Format

Send to

Choose Destination
  • Showing results for fixed low-dose triple combination antihypertensive medication vs usual care for blood pressure control in patients with mild to moderate hypertension in sri lanka a randomized clinical trial. Your search for Fixed Low-Dose Triple Combination Antihypertensive Medication vs Usual Care for BloodPressure Control in Patients With Mild to Moderate Hypertension in Sri Lanka: A Randomized Clinical Trial retrieved no results.
JAMA. 2018 Aug 14;320(6):566-579. doi: 10.1001/jama.2018.10359.

Fixed Low-Dose Triple Combination Antihypertensive Medication vs Usual Care for Blood Pressure Control in Patients With Mild to Moderate Hypertension in Sri Lanka: A Randomized Clinical Trial.

Author information

1
The George Institute for Global Health, University of New South Wales, Sydney, Australia.
2
The George Institute for Global Health, University of New South Wales, Hyderabad, India.
3
Clinical Trials Unit, Faculty of Medicine, University of Kelaniya, Ragama, Sri Lanka.
4
Department of Epidemiology and Biostatistics, University of Auckland, Auckland, New Zealand.
5
Department of Medicine, Faculty of Medicine, University of Colombo, Colombo, Sri Lanka.
6
National Hospital of Sri Lanka, Colombo.
7
Sri Jayawardenapura General Hospital, Nugegoda, Sri Lanka.
8
Department of Medicine, Faculty of Medicine, University of Kelaniya, Ragama, Sri Lanka.
9
General Directorate of Health Affairs in Jizan, Ministry of Health, Sabya, Saudi Arabia.
10
The George Institute for Global Health, University of New South Wales, New Delhi, India.
11
Colombo North Teaching Hospital, Ragama, Sri Lanka.
12
All India Institute of Medical Sciences, New Delhi.
13
Centre for Chronic Disease Control, New Delhi, India.
14
International Centre for Circulatory Health, Imperial College London, London, England.
15
Department of Medicine, Faculty of Medical Sciences, University of Sri Jayawardenapura, Nugegoda, Sri Lanka.

Abstract

Importance:

Poorly controlled hypertension is a leading global public health problem requiring new treatment strategies.

Objective:

To assess whether a low-dose triple combination antihypertensive medication would achieve better blood pressure (BP) control vs usual care.

Design, Setting, and Participants:

Randomized, open-label trial of a low-dose triple BP therapy vs usual care for adults with hypertension (systolic BP >140 mm Hg and/or diastolic BP >90 mm Hg; or in patients with diabetes or chronic kidney disease: >130 mm Hg and/or >80 mm Hg) requiring initiation (untreated patients) or escalation (patients receiving monotherapy) of antihypertensive therapy. Patients were enrolled from 11 urban hospital clinics in Sri Lanka from February 2016 to May 2017; follow-up ended in October 2017.

Interventions:

A once-daily fixed-dose triple combination pill (20 mg of telmisartan, 2.5 mg of amlodipine, and 12.5 mg of chlorthalidone) therapy (n = 349) or usual care (n = 351).

Main Outcomes and Measures:

The primary outcome was the proportion achieving target systolic/diastolic BP (<140/90 mm Hg or <130/80 mm Hg in patients with diabetes or chronic kidney disease) at 6 months. Secondary outcomes included mean systolic/diastolic BP difference during follow-up and withdrawal of BP medications due to an adverse event.

Results:

Among 700 randomized patients (mean age, 56 years; 58% women; 29% had diabetes; mean baseline systolic/diastolic BP, 154/90 mm Hg), 675 (96%) completed the trial. The triple combination pill increased the proportion achieving target BP vs usual care at 6 months (70% vs 55%, respectively; risk difference, 12.7% [95% CI, 3.2% to 22.0%]; P < .001). Mean systolic/diastolic BP at 6 months was 125/76 mm Hg for the triple combination pill vs 134/81 mm Hg for usual care (adjusted difference in postrandomization BP over the entire follow-up: systolic BP, -9.8 [95% CI, -7.9 to -11.6] mm Hg; diastolic BP, -5.0 [95% CI, -3.9 to -6.1] mm Hg; P < .001 for both comparisons). Overall, 419 adverse events were reported in 255 patients (38.1% for triple combination pill vs 34.8% for usual care) with the most common being musculoskeletal pain (6.0% and 8.0%, respectively) and dizziness, presyncope, or syncope (5.2% and 2.8%). There were no significant between-group differences in the proportion of patient withdrawal from BP-lowering therapy due to adverse events (6.6% for triple combination pill vs 6.8% for usual care).

Conclusions and Relevance:

Among patients with mild to moderate hypertension, treatment with a pill containing low doses of 3 antihypertensive drugs led to an increased proportion of patients achieving their target BP goal vs usual care. Use of such medication as initial therapy or to replace monotherapy may be an effective way to improve BP control.

Trial Registration:

anzctr.org.au Identifier: ACTRN12612001120864; slctr.lk Identifier: SLCTR/2015/020.

PMID:
30120478
DOI:
10.1001/jama.2018.10359
[Indexed for MEDLINE]

Supplemental Content

Full text links

Icon for Silverchair Information Systems
Loading ...
Support Center