PDE5-Is plus ABs had higher incidences of AEs (3.69 [2.38 to 5.74]; P < 0.0001), headache (4.87 [2.28 to 5.74]; P < 0.0001) and dyspepsia (6.67 [1.46 to 30.55]; P = 0.01) than ABs alone. This evidence concerns the gene PDE5A and dyspepsia.