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Biomedical subjects

K Gangar

Publications and source records attributed to K Gangar.

8 recordsLinked to original sources
PubMed2000

Clinical equivalence of intranasal and oral 17beta-estradiol for postmenopausal symptoms.

OBJECTIVE: The aim of this study was to demonstrate clinical equivalence between a novel intranasal estradiol formulation and a reference oral drug. STUDY DESIGN: In this multinational, double-blind, parallel-group study 659 postmenopausal women with moderate to severe postmenopausal symptoms were randomly assigned to receive either 300 microg/d intranasal 17beta-estradiol (S21400) or 2 mg/d oral micronized estradiol, plus the appropriate placebo, for 24 weeks. All patients also received 10 mg/d dydrogesterone for 14 days per 28-day cycle. Adjustment of intranasal dosage was permitted from week 14 on. The primary efficacy criterion was the Kupperman index at week 14, with a predefined limit of equivalence of 4. RESULTS: Kupperman index scores improved similarly in the 2 groups, from 28.4 +/- 6.2 to 10.0 +/- 8.6 (mean +/- SD) for S21400 and from 28.1 +/- 6.0 to 8.9 +/- 8.0 for oral therapy, with a difference between groups at week 14 of 1.1 +/- 0.6 (90% confidence interval, 0. 0 to 2.2). This was below the predefined equivalence limit of +4 for statistical noninferiority (P <.001). The daily number and intensity of hot flushes decreased similarly in the two treatment groups. Withdrawal bleeding was 20% less frequent with intranasal therapy (90% confidence interval, 12.5 to 27.6). Severe mastalgia was less frequent in the S21400 group (1.0%) than in the group with oral therapy (5.2%; P <.01). Triglyceride and angiotensinogen levels increased significantly with oral therapy but not with S21400. The same number of patients required dose adaptation in the 2 groups (approximately 20%). CONCLUSION: Intranasal administration of 300 microg/d estradiol was at least as effective as oral administration of 2 mg/d estradiol in alleviating postmenopausal symptoms, with less frequent mastalgia and uterine bleeding and without the metabolic consequences of the first-pass effect.

Administration, Intranasal↗
PubMed1999

Ectopic pregnancy - laparoscopic management in a district general hospital.

A 2-year retrospective study was carried out in a district general hospital to review the outcome of laparoscopic management versus laparotomy for the management of ectopic pregnancy. Outcome measures included operating time, postoperative analgesia requirements, complications, length of hospital stay, the post-ectopic intrauterine pregnancy rates and the recurrent ectopic pregnancy rates over an observational period of 16 months. Forty-nine consecutive women were seen. Twenty-six were managed laparoscopically and 23 were managed by laparotomy. There was no significant difference between the operating times and complications but the laparoscopy group had significantly fewer doses of opiate analgesia (P<0.05), shorter length of stay (P<0.05), and significantly higher post-ectopic intrauterine pregnancy rates (P<0.05) compared with the laparotomy group. Laparoscopic management of ectopic pregnancy is a viable alternative to conventional laparotomy in district general hospitals.

Journal Article↗
PubMed1995

Postmenopausal oestrogens and arteries.

Postmenopausal oestrogen use is associated with a significant reduction in cardiovascular morbidity and mortality. The fact that a large scale controlled trial has not been conducted is a valid criticism, but the epidemiological data are compelling and there is evidence of biologically plausible mechanisms which may mediate this effect. Postmenopausal HRT also abolishes climacteric symptoms and conserves bone. For the postmenopausal woman who has had a hysterectomy, unless there are compelling reasons to the contrary, we believe that unopposed oestrogen therapy should be offered routinely. Women who still have a uterus (and these form the majority of potential HRT users) require oestrogens with cyclical progestogens. Whether such opposed therapy results in any reduction in cardiovascular protection needs to be addressed urgently. Meanwhile, it could be argued that these women should also be offered HRT routinely. Indeed, a recent consensus conference (Lobo & Speroff 1994) concluded that because of the magnitude of cardiovascular disease as a cause of morbidity and mortality, the beneficial role of estrogen in the primary prevention of cardiovascular disease in most women outweighs its potential risk. At the present time, there are insufficient data to indicate whether there are any groups of women for whom the risks may be too great to prescribe some form of estrogen therapy. As life expectancy increases in developed countries, such reductions in the leading cause of mortality are likely to benefit not only the individual woman, but the society in which she lives.

Cardiovascular Diseases↗
PubMed1993

Insulin resistance, secretion, and elimination in postmenopausal women receiving oral or transdermal hormone replacement therapy.

Estrogen/progestin steroid combinations adversely affect glucose tolerance and insulin resistance, but their effects in combined hormone replacement therapy (HRT) have rarely been evaluated. We studied 61 untreated symptomatic postmenopausal women randomized to receive oral (conjugated equine estrogens, 0.625 mg/d continuous + levonorgestrel, 0.075 mg/d for 12 days of each 28-day cycle) or transdermal therapy (estradiol 17 beta, 0.05 mg/d continuous + norethindrone acetate, 0.25 mg/d for 14 days of each 28-day cycle). An untreated control group of 30 postmenopausal women not seeking HRT was also studied. Intravenous glucose tolerance tests (IVGTT) were performed at baseline and 3, 6, and 18 months later. Mathematical modeling analysis of plasma glucose, insulin, and C-peptide concentration profiles provided measures of insulin resistance, secretion, and elimination. There were no changes in glucose or insulin concentrations with transdermal therapy. Oral therapy caused a deterioration of glucose tolerance and an increased overall plasma insulin response, apparently due to a reduction in the immediate plasma insulin response to glucose. This may have resulted from increased hepatic insulin uptake, uncompensated for by an increase in first-phase pancreatic insulin secretion. Neither treatment caused significant insulin resistance compared with baseline, but with the oral treatment insulin resistance was greater during the combined phase compared with the estrogen-only phase. Thus the oral regimen affected both insulin delivery and insulin resistance. The transdermal regimen had relatively few effects on insulin metabolism.

Administration, Cutaneous↗