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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

JAMA Aug 18, 2018

Webster R, et al. - Researchers evaluated if better blood pressure (BP) control could be achieved with a low-dose triple combination antihypertensive medication vs usual care. An increased proportion of patients with mild to moderate hypertension achieved their target BP goal with a single pill containing low doses of three antihypertensive drugs vs usual care. An effective way to improve BP control may be the use of such medication as initial therapy or to replace monotherapy.

Methods

  • Experts conducted a 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.
  • They enrolled the patients from 11 urban hospital clinics in Sri Lanka from February 2016 to May 2017; follow-up ended in October 2017.
  • Interventions included 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).
  • 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 was the primary outcome.
  • Mean systolic/diastolic BP difference during follow-up and withdrawal of BP medications due to an adverse event were the secondary outcomes.

Results

  • As per data, 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 proportion achieving target BP was increased with triple combination pill vs usual care at 6 months (70% vs 55%, respectively; risk difference, 12.7% [95% CI, 3.2% to 22.0%]; P < .001).
  • At 6 months, mean systolic/diastolic BP 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).
  • Results demonstrated that overall, in 255 patients, 419 adverse events were reported (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%).
  • Findings did not suggest any 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).
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