Abstract:
OBJECTIVES:GOAL (Gauging Osteoarthritis [OA] with Limbrel*), an open-label, post-marketing study was performed to determine the overall efficacy and gastrointestinal (GI) tolerability of flavocoxid, a novel, plant-based, anti-inflammatory medication, in a 'real world' clinical practice setting. To this end, the study enrolled several unique patient types including nonsteroidal anti-inflammatory drug (NSAID) naïve patients, those who had used NSAIDs in the past, regardless of outcome (positive or negative), and those who had previously taken a gastroprotective medication to improve GI tolerability or continued to take it as a precautionary measure to prevent NSAID-associated GI damage. METHODS:A total of 1067 individuals at 41 rheumatology practices were enrolled and prescribed flavocoxid, 500 mg b.i.d., for 60 days. The Physician Global Assessment of Disease (PGAD) visual analog scale (VAS) was used as a global measure to assess the signs and symptoms of OA, including joint discomfort, functional stiffness, functional mobility and quality of life. In addition, overall tolerability and upper GI tolerability were assessed by individual questions scored on a 5-part Likert scale. The physicians also monitored any interruption in, or cessation of use of flavocoxid due to a GI issue as well as changes in the use of gastroprotective medications. Adverse event (AE) monitoring was also conducted. RESULTS:Of the 1005 patients who completed all follow-up visits, physicians recorded an average improvement in VAS scores from 60.1 +/- 18.8 at baseline to 42.5 +/- 21.9 at 8 weeks (p < 0.001) in 65.8% of patients. The PGAD VAS noted the most significant improvement in those patients with moderate to severe OA (baseline VAS [0 = least severe, 100 = most severe]: 0-25 mm, -3.5 +/- 6.9; 26-50 mm, -10.1 +/- 17.0; 51-75 mm, -19.3 +/- 19.5; 76-100 mm, -29.6 +/- 23.6; p < 0.001) and in those patients who were historically non-responders to NSAIDs (40.3 +/- 21.1 vs. 66.3 +/- 17.7 at baseline; p < 0.001). Patients who had previously responded well to NSAIDs had VAS scores of 42.6 +/- 19.8 vs. 58.0 +/- 18.0 (p < 0.001) and NSAID naïve subjects showed improvement in VAS scores from 60.5 +/- 18.0 at baseline to 46.3 +/- 23.7 (p < 0.001). The study recorded a low incidence ( approximately 10%) of AEs reported to physicians and good overall tolerability to flavocoxid. Flavocoxid showed improved upper GI tolerability in almost 50% of previous NSAID users (p < 0.001) and reduced therapy interruption in approximately 90% of previous NSAID users with a history of GI-related therapy interruptions (p < 0.0001). Finally, the use of flavocoxid resulted in a >30% reduction in or cessation of the use of gastroprotective medications such as proton pump inhibitors (PPI) or histamine-2 receptor antagonists (H2s) in subjects (p < 0.001). CONCLUSIONS:Within a 'real world' clinical rheumatology practice setting, flavocoxid demonstrated significant efficacy in the management of OA in multiple patient types and displayed significant potential for reducing the possibility of adverse GI side-effects and use of gastroprotective agents associated with more traditional OA medications. A limitation of this study was that it was open-label and not rigorously controlled. The large population may compensate for this lack of control.
journal_name
Curr Med Res Opinjournal_title
Current medical research and opinionauthors
Pillai L,Burnett BP,Levy RM,GOAL Study Cooperative Group.doi
10.1185/03007991003694522subject
Has Abstractpub_date
2010-05-01 00:00:00pages
1055-63issue
5eissn
0300-7995issn
1473-4877journal_volume
26pub_type
杂志文章,多中心研究abstract::In a multi-centre study, the antidepressant efficacy and incidence of on-therapy events of trazodone (100 to 400 mg daily) and mianserin (30 to 120 mg daily) was compared using a double-blind pre-determined randomized parallel group design in depressed patients unresponsive to placebo after a 7-day screening period. 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:10.1185/03007998409109588
更新日期:1984-01-01 00:00:00
abstract::The effect of spironolactone in the alleviation of the symptoms of the premenstrual syndrome was compared with placebo in a double-blind, parallel group controlled study. One tablet daily of 100 mg spironolactone or placebo was given to 63 women from Day 12 of the menstrual cycle until the first day of the next menstr...
journal_title:Current medical research and opinion
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1185/03007998709112403
更新日期:1987-01-01 00:00:00
abstract::The use of steroid compounds formulated in oil for depot injection can be associated with acute pulmonary reactions characterized primarily by cough, but sometimes with other associated symptoms. The pathophysiology of these reactions remains unclear, although they are reported in the literature as 'POMEs' or pulmonar...
journal_title:Current medical research and opinion
pub_type: 杂志文章,评审
doi:10.1185/03007995.2015.1012254
更新日期:2015-04-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:Reduction in total cholesterol (TC) and LDL-cholesterol (LDL-C) forms one of the principal objectives of most cardiovascular secondary prevention strategies. Many patients being treated with statins, however, have significant residual dyslipidaemia, with many having suboptimal HDL-cholesterol ...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/03007990802374633
更新日期:2008-09-01 00:00:00
abstract:OBJECTIVE:Chronic respiratory failure (CRF) is a syndrome defined by certain disturbances in arterial blood gases. Non-invasive mechanical ventilation (NIMV) is an increasingly used treatment modality in respiratory failure. The aim of this study was to investigate the long-term effects of NIMV on pulmonary function an...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/03007995.2010.508703
更新日期:2010-09-01 00:00:00
abstract:OBJECTIVE:To evaluate the efficacy and long-term safety of linagliptin added to basal insulin in Asian patients with type 2 diabetes mellitus (T2DM) inadequately controlled by basal insulin with/without oral agents. RESEARCH DESIGN AND METHODS:This was a post hoc analysis of Asian patients from a global ≥52 week study...
journal_title:Current medical research and opinion
pub_type: 杂志文章,随机对照试验
doi:10.1185/03007995.2015.1010638
更新日期:2015-03-01 00:00:00
abstract:OBJECTIVE:To evaluate four models based on potential predictors for achieving a response to pregabalin treatment for neuropathic pain (NeP). METHODS:In total, 46 pain studies were screened, of which 27 NeP studies met the criteria for inclusion in this analysis. Data were pooled from these 27 placebo-controlled random...
journal_title:Current medical research and opinion
pub_type: 杂志文章,meta分析
doi:10.1080/03007995.2018.1520694
更新日期:2018-12-01 00:00:00
abstract:OBJECTIVE:Hyperuricaemia is associated with indapamide administration. In contrast, micronised fenofibrate can significantly decrease serum uric acid levels. However, there are no data on the effect of combination therapy of indapamide with micronised fenofibrate on uric acid metabolism. METHODS:We studied 20 non-diab...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/030079902125000273
更新日期:2002-01-01 00:00:00
abstract:OBJECTIVE:The use of embolic protection devices to decrease major adverse cardiac events (MACEs) in patients with saphenous vein graft lesions is considered class I therapy by the recent practice guidelines. However, the benefits of adjunctive protection devices to prevent distal embolization in patients with native co...
journal_title:Current medical research and opinion
pub_type: 杂志文章,meta分析
doi:10.1185/03007995.2012.686445
更新日期:2012-06-01 00:00:00
abstract:INTRODUCTION:This brief review describes conservative treatment methods for pelvic venous congestion. Therapy options: The authors present an analysis of the efficacy of nonsteroidal anti-inflammatory drugs (NSAIDs), ergot alkaloid derivatives, hormonal agents, venoprotective agents, and compression therapy in the trea...
journal_title:Current medical research and opinion
pub_type: 杂志文章,评审
doi:10.1080/03007995.2017.1302414
更新日期:2017-06-01 00:00:00
abstract:INTRODUCTION:Normoglycaemia in people with diabetes results in improved outcome. Continuous glucose monitoring provides detailed diagnostic information used to optimise therapy with the goal of achieving normoglycaemia. The objective of this study was to review the published literature evaluating the single device avai...
journal_title:Current medical research and opinion
pub_type: 杂志文章,评审
doi:10.1185/03007990903094452
更新日期:2009-10-01 00:00:00
abstract::Using an equilibrium dialysis method, the competition was investigated between tritated-progesterone and a range of synthetic steroids for binding to 20,000 g. supernatants of human uterine endometrium and myometrium. Both types of uterine tissue showed similar patterns of progestogen binding and probably contain sim...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/03007997509113654
更新日期:1975-01-01 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:BACKGROUND:Omega-3 fatty acids from fish and fish oils can protect against coronary heart disease (CHD), which is still the most common cause of death in the Western economies. Evidence from epidemiological and case cohort studies indicate that consumpton of fatty fish and omega-3 fatty acids reduces the risk of cardio...
journal_title:Current medical research and opinion
pub_type: 杂志文章,评审
doi:10.1185/030079904x17956
更新日期:2005-01-01 00:00:00
abstract::In a randomized trial, 149 patients with uncomplicated gonorrhoea were treated with a single intramuscular dose of 1.0 g mezlocillin, 150 with 2.0 g ampicillin plus 1.0 g probenecid orally and 150 with a single dose of 1.8 mega units of procaine penicillin. Cure rates at 3, 10 and 17 days after treatment were 97%, 99%...
journal_title:Current medical research and opinion
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1185/03007998209109774
更新日期:1982-01-01 00:00:00
abstract::Objective: Hypertension is a serious health problem in Egypt, with prevalence rate of 17% as reported in 2015. Despite receiving treatment, many do not achieve blood pressure (BP) control. The current study aimed to evaluate the efficacy and tolerability of amlodipine/valsartan/hydrochlorothiazide (Aml/Val/HCTZ) singl...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1080/03007995.2020.1719394
更新日期:2020-04-01 00:00:00
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journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/030079903125002478
更新日期:2003-01-01 00:00:00
abstract:: Background & aims: Vitamin D deficiency is widespread worldwide. In this study, we aimed to evaluate the effect of a nano encapsulated form of vitamin D used for fortifying low-fat dairy products (milk and yogurt) on anthropometric indices, glycemic status, and lipid profi...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1080/03007995.2021.1874324
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abstract:BACKGROUND:Most patients with hypertension require more than one drug to attain recommended blood pressure (BP) targets. Initiating therapy with two agents is recommended for patients at high risk of a cardiovascular event or with a BP > 20/10 mmHg above goal. Combination therapy is effective when comprised of agents w...
journal_title:Current medical research and opinion
pub_type: 杂志文章,评审
doi:10.1185/03007990802597456
更新日期:2009-01-01 00:00:00
abstract::A double-blind, parallel-group study was carried out to compare the efficacy and tolerability of a controlled-release tablet formulation of trazodone with the standard trazodone tablet. Three hundred and forty-seven general practice patients with depressive symptoms were recruited into the trial. Patients were randoml...
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:10.1185/03007999009111497
更新日期:1990-01-01 00:00:00
abstract:OBJECTIVE:To estimate the costs and consequences of using pamidronate compared to zoledronic acid in the prophylactic management of skeletal morbidity among breast cancer patients in the UK. DESIGN AND SETTING:This was a modelling study performed from the perspective of the UK's National Health Service (NHS). METHODS...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/030079905X40472
更新日期:2005-05-01 00:00:00
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journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/03007995.2014.899207
更新日期:2014-07-01 00:00:00
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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
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journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1080/03007995.2018.1435520
更新日期:2018-05-01 00:00:00
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journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1080/03007995.2020.1844645
更新日期:2021-01-01 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::Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia seen in clinical practice and has attracted much attention due to its association with a substantial mortality and morbidity, particularly from stroke, thromboembolism and heart failure. This Editorial Commentary provides a brief overview of the ...
journal_title:Current medical research and opinion
pub_type: 评论,社论
doi:10.1185/03007990902910443
更新日期:2009-05-01 00:00:00
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journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1080/03007995.2017.1308920
更新日期:2017-06-01 00:00:00
abstract:OBJECTIVE:To provide a commentary on recent studies with the new IOP-lowering fixed-combination product brinzolamide 1%/timolol 0.5%. METHODS:Medline was searched for brinzolamide/timolol fixed-combination clinical literature (up to May 18, 2010) and the current comprehensive brinzolamide/timolol literature was review...
journal_title:Current medical research and opinion
pub_type: 杂志文章,评审
doi:10.1185/03007995.2010.517718
更新日期:2010-11-01 00:00:00
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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