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 included 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.
Long-term safety and effectiveness of biosimilar insulin glargine in Japanese patients with diabetes mellitus in routine clinical practice: results of a post-marketing safety study
