PMID- 19843484
OWN - NLM
STAT- MEDLINE
DCOM- 20100118
LR  - 20151119
IS  - 1879-114X (Electronic)
IS  - 0149-2918 (Linking)
VI  - 31
IP  - 9
DP  - 2009 Sep
TI  - Efficacy and tolerability of nebivolol monotherapy by baseline systolic blood 
      pressure: a retrospective analysis of pooled data from two multicenter, 12-week, 
      randomized, double-blind, placebo-controlled, parallel-group, dose-ranging 
      studies in patients with mild to moderate essential hypertension.
PG  - 1946-56
LID - 10.1016/j.clinthera.2009.08.028 [doi]
AB  - BACKGROUND: In clinical studies, nebivolol at doses of 2.5 to 40 mg once daily 
      was associated with significant decreases in systolic blood pressure (SBP) and 
      diastolic BP (DBP) in patients with hypertension and was well tolerated. 
      OBJECTIVES: This post hoc analysis of pooled data from 2 previously published 
      registration studies was conducted to further evaluate the antihypertensive 
      efficacy and tolerability of nebivolol in patients with mild to moderate (stage 
      1-2) hypertension. METHODS: The 2 trials were similarly designed multicenter, 
      12-week, randomized, double-blind, placebo-controlled, parallel-group, 
      dose-ranging studies in patients 18 years of age and older with stage 1 or 2 
      hypertension (SBP 140-159 mm Hg and/or DBP 90-99 mm Hg [stage 1] or SBP >or= 160 
      mm Hg and/or DBP >or= 100 mm Hg [stage 2]). The primary efficacy end point of the 
      2 studies was the change from baseline in mean trough SiDBP at week 12. A 
      secondary end point was the change from baseline to week 12 in mean trough 
      sitting SBP (SiSBP). The present analysis included only patients who received 
      nebivolol 5, 10, or 20 mg (the doses were common to both studies) or placebo, 
      including analyses stratified by baseline SBP, although DBP represented a 
      criterion for entry into the studies. Baseline SBP stratification levels were 140 
      to 149 mm Hg, 150 to 159 mm Hg, 160 to 169 mm Hg, and 170 to 179 mm Hg. For the 
      tolerability analysis, the prevalences of treatment-emergent adverse events (AEs) 
      were compared between the 3 nebivolol dose groups and the placebo group. RESULTS: 
      Of the 1716 randomized patients who received study medication in the 2 trials, 
      data from 1385 patients were included in this pooled analysis (759 men, 626 
      women; median age, ~54 years; 13.6% black). Mean (SD) baseline SiSBP and SiDBP 
      values were 151.9 to 152.7 and 99.2 to 99.5 mm Hg, respectively. Reductions from 
      baseline in trough SiSBP were -10.8 (13.5), -10.7 (14.7), and -12.4 (15.5) mm Hg 
      with nebivolol 5, 10, and 20 mg, respectively, compared with -4.5 (13.4) mm Hg 
      with placebo (all, P < 0.001). Reductions from baseline in trough SiDBP (the 
      primary end point) were -9.8 (7.9), -10.5 (8.2), and -11.1 (8.6) mm Hg with 
      nebivolol 5, 10, and 20 mg, respectively, compared with -5.1 (8.1) mm Hg with 
      placebo (all, P < 0.001). In a subgroup of 1227 patients stratified by baseline 
      SBP, the reductions in SBP and DBP were significantly greater (P < 0.03 and P < 
      0.001, respectively) with nebivolol at each dose compared with placebo in those 
      with baseline SBP of 140 to 149 mm Hg and 150 to 159 mm Hg (the lowest 2 baseline 
      strata); in the highest 2 baseline strata (SBP 160-169 and 170-179 mm Hg), the 
      reductions in SBP with nebivolol 5 mg and nebivolol 20 mg in the 160 to 169-mm Hg 
      baseline SBP stratum and in DBP with nebivolol 20 mg in the 170 to 179-mm Hg 
      baseline stratum were significantly greater (P < 0.03) compared with placebo. The 
      most common AE in the nebivolol 5-, 10-, and 20-mg groups and the placebo group 
      was headache (36/409 [8.8%], 25/410 [6.1%], 27/410 [6.6%], and 10/156 [6.4], 
      respectively), followed by fatigue (9/409 [2.2%], 10/410 [2.4%], 25/410 [6.1%], 
      and 3/156 [1.9%]) and dizziness (6/409 [1.5%], 9/410 [2.2%], 15/410 [3.7%], and 
      4/156 [2.6%]). CONCLUSION: The present analysis of pooled data from 2 previously 
      published registration studies found that nebivolol was associated with 
      significant reductions in BP compared with placebo in these patients with stage 1 
      or 2 hypertension, with a tolerability similar to that of placebo.
FAU - Germino, F Wilford
AU  - Germino FW
AD  - Department of Internal Medicine, Orland Primary Care Specialists, Orland Park, 
      Illinois 60467, USA. wgermino@hotmail.com
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Clin Ther
JT  - Clinical therapeutics
JID - 7706726
RN  - 0 (Antihypertensive Agents)
RN  - 0 (Benzopyrans)
RN  - 0 (Ethanolamines)
RN  - 030Y90569U (Nebivolol)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Antihypertensive Agents/administration & dosage/adverse effects/*therapeutic use
MH  - Benzopyrans/administration & dosage/adverse effects/*therapeutic use
MH  - Blood Pressure/*drug effects
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Ethanolamines/administration & dosage/adverse effects/*therapeutic use
MH  - Female
MH  - Humans
MH  - Hypertension/*drug therapy
MH  - Male
MH  - Middle Aged
MH  - Nebivolol
MH  - Randomized Controlled Trials as Topic
MH  - Retrospective Studies
MH  - Severity of Illness Index
MH  - Young Adult
EDAT- 2009/10/22 06:00
MHDA- 2010/01/19 06:00
CRDT- 2009/10/22 06:00
PHST- 2009/08/23 00:00 [accepted]
PHST- 2009/10/22 06:00 [entrez]
PHST- 2009/10/22 06:00 [pubmed]
PHST- 2010/01/19 06:00 [medline]
AID - S0149-2918(09)00311-7 [pii]
AID - 10.1016/j.clinthera.2009.08.028 [doi]
PST - ppublish
SO  - Clin Ther. 2009 Sep;31(9):1946-56. doi: 10.1016/j.clinthera.2009.08.028.