Extemporaneous combination therapy with amlodipine/zofenopril in hypertensive patients: a real-world data analysis in Italy

Figures & data

Figure 1. Patients attrition flow-chart for inclusion in the cohort of incident users of the extemporaneous combination AZ-EXC.

Figure 2. Incident users of the extemporaneous combination AZ-EXC stratified by age class.

Table 1. Demographic and clinical characteristics of incident users of the extemporaneous combination AZ-EXC and AZ-EXC (SM + SPC).

Patient characteristics	AZ-EXC (N = 2394)	AZ-EXC (SM + SPC) (N = 4068)
Sex, n (%)
Male	1259 (52.6)	2055 (50.5)
Female	1135 (47.4)	2013 (49.5)
Age
Mean (SD)	68.6 (12.7)	68.3 (12.6)
median	70.0	69.0
p25, p75	60.0 78.0	60.0 78.0
Age class, n (%)
<18	2 (0.1)	2 (0.0)
18–39	38 (1.6)	58 (1.4)
40–49	138 (5.8)	267 (6.6)
50–59	398 (16.6)	678 (16.7)
60–69	600 (25.1)	1040 (25.6)
70–79	698 (29.2)	1201 (29.5)
80–89	460 (19.2)	728 (17.9)
90+	60 (2.5)	94 (2.3)
BMI (kg/m2)^a
Mean (SD)	28.4 (5.2)	28.4 (5.1)
Median	27.7	27.7
p25, p75	24.8 31.2	25.0 31.1
Missing: n (%)	616 (35.3)	1440 (35.4)
BMI class^a, n (%)
Underweight (<20 kg/m2)	45 (2.9)	64 (2.4)
Normal weight (20–24 kg/m2)	391 (25.0)	588 (22.4)
Overweight (25–29 kg/m2)	636 (40.6)	1106 (42.1)
Obese – Class I (30–34 kg/m2)	343 (21.9)	605 (23.0)
Obese – Class II (35–39 kg/m2)	105 (6.7)	191 (7.3)
Obese – Class III (≥40 kg/m2)	45 (2.9)	74 (2.8)
Comorbidities^b, n (%)
Diabetes mellitus	518 (21.6)	807 (19.8)
Dyslipidaemia	439 (18.3)	713 (17.5)
Other forms of chronic ischaemic heart disease	251 (10.5)	372 (9.1)
Cardiac dysrhythmias	222 (9.3)	335 (8.2)
Gout	132 (5.5)	217 (5.3)
Acquired hypothyroidism	111 (4.6)	185 (4.5)
Chronic bronchitis	102 (4.3)	168 (4.1)
Asthma	96 (4.0)	141 (3.5)
Chronic kidney disease	87 (3.6)	114 (2.8)
Occlusion and stenosis of precerebral arteries	87 (3.6)	136 (3.3)
Acute myocardial infarction	86 (3.6)	114 (2.8)
Chronic airway obstruction, not elsewhere classified	78 (3.3)	133 (3.3)
Nontoxic nodular goiter	62 (2.6)	101 (2.5)
Other and ill-defined cerebrovascular disease	61 (2.6)	111 (2.7)
Atherosclerosis	59 (2.5)	80 (2.0)
Transient cerebral ischaemia	54 (2.3)	71 (1.8)
Heart failure	54 (2.3)	75 (1.8)
Other treatments^c, n (%)
Antithrombotics	1029 (43.0)	1582 (38.9)
Lipid-lowering agents	859 (35.9)	1318 (32.4)
Beta-blocking agents	807 (33.7)	1261 (31.0)
(Other) agents acting on the renin-angiotensin system	644 (26.9)	1177 (28.9)
Nonsteroidal anti-inflammatory drugs	618 (25.8)	1133 (27.8)
Diuretics	573 (23.9)	821 (20.2)
Antihyperglycemic drugs	457 (19.1)	706 (17.3)
Antidepressants	233 (9.7)	398 (9.8)
Corticosteroids	231 (9.6)	382 (9.4)
(Other) calcium-channel blockers	210 (8.8)	370 (9.1)
Antigout preparations	187 (7.8)	299 (7.3)
Thyroid therapy	179 (7.5)	311 (7.6)
Antihypertensive	151 (6.3)	278 (6.8)
Organic nitrates	129 (5.4)	175 (4.3)
Antiarrhythmics	92 (3.8)	140 (3.4)
Other cardiac preparations	53 (2.2)	66 (1.6)
Cardiologic visit request, n (%)
At baseline	444 (18.6)	740 (18.2)
During follow-up period	340 (14.2)	580 (14.3)
Both during baseline and follow-up	221 (9.2)	339 (8.3)
No requests	1389 (58.0)	2409 (59.2)

Note: Age and sex measured at index date; comorbidities and other treatments measured during baseline period (6 months before the index date); BMI measured in the 12 months before the index date.

Abbreviations. BMI, body mass index; SD, standard deviation; p25, 25th percentile; p75, 75th percentile.

^a Proportions calculated over the total number of patients with an available BMI value, which was 1565 (AZ-EXC) and 2628 (for AZ-EXC/SM + SPC).

^b For each comorbidity, percentage of patients with at least one registration; only frequencies ≥2% were reported.

^c For each treatment, percentage of patients with at least one prescription for that treatment; only frequencies ≥2% were reported.

Figure 3. Incident users of the extemporaneous combination AZ-EXC stratified by presence/absence of cardiologic visit requests at baseline and during follow-up.

Table 2. Prescription adherence of incident users of the extemporaneous combination AZ-EXC and AZ-EXC (SM + SPC).

Characteristic	AZ-EXC (N = 2394)	AZ-EXC (SM + SPC) (N = 4068)
PDC by prescriptions
Mean (SD)	43.2 (30.9)	45.1 (31.1)
Median	31.1	35.6
p25, p75	15.6 73.3	15.6 75.6
Prescription adherence
Low (PDC < 40%)	1305 (54.5)	2109 (51.8)
Intermediate (40% ≤ PDC < 80%)	621 (25.9)	1087 (26.7)
High (PDC ≥ 80%)	468 (19.6)	872 (21.4)

Abbreviations. PDC, proportion of days covered; SD, standard deviation; p25, 25th percentile; P75, 75th percentile.

Table 3. Incident users of amlodipine as part of the extemporaneous combination with zofenopril stratified by strength formulation.

Characteristic	AZ-EXC (N = 2394)	AZ-EXC (SM + SPC) (N = 4068)
Amlodipine strength
Only 5 mg	1496 (62.5)	2587 (63.6)
Only 10 mg	705 (29.4)	1167 (28.7)
5/10 mg	193 (8.1)	314 (7.7)

Data availability statement

The authors confirm that the data supporting the findings of this study are available within the article and its supplementary materials.