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Journal of Family Planning and Reproductive Health Care 07/2012; 38(3):206-7. · 1.64 Impact Factor
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Journal of Family Planning and Reproductive Health Care 11/2011; 38(1):2-6. · 1.64 Impact Factor
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ABSTRACT: This study compares the risk of breast cancer for levonorgestrel-releasing intrauterine devices (LNG(IUD)) versus copper IUDs (CU(IUD)) in women younger than 50 years of age.
Retrospective, population-based, case-control study using cancer registers in Finland and Germany, powered to exclude a 1.5-fold risk of breast cancer.
Analysis of 5113 breast cancer cases diagnosed 2000-2007 and 20,452 controls - matched by year of birth and area of residence - yielded relative risk estimates approaching unity with 95% CI crossing 1.0 for all comparisons, including ever-use of LNG(IUD) versus CU(IUD) (adjusted OR, 0.99; 95% CI, 0.88-1.12) and current use at time of diagnosis (adjusted OR, 0.85; 95% CI, 0.52-1.39), as well as for sub-analyses by country, age, tumor characteristics and period, recency and duration of use prior to diagnosis.
This study does not indicate an increased risk of breast cancer for users of LNG(IUD). No indications for tumor promotion or tumor induction were found.
Contraception 03/2011; 83(3):211-7. · 2.72 Impact Factor
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ABSTRACT: To estimate real-life effectiveness of oral contraceptive pills by progestogen, length of pill-free interval, and body mass index while focusing on the effect of progestogens with a long half-life and on 24-day oral contraceptive pills regimens.
Outcome data from 52,218 U.S. participants in the International Active Surveillance of Women Taking Oral Contraceptives—a large, prospective, controlled, noninterventional, long-term cohort study with active surveillance of the study participants—were used to analyze contraceptive failure in association with oral contraceptive pills use. Low loss to follow-up is ensured by a comprehensive follow-up procedure. Contraceptive failure rates are described by Pearl Index and life-table analysis. Inferential statistics for contraceptive failure are based on Cox regression models.
Analyses are based on 1,634 unintended pregnancies during 73,269 woman-years of oral contraceptive pills exposure. Life-table estimates of contraceptive failure for a 24-day regimen of drospirenone and ethinyl estradiol and 21-day regimens of other progestogens were 2.1% and 3.5% after the first study year, and 4.7% and 6.7% after the third year. The adjusted hazard ratio was 0.7 (95% confidence interval 0.6–0.8). Direct comparisons of the 24-day and 21-day regimens of drospirenone and norethisterone, respectively, showed also lower contraceptive failure rates for 24-day regimens. Contraceptive failure rates adjusted for age, parity and educational level showed a slight increase with higher body mass index.
The 24-day oral contraceptive regimens containing a progestogen with a long half-life show higher contraceptive effectiveness under routine medical conditions compared with conventional 21-day regimens. Obesity seems to be associated with a slight reduction of contraceptive effectiveness.
ClinicalTrials.gov, www.clinicaltrials.gov, NCT00335257.
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Obstetrics and Gynecology 01/2011; 117(1):33-40. · 4.73 Impact Factor
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ABSTRACT: The primary objective of the study was to clarify whether the use of the oral contraceptive 2 mg dienogest/30 microg ethinylestradiol (DNG/EE) is associated with a higher risk of venous thromboembolism (VTE) than the use of other combined oral low-dose contraceptives (i.e. containing < or =30 microg EE), particularly oral contraceptives containing levonorgestrel (LNG). The secondary objective was to investigate the VTE risk associated with drospirenone/ethinylestradiol (DRSP/EE) in comparison to low-dose LNG/EE.
This German community-based, case-control study recruited VTE cases from the primary care sector. Eligible cases were women aged 15-49 years with a VTE between January 2002 and February 2008. Four controls (women without a confirmed or potential VTE before the index date) were matched by age and region to each case. Medical information relevant for the assessment of VTE was abstracted from patient charts. Data on personal characteristics of the patients were collected via self-administered questionnaires. At the end of the study a blinded adjudication of the reported VTE was conducted. Conditional logistic regression techniques were used, adjusting for nine potential confounders, including personal history of VTE, family history of VTE, body mass index, duration of current combined oral contraceptive (COC) use and smoking.
A total of 680 VTE cases and 2720 corresponding controls were analysed. The mean age of cases and controls was - as a result of matching - almost identical (36.1 years). A total of 35, 25, and 60 of the cases had used DNG-, DRSP- and LNG-containing low-dose COCs, respectively, at the time of the VTE diagnosis. The crude odds ratio (OR) for VTE associated with current COC use in comparison to women who had never used a COC before the index date was 1.9 (95% CI 1.5-2.5), the adjusted OR was 2.3 (95% CI 1.7-3.0). The point estimate of the crude OR of DNG/EE vs any other low-dose COCs was 0.9 (95% CI 0.6-1.3), the adjusted OR was 0.9 (95% CI 0.6-1.4). The crude ORs for DNG/EE and DRSP/EE vs low-dose LNG/EE were 1.1 (95% CI 0.7-1.8) and 1.0 (95% CI 0.6-1.6), respectively; the adjusted ORs were 1.1 (95% CI 0.7-1.9) and 1.0 (95% CI 0.6-1.8).
The study confirms that COC use is associated with an increased risk of VTE. The VTE ORs (adjusted and crude) that compared DNG/EE and DRSP/EE with other low-dose COCs (including LNG/EE) were close to unity and do not indicate a higher risk for users of DNG/EE or DRSP/EE.
Journal of Family Planning and Reproductive Health Care 07/2010; 36(3):123-9. · 1.64 Impact Factor
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ABSTRACT: BACKGROUND: Two recent studies, a cohort study from Denmark, and a case-control study from The Netherlands, have reported increased risks of venous thromboembolism (VTE) among users of oral contraceptives (OCs) containing desogestrel, gestodene, drospirenone and cyproterone, relative to the use of levonorgestrel. CRITIQUE: In the Danish study the comparisons were not valid. (1) VTE risk is highest soon after commencement of OC use, and duration of use was underestimated for levonorgestrel users, but not for drospirenone users; for the remaining compounds duration was only slightly underestimated. The underestimation for levonorgestrel resulted in systematic overestimation of the relative risks for the compared OCs. (2) Duration was also incorrectly estimated: only the duration of current use, not duration of all episodes of use was relevant to VTE risk. (3) Confounding was not adequately controlled. In The Netherlands study the comparisons were not valid. (1) The relative risk for drospirenone versus levonorgestrel was not statistically significant. (2) Extensive publicity had been given to the risk of VTE among users of desogestrel, gestodene, drospirenone and cyproterone: information bias and detection bias were therefore likely. (3) Inadequate allowance was made for duration of use. (4) The combination of two different control groups, both of them likely to have been biased, into a single category was not valid. CONCLUSION: The best evidence continues to suggest that the increased risk of VTE in OC users is a class effect, dependent on the estrogen dose and duration of use, and independent of the progestogen used.
Journal of Family Planning and Reproductive Health Care 01/2010; 36(1):33-8. · 1.64 Impact Factor
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ABSTRACT: To determine whether prior oral-contraceptive use has a negative effect on the ability of women to conceive in both the short-term and long-term.
The European Active Surveillance Study on Oral Contraceptives (EURAS-OC) was a controlled, prospective, noninterventional cohort study of 59,510 users of oral contraceptives containing drospirenone or other progestins in clinical practice in seven European countries. In a planned secondary analysis, pregnancy outcomes were investigated in 2,064 participants in EURAS-OC who stopped oral-contraceptive use after study entry because of planned pregnancy. The influence of age, parity, progestin type, ethinylestradiol dose, duration of oral-contraceptive use, and smoking status on the rate of pregnancy was assessed.
Overall, 21.1% (95% confidence interval [CI] 19.4-23.0%) of the past oral-contraceptive users were pregnant one cycle after oral-contraceptive cessation. This rate increased to 79.4% (95% CI 77.6-81.1%) at 1 year (13 cycles). Progestin type, ethinylestradiol dose, duration of oral-contraceptive use, and parity had no major influence on the rate of pregnancy after oral-contraceptive cessation. Up to age 35 years, age had only a minor influence on the rate of pregnancy. Rates of pregnancy were reduced in women older than 35 years and in current smokers.
Previous oral-contraceptive use does not negatively affect initial and 1-year rates of pregnancy after oral-contraceptive cessation. A comparison of these data with data external to this study indicates that the negative effect of aging on fecundity is not amplified by oral-contraceptive use.
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Obstetrics and Gynecology 10/2009; 114(3):616-22. · 4.73 Impact Factor
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Jürgen Dinger
Journal of Family Planning and Reproductive Health Care 10/2009; 35(4):211-3. · 1.64 Impact Factor
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ABSTRACT: The Menopause Rating Scale is a health-related Quality of Life scale developed in the early 1990s and step-by-step validated since then. Recently the MRS scale was validated as outcomes measure for hormone therapy. The suspicion however was expressed that the data were too optimistic due to methodological problems of the study. A new study became available to check how founded this suspicion was.
An open post-marketing study of 3282 women with pre- and post- treatment data of the self-administered version of the MRS scale was analyzed to evaluate the capacity of the scale to detect hormone treatment related effects with the MRS scale. The main results were then compared with the old study where the interview-based version of the MRS scale was used.
The hormone-therapy related improvement of complaints relative to the baseline score was about or less than 30% in total or domain scores, whereas it exceeded 30% improvement in the old study. Similarly, the relative improvement after therapy, stratified by the degree of severity at baseline, was lower in the new than in the old study, but had the same slope. Although we cannot exclude different treatment effects with the study method used, this supports our hypothesis that the individual MRS interviews performed by the physician biased the results towards over-estimation of the treatment effects. This hypothesis is underlined by the degree of concordance of physician's assessment and patient's perception of treatment success (MRS results): Sensitivity (correct prediction of the positive assessment by the treating physician) of the MRS and specificity (correct prediction of a negative assessment by the physician) were lower than the results obtained with the interview-based MRS scale in the previous publication.
The study confirmed evidence for the capacity of the MRS scale to measure treatment effects on quality of life across the full range of severity of complaints before treatment. The difference of the relative improvement after therapy between the old and current study as well as the observed different sensitivity/specificity is--as a matter of probability--more likely to be caused by a bias introduced by the different application of the MRS scale than by real differences in the efficacy of the therapy. A randomized clinical trial would be needed to test the impact of the latter. The message for future studies is: The MRS scale should be only used as self-administered tool where the suggestive effect of questions raised by health professionals ("therapeutic optimism") can be largely excluded.
Health and Quality of Life Outcomes 02/2006; 4:32. · 2.11 Impact Factor
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ABSTRACT: New chemical entities must undergo rigorous, and preferably independent, safety and efficacy assessments before entry into the market. This is also true for oral contraceptives (OCs) given their extensive usage by healthy women and the safety concerns highlighted by the so-called 'third generation pill scare' in Europe a decade ago. This scare heightened patient and physician awareness of the increased risk of thromboembolic complications (mainly venous thromboembolism [VTE]) associated with OC use. Yasmin (ethinylestradiol 30 microg/drospirenone 3 mg [EE/DRSP]) is a novel OC that was demonstrated in clinical phase I-III studies to be highly effective in preventing pregnancy and to have a good safety profile. Nonetheless, clinical trials are not usually sufficiently powered to detect rare adverse events such as VTE to enable comparison with other OCs, which could allay fears and concerns about their inherent risks. Therefore, an extensive assessment of the VTE risk associated with EE/DRSP has been undertaken by reviewing data from the clinical development programme, postmarketing surveillance and spontaneous worldwide reporting, as well as information from other sources. Spontaneous worldwide reporting has revealed a VTE reporting rate of 5.1/100 000 women-years with EE/DRSP use. In contrast, 3-year interim results from a large, controlled, prospective postmarketing surveillance study suggest a VTE rate of 61/100 000 women-years for EE/DRSP, which is similar to the rates of 60/100 000 and 73/100 000 women-years for levonorgestrel-containing OCs and other OCs, respectively. When placed in context with potential biases and confounding factors that would inflate the perceived risk of VTEs with a novel OC, the VTE rate with EE/DRSP does not highlight any safety concerns. Furthermore, the risk of VTE with EE/DRSP or other OCs is far less than that associated with pregnancy and delivery (up to 800/100 000 women-years) or than other risks of daily living. Available data indicate that EE/DRSP is not associated with any increased risk of other serious adverse events such as hyperkalaemia, cardiac arrhythmia or birth defects. Nonetheless, caution should be exerted in prescribing EE/DRSP to women with conditions that predispose to hyperkalaemia.Overall, the safety data with EE/DRSP and other OCs indicate that these products have no negative impact on the risk of VTE (and other adverse events) in women who receive OCs for contraception.
Drug Safety 02/2004; 27(13):1001-18. · 3.63 Impact Factor
