-
Views
-
Cite
Cite
M. Anegon, R. Jimenez, J. Esteban, V. Sanz, J. Martinez, A. Gil, G. Hernandez, for the DLM Study Investigators, P-216: Postmarketing surveillance study to evaluate the effectiveness and safety of doxazosin gastro-intestinal therapeutic system (GITS) in hypertensive patients previously treated with doxazosin tablets, American Journal of Hypertension, Volume 14, Issue S1, April 2001, Page 101A, https://doi.org/10.1016/S0895-7061(01)01406-6
Close - Share Icon Share
Abstract
The purpose of this study was to evaluate the effectiveness and safety of the new GITS formulation of doxazosin in hypertensive patients previously treated with Doxazosin standard.
It was designed an open, multicenter, prospective, postmarketing surveillance study in hypertensive patients in primary care settings. 4512 hypertensive patients (SPB≥140 and/or DBP≥90 mmHg) were enrolled after obtaining their informed consent. 4512 were considered valuable for the safety analysis and 4227 for the effectiveness analysis. After a follow-up period of 3-9 months on Doxazosin standard (Phase 1) patients were switched to doxazosin GITS and followed during 3 additional months (Phase 2). The outcome measures included blood pressure and incidence of adverse events (AE).
Results: Mean age of the patients (59.6% male) was 62.4 ± 10.6 years. A statistical significant decrease in SBP and DBP mean values was observed from 160.9 mmHg at the beginning of this study, to 135.3 mmHg at the end, and from 93.3 mmHg to 79.3 mmHg respectively (p<0.001).The percentage of patients presenting optimal control (SBP<140 and DBP<90mmHg) grew significantly from 0% at the beginning to 63.4% at the end of the study (p<0.01).
A total of 343 AE (7.2%) were reported in 322 patients, regardless their relationship with the drug treatment, being serious 38 (0.9%). Most of the AE were mild or moderate. The most common AE in both phases (Standard/GITS) were:49(20%)/3(1.2%) dizziness, 21(8.6%)/6(2.4%) headache, 19(7.8%)/3(1.2%) hypotension, 3(1.2%)/4(1.6%) diarrhea, 5(2%)/0(0%) arrhythmia and asthenia 10(4.1%)/2(0.8%), respectively. The incidence observed while doxazosin GITS therapy was lower than while standard form. Only one serious AE was considered drug-related.
Conclusion: the study showed that switching doxazosin standard to doxazosin GITS is safe and seems to improve the drug toleration.
Grant/Research Support: Pfizer
