- 作者：Abdul Salam ; Ruth Webster ; Kavita Singh ; Sudha Kallakuri ; Anthony Rodgers ; Dorairaj Prabhakaran ; Pallab K. Maulik ; Stephen Jan ; Simon Thom ; Nitish Naik ; Rama Guggilla ; Vanessa Selak ; Anushka Patel
- 刊名：American Heart Journal
- 出版年：February, 2014
- 年：2014
- 卷：167
- 期：2
- 页码：127-132
- 全文大小：373 K
Background
Hypertension management strategies have traditionally focused on 鈥渢ailored therapy鈥?and 鈥渟tepped-care鈥?approaches. These tend to be costly and time consuming and often fail to achieve adequate blood pressure (BP) control. The TRIUMPH study aims to investigate the effectiveness, cost-effectiveness, and acceptability of early use of a 3-in-1 BP-lowering pill (鈥淭riple Pill鈥? compared with usual care for the management of hypertension.Methods
The prospective, open, randomized controlled clinical trial (n = 700) will compare Triple Pill-based strategy to usual care among individuals with persistent mild-to-moderate hypertension (systolic BP >140 mm Hg and/or diastolic BP >90 mm Hg, or systolic BP >130 mm Hg and/or diastolic BP >80 mm Hg in patients with diabetes or chronic kidney disease) on no or minimal drug therapy. The study will be conducted within approximately 20 hospital-based clinics in India. Participants will be randomized to the Triple Pill (initially strength 1鈥攖elmisartan 20 mg, amlodipine 2.5 mg, hydrochlorothiazide 6.25 mg, with the option of subsequent titration to strength 2鈥攖elmisartan 40 mg, amlodipine 5 mg, hydrochlorothiazide 12.5 mg) or continued usual care. Participants will be followed up for 6 months. The primary outcome is the proportion of participants achieving target BP at the end follow-up.
Conclusion
This study will determine whether early use of a low-dose triple combination therapy has the potential to address some of the challenges in hypertension control through earlier achievement of BP control, better adherence, and fewer adverse effects, in the context of less intensive clinical follow-up.