Table 3.

Subject demographics and characteristics in the pooled clinical trials of lacosamide monotherapy for diabetic neuropathic pain

	Total N = 1,863	<65 years N = 1,361	≥65 years N = 502
Age, mean (SD), years	58.1 (10.02)	53.8 (7.85)	69.9 (4.01)
Male/female, %	52.9/47.1	53.0/47.0	52.6/47.4
Concomitant diseases ≥5% in total population, %
Diabetic neuropathy	99.8	99.9	99.8
Diabetes mellitus—non–insulin‐dependent	83.5	79.9	93.0
Hypertension	68.9	64.6	80.7
Hyperlipidemia	21.0	19.9	23.9
Hypercholesterolemia	20.6	18.8	25.3
Osteoarthritis	14.9	12.7	20.7
Obesity	14.7	14.3	15.7
Diabetic retinopathy	11.8	13.5	7.2
Gastroesophageal reflux disease	11.1	9.5	15.5
Depression	10.5	11.4	8.0
Drug hypersensitivity	10.4	9.3	13.1
Diabetes mellitus—insulin‐dependent	10.1	12.9	2.6
Insomnia	7.8	7.9	7.8
Hypothyroidism	7.6	6.7	10.2
Seasonal allergy	7.1	7.0	7.6
Coronary artery disease	7.0	5.7	10.6
Back pain	6.9	6.0	9.4
Arthritis	6.0	4.9	9.0
Erectile dysfunction	6.0	5.1	8.6
Asthma	5.8	6.5	3.8
Edema peripheral	5.1	3.9	8.4
Cataract	5.0	3.2	9.8
Concomitant medications taken by ≥10% in total population, %
Antidiabetics—biguanides	49.9	49.3	51.6
ACE inhibitors	44.0	44.7	42.0
Lipid‐lowering agent—statins	39.5	36.9	46.6
Analgesics	38.4	38.3	38.8
Antithrombotic agents	37.8	33.0	51.0
Antidiabetics—sulfonamides	33.9	31.7	39.8
Antidiabetics—insulins fast‐acting	32.6	35.9	23.9
Beta‐blocking agents	24.6	23.1	28.5
Antidiabetics—insulins intermediate‐acting	17.5	18.8	13.9
Calcium channel blockers	14.3	12.4	19.5
Antidiabetics—insulins long‐acting	14.2	15.0	12.2
Antidiabetics—thiazolidinediones	14.0	14.3	13.1
Proton pump inhibitors	12.7	11.7	15.5
Angiotensin II antagonists	12.2	10.7	16.5
Diuretics—sulfonamides	10.3	9.0	13.5
Multivitamins	10.3	9.3	12.7

ACE, angiotensin‐converting enzyme; SD, standard deviation.