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. 2017 Jan 6;9(2):59–63. doi: 10.1177/1756287216685027

Table 1.

Summary of human trials.

Trial/design Duration/intervention Baseline
characteristics		 Efficacy
outcomes		 Results Remarks
Boydak et al. [2005]
DB, Pro, R, MC, PG		 12 w active;
Neb 5 mg/d versus Aten 50 mg/d versus Aten 50 mg/Chlor 12.5 mg/d		 131 new HTN pts
without ED;
Age 47.3 ± 4.6 y;
162/98 mmHg;
≈ 40% smokers		 Mean # of episodes of satisfactory sexual intercourse during w 8–12 versus baseline Intercourse (#/ 4 w) decreased from 7.0 ± 1.5 to 3.7 ± 1.3 (p < 0.01) with Aten, 6.4 ± 1.2 to 2.8 ± 1.6 (p < 0.01) with Aten/Chlor, and 6.4 ± 1.6 to 6.0 ± 1.4 (p > 0.05) with Neb; BP ≈ 137/88 mmHg in all groups; Excluded DM, major CVD, BMI > 28 kg/m2, TC > 250 mg/dl, & CI to BB therapy;
Cordero et al. [2010]
Desc, UC, CS, MC, Registry		 4 months 1007 pts with HTN & > 6 m BB;
Age 57.9 ± 10.6 y;
IIEF ED in 71% (16.1% sev, 16.8% mod & 38.1% mild)		 IIEF score and ED classification IIEF ED less common with Neb (65.1%) than Carv (90.7%) (p < 0.01); Mild ED more common with Aten, Bis, & Neb; Mod-Sev ED more common with Meto & Carv; Neb associated with higher IIEF sub-scores than all other BBs Excluded secondary HTN & prostate disease; observational;
ED associated with known risk factors;
Pts on other meds
Doumas et al. [2006]
OL, Pro, UC		 3 months;
Pts switched from other BB to Neb (mean dose 6.45 mg/d)		 44 pts; Age 55.6 ± 7.1 y; 164/91 mmHg;
IIEF score 17;
IIEF ED in 65.9% (18.2% sev, 29.5% mod & 18.2% mild)		 IIEF score and ED classification before and after Neb switch IIEF score 22 (p < 0.001); IIEF ED in 41% (5% sev, 27% mod & 9% mild);
69% pts with ED improved on Neb;
BP ≈ 165 ± 14/90 ± 5 mmHg		 Excluded DM, CVD, CRF, HF & penile malformations;
Pts informed of potential negative effects of BB
Brixius et al. [2007]
DB, R, Pro, PG, CO		 2 w run in → 12 w (Neb 5 mg or Meto 95 mg) → 2 w washout → 12 w (Neb 5 mg or Meto 95 mg) 48 HTN pts without ED;
Age 48 ± 5.3 y;
149/93 mmHg;
BMI 28 kg/m2;
IIEF score 28		 IIEF score;
Sexual activity diary;
Satisfaction with therapy & erectile function		 Neb IIEF score + 0.13 (p > 0.05);
Meto IIEF score: 0.92 (p < 0.05);
Intercourse frequency: Neb 5.6 versus Meto 5.8 per month;
Satisfaction results favored Neb but were unimpressive		 Excluded DM, DA, major disease & other BP meds; no clinically significant changes in IIEF score during trial

Aten, atenolol; BB, beta blocker; Bis, bisoprolol; BMI, body mass index; BP, blood pressure; Carv, carvedilol; Chlor, chlorthalidone; CI, contraindication; CO, crossover; CRF, chronic renal failure; CS, cross-sectional; CVD, cardiovascular disease; d, day; DA, drug abuse; DB, double blind; Desc, descriptive; DM, diabetes; ED, erectile dysfunction; HF, heart failure; HTN, hypertension; IIEF, International Index of Erectile Dysfunction; MC, multicenter; Meto, metoprolol; mod, moderate; n, number; Neb, nebivolol; OL, open label; PG, parallel group; Pro, prospective; Pts, patients; R, randomized; sev, severe; TC, total cholesterol; UC, uncontrolled; w, weeks; y, years. Data presented as mean or mean ± standard deviation unless otherwise noted.