Abstract | CONTEXT: OBJECTIVE: DESIGN, SETTING, AND PARTICIPANTS: Two randomized, double-blind, placebo-controlled trials conducted at 40 US clinical centers. The volunteer sample was 22,579 community-dwelling women aged 50 to 79 years without prior cholecystectomy. INTERVENTION: MAIN OUTCOME MEASURES: Participants reported hospitalizations for gallbladder diseases and gallbladder-related procedures, with events ascertained through medical record review. Cox proportional hazards regression was used to assess hazard ratios (HRs) and 95% confidence intervals (CIs) using intention-to-treat and time-to-event methods. RESULTS: The CEE and the E + P groups were similar to their respective placebo groups at baseline. The mean follow-up times were 7.1 years and 5.6 years for the CEE and the E + P trials, respectively. The annual incidence rate for any gallbladder event was 78 events per 10,000 person-years for the CEE group (vs 47/10,000 person-years for placebo) and 55 per 10,000 person-years for E + P (vs 35/10,000 person-years for placebo). Both trials showed greater risk of any gallbladder disease or surgery with estrogen (CEE: HR, 1.67; 95% CI, 1.35-2.06; E + P: HR, 1.59; 95% CI, 1.28-1.97). Both trials indicated a higher risk for cholecystitis (CEE: HR, 1.80; 95% CI, 1.42-2.28; E + P: HR, 1.54; 95% CI 1.22-1.94); and for cholelithiasis (CEE: HR, 1.86; 95% CI, 1.48-2.35; E + P: HR, 1.68; 95% CI, 1.34-2.11) for estrogen users. Also, women undergoing estrogen therapy were more likely to receive cholecystectomy (CEE: HR, 1.93; 95% CI, 1.52-2.44; E + P: HR, 1.67; 95% CI, 1.32-2.11), but not other biliary tract surgery (CEE: HR, 1.18; 95% CI, 0.68-2.04; E + P: HR, 1.49; 95% CI, 0.78-2.84). CONCLUSIONS:
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Authors | Dominic J Cirillo, Robert B Wallace, Rebecca J Rodabough, Philip Greenland, Andrea Z LaCroix, Marian C Limacher, Joseph C Larson |
Journal | JAMA
(JAMA)
Vol. 293
Issue 3
Pg. 330-9
(Jan 19 2005)
ISSN: 1538-3598 [Electronic] United States |
PMID | 15657326
(Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Estrogens, Conjugated (USP)
- Medroxyprogesterone Acetate
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Topics |
- Aged
- Cholecystectomy
(statistics & numerical data)
- Cholecystitis
(chemically induced, epidemiology)
- Cholelithiasis
(chemically induced, epidemiology)
- Double-Blind Method
- Estrogen Replacement Therapy
(adverse effects)
- Estrogens, Conjugated (USP)
(adverse effects, therapeutic use)
- Female
- Gallbladder Diseases
(chemically induced, epidemiology, surgery)
- Humans
- Incidence
- Medroxyprogesterone Acetate
(therapeutic use)
- Middle Aged
- Postmenopause
- Proportional Hazards Models
- Risk Factors
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