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Biomedical subjects

G Hitzenberger

Publications and source records attributed to G Hitzenberger.

At least 19 recordsLinked to original sources

Blood pressure characteristics of hypertensive patients in Austria as determined by self-monitoring (SCREEN-II).

This is the first large-scale, countrywide study evaluating blood pressure levels in treated hypertensive patients based on home blood pressure monitoring. The study was conducted all over Austria by 166 physicians enrolling a total of 1303 patients each taking at least 30 home blood pressure readings (a total of 39,000 readings). Stratification of patients into groups with normotension, mild hypertension or severe hypertension followed the recommendations of the Austrian Hypertension League (normotension defined as no more than seven readings higher than 135/85 mmHg, according to a blood pressure load of no more than 25%). The data collected show that these patients are inadequately treated, with only 17% being normotensive. Treatment results are no better than in patients with blood pressure measured in an office setting: the number of those achieving normotension is 17% vs 16%, although the self-measuring patients obviously receive better treatment with more patients being prescribed combination therapy.

Adult↗

[Education for medical career].

Medical education must be more than transmitting knowledge about selected diseases and their therapy. To change for better the conditions under which doctors have to practice must be taught too. Students must get knowledge about epidemiological methods and data as well as about specific nomenclatures and other elements of the technical language necessary to cope with the difficulties of medicine applied in practice. It should be found out how to guarantee that the profession is pursued till to it's end on the highest possible level. Results of research concerning the latter topic don't exist at present.

Austria↗

[Ethical problems in the clinical evaluation of drugs--role of ethics committees].

The most important item in clinical trials is the informed consent. Information of the patient/subject has to be provided in a clear, for medically not educated people understandable language. Consent has to be given voluntarily and not under duress. The Ethic Committees should--among other things--fulfill the following requirements: Review of the written information sheets, checking of the benefit/risk profile (placebo control group?) and--in the future--perhaps to insist to make the results of the study available to the public.

Austria↗

[Clinical pharmacology of angiotensin II receptor antagonists].

Angiotensin II is not only generated by the circulating ACE (Angiotensin II converting enzyme) but also locally in several tissues. Therefore substances were developed, which act directly at its receptor. This receptor contains 2 subtypes, which are influenced by these antagonists in a different way. The marketed drugs of this group have different pharmacokinetic properties.

Angiotensin II↗

Amelioration of arterial properties with a perindopril-indapamide very-low-dose combination.

BACKGROUND: Epidemiological studies have shown that increased arterial stiffness and wave reflections, major determinants of systolic and pulse pressure, are associated with morbidity and mortality. Therapeutic trials based on cardiovascular mortality have recently shown that reduction of systolic blood pressure (SBP) requires normalization of both large-artery stiffness and wave reflections. AIMS: To compare the antihypertensive effects of the very-low-dose combination of perindopril (2 mg) and indapamide (0.625 mg) (one or two tablets per day) with the beta-blocking agent atenolol (50 mg; one or two tablets per day) in order to determine whether the combination decreased SBP and pulse pressure more than did atenolol, and whether this decrease occurred in relation to a reduction in arterial stiffness [aortic pulse wave velocity (PWV)] or a decrease in the intensity of, or delay in, wave reflections (augmentation index, measured by applanation tonometry) or a combination of both. MATERIAL AND METHODS: This was a double-blind randomized study in 471 individuals with essential hypertension followed for 12 months. Arterial pressure was measured in the brachial artery (mercury sphygmomanometer) and in the carotid artery (applanation tonometry). RESULTS: For the same reduction in diastolic blood pressure (DBP), the combination of perindopril and indapamide decreased brachial SBP and pulse pressure significantly more than did atenolol (adjusted differences between groups -6.2 +/- 1.5 and -5.5 +/- 1.0 mmHg, respectively; P < 0.001). This difference was even more pronounced for the carotid than for the brachial artery. Whereas both antihypertensive agents similarly decreased PWV, only the combination significantly attenuated wave reflections. CONCLUSION: Normalization of SBP, pulse pressure and arterial function--a haemodynamic profile known to improve survival significantly in hypertensive populations at high cardiovascular risk--was achieved to a greater extent with a very-low-dose combination of perindopril and indapamide than with atenolol.

Antihypertensive Agents↗

[How reproducible is blood pressure measurement? Intra- and interindividual blood pressure variability in routine practice].

Considering the reproducibility of blood pressure readings the epidemiologist and the physician in his clinical work take two different points of view. Studying drug effects the epidemiologist is interested in significant differences of blood pressures in a study population. The physician however, who estimates the effect of his prescription given to an individual patient has to compare single blood pressure readings in single individuals. In a pharmacological study we accept without any doubt the need of certain numbers of investigations to define a difference of 10 mm Hg as significant. In clinical routine however we behave quite differently and judge single readings intuitively as equal or different, independent of any statistical considerations. Not only the doctor but also the scientific societies with the highest reputation share the same point of view. In their recommendations they accept an arithmetic mean of two blood pressure readings as sufficient to judge blood pressures in individuals. In order to discuss this topic primarily from the doctors point, we analysed repeated blood pressure readings of 21 volunteers who tested 20 different blood pressure devices. We conclude, that the ongoing practice of judging the blood pressures of the patients meets only the needs of the epidemiologist. Reproducibility of single readings or mean values of two readings however are insufficient to draw satisfactory conclusions from the distributions of blood pressure in single individuals. Due to the short and long term blood pressure variability increasing the numbers of readings within a single day does not improve reproducibility sufficiently. It seems that the amount of blood pressure readings which are necessary to improve reproducibility of "the patients blood pressures" should be increased and taken over several days. If this is true, daily self-recordings should be the most promising approach.

Adult↗

[Hypertension--the status in Austria].

In Austria approximately 25-30% of the population have hypertension. Nearly half of them is not aware of their condition. Only one third undergoes treatment. Of those who are treated only 10% reach normotension. Among physicians these values are even worse: nearly two thirds show an elevated pressure, but only 20% of them are treated. Treatment itself is unsatisfactory: nearly 100% of patients receive a monotherapy only.

Adolescent↗

A comparative study of pharmacodynamics and bioavailability of 2 different desmopressin nasal sprays.

The antidiuretic effect and pharmacokinetics were investigated in 16 healthy, male overhydrated volunteers after intranasal administration of 20 microg desmopressin. The antidiuretic activity was measured by determination of urine osmolality and diuresis every 15 minutes over a period of 8 hours. Both study preparations were equally effective regarding a rapid onset of activity and a highly reproducible magnitude of effect. Urine osmolalities, analyzed as area under the time curve (AUCosm) and maximum urine osmolalities were similar for both nasal sprays. Urine volume, analyzed as area under the time curve, was raised after treatment with the test preparation. Bioequivalence was assessed for the primary criterion AUCosm by a calculated mean ratio (test/reference) of 102.8% and a 90% confidence interval ranging from 95.4% to 110.8%. Plasma levels of desmopressin, measured by a specific and sensitive radio-immunoassay method, were already detectable 20 minutes after administration. The mean time curves were parallel at different concentration levels. The maximum desmopressin plasma concentrations of both preparations were comparable, showing high interindividual variability. The times of reaching maximum plasma concentrations were similar. Desmopressin bioavailability was increased after treatment with the test preparation (mean ratio of 130.8% and a 90% confidence interval ranging from 109.9% to 155.7%). Both preparations showed a pronounced biological effect with similarly raised urine osmolalities. The detected differences in bioavailability seem to have no direct correlation to the biological response.

Administration, Intranasal↗

The duration of antidiuretic response of two desmopressin nasal sprays.

The duration of antidiuretic response and pharmacokinetics of desmopressin were investigated in 16 healthy, male overhydrated volunteers after intranasal administration of 20 microg desmopressin (dDAVP). The antidiuretic activity was determined by measuring urine osmolality and diuresis over a period of 24 hours. Both study preparations were equally effective regarding a rapid onset of activity and a highly reproducible extent of effect. Urine osmolalities, analyzed as areas under the time curve (AUCosm) were similar for both nasal sprays. Urine volumes were comparable. Bioequivalence was assessed for the primary criterion AUCosm by a calculated mean ratio (test/reference) of 100.9% (90% confidence interval ranging from 88.0% to 115.6%). Plasma levels of desmopressin, measured by a specific and sensitive radioimmunoassay method, were already detectable 20 minutes after administration. The mean time courses showed a similar shape with increased concentration levels for the test preparation. Consequently maximum desmopressin plasma concentrations were different, showing high interindividual variability. However, the times of reaching maximum plasma concentrations were similar. AUC(0-24h) was significantly raised after treatment with the test preparation (mean ratio of 127.9%; 90% confidence interval ranging from 106.6% to 153.5%). A subanalysis of the 2 reference batches with the two-sided t-test procedure for parallel groups resulted in a mean ratio of 83.1% with a 90% confidence interval ranging from 67.2% to 102.7%. The estimated ratios of the 2 batches of the reference preparation were borderline to the equivalence range. In conclusion, both study preparations had the same pronounced biological effect with different desmopressin bioavailabilities.

Administration, Intranasal↗

[Therapeutic effectiveness of flavonoids illustrated by daflon 500 mg].

Besides the standard therapy of chronic venous insufficiency with compression drug treatment with effective substances considerably improves the prognosis. Among these substances Daflon 500 mg, consisting of a micronized fraction of flavonoids, is one of the best investigated drugs. It shows a very good tolerability: in none of the toxicological studies substance-related alterations were found. This statement refers as well to questions of acute, subacute and chronic toxicity as also to mutagenicity, fertility, embryotoxicity, respectively. Pharmacokinetic studies showed that it is well absorbed from the gastrointestinal tract, although is is not clear whether this concerns the unchanged drug or only metabolites. Pharmacodynamically an improvement of the velocity of lymphstream was shown and clinically the effects on chronic venous insufficiency, venous leg ulcers and hemorrhoids were statistically highly significant. The micronized flavonoids in Daflon 500 mg allow an exact dose regimen (2 tablets a 500 mg/day, once daily given), shows an excellent tolerability and therefore a high acceptance by the patient.

Clinical Trials as Topic↗