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Absolute and attributable risk of venous thromboembolism in women on combined cyproterone acetate and ethinylestradiol.

https://arctichealth.org/en/permalink/ahliterature184568
Source
J Obstet Gynaecol Can. 2003 Jul;25(7):575-7
Publication Type
Article
Date
Jul-2003
Author
Øjvind Lidegaard
Author Affiliation
Danish Centre for Human Reproductive Epidemiology (DaHRE), Department of Obstetrics and Gynaecology, Herlev University Hospital, Copenhagen County, Denmark.
Source
J Obstet Gynaecol Can. 2003 Jul;25(7):575-7
Date
Jul-2003
Language
English
Publication Type
Article
Keywords
Adolescent
Adult
Contraceptives, Oral, Combined - administration & dosage - adverse effects
Cyproterone Acetate - administration & dosage - adverse effects
Denmark - epidemiology
Epidemiologic Studies
Ethinyl Estradiol - administration & dosage - adverse effects
Female
Humans
Risk assessment
Risk factors
Thromboembolism - chemically induced - epidemiology
Venous Thrombosis - chemically induced - epidemiology
Abstract
To achieve absolute risk estimates of venous thromboembolism (VTE) among women on cyproterone acetate plus ethinylestradiol (CPA/EE), and among women on combined oral contraceptives (COCs).
From the Danish National Register of Patients (NRP), 1996 to 1998, the records of 1.1 million Danish women, ages 15 to 44 years, were searched for evidence of VTE. COC use was ascertained through mailed questionnaires. Sales statistics of COCs and CPA/EE were provided through Danish Drug Statistics.
During the time frame of the study, 330 women were found to have had VTE while on COCs. Of these women, 67 were on levonorgestrel-containing COCs. Eleven were on CPA/EE. The corresponding absolute risk of VTE was 3.4 (range, 3.1-3.8) per 10 000 women years among the women on COCs, 4.2 (range, 3.2-5.2) per 10 000 women years among women on levonorgestrel-containing COCs, and 3.1 (range, 1.3-4.9) per 10 000 women years among the women on CPA/EE.
Our results suggest the absolute risk of VTE among Danish women on COCs is similar to that among women taking CPA/EE.
PubMed ID
12851669 View in PubMed
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Association of venous thromboembolism and clozapine.

https://arctichealth.org/en/permalink/ahliterature198734
Source
Lancet. 2000 Apr 1;355(9210):1155-6
Publication Type
Article
Date
Apr-1-2000
Author
S. Hägg
O. Spigset
T G Söderström
Source
Lancet. 2000 Apr 1;355(9210):1155-6
Date
Apr-1-2000
Language
English
Publication Type
Article
Keywords
Adult
Adverse Drug Reaction Reporting Systems - statistics & numerical data
Antipsychotic Agents - adverse effects
Clozapine - adverse effects
Female
Humans
Male
Middle Aged
Pulmonary Embolism - chemically induced
Sweden - epidemiology
Venous Thrombosis - chemically induced
Abstract
Data from the Swedish Adverse Reactions Advisory Committee suggest that use of clozapine is associated with venous thromboembolic complications. We summarise 12 cases of thromboembolism during clozapine treatment. In five cases the outcome was fatal.
Notes
Comment In: Lancet. 2000 Jul 15;356(9225):252-310963226
Comment In: Lancet. 2000 Jul 15;356(9225):25210963225
Comment In: Lancet. 2000 Jul 15;356(9225):25210963224
PubMed ID
10791380 View in PubMed
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The changing scene--an unnecessary pill crisis.

https://arctichealth.org/en/permalink/ahliterature54139
Source
Hum Reprod Update. 1999 Nov-Dec;5(6):746-55
Publication Type
Article
Author
L A Heinemann
Author Affiliation
ZEG-Centre for Epidemiology and Health Research Berlin, Germany. zeg@snafu.de
Source
Hum Reprod Update. 1999 Nov-Dec;5(6):746-55
Language
English
Publication Type
Article
Keywords
Brain Ischemia - chemically induced
Cerebrovascular Accident - chemically induced
Contraceptives, Oral - adverse effects
Female
Humans
Myocardial Infarction - chemically induced
Risk factors
Thromboembolism - chemically induced
Venous Thrombosis - chemically induced
Abstract
A number of case-control studies published in 1995/1996 have shown an apparent increase in the risk of venous thromboembolism (VTE) associated with the use of third-generation oral contraceptives (OC). However, it was discussed very early on that these studies were subject to a number of biases or residual confounding that would have increased the risk estimates for third-generation OC while lowering those for second-generation preparations. Six new studies or analyses were performed trying to take into account many of the methodological problems that were discussed for the initial studies: Two population-based database analyses in the UK and Germany, a new analysis of the General Practice Registry database (GPRD) in the UK, an analysis of a new database of the Transnational study, a re-analysis of the original Transnational study with a new technique, and a population-based study in Denmark. These studies could not confirm a higher VTE risk in users of third-generation OC compared with those using second-generation OC. Data on the risk of arterial thromboembolism (ischaemic stroke and myocardial infarction) show no such difference between generations of OC, with a statistically significant reduction in the risk of acute myocardial infarction from first- to third-generation preparations in one major study. Some of the investigators concluded that there is very likely no increased risk of arterial thromboembolism associated with the use of low-dose oestrogen OC in young women who are properly screened for cardiovascular risk factors or for such conditions. These findings should be taken into account when interpreting the results of studies on the risk of VTE in women taking combined OC.
PubMed ID
10652983 View in PubMed
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COX-2 inhibition and thrombotic tendency: a need for surveillance.

https://arctichealth.org/en/permalink/ahliterature14005
Source
Med J Aust. 2001 Aug 20;175(4):214-7
Publication Type
Article
Date
Aug-20-2001
Author
L G Cleland
M J James
L K Stamp
P S Penglis
Author Affiliation
Rheumatology Unit, Royal Adelaide Hospital, SA. Iceland@mail.rah.sa.gov.au
Source
Med J Aust. 2001 Aug 20;175(4):214-7
Date
Aug-20-2001
Language
English
Publication Type
Article
Keywords
Anti-Inflammatory Agents, Non-Steroidal - adverse effects - therapeutic use
Arthritis, Rheumatoid - drug therapy
Aspirin - adverse effects - therapeutic use
Cyclooxygenase Inhibitors - adverse effects - therapeutic use
Female
Gastrointestinal Diseases - chemically induced
Humans
Lactones - adverse effects - therapeutic use
Middle Aged
Pyrazoles
Randomized Controlled Trials
Research Support, Non-U.S. Gov't
Risk factors
Sulfonamides - adverse effects - therapeutic use
Sulfones
Venous Thrombosis - chemically induced
Abstract
Cyclooxygenase-2 (COX-2) inhibitors belong to a new class of drugs which have anti-inflammatory efficacy similar to that of traditional non-steroidal anti-inflammatory drugs (NSAIDs), but are associated with a reduced incidence of adverse upper gastrointestinal events. Biochemical evidence that COX-2 inhibitors could promote or exacerbate a tendency to thrombosis is supported by recent results from clinical trials and case reports. Two agents in this class, celecoxib and rofecoxib, have been listed on the Pharmaceutical Benefits Scheme (PBS) for very broad indications in chronic arthropathies, suggesting that they will move into widespread community use. It is important to canvass the possibility that use of these agents could be associated with thrombotic events.
Notes
Comment In: Med J Aust. 2002 Jan 21;176(2):88-9; author reply 8911936297
PubMed ID
11587283 View in PubMed
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Diane-35 (cyproterone acetate): safety concerns.

https://arctichealth.org/en/permalink/ahliterature186611
Source
CMAJ. 2003 Feb 18;168(4):455-6
Publication Type
Article
Date
Feb-18-2003
Author
Eric Wooltorton
Source
CMAJ. 2003 Feb 18;168(4):455-6
Date
Feb-18-2003
Language
English
Publication Type
Article
Keywords
Androgen Antagonists - adverse effects - standards
Canada
Consumer Product Safety
Contraceptives, Oral, Hormonal - adverse effects - standards
Cyproterone Acetate - adverse effects - standards
Drug Combinations
Ethinyl Estradiol - adverse effects - standards
Female
Great Britain
Humans
Risk factors
Venous Thrombosis - chemically induced - epidemiology
Women's health
Notes
Cites: N Engl J Med. 2001 May 17;344(20):1527-3511357157
Cites: BMJ. 2001 Jul 21;323(7305):131-411463678
Cites: Lancet. 2001 Oct 27;358(9291):1427-911705493
Cites: Contraception. 2002 Mar;65(3):187-9611929640
Cites: CMAJ. 2002 Apr 2;166(7):93111949993
Cites: CMAJ. 2002 Jul 9;167(1):48-5412137081
Cites: BMJ. 2000 Nov 11;321(7270):1190-511073511
Cites: BMJ. 2000 Jul 22;321(7255):190-110903631
Cites: Lancet. 2000 Jun 17;355(9221):2133-410902629
Cites: Lancet. 1995 Dec 16;346(8990):1575-827500748
Cites: Contraception. 1998 Jan;57(1):61-59554253
Cites: BMJ. 1996 Jan 13;312(7023):121-28555906
Cites: Lancet. 1995 Dec 16;346(8990):1589-937500750
Comment In: CMAJ. 2003 May 27;168(11):139412771065
PubMed ID
12591790 View in PubMed
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Fatal venous thromboembolism associated with different combined oral contraceptives: a study of incidences and potential biases in spontaneous reporting.

https://arctichealth.org/en/permalink/ahliterature83242
Source
Drug Saf. 2005;28(10):907-16
Publication Type
Article
Date
2005
Author
Hedenmalm Karin
Samuelsson Eva
Author Affiliation
Pharmacovigilance Unit and Clinical Trial Unit, Medical Products Agency, Uppsala, Sweden. karin.hedenmalm@mpa.se
Source
Drug Saf. 2005;28(10):907-16
Date
2005
Language
English
Publication Type
Article
Keywords
Adolescent
Adult
Adverse Drug Reaction Reporting Systems
Bias (epidemiology)
Contraceptives, Oral, Combined - adverse effects
Female
Humans
Incidence
Retrospective Studies
Thromboembolism - chemically induced - mortality
Venous Thrombosis - chemically induced - mortality
Abstract
BACKGROUND: Fatal venous thromboembolism (VTE) is a rare complication of combined oral contraceptive (COC) treatment. This study aims to determine incidences of fatal VTE in relation to the type of COC and the percentage of cases reported to the Swedish Adverse Drug Reactions Advisory Committee (SADRAC). A further aim is to compare the characteristics of reported and not reported cases. METHODS: This retrospective study is a separate analysis using data from a larger study that included women aged 15-44 years between 1990 and 1999 with VTE coded as the underlying or contributory cause of death in the Swedish Cause of Death Register. COC use within 2 months of the date of symptom onset or death was identified in 28 cases. Sales data were obtained from the National Corporation of Swedish Pharmacies. Reported cases were identified in the SADRAC database. RESULTS: After excluding two cases where the type of COC was unknown, the crude incidences of fatal VTE were 5.1 (95% CI 2.3, 9.6), 8.6 (95% CI 4.3, 15.4) and 9.1 (95% CI 3.3, 19.8) cases per million women per year for levonorgestrel-, desogestrel- and norethisterone-containing COCs, respectively. Age-adjusted incidences were approximately twice as high for desogestrel- and norethisterone-containing COCs compared with levonorgestrel-containing COCs, although differences were not statistically significant. Thirty-six percent of cases were reported. Reporting was positively associated with information in medical records relevant to the VTE diagnosis that the patient was a COC user and was significantly higher in northern Sweden. CONCLUSION: Results from this study support a higher incidence of fatal VTE with desogestrel-containing COCs than with levonorgestrel-containing COCs.
PubMed ID
16180940 View in PubMed
Less detail
Source
CMAJ. 2003 May 27;168(11):1394
Publication Type
Article
Date
May-27-2003
Author
Timothy C Rowe
Source
CMAJ. 2003 May 27;168(11):1394
Date
May-27-2003
Language
English
Publication Type
Article
Keywords
Androgen Antagonists - adverse effects
Canada - epidemiology
Consumer Product Safety
Cyproterone Acetate - adverse effects
Drug Combinations
Ethinyl Estradiol - adverse effects
Female
Humans
Risk assessment
Risk factors
Thromboembolism - chemically induced - epidemiology
Venous Thrombosis - chemically induced - epidemiology
Notes
Cites: Lancet. 2001 Oct 27;358(9291):1427-911705493
Cites: Contraception. 1997 Sep;56(3):141-69347203
Cites: CMAJ. 2003 Feb 18;168(4):455-612591790
Comment On: CMAJ. 2003 Feb 18;168(4):455-612591790
PubMed ID
12771065 View in PubMed
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Incidence of venous thromboembolism in young Swedish women and possibly preventable cases among combined oral contraceptive users.

https://arctichealth.org/en/permalink/ahliterature63363
Source
Acta Obstet Gynecol Scand. 2004 Jul;83(7):674-81
Publication Type
Article
Date
Jul-2004
Author
Eva Samuelsson
Staffan Hägg
Author Affiliation
Division of Family Medicine, Department of Public Health and Clinical Medicine, Umeå University, Umeå, Sweden. eva.samuelsson@jll.se
Source
Acta Obstet Gynecol Scand. 2004 Jul;83(7):674-81
Date
Jul-2004
Language
English
Publication Type
Article
Keywords
Adolescent
Adult
Contraceptives, Oral, Combined - administration & dosage - adverse effects
Databases, Factual
Female
Humans
Incidence
Interviews
Pregnancy
Research Support, Non-U.S. Gov't
Retrospective Studies
Risk factors
Sweden - epidemiology
Thromboembolism - epidemiology
Venous Thrombosis - chemically induced - epidemiology
Abstract
BACKGROUND: We wanted to study the incidence of venous thromboembolism (VTE), acquired risk factors of VTE and preventable cases among users of combined oral contraceptives (COCs). METHODS: All women aged 15-44 years, (n = 24 373) living in the county of Jämtland, Sweden, between 1991 and 2000, constituted the study base in a retrospective case-reference study. Women with VTE were identified through hospital registers and interviewed by telephone. The utilization of COCs according to age was obtained from a prospective prescription database, and data from national health databases were used. RESULTS: Of 88 women with first-time VTE, 43 (49%) were COC users and 13 (15%) were pregnant. All women had at least one known risk factor, and 51 (58%) women had combinations of risk factors. The total incidence rate of VTE per 100,000 women-years for all women were 36 (29-44), for nonusers 19 (12-25) for women using third generation COCs 115 (67-184), for women using other COCs 60 (37-83), and for women during pregnancy and postpartum 103 (55-177). Of the total 244,000 women-years represented, COC users constituted 24%, pregnant women 5%, and women with other acquired risk factors 5%. The corresponding incidence rates after excluding VTE cases with other acquired risk factors were 10 (6-14), 1.2 (0.14-4.4), 64 (29-121), 27 (13-48), and 59 (24-121), per 100,000 women-years. In 11 (26%) of the COC-related VTE cases, there were relative contraindications for use of COCs or lack of thromboprophylaxis in relation to surgery. CONCLUSION. We found a very low incidence of idiopathic VTE among young non-OC users. The incidence of VTE during pregnancy was only slightly higher than during COC use. It was considered that a significant part of COC-related VTE might have been avoided.
PubMed ID
15225194 View in PubMed
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Low molecular weight heparin, therapy with dalteparin, and survival in advanced cancer: the fragmin advanced malignancy outcome study (FAMOUS).

https://arctichealth.org/en/permalink/ahliterature180113
Source
J Clin Oncol. 2004 May 15;22(10):1944-8
Publication Type
Article
Date
May-15-2004
Author
Ajay K Kakkar
Mark N Levine
Zbigniew Kadziola
Nicholas R Lemoine
Vanessa Low
Heman K Patel
Gordon Rustin
Michael Thomas
Mary Quigley
Robin C N Williamson
Author Affiliation
Department of Surgical Oncology and Technology, and Cancer Research UK Laboratories, Imperial College, London, United Kingdom. akkakkar@tri-london.ac.uk
Source
J Clin Oncol. 2004 May 15;22(10):1944-8
Date
May-15-2004
Language
English
Publication Type
Article
Keywords
Aged
Anticoagulants - administration & dosage
Antineoplastic Combined Chemotherapy Protocols - adverse effects
Dalteparin - administration & dosage
Double-Blind Method
England
Female
Humans
Italy
Male
Middle Aged
Neoplasms - drug therapy - mortality
Ontario
Survival Analysis
Treatment Outcome
Venous Thrombosis - chemically induced - prevention & control
Abstract
In experimental systems, interference with coagulation can affect tumor biology. Furthermore, it has been suggested that low molecular weight heparin therapy may prolong survival in patients with cancer. The primary aim of this study was to assess survival at 1 year of patients with advanced cancer.
Patients with advanced malignancy (N = 385) were randomly assigned to receive either a once-daily subcutaneous injection of dalteparin (5,000 IU), a low molecular weight heparin, or placebo for 1 year.
The Kaplan-Meier survival estimates at 1, 2, and 3 years after randomization for patients receiving dalteparin were 46%, 27%, and 21%, respectively, compared with 41%, 18%, and 12%, respectively, for patients receiving placebo (P =.19). In an analysis not specified a priori, survival was examined in a subgroup of patients (dalteparin, n = 55; and placebo, n = 47) who had a better prognosis and who were alive 17 months after randomization. In these patients, Kaplan-Meier survival estimates at 2 and 3 years from randomization were significantly improved for patients receiving dalteparin versus placebo (78% v 55% and 60% v 36%, respectively, P =.03). The rates of symptomatic venous thromboembolism were 2.4% and 3.3% for dalteparin and placebo, respectively, with bleeding rates of 4.7% and 2.7%, respectively.
Dalteparin administration did not significantly improve 1-year survival rates in patients with advanced malignancy. However, the observed improved survival in a subgroup of patients with a better prognosis suggests a potential modifying effect of dalteparin on tumor biology.
PubMed ID
15143088 View in PubMed
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Mortality from venous thromboembolism in young Swedish women and its relation to pregnancy and use of oral contraceptives--an approach to specifying rates.

https://arctichealth.org/en/permalink/ahliterature16816
Source
Eur J Epidemiol. 2005;20(6):509-16
Publication Type
Article
Date
2005
Author
Eva Samuelsson
Karin Hedenmalm
Ingemar Persson
Author Affiliation
Division of Family Medicine, Department of Public Health and Clinical Medicine, Umeå University, Umeå, Sweden. eva.samuelsson@jll.se
Source
Eur J Epidemiol. 2005;20(6):509-16
Date
2005
Language
English
Publication Type
Article
Keywords
Adolescent
Adult
Age Distribution
Autopsy
Cause of Death
Contraceptives, Oral, Combined - adverse effects - therapeutic use
Death Certificates
Female
Hospital records
Humans
International Classification of Diseases
Pregnancy
Pregnancy Complications, Cardiovascular - chemically induced - mortality
Registries
Research Support, Non-U.S. Gov't
Risk factors
Sweden - epidemiology
Thromboembolism - chemically induced - diagnosis - mortality
Venous Thrombosis - chemically induced - diagnosis - mortality
Abstract
BACKGROUND: Pregnancy and use of combined oral contraceptives (COCs) are major risk factors for venous thromboembolism (VTE) in young women and we wanted to obtain accurate VTE mortality data overall, by age, associated with the use of COCs and pregnancy. METHODS: From the Swedish Cause of Death Register (CDR) we identified women aged 15-44 with VTE as underlying or contributory cause of death during the period 1990-1999. We scrutinized medical records and included verified VTE cases without active cancer or terminal disease. Pregnancy statistics and COC utilization data were obtained from national databases. RESULTS: Of the 120 cases included, 9 (8%) were associated with pregnancy and 28 (23%) with current COC use. The overall refined VTE mortality rate in current COC users was 7.5[4.7; 10.3] per million user-years and the corresponding pregnancy-related rate was 8.9[4.1;17.0] per million pregnancy years, rates increasing with age. For ages 15-24, the rate was significantly higher in current COC users than in non-pregnant women not using COCs: 6.0[3.1; 10.5] per million user-years vs. 0.3[0.0; 1.2] per million woman years. Underlying cause mortality data included 82% of VTE deaths associated with COCs, and 56% of maternal deaths had a pregnancy-related code. CONCLUSION: Mortality figures from VTE associated with the use of COCs and pregnancy were similar. COC use had an important impact on the total VTE mortality in the youngest age group. Standard mortality statistics do not allow accurate monitoring of VTE mortality in young women due to missing data, misdiagnoses and coding rules.
PubMed ID
16121760 View in PubMed
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21 records – page 1 of 3.