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Biomedical subjects

B Ettinger

Publications and source records attributed to B Ettinger.

At least 37 records · Page 2Linked to original sources

First 20 months' experience with use of metformin for type 2 diabetes in a large health maintenance organization.

OBJECTIVE: To assess adherence to prescribing guidelines, continuation rates, population effects on glycemic control, and occurrence of lactic acidosis during the first 20 months of the availability of metformin in a large health maintenance organization. RESEARCH DESIGN AND METHODS: A retrospective cohort study was performed in the 90,000-member diabetes registry of Kaiser Permanente, northern California. Principal study measures were the proportions of patients started on metformin who met prescribing guidelines (previously on sulfonylureas, HbA1c, obesity, creatinine), the change in HbA1c at 6 months after starting metformin, and hospitalization rates for lactic acidosis. RESULTS: A total of 9,875 patients received metformin during this interval. At least 74% were previously treated with sulfonylureas alone, 81% had baseline HbA1c > or = 8.5%, 71% were obese, and 99% had a serum creatinine < or = 1.5 mg/dl. Among patients on sulfonylureas at baseline, those starting metformin had significantly lower HbA1c levels 6 months later than those not started, after adjustment for age, sex, and the higher baseline levels in those started (adjusted difference: 0.5%, P < 0.0001). Patients starting metformin as initial monotherapy also improved significantly, but patients previously treated with insulin (with or without sulfonyl-ureas) had slightly higher follow-up HbA1c levels than similar patients not starting metformin. Continuation of metformin at 12 months was significantly higher for patients previously treated with sulfonylureas than other groups. One probable case of lactic acidosis was identified during 4,502 person-years on metformin. CONCLUSIONS: Adherence to prescribing guidelines was relatively high during metformin's first 20 months of availability. Glycemic control improved substantially for patients previously treated with sulfonylureas. Lactic acidosis was rare.

Adolescent↗

Continuation of postmenopausal hormone replacement therapy in a large health maintenance organization: transdermal matrix patch versus oral estrogen therapy.

OBJECTIVE: To determine possible differences in continuation of postmenopausal estrogen replacement therapy among women initiating treatment with transdermal estradiol versus those initiating treatment with oral estrogen. STUDY DESIGN: A retrospective database search. PATIENTS AND METHODS: We analyzed estrogen use among 45- to 74-year-old women who filled index prescriptions for estrogen during 1996 for either once-a-week transdermal estradiol or daily oral estrogen. Prescription use was analyzed separately for each of 2 groups: 276 hysterectomized women who filled prescriptions for estrogen alone (ERT) and 4182 women who filled prescriptions for medroxyprogesterone acetate (MPA) with estrogen (HRT) on the same day. RESULTS: Risk of discontinuing therapy after 12 months ranged from 59% to 76% among the 4 subgroups: ERT with unopposed transdermal estradiol; ERT with unopposed oral estrogen; HRT with MPA-opposed transdermal estradiol; and HRT with MPA-opposed oral estrogen. The relative risk (RR) of discontinuation was significantly greater among women starting HRT with transdermal estradiol than among women starting oral estrogen (RR = 1.5; 95% confidence interval [CI] = 1.3 to 1.8). RR of discontinuation among women starting ERT with transdermal estradiol compared with women starting oral estrogen therapy was 1.3 (95% CI = 1.0 to 1.8). CONCLUSIONS: Approximately 2 of 3 women who start either ERT or HRT discontinue therapy within a year, regardless of hysterectomy status. Furthermore, women who start ERT or HRT with a transdermal estradiol system are more likely to discontinue therapy.

Administration, Cutaneous↗

Endogenous hormones and the risk of hip and vertebral fractures among older women. Study of Osteoporotic Fractures Research Group.

BACKGROUND AND METHODS: In postmenopausal women, the serum concentrations of endogenous sex hormones and vitamin D might influence the risk of hip and vertebral fractures. In a study of a cohort of women 65 years of age or older, we compared the serum hormone concentrations at base line in 133 women who subsequently had hip fractures and 138 women who subsequently had vertebral fractures with those in randomly selected control women from the same cohort. Women who were taking estrogen were excluded. The results were adjusted for age and weight. RESULTS: The women with undetectable serum estradiol concentrations (<5 pg per milliliter [18 pmol per liter]) had a relative risk of 2.5 for subsequent hip fracture (95 percent confidence interval, 1.4 to 4.6) and subsequent vertebral fracture (95 percent confidence interval, 1.4 to 4.2), as compared with the women with detectable serum estradiol concentrations. Serum concentrations of sex hormone-binding globulin that were 1.0 microg per deciliter (34.7 nmol per liter) or higher were associated with a relative risk of 2.0 for hip fracture (95 percent confidence interval, 1.1 to 3.9) and 2.3 for vertebral fracture (95 percent confidence interval, 1.2 to 4.4). Women with both undetectable serum estradiol concentrations and serum sex hormone-binding globulin concentrations of 1 microg per deciliter or more had a relative risk of 6.9 for hip fracture (95 percent confidence interval, 1.5 to 32.0) and 7.9 for vertebral fracture (95 percent confidence interval, 2.2 to 28.0). For those with low serum 1,25-dihydroxyvitamin D concentrations (< or =23 pg per milliliter [55 pmol per liter]), the risk of hip fracture increased by a factor of 2.1 (95 percent confidence interval, 1.2 to 3.5). CONCLUSIONS: Postmenopausal women with undetectable serum estradiol concentrations and high serum concentrations of sex hormone-binding globulin have an increased risk of hip and vertebral fracture.

Aged↗

The association of radiographically detected vertebral fractures with back pain and function: a prospective study.

BACKGROUND: Vertebral fractures are a hallmark of postmenopausal osteoporosis and an important end point in trials of osteoporosis treatment, but the clinical significance of these fractures remains uncertain. OBJECTIVE: To determine the association of new vertebral fractures with back pain and back-related functional limitation in older women. DESIGN: Prospective observational study. SETTING: Multicenter Study of Osteoporotic Fractures. PARTICIPANTS: 7223 white women aged 65 years and older. MEASUREMENTS: Lateral spine radiographs were obtained at baseline and at a follow-up examination an average of 3.7 years later. Prevalent and incident radiographic vertebral fractures were assessed by quantitative morphometry. Frequency and severity of back pain, disability in doing six activities involving the back, and days of bed rest and days of limited activity due to back pain were assessed annually by questionnaire during follow-up. RESULTS: Among women without a vertebral fracture at baseline, those with at least one incident vertebral fracture were more likely to have increased back pain (odds ratio [OR], 2.4 [95% CI, 1.7 to 3.3]) and back disability (OR, 2.6 [CI, 1.9 to 3.7]) and at least 1 day of bed rest due to back pain (OR, 6.7 [CI, 4.4 to 10.2]) and 7 days of limited activity due to back pain per year (OR, 3.8 [CI, 2.7 to 5.0]). Among women with a fracture at baseline, those with an incident vertebral fracture also had a greater risk for increased back pain (OR, 2.0 [CI, 1.4 to 2.8]) and back disability (OR, 2.2 [CI, 1.5 to 3.1]) and at least 1 day of bed rest (OR, 7.9 [CI, 4.9 to 12.9]) and 7 days of limited activity per year (OR, 3.5 [CI, 2.4 to 5.0]). Women with incident fracture had about 10 additional limited-activity days and 1 to 2 days of bed rest per year. New vertebral fractures that did not come to medical attention were associated with increased back pain and functional limitation. CONCLUSION: New vertebral fractures, even those not recognized clinically, are associated with substantial increases in back pain and functional limitation due to back pain in older white women. Prevention of new vertebral fractures should reduce the burden of back pain and functional limitation in women with vertebral osteoporosis.

Activities of Daily Living↗

Neuropsychiatric function and dehydroepiandrosterone sulfate in elderly women: a prospective study.

BACKGROUND: Though among the most abundant human steroid hormones, the physiologic role of dehydroepiandrosterone and its sulfate (DHEAS) is not known. Our goal was to determine if DHEAS is associated with cognition and mood in older women, and if baseline DHEAS levels are predictive of cognitive decline. METHODS: In a prospective cohort, we studied 394 randomly selected community-dwelling women, aged 65 years or older, currently enrolled in the Study of Osteoporotic Fractures. Subjects were administered a modified Mini-Mental State Exam, Trials B, Digit Symbol, and the Geriatric Depression Scale-Shortened (GDSS), at study onset and 4-6 years later. Serum was obtained at study initiation for DHEAS analysis. RESULTS: DHEAS levels declined with age, as expected. There was no consistent association of DHEAS quartile or log DHEAS with any of the four outcomes, even after multivariate adjustment. Change in cognitive performance overtime was not associated with DHEAS levels. Analysis of the 32 women without any detectable DHEAS compared to those with detectable levels revealed higher measures on the GDSS (mean score 3.4 +/- 3.6 compared with 1.6 +/- 2.3, p = .028) and a higher percentage with depression (21.7% compared with 4.6%, p = .001). CONCLUSIONS: Serum DHEAS is not a sensitive predictor of cognitive performance or decline on a selected neuropsychological battery in elderly community women; however, nondetectable levels may be associated with depression.

Aged↗

Comparison of serum fructosamine vs glycohemoglobin as measures of glycemic control in a large diabetic population.

In diabetic patients, measurement of glycohemoglobin (HbA1C) is widely accepted as the standard method for determining long-term glycemic control. Another test, the serum fructosamine test, has been suggested as a less costly alternative. To compare these two tests, we evaluated how well each correlated with fasting blood glucose and how well each could predict the degree of glycemic control perceived by treating physicians. Among 222 diabetic subjects, fructosamine (r=0.74) and fructosamine corrected for serum albumin (c-fructosamine) (r=0.79) correlated better with fasting blood glucose than did HbA1C (r=0.68) (P<0.05). Among 450 diabetic subjects, fructosamine, c-fructosamine, and HbA1C showed similar error rates (23%-26%) when discriminating between subjects who had either poor vs not-poor control or poor-to-fair versus good-to-excellent control. However, receiver operating characteristic curves for these tests indicated that HbA1C was the best discriminator because it showed a 9% to 10% greater area under the curve (P<0.05).

Adolescent↗

Thyroid functions and serum lipids in older women: a population-based study.

PURPOSE: To determine if thyroid hormone deficiency, manifested by elevated serum thyrotropin (TSH), is associated with alterations in serum lipids in an unselected population of older women. SUBJECTS AND METHODS: Population-based sampling of 279 ambulatory white women over age 65 studied at four US clinical centers, randomly selected from a cohort of 9,704 participants enrolled in the Study of Osteoporotic Fractures. A third-generation chemiluminescent TSH assay and serum lipid levels--total cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, and triglycerides--were measured on fasting sera collected at the baseline visit. The cross-sectional relationships between TSH and lipid levels were analyzed. RESULTS: TSH was high (>5.5 mU/L) in 19 women (6.8%), and was low (< or =0.1 mU/L) in 10 (3.6%). After multiple adjustment, LDL-C was 17 mg/dL or 13% higher (95% confidence interval [CI] 1%, 25%), and HDL-C was 6.5 mg/dL or 12% lower (CI -0.2%, -25%) in women with high TSH compared with those with normal TSH. The ratio of LDL-C to HDL-C was 29% greater (CI 4%, 53%) among women with elevated TSH. Although total cholesterol was 8% higher among women with high TSH, this difference was not statistically significant (CI -1%, 15%). High TSH was found in 12% of the women with the combination of high cholesterol (>240 mg/dL), high LDL-C (>160 mg/dL), and low HDL-C (<45 mg/dL); likelihood ratio = 1.8) whereas high TSH was found in only 2.2% of women with normal lipids (likelihood ratio = 0.3). CONCLUSION: Among older white women, high TSH is associated with deleterious changes in serum lipids, particularly HDL-C, LDL-C, and the ratio of LDL-C to HDL-C cholesterol. Women with multiple lipid abnormalities are twice as likely to have an increased TSH.

Aged↗

Unexpected vaginal bleeding and associated gynecologic care in postmenopausal women using hormone replacement therapy: comparison of cyclic versus continuous combined schedules.

OBJECTIVE: To measure gynecologic resources required to care for women who have unexpected vaginal bleeding while using hormone replacement therapy (HRT). DESIGN: A retrospective cohort study based on review of medical records. SETTING: A large health maintenance organization. PATIENT(S): We studied 284 women using continuous combined HRT and 306 women receiving cyclic HRT. MAIN OUTCOME MEASURE(S): We noted episodes of unexpected vaginal bleeding and associated clinic visits and gynecologic procedures recorded during a mean follow-up period of 2 years. RESULT(S): Among women using cyclic HRT for the first time, 38.3% had > or = 1 visit for unexpected bleeding and 12.3% had > or = 1 endometrial biopsy. Among women starting continuous combined HRT, 41.6% had > or = 1 visit for unexpected bleeding and 20.1% had > or = 1 endometrial biopsy. After adjusting for potential confounding variables, we found that recipients of cyclic and continuous combined HRT had similar risks of unexpected bleeding and endometrial biopsy. However, among women continuing HRT for >2 years, those using the continuous combined regimen had somewhat lower rates of unexpected bleeding (22.3 events per 100 patient-years) and endometrial biopsy (10.3 events per 100 patient-years) than those using the cyclic regimen (37.8 episodes of unexpected bleeding per 100 patient-years and 13.9 endometrial biopsies per 100 patient-years). CONCLUSION(S): Unexpected vaginal bleeding and the gynecologic resources required to manage it decreased after 2 years in women using continuous combined HRT but did not decline among those using cyclic HRT.

Aged↗

Evaluation and interference study of hemoglobin A1c measured by turbidimetric inhibition immunoassay.

The technical performance of the turbidimetric immunoinhibition (TI) assay for hemoglobin (Hb) A1c (Tina-quant Hb A1c, Boehringer Mannheim, Indianapolis, Ind) was evaluated by using the BM/Hitachi 911 analyzer. Intra-assay imprecision was less than 2.7%, and interassay imprecision was less than 2.8% as measured by coefficient of variation. In 93 subjects with diabetes who did not have hemoglobin variants, results of the TI assay for Hb A1c correlated strongly with those obtained by using a high-performance liquid chromatography analyzer (Diamat, BioRad Laboratories, Hercules, Calif). Among 241 subjects who had or did not have hemoglobin variants, the TI assay for Hb A1c correlated strongly with results of affinity chromatography for total glycated hemoglobin (Glyc-Affin GHb, IsoLab, Akron, Ohio). We also studied the effect of various percentages of hemoglobin S, C, E, and F on the accuracy of the TI Hb A1c assay. Only high hemoglobin F percentages caused interference. More than 14 times as many samples can be analyzed per hour by using the TI Hb A1c assay than can be analyzed by using the HPLC assay. For high-volume reference laboratories, using the fully automated TI Hb A1c assay to monitor glycemic control in patients with diabetes may be preferable to using the conventional ion-exchange high-performance liquid chromatography Hb A1c assay because the TI assay measures Hb A1c more accurately in patients with diabetes who have hemoglobin variants, and it requires less time.

Autoanalysis↗

Associations between low levels of serum estradiol, bone density, and fractures among elderly women: the study of osteoporotic fractures.

To evaluate the skeletal effects of endogenous serum estradiol, we measured bone mineral density (BMD) at the calcaneus and radius (single photon absorptiometry) and at the hip and spine (dual x-ray absorptiometry) in 274 women aged 65 yr or more who participated in the Study of Osteoporotic Fractures. Lateral radiographs of the thoracic and lumbar spine were also taken, and serum was assayed for estradiol. Those who had estradiol levels from 10-25 pg/mL had 4.9%, 9.6%, 7.3%, and 6.8% greater BMD at total hip, calcaneus, proximal radius, and spine than those with levels below 5 pg/mL. After multiple adjustments, BMD differences remained statistically significant and corresponded to about 0.4 SD. Vertebral deformities were less prevalent among women whose estradiol level exceeded 5 pg/mL; the multiple adjusted odds ratio was 0.4 (95% confidence interval, 0.2-0.8). We conclude that physiologically low estradiol has a salutary effect on the skeleton in elderly women, possibly by reducing skeletal remodeling.

Aged↗

Overview of estrogen replacement therapy: a historical perspective.

In the last 30 years, we have made enormous advances in understanding how estrogen works in multiple physiologic systems and how much it affects the health of aging women. We have also made major improvements in how we prescribe estrogen. As clinicians, we are obliged to provide our patients with acceptable, tolerable, safe therapy which can be continued long enough to provide clinically significant health benefits. Determining optimal long-term hormone replacement therapy is therefore the challenge for the 21st century.

Aged↗

Clinic visits and hospital admissions for care of acid-related upper gastrointestinal disorders in women using alendronate for osteoporosis.

CONTEXT: About 1 in 3 women taking alendronate for osteoporosis report gastrointestinal symptoms, a rate much higher than that found during clinical trials. OBJECTIVE: To establish the frequency of outpatient visits and hospital admissions for acid-related upper gastrointestinal disorder (ARD) among women taking alendronate and to identify potential risk factors. METHODS: A retrospective database analysis identified 812 women with osteoporosis who had filled one or more 10-mg alendronate prescriptions from October 1995 through October 1996. RESULTS: One hundred (12.3%) of the 812 women received healthcare for ARD, a clinical encounter rate of 28.5 per 100 person-years. A reference group of 362,109 women from the same health plan had 17.6 ARD encounters per 100 person-years. Excluding women who had ARDs before receiving alendronate, alendronate users were 1.6 (95% CI = 1.2, 2.7) times more likely to have an ARD encounter than nonusers. Risk of having ARD increased with age [users aged 70 years and older had a relative risk of 1.5 (95% confidence interval (CI) 1.0-2.30) compared with younger women] and with concurrent use of nonsteroidal anti-inflammatory drugs (NSAIDS) (relative risk 1.7, 95% CI 1.1-2.6). CONCLUSIONS: Elderly alendronate users or those concurrently taking NSAIDS should be carefully monitored because of their high risk of having ARD. Cost/benefit analyses of alendronate treatment for osteoporosis should include costs of treating ARD.

Aged↗

Comparison of continuation of postmenopausal hormone replacement therapy: transdermal versus oral estrogen.

OBJECTIVE: To determine possible differences in the rate at which hormone replacement therapy (HRT) is continued among postmenopausal women treated initially with transdermal estradiol versus those treated initially with oral conjugated estrogens. DESIGN: A retrospective database search for prescription use. SETTING: Northern California facilities of Kaiser Permanente, a health maintenance organization. PATIENTS: Women aged > or = 45 years who filled index prescriptions for HRT during 1995 for either 0.05 mg transdermal estradiol semiweekly or 0.625 mg oral conjugated estrogen daily. All had filled prescriptions for medroxyprogesterone acetate (MPA) on the same day as the index estrogen prescription. RESULTS: We found statistically significantly greater relative risk (RR) of discontinuation among women whose HRT began with transdermal estradiol compared with women whose HRT began with oral conjugated estrogens [RR = 2.6, 95% confidence interval (CI) = 1.8-3.8]. After multiple adjustments, RR was 2.7 (95% CI = 1.8-3.9). Complete discontinuation of HRT treatment accounted for most of the stopping we observed, but more women switched from transdermal to oral (25% of those discontinuing this route) than switched from oral to transdermal (0.9% of those discontinuing this route). Risk of discontinuation was not associated with whether prescriber was a gynecologist (RR = 1.2, 95% CI = 0.9-1.7). Type of progestin schedule (cyclic vs. continuous combined) also was not a predictor for discontinuation (RR = 0.9, 95% CI = 0.8-1.0). Older age at start of treatment was associated with discontinuation (RR = 1.1, 95% CI = 1.0-1.2) for every additional 5 years of age. CONCLUSION: Among women starting HRT, those using a semiweekly transdermal estradiol regimen have a lower rate of continuation than do those using oral estrogen daily.

Administration, Cutaneous↗

Women and menopause: beliefs, attitudes, and behaviors. The North American Menopause Society 1997 Menopause Survey.

OBJECTIVE: The main purpose in organizing this survey was to collect information relevant to The North American Menopause Society's (NAMS) educational mission and to document women's knowledge of, and attitudes toward, menopause. DESIGN: During June-July 1997, The Gallup Organization conducted 750 telephone interviews with a randomly selected sample of women 45-60 years of age from across the United States. Women were asked about their sources of information on menopause, what changes in health they anticipated as a result of menopause, why they used hormone therapy, and their attitudes toward menopause as a natural or a medical event. RESULTS: Women are more likely to believe that depression and irritability are associated with menopause than heart disease, but only a few associate menopause with an increasing vulnerability to either memory loss or Alzheimer's disease. Relief of physical symptoms of menopause was mentioned as the reason for starting hormone therapy more often than to protect against osteoporosis (25% relative to 15%), or to prevent stroke or a heart attack (10%), or to reduce the risk of developing Alzheimer's disease (2%). The single main source of women's information on menopause was a health professional (49%). The majority of women who were already menopausal or experiencing menstrual changes expressed an attitude toward menopause that was either neutral (42%) or positive (36%). CONCLUSIONS: Women are divided in their views of menopause, some seeing it as a medical condition requiring medical treatment, whereas others see it as a natural transition to be managed by "natural" means. Providing women with accurate, up-to-date information and enhancing communication between healthcare providers and menopausal women remain the challenges for NAMS.

Attitude to Health↗

Comparison of endometrial growth produced by unopposed conjugated estrogens or by micronized estradiol in postmenopausal women.

OBJECTIVE: When unopposed estrogen replacement treatment is used, what is the pattern of endometrial growth? Does endometrial growth differ for various dosages and formulations? STUDY DESIGN: A total of 87 postmenopausal women, median age 57 years (mean 56.7 +/- 5.6 years, range 45 to 69 years), were studied in a prospective, randomized, open clinical trial lasting 24 weeks. The treatment arms consisted of micronized estradiol, 0.5 or 1.0 mg (Estrace, Bristol-Myers Squibb, Princeton, N.J.), and conjugated estrogens, 0.625 mg (Premarin, Wyeth-Ayerst, Philadelphia). Endometrial thickness was evaluated by vaginal probe ultrasonography at outset and after 6, 12, and 24 weeks of treatment. RESULTS: Endometrial growth was progressive over time; more than half the total 24-week growth occurred in the first 6 weeks. The mean weekly rate (+/-SD) of endometrial growth was similar for micronized estradiol, 1.0 mg, and conjugated estrogens, 0.625 mg (0.19 +/- 0.15 mm for micronized estradiol, 1.0 mg, and 0.19 +/- 0.14 mm for conjugated estrogens, 0.625 mg). These rates differed to a statistically significant degree (p < 0.05) from the growth rate produced by micronized estradiol, 0.5 mg (0.08 +/- 0.16 mm). Both unscheduled and scheduled uterine bleeding was less likely among women using micronized estradiol, 0.5 mg, than among women using micronized estradiol, 1.0 mg, or conjugated estrogens, 0.625 mg. CONCLUSIONS: In a 24-week trial the therapeutically equivalent estrogen doses produced the same mean increment in endometrial thickness, but half-strength estradiol produced half as much endometrial growth.

Endometrium↗

Does dong quai have estrogenic effects in postmenopausal women? A double-blind, placebo-controlled trial.

OBJECTIVE: To evaluate possible estrogenic effects of dong quai on vaginal cells and on endometrial thickness in postmenopausal women. DESIGN: Double-blind, randomized, placebo-controlled clinical trial. SETTING: Department of Obstetrics and Gynecology in a large health maintenance organization (HMO). PATIENT(S): Seventy-one postmenopausal women (mean age [+/- SD], 52.4 +/- 6 years) who had follicle-stimulating hormone levels (third-generation assay) of > 30 mIU/mL with hot flashes. INTERVENTION(S): Subjects were randomized to treatment with either dong quai or placebo for 24 weeks. MAIN OUTCOME MEASURE(S): Endometrial thickness was measured by transvaginal ultrasonography; vaginal cells were evaluated for cellular maturation; menopausal symptoms were evaluated by reviewing the Kupperman index and the diary of vasomotor flushes. RESULT(S): We observed no statistically significant differences between groups in endometrial thickness, in vaginal maturation index, in number of vasomotor flushes, or in the Kupperman index. CONCLUSION(S): Used alone, dong quai does not produce estrogen-like responses in endometrial thickness or in vaginal maturation and was no more helpful than placebo in relieving menopausal symptoms.

Angelica sinensis↗