Office and ambulatory blood pressure control with a fixed-dose combination of candesartan and hydrochlorothiazide in previously uncontrolled hypertensive patients: results of CHILI CU Soon

Abstract

Background

Fixed-dose combinations of candesartan 32 mg and hydrochlorothiazide (HCTZ) have been shown to be effective in clinical trials. Upon market entry we conducted a noninterventional study to document the safety and effectiveness of this fixed-dose combination in an unselected population in primary care and to compare blood pressure (BP) values obtained during office measurement (OBPM) with ambulatory blood pressure measurement (ABPM).

Methods

CHILI CU Soon was a prospective, noninterventional, noncontrolled, open-label, multicenter study with a follow-up of at least 10 weeks. High-risk patients aged ≥18 years with previously uncontrolled hypertension were started on candesartan 32 mg in a fixed-dose combination with either 12.5 mg or 25 mg HCTZ. OBPM and ABPM reduction and adverse events were documented.

Results

A total of 4131 patients (52.8% male) with a mean age of 63.0 ± 11.0 years were included. BP was 162.1 ± 14.8/94.7 ± 9.2 mmHg during office visits at baseline. After 10 weeks of candesartan 32 mg/12.5 mg or 25 mg HCTZ, mean BP had lowered to 131.7 ± 10.5/80.0 ± 6.6 mmHg (P < 0.0001 for both comparisons). BP reduction was comparable irrespective of prior or concomitant medication. In patients for whom physicians regarded an ABPM to be necessary (because of suspected noncontrol over 24 hours), ABP at baseline was 158.2/93.7 mmHg during the day and 141.8/85.2 mmHg during the night. At the last visit, BP had significantly reduced to 133.6/80.0 mmHg and 121.0/72.3 mmHg, respectively, resulting in 20.8% being normotensive over 24 hours (<130/80 mmHg). The correlation between OBPM and ABPM was good (r = 0.589 for systolic BP and r = 0.389 for diastolic BP during the day). Of those who were normotensive upon OBPM, 35.1% had high ABPM during the day, 49.3% were nondippers, and 3.4% were inverted dippers. Forty-nine adverse events (1.19%) were reported, of which seven (0.17%) were regarded as serious.

Conclusion

Candesartan 32 mg in a fixed-dose combination with either 12.5 mg or 25 mg HCTZ is safe and effective for further BP lowering irrespective of prior antihypertensive drug class not being able to control BP.

Keywords:

• ambulatory blood pressure
• office blood pressure
• normalization
• response

Acknowledgments

This noninterventional study was conducted by Takeda Pharma GmbH, Aachen, Germany. We would like to thank the participating physicians for their assistance and all patients observed during the study. Special gratitude goes to the clinical research organization Factum GmbH for data processing and conducting the statistical analyses. Takeda Pharma GmbH (Reinhold Hübner) designed the study. Thomas Mengden and Peter Bramlage explored the data and requested statistical analyses from the Factum GmbH (responsible statistician Dr Michael Vornkahl). Peter Bramlage wrote the first draft of the manuscript. Thomas Mengden and Reinhold Hübner revised the manuscript for important intellectual content. All authors reviewed and approved the final manuscript.

Disclosure

Thomas Mengden and Peter Bramlage have received research support and honoraria for medical consulting. Reinhold Hübner is an employee of the sponsor, Takeda Pharma GmbH.