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Assessing the appropriateness of combining economic data from multinational clinical trials.

https://arctichealth.org/en/permalink/ahliterature184987
Source
Stat Med. 2003 Jun 30;22(12):1955-76
Publication Type
Article
Date
Jun-30-2003
Author
John R Cook
Michael Drummond
Henry Glick
Joseph F Heyse
Author Affiliation
Health Economic Statistics, Merck Research Laboratories, UN-A102, West Point, PA 19486, U.S.A.
Source
Stat Med. 2003 Jun 30;22(12):1955-76
Date
Jun-30-2003
Language
English
Publication Type
Article
Keywords
Anticholesteremic Agents - therapeutic use
Data Interpretation, Statistical
Health Care Costs
Humans
Multicenter Studies as Topic - economics - methods
Randomized Controlled Trials as Topic - economics - methods
Scandinavia
Simvastatin - therapeutic use
Abstract
Because of the potential for large variability among countries in the utilization and cost of health care resources, it is important to assess the appropriateness of combining economic data across the countries in a multinational clinical economic trial. We show how available tests for interaction can be applied to economic endpoints, including cost-effectiveness ratios and net health benefits. This analysis includes a characterization of possible interactions being quantitative or qualitative in nature. In the absence of interaction, a pooled estimate of the economic endpoint should be representative of the participating countries. We explore the analytic issues by further analysing data from the Scandinavian Simvastatin Survival Study (4S).
PubMed ID
12802815 View in PubMed
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Asymmetrical dimethylarginine (ADMA) and risk of acute coronary events. Does statin treatment influence plasma ADMA levels?

https://arctichealth.org/en/permalink/ahliterature182467
Source
Atheroscler Suppl. 2003 Dec;4(4):19-22
Publication Type
Article
Date
Dec-2003
Author
Veli-Pekka Valkonen
Juha Laakso
Hannu Päivä
Terho Lehtimäki
Timo A Lakka
Marja Isomustajärvi
Inkeri Ruokonen
Jukka T Salonen
Reijo Laaksonen
Author Affiliation
Research Institute of Public Health, University of Kuopio, Kuopio, Finland
Source
Atheroscler Suppl. 2003 Dec;4(4):19-22
Date
Dec-2003
Language
English
Publication Type
Article
Keywords
Acute Disease
Adult
Aged
Arginine - analogs & derivatives - blood - drug effects
Biological Markers - blood
Blood Glucose - drug effects - metabolism
Case-Control Studies
Cholesterol, HDL - blood - drug effects
Cholesterol, LDL - blood - drug effects
Coronary Disease - blood - drug therapy - epidemiology
Double-Blind Method
Endothelium, Vascular - metabolism - physiopathology
Enzyme Inhibitors - blood
Female
Finland - epidemiology
Heptanoic Acids - therapeutic use
Humans
Hydroxymethylglutaryl-CoA Reductase Inhibitors - therapeutic use
Hypolipidemic Agents - therapeutic use
Male
Middle Aged
Prospective Studies
Pyrroles - therapeutic use
Risk factors
Simvastatin - therapeutic use
Statistics as Topic
Triglycerides - blood
Abstract
The purpose of this study was to evaluate the hypothesis that high serum levels of ADMA, an indicator of endothelial dysfunction, are associated with an elevated risk of acute coronary events in middle-aged men. To test the hypothesis that lipid lowering medication with statins lowers circulating ADMA levels, we also investigated the effect of simvastatin and atorvastatin treatment on plasma ADMA concentration. In a prospective nested case-control study in 150 middle-aged non-smoking men from Eastern Finland, those who were in the highest quartile for serum ADMA (>0.62 micromol/l) had a 3.9-fold (95% CI: 1.25-12.3, P=0.02) increase in risk of acute coronary events compared with other quartiles. In an 8-week randomised double-blind placebo-controlled trial, plasma ADMA concentrations remained unchanged in simvastatin 80 mg/day (n=16), atorvastatin 40 mg/day (n=16) and placebo (n=16) groups over the study period. Our findings indicate that high serum levels of ADMA, a potential marker for endothelial dysfunction, may increase the risk of acute coronary syndromes. However, aggressive treatment with either simvastatin or atorvastatin did not reduce plasma ADMA levels.
PubMed ID
14664898 View in PubMed
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Baseline serum cholestanol as predictor of recurrent coronary events in subgroup of Scandinavian simvastatin survival study. Finnish 4S Investigators.

https://arctichealth.org/en/permalink/ahliterature205937
Source
BMJ. 1998 Apr 11;316(7138):1127-30
Publication Type
Article
Date
Apr-11-1998
Author
T A Miettinen
H. Gylling
T. Strandberg
S. Sarna
Author Affiliation
Department of Medicine, University of Helsinki, Finland.
Source
BMJ. 1998 Apr 11;316(7138):1127-30
Date
Apr-11-1998
Language
English
Publication Type
Article
Keywords
Adult
Biological Markers - blood
Cholestanol - blood
Cholesterol, HDL - blood
Cholesterol, LDL - blood
Coronary Disease - blood - diagnosis - drug therapy
Drug resistance
Finland
Follow-Up Studies
Humans
Recurrence
Regression Analysis
Risk factors
Simvastatin - therapeutic use
Treatment Outcome
Notes
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Comment In: BMJ. 1998 Oct 31;317(7167):1252-39794879
PubMed ID
9552949 View in PubMed
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Benefits of pharmaceutical innovation: the case of simvastatin in Canada.

https://arctichealth.org/en/permalink/ahliterature120591
Source
Int J Technol Assess Health Care. 2012 Oct;28(4):390-7
Publication Type
Article
Date
Oct-2012
Author
Nguyen Xuan Thanh
Anderson W Chuck
Arto Ohinmaa
Philip Jacobs
Author Affiliation
Institute of Health Economics, Canada. tnguyen@ihe.ca
Source
Int J Technol Assess Health Care. 2012 Oct;28(4):390-7
Date
Oct-2012
Language
English
Publication Type
Article
Keywords
Adolescent
Adult
Anticholesteremic Agents - therapeutic use
Canada
Coronary Artery Disease - drug therapy - economics - mortality
Diffusion of Innovation
Drug Industry - economics
Female
Health Care Costs
Humans
Male
Middle Aged
Public Health - economics
Simvastatin - therapeutic use
Survival Analysis
Young Adult
Abstract
The benefits of pharmaceutical innovations are widely diffused; they accrue to the healthcare providers, patients, employers, and manufacturers. We estimate the societal monetary benefits of simvastatin in Canada and its distribution among different beneficiaries overtime.
Monetary benefits to developing and generic manufacturers were estimated by calculating public and private revenues minus the development costs of simvastatin and the contribution toward further research and development. We used a dynamic Markov model to estimate monetary benefits to healthcare and employment sectors in terms of cost avoidance associated with prevented cardiovascular events, including stroke and myocardial infarction, and lost productivity due to disability and premature death in working population.
Cumulative monetary benefits of simvastatin from 1990 to 2009 were $4.8 billion (2010 CA$), of which developing and generic manufacturers, and healthcare and employment sectors accounted for 32 percent, 27 percent, 32 percent, and 9 percent, respectively. The yearly trend showed that after the patent expired in 2002 the generic manufacturers became dominant in the market. Benefits for the healthcare sector started to decrease from 2003 corresponding to the decreasing population taking simvastatin during the same time period. Sensitivity analysis showed the higher the compliance or the efficacy, the larger the benefits to healthcare and employment sectors, while monetary benefits for manufacturers were unchanged.
Societal monetary benefits of simvastatin are significant and the distributions of the benefits have changed overtime. Patent, compliance, and efficacy play a vital role in the estimation of the benefits. Analysis of all beneficiaries separately overtime is important when assessing the value of pharmaceutical innovation.
PubMed ID
22989373 View in PubMed
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Cholesterol lowering after participation in the Scandinavian Simvastatin Survival Study (4S) in Finland.

https://arctichealth.org/en/permalink/ahliterature207110
Source
Eur Heart J. 1997 Nov;18(11):1725-7
Publication Type
Article
Date
Nov-1997
Author
T E Strandberg
S. Lehto
K. Pyörälä
A. Kesäniemi
H. Oksa
Author Affiliation
Department of Medicine, University of Helsinki, Finland.
Source
Eur Heart J. 1997 Nov;18(11):1725-7
Date
Nov-1997
Language
English
Publication Type
Article
Keywords
Anticholesteremic Agents - therapeutic use
Attitude to Health
Cholesterol - blood
Coronary Disease - prevention & control
Female
Finland
Humans
Male
Patient compliance
Questionnaires
Simvastatin - therapeutic use
Abstract
Patient compliance is crucial for the effectiveness of preventive medication. The aim of the study was to investigate changes in serum cholesterol levels and the use of cholesterol lowering drugs one year after the end of the Scandinavian Simvastatin Survival Study (4S), a randomized secondary prevention study of coronary heart disease with simvastatin and placebo.
A questionnaire asking the current use of cholesterol lowering drugs, most recent serum cholesterol value and attitudes towards cholesterol lowering was sent to 785 surviving 4S participants in four 4S centres in Finland. The response rate was 94%. The current use of cholesterol lowering drugs and the reported mean serum cholesterol values were similar to the original simvastatin and placebo groups. In all, 74% (n = 546) reported that they had used cholesterol lowering drugs after the study, and 63% (n = 467) were currently using them, mostly simvastatin (96%) with an average dose of 14 (SD 5) mg.day-1. Cholesterol lowering was considered to be 'very important' by 53% and 'important' by 37% of the respondents. The most frequent reasons for discontinuation were 'drug costs' (38%) and 'normal cholesterol values' (30%). The reported mean serum cholesterol levels were 5.1 (SD 1.0) and 5.7 (SD 1.1) mmol-1 in the current cholesterol lowering drug users and non-users, respectively (P
Notes
Comment In: Eur Heart J. 1997 Nov;18(11):1695-69402441
PubMed ID
9402446 View in PubMed
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Clinical use and effectiveness of lipid lowering therapies in diabetes mellitus--an observational study from the Swedish National Diabetes Register.

https://arctichealth.org/en/permalink/ahliterature134613
Source
PLoS One. 2011;6(4):e18744
Publication Type
Article
Date
2011
Author
Björn Eliasson
Ann-Marie Svensson
Mervete Miftaraj
Junmei Miao Jonasson
Katarina Eeg-Olofsson
Karolina Andersson Sundell
Soffia Gudbjörnsdóttir
Author Affiliation
Department of Medicine, University of Gothenburg, Sahlgrenska University Hospital, Göteborg, Sweden. bjorn.eliasson@gu.se
Source
PLoS One. 2011;6(4):e18744
Date
2011
Language
English
Publication Type
Article
Keywords
Adolescent
Adult
Aged
Diabetes Mellitus, Type 1 - drug therapy
Diabetes Mellitus, Type 2 - drug therapy
Female
Fluorobenzenes - therapeutic use
Heptanoic Acids - therapeutic use
Humans
Hydroxymethylglutaryl-CoA Reductase Inhibitors - therapeutic use
Male
Middle Aged
Models, Statistical
Pyrimidines - therapeutic use
Pyrroles - therapeutic use
Registries
Simvastatin - therapeutic use
Sulfonamides - therapeutic use
Sweden
Treatment Outcome
Abstract
To describe the use and evaluate the effectiveness of different lipid lowering therapies in unselected patients with type 1 and type 2 diabetes in clinical practice.
Observational population-based study using the personal identification number to link information from the National Diabetes Register, the Prescribed Drug Register and the Patient register in Sweden. All patients in the NDR aged 18-75 years with diabetes more than one year were eligible, but only patients starting any lipid lowering treatment with at least three prescriptions 1 July 2006-30 June 2007 were included (n?=?37,182). The mean blood lipid levels in 2008 and reductions in LDL cholesterol were examined.
Blood lipid levels were similar in patients treated with simvastatin, atorvastatin and rosuvastatin, showing similar lipid lowering effect as currently used. Users of pravastatin, fluvastatin, ezetimib and fibrate more seldom reach treatment goals. Moderate daily doses of the statins were used, with 76% of simvastatin users taking 20 mg or less, 48% of atorvastatin users taking 10 mg, 55% of pravastatin users taking 20 mg, and 76% of rosuvastatin users taking 5 or 10 mg.
This observational study shows that the LDL-C levels in patients taking simvastatin, atorvastatin or rosuvastatin are very similar as currently used, as well as their LDL-C lowering abilities. There is potential to intensify lipid lowering treatment to reduce the remaining high residual risk and achieve better fulfilment of treatment goals, since the commonly used doses are only low to moderate.
Notes
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PubMed ID
21559521 View in PubMed
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Combined hyperlipidemia in patients with lysinuric protein intolerance.

https://arctichealth.org/en/permalink/ahliterature145267
Source
J Inherit Metab Dis. 2010 Dec;33 Suppl 3:S145-50
Publication Type
Article
Date
Dec-2010
Author
Laura M Tanner
Harri Niinikoski
Kirsti Näntö-Salonen
Olli Simell
Author Affiliation
Department of Pediatrics, University of Turku, Turku, Finland. lamaer@utu.fi
Source
J Inherit Metab Dis. 2010 Dec;33 Suppl 3:S145-50
Date
Dec-2010
Language
English
Publication Type
Article
Keywords
Adolescent
Adult
Amino Acid Metabolism, Inborn Errors - blood - complications - diagnosis - therapy
Biological Markers - blood
Child
Child, Preschool
Cholesterol - blood
Cholesterol, HDL - blood
Cystatin C - metabolism
Disease Progression
Female
Finland
Heptanoic Acids - therapeutic use
Humans
Hydroxymethylglutaryl-CoA Reductase Inhibitors - therapeutic use
Hyperlipidemias - blood - diagnosis - drug therapy - etiology
Male
Middle Aged
Pyrroles - therapeutic use
Retrospective Studies
Risk factors
Simvastatin - therapeutic use
Time Factors
Treatment Outcome
Triglycerides - blood
Young Adult
Abstract
Lysinuric protein intolerance (LPI) is an autosomal recessive disorder characterized by defective transport of cationic amino acids lysine, arginine, and ornithine. Low plasma concentrations of arginine and ornithine lead to impaired urea cycle function and, subsequently, decreased protein tolerance. Patients often develop natural aversion to protein-rich foods, which may predispose them to nutritional problems. The objective of this retrospective study was to investigate lipid values and efficacy of lipid-lowering therapy in patients with LPI.
Serum total and high-density-lipoprotein (HDL)-cholesterol and triglyceride concentrations were analyzed in 39 Finnish LPI patients (14 males) aged 3-64 years. Dietary intakes were analyzed from food records. Mean [standard deviation (SD)] serum and HDL-cholesterol and triglyceride concentrations were 7.16 (2.13) mmol/l, 1.21 (0.58) mmol/l, and 4.0 (2.4) mmol/l, respectively. Patients with renal dysfunction had marginally higher total cholesterol and significantly higher triglyceride concentration than patients without renal impairment. Twenty-two patients were started on 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitors (atorvastatin or simvastatin). After 6 months, serum cholesterol and triglyceride concentrations had decreased by 32% (p
PubMed ID
20177788 View in PubMed
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Comparative effect of atorvastatin (80 mg) versus simvastatin (20 to 40 mg) in preventing hospitalizations for heart failure in patients with previous myocardial infarction.

https://arctichealth.org/en/permalink/ahliterature89073
Source
Am J Cardiol. 2009 May 15;103(10):1381-5
Publication Type
Article
Date
May-15-2009
Author
Strandberg Timo E
Holme Ingar
Faergeman Ole
Kastelein John J P
Lindahl Christina
Larsen Mogens Lytken
Olsson Anders G
Pedersen Terje R
Tikkanen Matti J
Author Affiliation
Department of Health Sciences/Geriatrics, University of Oulu, and Oulu University Hospital, Unit of General Practice, Oulu, Finland. timo.strandberg@oulu.fi
Source
Am J Cardiol. 2009 May 15;103(10):1381-5
Date
May-15-2009
Language
English
Publication Type
Article
Keywords
Female
Heart Failure - epidemiology - prevention & control
Heptanoic Acids - therapeutic use
Hospitalization - statistics & numerical data
Humans
Hydroxymethylglutaryl-CoA Reductase Inhibitors - therapeutic use
Incidence
Male
Middle Aged
Myocardial Infarction - drug therapy
Proportional Hazards Models
Prospective Studies
Pyrroles - therapeutic use
Simvastatin - therapeutic use
Treatment Outcome
Abstract
We investigated whether intensive cholesterol lowering could more effectively prevent heart failure (HF) in secondary prevention. The IDEAL study was a 4.8-year prospective, randomized trial comparing "usual" simvastatin treatment (20 to 40 mg/day, n = 4,449) with high-dose atorvastatin (80 mg/day, n = 4,439) in patients with a history of myocardial infarction (MI). At baseline, 94% of patients (n = 8,351) had no history of HF. During the course of the trial, there were 222 new or recurrent hospitalizations for HF (57 and 165 in those with and without HF at baseline, respectively), 123 (2.8%) in the simvastatin group and 99 (2.2%) in the atorvastatin group (hazard ratio [HR] 0.81, 95% confidence interval [CI] 0.62 to 1.05, p = 0.11). After adjustments, atorvastatin 80 mg was associated with a 26% decrease of new HF events compared with simvastatin 20 to 40 mg (HR 0.74, 95% CI 0.57 to 0.97, p = 0.03). Atorvastatin tended to be associated with fewer HF events in those with HF at baseline (n = 537, HR 0.65, 95% CI 0.38 to 1.11, p = 0.11) and those without HF at baseline (n = 8,351, HR 0.80, 95% CI 0.59 to 1.09, p = 0.15). Also, HF without preceding MI (n = 187) was decreased (HR 0.73, 95% CI 0.54 to 0.97, p = 0.03). In conclusion, atorvastatin 80 mg was more efficient than simvastatin 20 to 40 mg in preventing development of HF in patients with previous MI.
PubMed ID
19427432 View in PubMed
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Differences in the treatment of coronary heart disease between countries as revealed in the Scandinavian Simvastatin Survival Study (4S)

https://arctichealth.org/en/permalink/ahliterature54320
Source
Eur Heart J. 1998 Oct;19(10):1531-7
Publication Type
Article
Date
Oct-1998
Author
O. Faergeman
J. Kjekshus
T. Cook
K. Pyörälä
L. Wilhelmsen
G. Thorgeirsson
T R Pedersen
Author Affiliation
Department of Medicine and Cardiology, Aarhus Amtssygehus, Aarhus, Denmark.
Source
Eur Heart J. 1998 Oct;19(10):1531-7
Date
Oct-1998
Language
English
Publication Type
Article
Keywords
Angiotensin-Converting Enzyme Inhibitors - therapeutic use
Anticholesteremic Agents - therapeutic use
Aspirin - therapeutic use
Calcium Channel Blockers - therapeutic use
Cause of Death
Comparative Study
Coronary Disease - mortality - therapy
Female
Finland - epidemiology
Follow-Up Studies
Humans
Iceland - epidemiology
Male
Middle Aged
Myocardial Revascularization
Prognosis
Scandinavia - epidemiology
Simvastatin - therapeutic use
Survival Rate
Warfarin - therapeutic use
Abstract
AIM: To assess differences in treatment of ischaemic heart disease in the Scandinavian countries. METHODS AND RESULTS: The Scandinavian Simvastatin Survival Study (4S) lasted 5.4 years and showed that death rates in 4444 patients with coronary heart disease were 30% lower in those treated with simvastatin to lower serum cholesterol than in those given placebo. Apart from this main result, the 4S provided detailed information on rates of death and other manifestations of coronary heart disease, as well as on use of non-lipid forms of therapy. There were substantial differences in 4S placebo group rates of mortality, coronary deaths and major coronary events between countries. Surgical and medical therapy varied importantly between countries. CONCLUSIONS: Major inter-country differences in rates of death and myocardial infarction in patients with coronary heart disease were likely to be due to a composite of differences in baseline characteristics including smoking. They occurred in a setting of very uneven exploitation of the potential for improving survival of patients with ischaemic heart disease.
Notes
Comment In: Eur Heart J. 1998 Oct;19(10):14199820981
PubMed ID
9820992 View in PubMed
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39 records – page 1 of 4.