Abstract

Introduction: Whether the presence of diabetes mellitus (DM) affects the ability of antihypertensive therapies to lower blood pressure (BP) is uncertain. We investigated whether DM affects the efficacy of a low dose triple combination pill or usual care among people with hypertension. Methods: TRIUMPH (TRIple pill vs Usual care Management for Patients with mild-to-moderate Hypertension) was a randomized controlled open-label trial of patients requiring initiation or escalation of antihypertensive therapy. Patients from urban hospital clinics in Sri Lanka were randomised to a once-daily low-dose triple combination polypill (telmisartan 20mg, amlodipine 2.5mg, chlorthalidone 12.5mg) or standard care. This analysis compared BP reduction and percentage of time below 140/90mmHg (time at target) in the intervention and usual care groups over 24 week follow-up, stratified by the presence of DM. Predicted potency of therapy was calculated according to estimation methods of Law et al. Results: The trial comprised 700 patients (56±11yrs, 58% women, 31% DM). Patients on the triple pill achieved greater BP reduction compared to standard care at week 24 in both diabetic and non-diabetic groups (Table 1, p>0.05 for heterogeneity). DM was a negative predictor of time at target BP (OR 0.18, 95%CI 0.10-0.31, p<0.001). Observed BP reduction from baseline to week 24 was lower in diabetics compared to non-diabetics on the triple pill (25/11 vs 31/15 mmHg, p≤0.01) and on usual care (17/7 vs 22/11, p≤0.01). Diabetics also achieved lower time at target BP than non-diabetics in the triple pill group (44% vs 73%, p<0.001) and in usual care (27% vs 51%, p<0.001). This was despite no difference between diabetics and non-diabetics in number of drugs prescribed or predicted potency of therapy. Conclusion: While both drug regimens were associated with reduced potency in the presence of DM, the triple pill achieved greater BP reduction compared to usual care in mild-moderate hypertension.

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