-01-01 00:00:00
abstract:BACKGROUND:The relationship between chronic pancreatitis (CP) and subsequent pyogenic liver abscess (PLA) is not well understood. METHODS:We investigated the risk of PLA in patients with CP using inpatient claims data from the Taiwan National Health Insurance Program for the period 2000-2010. We identified 17,810 pati...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1080/03007995.2016.1266312
更新日期:2017-03-01 00:00:00
abstract:BACKGROUND:In controlled clinical trials, rabeprazole effectively improves symptoms and heals oesophageal erosions in patients with gastro-oesophageal reflux disease (GORD). AIM:To examine symptom relief during week 1 of rabeprazole therapy, in addition to GORD healing, in a clinical practice setting. METHODS:In this...
journal_title:Current medical research and opinion
pub_type: 临床试验,杂志文章,多中心研究
doi:10.1185/030079905X41444
更新日期:2005-04-01 00:00:00
abstract:OBJECTIVE:The efficacy of antihistamines in perennial allergic rhinitis in children has been evaluated in studies using active comparators, whereas placebo-controlled studies are very few. A randomized, multicenter, double-blind, parallel-group clinical study was carried out to evaluate the dose-response relationship a...
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:10.1185/03007995.2010.485413
更新日期:2010-07-01 00:00:00
abstract::Twenty-five acutely disturbed psychotic patients were treated in an open study with a single injection of zuclopenthixol acetate 5% in 'Viscoleo, a thin vegetable oil. Patients were assessed post-injection for 3 days using the BPRS, CGI, and a specially designed behaviour/activity scale. Doses of 50 to 150 mg proved e...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/03007999009111492
更新日期:1990-01-01 00:00:00
abstract:OBJECTIVE:To investigate the predictive factors associated with physical impairment among older patients with type 2 diabetes mellitus (T2DM) in Japan and to examine the potential impact of physical impairment on patient-reported health outcomes in this population. METHODS:A cross-sectional analysis was conducted usin...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1080/03007995.2020.1846170
更新日期:2020-11-23 00:00:00
abstract::In a double-blind trial in 26 patients with symptomatic gastro-oesophageal reflux, the alginate/effervescent/antacid compound 'Gaviscon' was compared with antacid containing placebo similarly formulated. Retrosternal pain after meals and at night was significantly reduced whilst patients were taking 'Gaviscon' and the...
journal_title:Current medical research and opinion
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1185/03007997509114793
更新日期:1975-01-01 00:00:00
abstract::Understanding of the damaging effects of significance testing has steadily grown. Reporting p values without dichotomizing the result to be significant or not, is not the solution. Confidence intervals are better, but are troubled by a non-intuitive interpretation, and are often misused just to see whether the null va...
journal_title:Current medical research and opinion
pub_type: 信件
doi:10.1185/03007995.2011.618493
更新日期:2011-11-01 00:00:00
abstract:OBJECTIVE:Osteoarthritis is one of the most common forms of arthritis seen in primary care. Non-steroidal anti-inflammatory drugs (NSAIDs) play an important role in the management of osteoarthritis. However, gastrointestinal (GI) side effects limit their use. Cyclooxygenase-2 (COX-2) selective inhibitors exhibit better...
journal_title:Current medical research and opinion
pub_type: 杂志文章,随机对照试验
doi:10.1185/030079906X104722
更新日期:2006-05-01 00:00:00
abstract:OBJECTIVES:Compare migraine duration with frovatriptan (versus baseline) in migraineurs reporting long- (24-72 h) or short-duration (<24 h) migraines at baseline. METHODS:Post hoc analysis of two postmarketing surveillance studies of migraineurs in German primary care clinics using frovatriptan (2.5 mg) to treat a sin...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/03007995.2010.503488
更新日期:2010-09-01 00:00:00
abstract:BACKGROUND:Low back pain in general and specifically chronic low back pain forms a major burden for the patient and society. Recently studies demonstrated that up to 65% of patients evolve to chronic pain as opposed to the previously accepted 8%. As low back pain patients present first with their general practitioner, ...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1080/03007995.2016.1220933
更新日期:2016-11-01 00:00:00
abstract:OBJECTIVE:The dopamine agonist rotigotine has shown efficacy and safety for the treatment of early and advanced Parkinson's disease (PD) in controlled clinical trials. This observational study evaluated rotigotine administration in combination with other antiparkinsonian medication in routine clinical practice. METHOD...
journal_title:Current medical research and opinion
pub_type: 临床试验,杂志文章,多中心研究
doi:10.1185/03007995.2011.611630
更新日期:2011-10-01 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::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 in 21 patients with Type IIb or Type IV hyperlipoproteinaemia to evaluate the effect of treatment with 600 mg bezafibrate per day over a period of 3 months. The results of the lipid parameters studied showed that there were significant reductions after 1 and 3-months' treatment, respectively, o...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/03007998309112398
更新日期:1983-01-01 00:00:00