Generic vs. brand-name drugs for the treatment of hypertension

Abstract

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. 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\xa0h 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\xa0mm Hg. Forty three patients (mean age of 61\xa0±\xa012 years, 73% male, 35% of kidney transplant patients) were included. Sixty % 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\xa0h ABP was 129/77\xa0mmHg and 128/77\xa0mmHg for patients under generics and branded drugs, respectively. 58% (n\xa0=\xa025) of patients presented optimal BP with generics vs. 69% (n\xa0=\xa030) with brand-name drugs. 18% (n\xa0=\xa08) of patients presented resistant hypertension with generics vs. 11% (n\xa0=\xa05) 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. 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. These results need to be confirmed in a larger cohort of patients allowing us the performed analysis according the class of antihypertensive drugs.