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PubMed2004

Influence of a continuous combined HRT (2 mg estradiol valerate and 2 mg dienogest) on postmenopausal depression.

OBJECTIVE: This randomized, double-blind, placebo-controlled study was planned to investigate the effects of continuous combined hormone replacement therapy (HRT) with 2 mg estradiol valerate and 2 mg dienogest (Climodien/Lafamme) over 24 weeks on postmenopausal depression. METHOD: A total of 129 patients with a mild to moderate depressive episode according to ICD-10: F32.0, F32.1 in the context of a postmenopausal syndrome (ICD-10: N95.1) and a baseline score in the Hamilton depression scale (HAMD) > or =16 were included in the study. The primary target variable was depression severity as measured by the HAMD after 24 weeks of treatment. A four-point difference between HRT and placebo at the end of the study and, in addition, a final score < or =8 (corresponding to an improvement of > or =50% as compared to baseline) for the individual patient (responders analysis) were considered clinically relevant. Clinical global impression (CGI) of investigators (therapeutic and side-effects) at the end of the study was investigated. Secondary effects of HRT on depression severity caused by its effect on vasomotor symptoms or sleep disturbances (domino hypothesis) were taken into consideration. Also, the study addressed the question of whether the effect of HRT on depression severity depends on a history of premenstrual syndrome (PMS) or postnatal depression (PND). RESULTS: The results showed a clear and clinically relevant reduction of depression severity under HRT after 24 weeks of treatment and superiority over placebo (p < 0.0005) in spite of a strong placebo effect. The effects of the estrogen-progestin combination thereby seemed only partially to be dependent on the improvement of vasomotor symptoms and sleep disturbances. Also, the effects of HRT could not be shown to be dependent on a history of PMS and/or PND, even though women with and without this history clearly differed in baseline depression scores (p < 0.0001). The assessment of CGI was positive: whereas HRT was clearly superior to placebo with regard to therapeutic effects (p = 0.0014), there were no differences with regard to side-effects (p = 0.35). CONCLUSION: The combination of 2 mg estradiol valerate and 2 mg dienogest can be regarded as an effective and safe treatment option for women with mild to moderate depression in the context of postmenopausal syndrome.

Depression↗
PubMed2004

Pimecrolimus cream 1% vs. betamethasone 17-valerate 0.1% cream in the treatment of seborrhoeic dermatitis. A randomized open-label clinical trial.

BACKGROUND: Seborrhoeic dermatitis is a chronic inflammatory disease with remissions and exacerbations, characterized by erythema, scaling and pruritus primarily on the face, scalp and chest. Corticosteroids and antifungals are the mainstay of therapy. However, chronic use of corticosteroids is associated with side-effects such as skin atrophy and telangiectasia. Pimecrolimus, an inhibitor of calcineurin, has been used successfully in one patient with seborrhoeic dermatitis. OBJECTIVES: The objective of this randomized open-label clinical trial was to compare the efficacy and tolerability of pimecrolimus in comparison with a potent corticosteroid (betamethasone 17-valerate) in the treatment of seborrhoeic dermatitis. METHODS: Twenty patients with seborrhoeic dermatitis were included in this study, 11 patients in the pimecrolimus 1% cream group and nine patients in the betamethasone 17-valerate 0.1% cream group. Patients were instructed to use a thin layer of the study products twice daily at the lesional area and to discontinue treatment as soon as symptoms were absent. Clinical measures assessed were erythema, scaling and pruritus which were evaluated using a four-point scale (0-3). RESULTS: Both pimecrolimus and betamethasone were highly effective in the treatment of seborrhoeic dermatitis. Betamethasone reduced all three parameters, erythema, scaling and pruritus, faster than pimecrolimus, but the differences in reduction were not statistically significant. Relapses were observed more frequently and were more severe with betamethasone than with pimecrolimus. Moreover, pruritus was not observed after discontinuation of treatment from day 15 and beyond in the pimecrolimus group, whereas it was reported in most patients of the betamethasone group. This difference was statistically significant. CONCLUSIONS: It appears that pimecrolimus, a nonsteroidal topical treatment, may be an excellent alternative therapeutic modality for treating seborrhoeic dermatitis.

Administration, Cutaneous↗
PubMed1976

A 12-month double-blind assessment of betamethasone valerate aerosol in the management of asthma.

A double-blind trial of the topically active corticosteroid, betamethasone valerate in aerosol form, in the control of chronic asthma is reported. The results show that this is an extremely effective therapeutic agent in non-steroid dependent but nonetheless moderately severe asthmatics. Patients were well controlled on 800 mug of betamethasone valerate daily and control was maintained over a 12-month period. This form of treatment has few undersirable side effects but there is probably an increased incidence of oropharyngeal and laryngeal candidiasis. In particular, adrenocortical suppression was not noted.

Adolescent↗
PubMed1993

Complete oxidation of propionate, valerate, succinate, and other organic compounds by newly isolated types of marine, anaerobic, mesophilic, gram-negative, sulfur-reducing eubacteria.

Anaerobic enrichment cultures with either propionate, succinate, lactate, or valerate and elemental sulfur and inocula from shallow marine or deep-sea sediments were dominated by rod-shaped motile bacteria after three transfers. By application of deep-agar dilutions, five eubacterial strains were obtained in pure culture and designated Kyprop, Gyprop, Kysw2, Gylac, and Kyval. All strains were gram negative and grew by complete oxidation of the electron donors and concomitant stoichiometric reduction of elemental sulfur to hydrogen sulfide. The isolates used acetate, propionate, succinate, lactate, pyruvate, oxaloacetate, maleate, glutamate, alanine, aspartate, and yeast extract. All isolates, except strain Gylac, used citrate as an electron donor but valerate was oxidized only by strain Kyval. Fumarate and malate were degraded by all strains without an additional electron donor or acceptor. Kyprop, Gyprop, and Gylac utilized elemental sulfur as the sole inorganic electron acceptor, while Kysw2 and Kyval also utilized nitrate, dimethyl sulfoxide, or Fe(III)-citrate as an electron acceptor.

Journal Article↗
PubMed1974

Steroid aerosols in asthma: an assessment of betamethasone valerate and a 12-month study of patients on maintenance treatment.

Betamethasone valerate aerosol is a new compound for the treatment of asthma. Its clinical effectiveness was established in a double-blind cross-over trial in non-steroid-dependent asthmatic patients. At a dosage of 400 to 800 mug/day for three months there was no evidence of suppression of hypothalamic-pituitary-adrenal function, as assessed by tetracosactrin and insulin stress tests.A 12-month follow-up study of 120 patients using steroid aerosols (betamethasone valerate or beclomethasone dipropionate) indicated that tolerance does not develop and that a daily maintenance dose of 200 mug/day was adequate in most patients. Temporary lack of response was observed during episodes of sputum production or of heavy exposure to antigen.There were no observed side effects other than fungal infections of the respiratory tract. However, the incidence of candidiasis of the pharynx (13%) and particularly of the larynx (5%) in apparently immunologically normal patients was disturbing. These infections were not seen in patients taking 200 mug/day. Though there is yet no evidence that fungal infections associated with steroid aerosols may penetrate the trachea and bronchi the possibility of this indicates that caution should be exercised in their use, particularly in long-term high dosage.

Adolescent↗
PubMedDate not supplied

Once-daily 0.1% mometasone furoate cream versus twice-daily 0.1% betamethasone valerate cream in the treatment of a variety of dermatoses.

A randomized, investigator-blind, parallel-group trial was conducted to compare the safety and efficacy of 0.1% mometasone furoate cream applied once daily with that of 0.1% betamethasone valerate cream applied twice daily in patients (n = 69) with allergic contact dermatitis, atopic dermatitis and other steroid-responsive dermatoses. After 3 day's treatment improvement in conditions averaged 38.2% and 39.3%, respectively, in the mometasone and betamethasone treatment groups, and after 21 days average improvements were 93.6% and 96.5%, respectively. The physicians' global evaluation of overall change in disease status and the patients' evaluation of treatment also indicated that the two treatment regimens produced comparable, rapid and progressive improvements in the patients' conditions, and no local side-effects were reported. It is concluded that mometasone furoate was as effective as betamethasone valerate in the treatment of a variety of steroid-responsive dermatoses, although mometasone furoate was applied only half as frequently.

Administration, Cutaneous↗
PubMed1983

A double blind cross-over study on the effects of ORG OD14 compared to estradiol valerate and placebo on the fatty acid composition of serum lecithin and cholesterol ester in oophorectomized women.

Twenty-two women, oophorectomized in connection with surgical treatment for cervical carcinoma in clinical stage IB or IIA, were given ORG OD14 [(7 alpha,17 alpha)17-hydroxy-7-methyl-19-norpregn-5-(10)20-yn-3-one; 2.5 mg/day], a placebo, and estradiol valerate (2 mg/day), six weeks each, in a double blind, cross-over study. ORG OD14 is a synthetic steroid for continuous treatment of climacteric symptoms which in traditional bioassays has been shown to have weak estrogenic and progestogenic as well as very weak androgenic-anabolic properties. The aim of this study was to evaluate its effects on serum lecithin as well as on the relative fatty acid composition of serum lecithin and serum cholesterol ester. In serum lecithin, OD14 induced an increase in palmitic acid and a decrease in stearic acid, effects typical of 17-C-alkylated steroids, compared to both placebo and estradiol valerate. Furthermore, there was an increase in linoleic acid and a decrease in both arachidonic and dihomo-gamma-linolenic acid after OD14 administration. This decrease is interpreted as an inhibitory action of the steroid on the mechanisms of elongation and desaturation of linoleic acid and is considered to be an androgenic influence. The relative decrease is further accentuated by the decrease in total serum lecithin induced by OD14. Since these fatty acids are the major precursors for prostaglandin synthesis, these findings might have relevance in that context.

Adult↗
PubMed2001

Production of poly(3-hydroxybutyrateco-3-hydroxyvalerate) from cottonseed oil and valeric acid in batch culture of Raistonia sp. strain JC-64.

A Ralstonia sp. strain JC-64 that is capable of accumulating poly(3-hydroxybutyrate-co-3-hydroxyvalerate) (P[3HB-co-3HV]) from cottonseed oil and valeric acid was isolated. By using a high limiting-nitrogen (HLN) mineral medium as the medium for the second stage of the fermentation process and by adding the two carbon sources at different times, a range of copolymers with 12-62 mol% of 3HV were produced from a series of HLN mineral mediums containing different compositions of cottonseed oil and valeric acid by Ralstonia sp. JC-64. The melting temperature (Tm) of polyhydroxybutyrate from cottonseed oil was 174 degrees C and that of P(3HB-co-3HV) with the highest 3HV-mol fraction (62%) was 81 degrees C.

Carbon↗
PubMed1982

[Irritation test of dexamethasone valerate (DV-17) and other steroid ointments in rabbits. Skin and eye primary irritation tests, and skin cumulative irritation test].

The skin and eye primary irritation tests, and skin cumulative irritation test were performed on male rabbits, which were topically treated with a volume of 1 g/body of 0.06% and 0.12% dexamethasone valerate (DV-17) ointments as a test drug, and 0.1% hydrocortisone butyrate (HB) and 0.12% betamethasone valerate (BMV) ointments as an active control drug in order to evaluate the topical and systemic effects. No skin and eye primary irritations except minimal skin erythema and slight conjunctival redness were seen in above four corticosteroids. Judging from the results such as skin atrophy, inhibition of body weight gains, and decreases of thymus, spleen and adrenal weights, the potency of toxicities among the four corticosteroid ointments appeared to be as follows: 0.12% DV-17, 0.12% BMV greater than 0.1% HB greater than 0.06% DV-17.

Adrenal Cortex Hormones↗
PubMed1982

[Comparative toxicity test of dexamethasone valerate (DV-17) and other steroid ointments in rats].

The comparative toxicity test was performed on male rats, which were topically treated with a volume of 0.25 g/kg of 0.12% dexamethasone valerate (DV-17) ointment as a test drug, and 0.1% dexamethasone (DEX), 0.05% fluocinonide (FAA), 0.025% beclomethasone dipropionate (BMD), 0.1% hydrocortisone butyrate (HB), 0.05% clobetasol propionate (CP) and 0.12% betamethasone valerate (BMV) ointments as an active control drug for 30 consecutive days to evaluate on the effects of following items: body weight changes, adrenal functions (organ weight, histological changes of the cortex and serum contents of corticosterone), pathological changes of hypophysis and lymphatic systems (thymus, mesenteric lymph nodes and spleen), and skin changes. Furthermore, the recovery test was also carried out. The severity of topical toxicities was in parallel with that of systemic toxicities. Judging from the results obtained in this study, the potency of toxicities among seven corticosteroid ointments appeared to be as follows: FAA greater than DEX much greater than CP greater than BMV, DV-17 greater than HB greater than BMD. The toxicities of DV-17 were comparable with that of BMV, and these side effects were found to be minimized on the recovery test.

Adrenal Cortex Hormones↗
PubMed2006

In vitro effects of hydrochloric acid and various concentrations of acetic, propionic, butyric, or valeric acids on bioelectric properties of equine gastric squamous mucosa.

OBJECTIVE: To compare the effects of hydrochloric acid (HCl) and various concentrations of volatile fatty acids (VFAs) on tissue bioelectric properties of equine stomach nonglandular (NG) mucosa. SAMPLE POPULATION: Gastric tissues obtained from 48 adult horses. PROCEDURES: NG gastric mucosa was studied by use of Ussing chambers. Short-circuit current (Isc) and potential difference (PD) were measured and electrical resistance (R) and conductance calculated for tissues after addition of HCl and VFAs (5, 10, 20, and 40 mM) in normal Ringer's solution (NRS). RESULTS: Mucosa exposed to HCl in NRS (pH of 1.5 and, to a lesser extent, 4.0) had a significant decrease in Isc, PD, and R, whereas tissues exposed to acetic acid at a pH of < 4.0, propionic and butyric acids at a pH of <or= 4.0, and valeric acid at a pH of <or= 7.0 induced a concentration-dependent effect on reduction in these same values. Values for Isc returned to baseline (recovery of sodium transport) after addition of calcium carbonate in tissues exposed to all concentrations of VFAs except the higher concentrations of valeric acid at a pH of <or= 4.0. Histologic examination revealed cell swelling in the mucosal layers below and adjacent to the stratum corneum in tissues exposed to HCl and VFAs at a pH of <or= 4.0. CONCLUSIONS AND CLINICAL RELEVANCE: The VFAs, especially acetic acid, in the presence of HCl at a pH of <or= 4.0 appear to be important in the pathogenesis of NG mucosal ulcers in horses.

Acetic Acid↗
PubMed1994

Effect of two different progestins (cyproterone acetate and norgestrel), administered in a cyclical estradiol valerate regimen, on markers of bone turnover.

It has been suggested that some progestogens could have a stimulating effect on bone formation. This study was therefore undertaken in order to compare the influence of cyproterone acetate and norgestrel on bone metabolism when administered in a discontinuous, sequentially combined regimen with estradiol valerate. Twenty healthy early postmenopausal women were randomly assigned to treatment with either Cyclo-Progynova, containing 0.5 mg of norgestrel, or Climen, containing 1 mg of cyproterone acetate (CPA), over two 28-day cycles. Markers of bone resorption-fasting urinary hydroxyproline/creatinine and calcium/creatinine ratios - and of bone formation-serum alkaline phosphatase and osteocalcin-were determined initially, before the start of treatment and thereafter twice weekly (a total of 17 assessments for each women) during the 8-week treatment period. Serum osteocalcin concentrations were slightly but not significantly higher throughout the study period in women receiving Climen, compared to those taking Cyclo-Progynova. Cyclical fluctuation of serum osteocalcin levels were more pronounced in women with a high baseline level of osteocalcin. During the period of progestogen administration, osteocalcin concentrations were either similar to or even lower than those in the phase of administration of estradiol valerate alone. Serum calcium and alkaline phosphatase concentrations were relatively stable during the study period with both treatment regimens. Urinary excretion of calcium and hydroxyproline varied during the cycle but the variation was unrelated to either type or time of progestogen administration. Mean urinary hydroxyproline excretion during the 8-week study period was similar for both preparations, although the mean decrease in the urinary hydroxyproline/creatinine ratio was insignificantly higher for the CPA-containing preparation.(ABSTRACT TRUNCATED AT 250 WORDS)

Alkaline Phosphatase↗
PubMed1998

Combined oral estradiol valerate-norethisterone treatment over three years in postmenopausal women. 1. Clinical aspects and endometrial histology.

The aim of this study was to determine the medium-term safety and efficacy of once-daily, oral estradiol valerate 2 mg with norethisterone 0.7 mg on menopausal symptoms, bleeding incidence, endometrial pathology, adverse events and other clinical parameters. A three-year, single-center, open study was performed. Women with menopausal symptoms and > or = 6 months since the last spontaneous menstrual period were recruited. Patients were assessed using questionnaires and daily records of bleeding incidence and severity. Adverse events were recorded at each visit and endometrial histopathology was determined at baseline and annually. There were 206 patients at entry and 133 completers at the end of year 3. Menopausal symptoms showed significant improvements within 4 months (p < 0.0001 compared with baseline). By the end of month 4, 79.9% of patients had stopped bleeding. The mean number of days bleeding per month declined from 2.8 (month 1) to 1.1 (month 12). Significantly less bleeding was observed in patients who were > or = 2 years postmenopausal. No abnormalities in endometrial histology were found. Bleeding and breast tenderness were the commonest adverse events. Twenty-four patients experienced serious adverse events although no definite relationship to drug therapy was considered likely. We therefore conclude that the oral combination of estradiol valerate 2 mg and norethisterone 0.7 mg given daily and continuously leads to amenorrhea and symptom alleviation in the majority of patients and is well tolerated.

Adult↗
PubMed1992

Etiology of acetonemia in Norwegian cattle. 2. Effect of butyric acid, valeric acid, and putrescine.

A feeding experiment was performed on 16 cows in order to test the effect of naturally occurring substances in silage on forage intake, ketonemia, and milk yield. The cows were divided into a control group and three experimental groups. The cows in the three experimental groups were fed 100 g/d of putrescine, 200 g/d of valeric acid, or 200 g/d of butyric acid through a ruminal tube for 3 d. Butyric acid increased plasma acetoacetate; the effect was largest in high yielding cows. Putrescine influenced both milk yield and forage intake and may possibly be a contributory factor, alone or combined with other amines, for the development of ketonemia. Valeric acid did not influence feed intake or plasma acetoacetate concentration. A rapid method for acetoacetate analysis also is described.

Acetoacetates↗
PubMed1976

[Biotransformation of diflucortolone valerate in the skin of rat, guinea pig and man (author's transl)].

The biotransformation of 6alpha,9-difluoro-11beta-hydroxy-16alpha-methyl-21-valeryloxy-1,4-pregnadiene-3,20-dione (diflucortolone valerate, DFV, Nerisona) was examined in vitro in the skin of rat and man and in vivo in the skin of guinea pigs. In the investigations with rat skin DFV in ethanolic solution (0.1 mumol) was added and the ester hydrolysis in buffer monitored in relation to the incubation time. In the experiments with guinea pigs and with human skin DFV was applied topically in the form of a 0.1% W/O emusion employing a dose of 6 mg/cm2 skin. After the substance which had not penetrated had been recovered by means of cotton wool and adhesive film at the end of the period of exposure the portions of skin were homogenized, extracted and the extracts separated by thin-layer chromatography. DFV is hydrolysed in the skin of rats and guinea pigs with a half-life of about 30-60 min to diflucortolone 6alpha,9-difluoro-11bets,21-dihydroxy-16alpha-methyl-1,4-pregnadiene-3,20-dione) and valeric acid. In excised human skin degradation of the ester proceeds much more slowly. Even 7 h p. appl. about 80-90% DFV and only 5-15% DF were identifiable in the skin extract. Despite the estremely low absorption rate the slow hydrolysis of DFV in human skin guarantees an adequate level of active ingredient in the skin over a long period.

Administration, Topical↗
PubMed1976

[Percutaneous absorption of diflucortolone valerate in guinea pigs and man (author's transl)].

Percutaneous absorption of 6alpha,9-difluoro-11beta-hydroxy-16alpha-methyl-21-valeryloxy-1,4-pregnadiene-3,20-dione (difucortolone valerate, Nerisona) as dependent on the base, the concentration in the base and the condition of the skin was investigated in man and in guinea pigs. In addition the distribution of the corticoid in the stratum corneum, epidermis and corium was determined by stripping the skin and by horizontal thin-section technique. 2. In man diflucortolone valerate from all of the formulations tested (0.1 and 0.3% cream, ointment and fatty ointment) was only absorbed to a slight extent by both the intact and the stripped areas of skin on the subjects' backs. In the case of the 0.1% formulations a total of about 0.2% of the dose was absorbed within 4 h via intact skin and about 0.4% via the stripped skin. After application of the 0.3% formulations the percutaneous absorption from the ointment, fatty ointment and cream were examined separately. This revealed percutaneous absorption within 7 h of 1.7% from the ointment, 0.7% from the fatty ointment and 0.5% for the cream by combined determination through 1 intact and 1 damaged area of skin. 3. Percutaneous absorption via intact skin is slight in the case of the guinea pig also. Absorption is accelerated considerably by the removal of the stratum corneum, however, and shows a characteristic dependence on the concentration of the corticoid in the base. Whereas the corticoid from the 0.03% ointment is almost quantitatively absorbed within 7 h, absorption from the 0.5% ointment is reduced to about 30%. 4. The absolute concentrations of active ingredient in the epidermis are approximately 10(-6) mol/l and drop to approximately 10(-7) mol/l in the corium (guinea pig in vivo, man in vitro). An active ingredient flow equilibrium (inflow = outflow) is reached in the skin of the guinea pig after only 1 h.

Administration, Topical↗
PubMed1976

A comparison of betamethasone benzoate gel and betamethasone valerate cream.

One hundred and twenty-one patients were treated in a double-blind fashion with .025% betamethasone benzoate gel and 0.1% betamethasone valerate cream. Results were not statistically significant, although 14 of 16 patients with psoriasis showed excellent results with betamethasone benzoate gel, as opposed to six of 14 patients given betamethasone valerate cream.

Betamethasone↗
PubMed1990

Abrogation of the selectivity of adriamycin for negatively-charged phospholipids by 14-valerate side chain substitution.

The impressive affinity of Adriamycin and related anthracycline antibiotics for negatively-charged phospholipids has been implicated in the mechanism of the cardiac toxicity of these drugs. In this report we employ the method of fluorescence anisotropy titration to examine the manner in which 14-valerate side chain substitution modulates anthracycline drug associations with electroneutral vesicles composed of dimyristoyl phosphatidylcholine as well as negatively-charged vesicles composed of dimyristoyl phosphatidylglycerol or a binary mixture of dimyristoyl phosphatidylcholine and cardiolipin. Equilibrium binding data gathered on several anthracycline analogs indicate that incorporation of a hydrophobic valerate side chain abolished the high levels of preferential drug binding to negatively-charged membranes. Thus, we propose that 14-O-acyl substitution may prove to be a useful synthetic modification to prevent the selective accumulation of positively-charged anthracyclines in tissues or membrane domains rich in negatively-charged lipid.

Antibiotics, Antineoplastic↗