Efficacy of amoxycillin versus amoxycillin/clavulanate in acute exacerbations of chronic pulmonary obstructive disease in primary care

Figures & data

Table 1 Baseline characteristics of the patients participating

	Amoxycillin	Amoxycillin/ clavulanate	Total
Number of patients	68	69	137
Mean age, years (SD)	71.9 (8.6)	70.8 (8.5)	71.4 (8.5)
Age range, years	53–88	49–85	49–88
Male (%)	53 (77.9)	56 (81.2)	109 (79.6)
Mean FEV1, % (SD)	62.9 (11.0)	60.4 (11.9)	61.6 (11.5)
FEV1 range, %	39–79	32–78	32–79
Smoking status
Current smoker, n (%)	15 (22.1)	12 (17.4)	27 (19.7)
Former smoker, n (%)	53 (77.9)	57 (82.6)	110 (80.3)
Never smoked, n (%)	0	0	0
Number of exacerbations in the previous year, n (SD)	1.69 (1.3)	1.56 (1.7)	1.63 (1.5)
Symptoms
Temperature > 38 ºC, n (%)	10 (14.7)	7 (10.1)	17 (12.4)
Increase in dyspnoea, n (%)	48 (70.6)	53 (76.8)	101 (73.7)
Increase in sputum volume, n (%)	63 (92.6)	56 (81.2)	119 (86.9)
Sputum purulence, n (%)	39 (57.4)	47 (68.1)	86 (62.8)
Anthonisen classification
I type, n (%)	20 (29.4)	19 (27.5)	39 (28.5)
II type, n (%)	48 (70.6)	50 (72.5)	98 (71.5)
Comorbidities
High blood pressure, n (%)	35 (51.5)	38 (55.9)	73 (53.3)*
Diabetes, n (%)	9 (13.2)	7 (10.1)	16 (11.7)
Hypercholesterolemia, n (%)	14 (20.6)	18 (26.1)	32 (23.4)
Coronary heart disease, n (%) [#]	26 (38.2)	14 (20.3)	40 (29.2)
Heart failure, n (%)	10 (14.7)	4 (5.8)	14 (10.2)
Uptake of pneumococcal vaccine, n (%)	50 (73.5)	49 (71.0)	99 (72.3)
Drugs taken
Anticholinergics n, (%)	33 (48.5)	35 (50.7)	68 (49.6)
Long-acting inhaled β agonists n, (%)	29 (42.6)	30 (43.5)	59 (43.1)
Short-acting inhaled β agonists n, (%)	61 (89.7)	59 (85.5)	120 (87.6)
Inhaled glucocorticoids, n (%)[# #]	52 (76.5)	38 (55.1)	90 (65.7)
Oral glucocorticoids, n (%)	21 (30.9)	19 (27.5)	40 (29.2)
Theophyllines, n (%)	2 (2.9)	4 (5.8)	6 (4.4)

Abbreviations: FEV₁, forced expiratory volume in one second; Anthonisen type I, all three criteria present (increased dyspnoea, increased sputum volume, and purulent sputum); Anthonisen type II, only two criteria present.

Notes: ^#p < 0.05; # #p < 0.01.

Figure 1 Trial profile flow chart.

Table 2 Failures observed on day 10 after the initiation of antibiotic therapy

Antibiotic	Anthonisen classification	Age (yr)	FEV1 (%)	Comorbid conditions
Amoxycillin	Type I	81	43	High blood pressure, heart failure
Amoxycillin	Type I	80	65	High blood pressure, coronary heart disease
Amoxycillin	Type II	76	45	High blood pressure, coronary heart disease
Amoxycillin	Type II	83	65	Hypercholesterolemia, coronary heart disease
Amoxycillin	Type II	74	39	None
Amoxycillin	Type I	79	44	High blood pressure
Amoxycillin/clavulanate	Type I	74	32	High blood pressure, diabetes mellitus, hypercholesterolemia, coronary heart failure
Amoxycillin/clavulanate	Type II	85	69	None
Amoxycillin/clavulanate	Type I	66	51	High blood pressure

Notes: Two patients assigned to amoxycillin/clavulanate discontinued the antibiotic due to adverse effects and were also considered as therapeutic failure.

Figure 2 Clinical cure at days 10 and 30 in the evaluable patients with COPD exacerbation.