Three Low-Dose Antihypertensive Agents in a Single Pill after Intracerebral Hemorrhage.
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Trident Research Group, Anderson Craig S, Chow Clara K, de Silva H Asita, Senanayake Bimsara, Wahab Kolawole, Al-Shahi Salman Rustam, Klijn Catharina J M, Martins Sheila Ouriques, Espinosa Natalie, Kuhles Lauren, Billot Laurent, Arima Hisatomi, Carcel Cheryl, Wang Xia, Li Qiang, Shan Sana, Shanthakumar Mathangi, Nguyen Huy Thang, Palliyaguruge Dilum, Peiris Janaka, Ranawaka Udaya K, Bandusena Senaka, Rajendiran Thambipillai, Wijegunasinghe Darshana, Gunasekera Harsha, Wijeweera Indunil, Dissanayake Athula, Keshavaraj Ajantha, Obiako Reginald O, Akinyemi Rufus, Nasi Luiz, Bazan Rodrigo, Moro Carla Heloisa Cabral, Battaglini Mariana, Zétola Viviane, Law Wan Chung, Chia Yuen Kang, Cordato Dennis, Grimley Rohan, Dahanayaka Anuradha, Liyanagamage Sonali, Fernando Nilukshi, Rasheed Nihara Abdul, Kakabadze Nodar, Beridze Maia, Aravinthan Mythily, Sahathevan Vithoosan, Wijesundara Devasmitha, Ruwanpathirana Pramith, Wan Zaidi Wan Asyraf, Kherkheulidze Tinatin, Fischer Urs, de Souza Ana Cláudia, Lee Tsong-Hai, Chen Christopher, Pontes-Neto Octavio, Robinson Thompson, Wang Jiguang, Naismith Sharon L, Barnett Michael, Delfino Carlos, You Shoujiang, Liu Feifeng, Delcourt Candice, Moullaali Tom J, Wilkinson Tim, Watson Neil, Santo Karla, Han Qiao, Souza Mariana Almudi, Jolink Wilmar M T, Cristofari Anderson Berni, Zhou Zien, Schreuder Floris H, Lindley Richard I, Armenis Manuela, Woodward Mark, Freed Ruth, Song Lili, Chalmers John, Rodgers Anthony
Аннотация
METHODS: We conducted a multinational, double-blind, randomized, placebo-controlled trial involving patients with a history of intracerebral hemorrhage. Patients were eligible for the trial if they had a systolic blood pressure of 130 to 160 mm Hg at baseline and were in clinically stable condition. After a 2-week active run-in phase during which all the patients received a once-daily pill containing three antihypertensive agents at low doses (telmisartan at 20 mg, amlodipine at 2.5 mg, and indapamide at 1.25 mg; the triple pill), the patients were randomly assigned to continue receiving the triple pill or to receive matching placebo. The primary outcome was the first recurrent stroke. Secondary outcomes included blood-pressure control, major cardiovascular events, death from cardiovascular causes, and safety.
RESULTS: Of 1670 patients who underwent randomization, 833 were assigned to receive the triple pill and 837 to receive placebo. The mean age of the patients was 58 years. At a median follow-up of 2.5 years, recurrent stroke had occurred in 38 patients (4.6%) in the triple-pill group and 62 (7.4%) in the placebo group (hazard ratio, 0.61; 95% confidence interval [CI], 0.41 to 0.92; P = 0.02). The mean systolic blood pressure during follow-up was 127 mm Hg and 138 mm Hg, respectively. The incidence of major cardiovascular events was lower with the triple pill than with placebo (6.6% vs. 9.8%; P = 0.04). Serious adverse events occurred in 23.2% of the patients in the triple-pill group and 26.0% of those in the placebo group. Early discontinuation of the trial regimen due to an adverse event occurred in 13.6% and 6.0%, respectively. The most common adverse event leading to discontinuation was an increase of 20% or more in the serum creatinine level.
CONCLUSIONS: Among patients with intracerebral hemorrhage, treatment with a combination of three low-dose antihypertensive agents in a single pill, in addition to standard care, was associated with a lower incidence of recurrent stroke and major cardiovascular events than placebo. (Funded by the National Health and Medical Research Council of Australia and the Brazilian Ministry of Health; TRIDENT ClinicalTrials.gov number, NCT02699645; Australian New Zealand Clinical Trials Registry number, ACTRN12616000327482.).