Significance of initial blood pressure and comorbidity for the efficacy of a fixed combination of an angiotensin receptor blocker and hydrochlorothiazide in clinical practice

Abstract

Background:

Two-thirds of all patients with arterial hypertension need drug combinations to achieve blood pressure (BP) goals. Fixed combinations have high efficacy and result in high patient compliance. 300 mg irbesartan plus 25 mg hydrochlorothiazide (HCTZ) has been investigated only in clinical trials but not in daily practice.

Methods:

A multicenter, noninterventional, noncontrolled observational study with 8123 patients seen by 1604 physicians in daily practice. BP reduction (office measurements), co-morbid disease and tolerability were documented over a 6-month observational period.

Results:

At mean baseline BP of 161 ± 15/94 ± 10 mmHg, administering of fixed combination resulted in a substantial BP reduction averaging 28 ± 15/14 ± 10 mmHg (P < 0.001). Decrease of systolic BP ran parallel with increasing systolic baseline BP (Spearman’s Rho −0.731; P < 0.0001; diastolic BP vs diastolic baseline BP Rho 0.740; P < 0.0001), independent from patient characteristics (age, obesity, diabetes or nephropathy) but enhanced with short history of hypertension (P < 0.0001 vs long history), prior beta blockers (P = 0.001 vs prior angiotensin receptor blockers [ARBs]), prior calcium channel blockers (P = 0.046 vs prior ARBs) and no prior medication (P = 0.012 vs prior ARBs). High compliance (>98%) and low incidence of adverse events (0.66%) were documented.

Conclusions:

The fixed combination of 300 mg irbesartan with 25 mg HCTZ was efficacious and tolerable in an unselected patient population in primary care.

Keywords:

• hypertension
• combination therapy
• obesity
• irbesartan
• noninterventional study
• diuretics

Acknowledgements

We wish to thank all the doctors who took part in this study and their assistants for participating in this study. Our special thanks also to the Clinical Research Organization (CRO) factum – Gesellschaft für Statistik, wissenschaftliche Information und Kommunikation mbH, Offenbach.

Disclosures

The study was conducted by sanofi-aventis Deutschland GmbH. RES declares to have received research support and lecture honoria from AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Novartis, sanofi-aventis, and Takeda. PB declares to have received research support and lecture honoria from sanofi-aventis, Daiichi Sankyo, Takeda. MS is an employee of sanofi-aventis.