[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].
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).


CONCLUSIONS
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.
Bramlage
P
P
Institut für Klinische Pharmakologie, Medizinische Fakultät Carl Gustav Carus, Technisch Universität Dresden. peter.bramlage@mailbox.tu-dresden.de
Schönrock
E
E
Odoj
P
P
Wolf
W-P
WP
Funken
C
C
D000368:Aged; D001562:Benzimidazoles / Q000009:adverse effects / Q000627:therapeutic use*; D001713:Biphenyl Compounds / Q000009:adverse effects / Q000627:therapeutic use*; D001794:Blood Pressure / Q000187:drug effects*; D002318:Cardiovascular Diseases / Q000517:prevention & control*; D004338:Drug Combinations; D005260:Female; D006801:Humans; D006852:Hydrochlorothiazide / Q000009:adverse effects / Q000627:therapeutic use*; D006973:Hypertension / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D011358:Product Surveillance, Postmarketing; D012307:Risk Factors; D013777:Tetrazoles / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
D001562:Benzimidazoles; D001713:Biphenyl Compounds; D004338:Drug Combinations; D013777:Tetrazoles; D006852:Hydrochlorothiazide; C077793:candesartan cilexetil