ORIENTIR Study: design and results

S. Yu. Martsevich, Yu. V. Lukina, I. B. Bondareva
2011 CARDIOVASCULAR THERAPY AND PREVENTION  
The paper summarizes the specific features of post-marketing studies, which are performed after the medication registration, in the settings close to the real-world clinical practice. In particular, the authors discuss the design and results of the Russian post-marketing study of nifedipine CR (controlled release) — ORIENTIR Study. The aim of the study was to assess antihypertensive effectiveness and tolerability of nifedipine CR in patients with arterial hypertension (AH). Results. The study
more » ... cluded 38 doctors from 24 clinical centres in 16 Russian cities, as well as 3179 patients with AH. Mean blood pressure (BP) reduction reached 22,9±6,75/16,56±8,74 mm Hg. Target BP levels were achieved in 94,9 % of AH patients without diabetes mellitus (DM), and in 72,1 % patients with a combination of AH and DM. At the last visit, 98 % of the participants continued taking the study medication. Adverse effects were registered in 1,5 % of the participants. Doctor-assessed effectiveness, tolerability, and therapy compliance for nifedipine CR were "excellent" or "good" in 95,8 %, 96,4 %, and 97,7 % of the patients, respectively. Conclusion. The results of this study are consistent with the data from other post-marketing studies of nifedipine CR, confirming its antihypertensive effectiveness and good tolerability.
doi:10.15829/1728-8800-2011-3-89-96 fatcat:iemhf4b25vbm3imtlw57r4ogt4