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Biomedical subjects

G Hoppe

Publications and source records attributed to G Hoppe.

At least 19 recordsLinked to original sources

The clinical relevance of oral contraceptive pill-induced plasma lipid changes: facts and fiction.

The changes in plasma lipids induced by the use of oral contraceptive pills have been shown in several studies to remain within normal physiologic limits. These changes are then probably without any clinical relevance because there is no evidence in the huge volume of oral contraceptive and cardiovascular literature that the use of oral contraceptives promotes or retards the development of atherosclerotic disease. What may appear to be favorable changes in the lipid profile attributed to oral contraceptive use may actually be associated with unfavorable changes in other parameters, such as the balance of clotting and fibrinolytic factors. A well-balanced, low-dose oral contraceptive formulation should alter any of the cardiovascular risk indicators as little as possible in either a supposedly positive or negative direction.

Animals

A study comparing a gestoden triphasic formulation with a fixed combination OC.

Metabolic parameters were studied in 30 patients over 12 treatment cycles in a double-blind randomized comparative trial of the new progestogen gestoden in a triphasic formulation against a fixed dose combination pill containing desogrestrel, in Bandung, Indonesia. The results of this laboratory experience affirm findings in similar previous metabolic studies that: (1) the changes induced by modern low-dose pills are clinically and statistically insignificant; (2) throughout the treatment cycles, the values of the various laboratory tests remain well within the normal range; and (3) the favorable balance between coagulation and fibrinolysis is maintained. Results of lipoprotein, coagulation, fibrinolytic and liver function tests in 27 patients are presented. Gestoden's pharmacologic profile and the worldwide clinical experience with the triphasic gestoden formulation in 4285 women are discussed.

Blood Coagulation

Gestoden, an innovative progestogen.

The most widely used estrogen component in oral contraceptive (OC) pills today is ethinylestradiol (EE), synthesized in the laboratories of Schering A.G. since the year 1938. Compared to natural estrogens, it has a much stronger effect on liver metabolism, thereby inducing greater metabolic and hemostatic changes. Some, but not all, epidemiological studies associated rare cardiovascular events to the use of the OC pills, although statistical and diagnostic deficiencies inherent in such studies may have created wrong associations. These events were either of thromboembolic or hypertensive but not of arteriosclerotic origin. If these associations were true, therefore EE-induced adverse changes on the blood coagulation and fibrinolytic systems and its stimulation of the renin-angiotensin-aldosterone mechanism would probably be more important than any changes on the lipid and lipoprotein pattern (e.g., HDL-cholesterol). To counteract adverse EE-induced changes, therefore, synthetic progestogens used in OC pills should have a pronounced anti-estrogenic effect, stronger than natural progesterone, like levenorgestrel, and if possible, an aldosterone-antagonistic effect, resembling natural progesterone. Gestoden is a new synthetic progestogen with a pronounced anti-estrogenic effect and a unique aldosterone-antagonistic effect, unlike other synthetic progestogens available. The high biological progestogenic activity allows very low hormonal content in the pill formulation. Multicentric clinical trials with a combination of only 75 mcg gestoden combined with 30 mcg EE confirm a reliable contraceptive efficacy combined with excellent cycle control and tolerance in 1,095 women over 14,281 treatment cycles. In about 60% of women with elevated blood pressure before treatment, the blood pressure normalized during treatment.(ABSTRACT TRUNCATED AT 250 WORDS)

Contraceptives, Oral

Diflucortolone valerate. Asian experience.

More than 10 years ago, diflucortolone valerate (Nerisone, Nerisona) was introduced in Germany and soon after in Asian countries in a concentration of 0.1% in cream, ointment and fatty ointment bases. 897 patients were included in the first Southeast Asian multicentre trial with these 3 formulations, and good efficacy and tolerability combined with a rapid onset of effect were shown. These results were confirmed later in Indonesia in an extended follow-up trial which included 1295 patients. A combination of 0.1% diflucortolone valerate with 1.0% chlorquinaldol was introduced after a multicentre Southeast Asian trial involving 8668 patients with inflammatory or allergic skin conditions for which a supplementary anti-infective treatment, for prophylaxis or therapy, was considered to be indicated. Excellent results were obtained in terms of efficacy, tolerability and cosmetic properties. A randomised double-blind trial comparing this preparation with a so-called 'shotgun' combination containing 0.05% betamethasone 17-valerate, 0.1% gentamicin, 1.0% tolnaftate and 1.0% clioquinol in 288 patients in the Philippines resulted in a better efficacy for the diflucortolone preparation in the 80 patients with bacterially or mycotically infected skin diseases. A 0.3% concentration of diflucortolone valerate was developed and introduced as a high potency topical corticosteroid. A trial in the Philippines which involved 143 patients with mostly severe chronic recurrent and resistant corticosteroid-responsive skin disease confirmed a pronounced clinical efficacy with a low incidence of side effects. For the treatment of inflammatory or eczematised dermatomycosis. 0.1% diflucortolone was combined with 1.0% isoconazole nitrate (Travocort). In a randomised double-blind study of 294 patients in Thailand, this preparation was compared with a plain 1.0% clotrimazole formulation. The results were significantly better for the diflucortolone plus isoconazole nitrate combination in terms of remission of symptoms, and after 1 week the mycological cure rates were also better, as shown in potassium hydroxide and culture investigations. It is concluded, therefore, that diflucortolone valerate in the available galenic bases and in effective combinations with other agents has been proven in extensive clinical trials to be a valuable therapeutic tool in dermatological practice.

Asia

Gestoden, an innovative progestogen.

The estrogen component used in virtually all oral contraceptive pills today was synthesized in the laboratories of Schering AG in 1938. The progestogen component varies, but levonorgestrel has become the standard among the lowest-dose pills available. Various attempts to modify the levonorgestrel molecule have resulted in new progestogens like norgestimate and desogestrel without much greater biological activity; therefore, further reduction in dose is unlikely. Gestoden, the newest progestogen from the levonorgestrel class, synthesized in Schering AG's laboratories, is different. Its enhanced biological activity allows for a progestogen content in a fixed combination pill half that in other low-dose pills available today. Furthermore, it has an improved pharmacologic profile with favorable dissociation of the androgenic and progestogenic activities. A unique anti-mineralocorticoid action is seen resembling natural progesterone, a property not presently shared with other synthetic progestogens. Results will be presented from clinical trials with a new monophasic gestoden preparation.

Blood Pressure

Oral contraceptive-induced changes in plasma lipids: do they have any clinical relevance?

The plethora of published studies investigating oral contraceptive pill (OC)-induced changes of various plasma lipids and their ratios together with repeated reviews of these studies in the literature, are all based on the assumption that OC-induced favourable or unfavourable lipid profiles decrease or increase a pill-associated cardiovascular risk. Some authorities have been led to recommend choice of pill formulations based on such changes of plasma lipids. In a combined review of relevant cardiovascular and OC epidemiological studies no evidence is found for these assumptions and recommendations. There is no evidence of OC-induced atherosclerotic disease, and pill-induced changes of plasma lipids within normal limits are therefore probably without any clinical relevance. Profound changes towards a so-called favourable plasma lipid profile may, on the contrary, be detrimental in terms of pill-associated cardiovascular events.

Contraceptives, Oral