[Importance of a fixed combination of AT1-receptor blockade and hydrochlorothiazide for blood pressure lowering in cardiac risk patients. A postmarketing surveillance study with Candesartan/HCTZ]. / Kombination aus AT1-Blocker und Hydrochlorothiazid zur Blutdrucksenkung bei kardialen Risikopatienten. Eine Anwendungsbeobachtung mit Candesartan/HCT.

BACKGROUND: The treatment of arterial hypertension in Germany is, compared to international control rates, not adequate. In particular patients having additional cardiac risk factors like diabetes mellitus, dyslipidemia, increased waist circumference as well as concomitant diseases like myocardial infarction, heart- as well as kidney failure would benefit from an effective antihypertensive therapy. Aim of the present study was therefore to investigate in more detail blood pressure control in patients receiving a fixed combination of 16 mg Candesartan and 12.5 mg hydrochlorothiazide (HCTZ). METHODS: The present studywas performed as a non-interventional observational study. Included were patients with previously uncontrolled hypertension with at least one further risk factor. Primary variable was the blood pressure reduction over a time period of 8 weeks; secondary variables were the achievement of blood pressure targets and the tolerability of Candesartan/HCTZ. RESULTS: Between August 2006 and February 2007 3,787 patients in 893 physicians' offices in Germany were included. Patients were 62.2 +/- 11.3 years old, 48.1% were female, 97.5% had at least one additional risk factor, 29.8% a cardiovascular event. The risk to die from cardiovascular disease within the next 10 years was 7.4% according to the SCORE Score. By prescribing patients a fixed combination of 16 mg Candesartan/12.5 mg HCTZ a mean blood pressure reduction of -27.2/-13.4 mmHg was achieved (p < 0.001), pulse pressure was reduced by 13.8 mmHg (p <0.001) - both compared to previous therapy. A mean of 83.1% of patients achieved the guideline defined blood pressure targets (140/90 mmHg), 42.9% of patients even 130/80 mmHg. Serious adverse events were extremely rare (0.5%; hypertensive crisis, transitory ischemic attack). CONCLUSION: Prescribing patients with previously uncontrolled hypertension a combination of 16 mg Candesartan/12.5 mg HCTZ was tolerable and effective for blood pressure reduction in patients with arterial hypertension and additional risk factors like diabetes mellitus, dyslipidemia and the metabolic syndrome.

Tissue implantation test in rabbits with gelatine sponges.

The purpose of this implantation study was to evaluate possible toxic effects and quality and quantity of resorption of two different resorbable gelatine sponges when implanted into the paravertebral muscle of the rabbit for a period of 7, 14 or 21 days and to evaluate bioequivalence of two types of test material. Test materials (Gelaspon) and a commercially available reference material were compared in three groups with 6 rabbits each. Tissue reaction to the implants and sponge degradation were scored on a graded scale and the sponges were compared for evaluation. No treatment-related mortality or body weight changes were observed. Clinical signs, indicative of local effects, were mainly seen for reference material. Tissue reaction after 7 days was comparable, after 14 and 21 days a significant increase in granulomatous reaction was seen for reference material. Sponge degradation was complete for test materials after 14 and 21 days without inflammatory tissue reaction, but small sponge rests of reference material were still present, accompanied by an increased inflammatory response. Results show test materials to fulfil the clinical requirements for implant material concerning fast resorption without inflammatory reactions and its superiority to reference material. Bioequivalence of used types of test material could be confirmed.