Single-Pill Triple Fixed Dose Combination Therapy with Single Component Drug Monitoring in Treatment-Resistant Hypertension: A Pilot Study.
BACKGROUND
Single-pill fixed dose combination (FDC) therapies are widely used in the treatment of arterial hypertension.


OBJECTIVE
This pilot study aimed to evaluate the effects of a FDC therapy combined with therapeutic drug monitoring (TDM) on blood pressure (BP) in patients with treatment resistant hypertension.


METHOD
The study population included patients with suspected treatment-resistant hypertension during treatment with at least 3 antihypertensive drugs. We evaluated the effect of switching all patients to a regime including a single-pill triple FDC containing olmesartan, amlodipine and hydrochlorothiazide. Adherence was evaluated by measuring serum concentrations of amlodipine in a single-blinded fashion.


RESULTS
We enrolled 13 patients (mean age 57.2±9.1 years, 8 males) with resistant hypertension (office systolic and diastolic BP 158.3±17.3 and 94.8±11.1 mmHg); mean use of antihypertensive drugs was 3.8±1.1. Medication intake of FDC was confirmed in all patients at 18 weeks. Systolic and diastolic office BP were significantly lower (-22.8 and -13.6 mmHg) after 18 weeks of treatment with triple FDC (135.5±20.1 and 81.2±6.3 mmHg, p<0.01, respectively); mean use of antihypertensive drugs was 3.8±0.9. In 9 patients with 24-h ambulatory BP monitoring (ABPM) both at baseline and after 18 weeks, 24-h mean arterial pressure decreased (-9.3 mmHg, p=0.055). Overall, 9 (69%) patients achieved BP control in office BP and 4 (31%) in 24-h ABPM.


CONCLUSION
Our results support the use of single-pill triple FDC therapy in combination with TDM for the management of patients with suspected treatment-resistant hypertension and further testing in clinical studies.
['Kreutz|Reinhold|R|', 'Scholze|Jurgen|J|', 'Douros|Antonios|A|']
D000284:Administration, Oral D000368:Aged D017311:Amlodipine D000959:Antihypertensive Agents D001794:Blood Pressure D018660:Blood Pressure Monitoring, Ambulatory D004338:Drug Combinations D016903:Drug Monitoring D004351:Drug Resistance D057915:Drug Substitution D005260:Female D005858:Germany D006801:Humans D006852:Hydrochlorothiazide D006973:Hypertension D007093:Imidazoles D008297:Male D055118:Medication Adherence D008875:Middle Aged D010865:Pilot Projects D013607:Tablets D013777:Tetrazoles D013997:Time Factors D016896:Treatment Outcome
single-pill fixed dose combination therapeutic drug monitoring blood pressure resistant hypertension Antihypertensive drugs adherence