GENERIC VS BRAND-NAME DRUGS FOR THE TREATMENT OF HYPERTENSION. (June 2018) - Dinic, M.
Abstract: Objective: Although antihypertensive generics and their brand-name counterparts are bioequivalent, their equivalence in lowering blood pressure and controlling hypertension is still debated. We thus, sought to compare the effect of generic and brand-name drugs in hypertensive patients. Design and method: We conducted an open crossover randomized controlled trial (NCT02853045) in which patients were allocated to take their usual antihypertensive treatment either exclusively with brand-name drugs for 6 weeks and then to switch for generics for another 6 weeks or following the opposite order. 24 h ambulatory blood pressure (ABP) was monitored twice, at the end of each 6-weeks period. We tested the hypothesis that generics were not worse than branded antihypertensive drugs for controlling hypertension with a non-inferiority margin of 7 mmHg. Results: Forty Three patients (mean age of 61 +/- 12 years, 73% male, 35% of kidney transplant patients) were included. 60% of them were under triple antihypertensive treatment (angiotensin renin blockers and channel calcium blockers being taken by 88% and 72% of the patients, respectively). Mean 24 h ABP was 129/77 mmHg and 128/77 mmHg for patients under generics and branded drugs, respectively. 58% (n = 25) of patients presented optimal BP with generics vs 69% (n = 30) with brand-name drugs. 18% (n = 8) of patients presented resistant hypertension with generics vs 11% (n = 5) with branded drugs. The differences of proportion were not statistically significant. Non-inferiority was confirmed in all subgroup analyses independently of age, gender, number of medications, severity/resistance of hypertension and dipper status. Reported adverse events were not different in nature and in frequency between generic and branded drugs. Conclusions: Our findings support the notion that generics are not inferior than brand-name antihypertensive agents and can be safely used at least for the control of blood pressure.