Bisoprolol medications in a comparative study on effectiveness and tolerability of original agent and its generic in patients with mild to moderate arterial hypertension

Aim. To study clinical equivalence of two bisoprolol medications (Concor ® and Bisogamma®) in patients with mild to moderate arterial hypertension (AH).
Material and methods. The study included 32 AH patients (15 men, 17 women): 66 % with Stage I, and 34 % with Stage II AH; mean age 60 years; mean AH duration 17,9 years. Most participants had intermediate or high-risk AH. After two-week wash-out period, without any antihypertensive therapy, the patients were administered bisoprolol or its generic (5 mg/d), with medication consequence randomly selected. In case of inadequate antihypertensive effect, the dose was doubled in two weeks, up to 10 mg/d, or, when appropriate, hydrochlorothiazide (HCT) was added (12,5–25 mg/d). After Phase 1 completion and two-week wash-out period, Phase 2 started.
Results. Two-week therapy with original bisoprolol or its generic significantly reduced systolic, diastolic blood pressure and heart rate (SBP, DBP, HR). Target SBP was achieved in 62,5 % and 43,7 % for Concor® and Bisogamma® groups, DBP – in 71,9 % and 62,5 %, respectively. Combined treatment with increased bisoprolol dose ± HCT was associated with target SBP achievement in 90,1 % and 75 % of the patients receiving original bisoprolol or its generic, respectively. Concor® and Bisogamma® monotherapy was effective in 84,4 % and 62 % of the cases (for inter-group difference, p<0,05). After 6 weeks of the treatment, target SBP and DBP levels were achieved in 96,9 % of the patients from each group. Similar antihypertensive effect was achieved with higher bisoprolol dose and HCT administration in Bisogamma® group.
Conclusion. Therefore, in AH patients, original bisoprolol was more effective than its generic, with similar tolerability.

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