Russian Study on Optimal Blood Pressure Reduction (ROSA 2). Two-year follow-up. What is the result?

Twenty centers from 19 Russian regions took part in ROSA 2, following the first ROSA study.
Aim. In arterial hypertension (AH) patients, to compare efficacy, safety, and impact on cardiovascular event (CVE) incidence for two treatment strategies: intensive stepwise therapy with four classes of antihypertensive agents (Group A), and non-standardized antihypertensive therapy (Group B), during two-year follow-up.
Material and methods. The study was national, multicenter, open, prospective, and included 1355 patients with AH, randomized into Groups A (n=697) and B (n=658). In total, 87.2% of the participants completed the study: 634 individuals from Group A, and 547 patients from Group B. There were 39.9% of males and 60.1% of females; mean age at baseline was 53.6±9.1 years, mean AH duration – 8.8±7.4 years. In Group A, patients received nifedipine retard monotherapy for 4 weeks, with 4-week intervals before adding enalapril, hydrochlorthiazide, and metoprolol. After target blood pressure (BP) level achievement, patients received the therapy at which this level was reached. Group B continued the same antihypertensive treatment that was administered before study recruitment.
Results. After two years of stepwise therapy with 4 classes of antihypertensive agents, target BP level was achieved and maintained in 98.3% of Group A patients, and 53.9% of Group B participants (р<0.0001). In Type 2 diabetes mellitus (DM) patients, these figures were 42.9% and 29.6%, respectively (р=0.05). During two-year follow-up, secondary endpoint was registered in 6.3% of participants: 0.9% in Group A, 5.4% in Group B (p<0.0001). In Group B, acute myocardial infarction (p=0.01), acute stroke or transitory ischemic attack (p=0.005), and hypertensive crises (p<0.0001) were significantly more frequent than in Group A. Drop-out rates were 12.8% for the whole group, 4.6% for Group A, and 8.2% for Group B (p=0.0001). Among drop-outs in Groups A and B, there were 2.7% and 4.4% refusals to continue the treatment (р=0.006); 1.8% vs 2.6% adverse effects (р=0.09); 0.1% and 1.2% secondary endpoint registration, respectively (p<0.001).
Conclusion. Stepwise antihypertensive treatment, comparing with non-standardized antihypertensive therapy, was more effective in achieving target BP level and CVE risk reduction, without increasing adverse effect rates.

1. Рекомендации по профилактике, диагностике и лечению артериальной гипертензии. Российские рекомендации (второй пересмотр). Комитет экспертов Всероссийского научного общества кардиологов. Секция артериальной гипертонии ВНОК. Москва 2004. Приложение к журналу Кардиоваск тер профил.

2. Hansson L, Zanchetti A, Carruthers SG, et al. Effects of intensive blood pressure lowering and low-dose aspirin in patients with hypertension: principal results of the Hypertension Optimal Treatment (HOT) randomized trial. Lancet 1998; 351: 1755-62.

3. Чазова И.Е., Беленков Ю.Н.. От идеи к клинической практике. Первые результаты российского национального исследования оптимального снижения артериального давления (РОСА). Систем гипертен 2004; 2: 18-23.

4. Vasan RS, Larson MG, Leip EP, et al. Impact of high-normal blood pressure on the risk of cardiovascular disease. N Engl J Med 2001; 345(18): 1291-7.

5. Беленков Ю.Н., Чазова И.Е. Первое российское национальное многоцентровое исследование – РОСА (Российское исследование Оптимального Снижения Артериального давления). Артер гиперт 2003; 5: 151-4.