Safety and effectiveness of a fixed-dose combination of olmesartan, amlodipine, and hydrochlorothiazide in clinical practice

Figures & data

Table 1 Patient demographics at baseline (n=5,831, safety set)

Parameters	Mean ± SD or %
Age in years	63.5±11.79
≥40 to <65 years	50.5
≥65 years	29.2
≥75 years	18.1
Female sex	47.0
Body mass index (kg/m^2)	29.4±4.89
Essential hypertension	97.9
Time since diagnosis
Unknown	6.5
<1 year	11.1
1 to 5 years	30.1
>5 years	47.5
Risk factors
Diabetes mellitus	29.4
Metabolic syndrome	21.1
Smoking	17.8
Left ventricular hypertrophy	9.9
Cardiac failure	7.4
Renal dysfunction	4.3
Stroke/TIA	4.1
Stable angina pectoris	4.0
Myocardial infarction	3.6
Peripheral artery disease	3.5
Hepatic impairment	1.3
Other unspecified risk factors	24.3

Abbreviations: SD, standard deviation; TIA, transient ischemic attack.

Table 2 Types and number of antihypertensive premedications, and the reason for switching to the FDC tablet (n=5,831, safety set)

Prior antihypertensive medication	Frequency (%)
By drug class*
ACE inhibitor	52.4
ARB	25.8
Beta-blocker	39.4
Calcium channel blocker	33.2
Diuretic	44.9
Renin inhibitor	0.9
Other antihypertensive drug classes	6.8
By number/separate tablets or FDC
None	6.6
Monotherapy	25.1
Separate dual-agent therapy	23.9
FDC dual-agent therapy	14.0
Separate triple-agent therapy	20.3
FDC triple-agent therapy	0.7
More than three agents	9.5
Reason for switching to the FDC*
Lack of efficacy	87.7
Noncompliance	20.3
Simplification of therapy	45.1
Wish of the patient	11.8
Other	6.5

Note:

* Multiple choices were possible.

Abbreviations: ACE, angiotensin converting enzyme; ARB, angiotensin receptor blocker; FDC, fixed-dose combination.

Table 3 Treatment regimens at baseline and follow-up (n=5,831, safety set)

	Baseline, N (%)	24-week follow-up, N (%)
Dose level of FDC tablet (mg)
20/5/12.5	2,179 (37.4)	1,863 (31.9)
40/10/12.5	779 (13.4)	925 (15.9)
40/10/25	604 (10.4)	756 (13.0)
40/5/12.5	1,711 (29.3)	1,699 (29.1)
40/5/25	558 (9.6)	576 (9.9)
Unknown	0 (0.0)	12 (0.2)
Antihypertensive concomitant medications	2,288 (39.2)	1,980 (35.2)
ACE inhibitor	319 (5.5)	91 (1.6)
ARB	148 (2.5)	44 (0.8)
Beta-blocker	1,778 (30.5)	1,641 (29.2)
Calcium channel blocker	263 (4.5)	121 (2.2)
Diuretic	457 (7.8)	286 (5.1)
Other antihypertensive drug classes	297 (5.1)	293 (5.2)
Non-antihypertensive concomitant medications	3,852 (66.1)	3,715 (66.1)
Lipid-lowering	1,885 (32.3)	1,834 (32.6)
Oral antidiabetics	1,282 (22.0)	1,273 (22.7)
Aspirin	1,112 (19.1)	1,098 (19.5)
Psychotropic agents	420 (7.2)	419 (7.5)
NSAID/COX II antagonists	373 (6.4)	373 (6.6)
Insulin	360 (6.2)	351 (6.2)
Anticoagulants	261 (4.5)	261 (4.6)
Others	1,423 (24.4)	1,332 (23.7)

Note: Values are expressed as the number of patients (N) and the frequency (%).

Abbreviations: ACE, angiotensin converting enzyme; ARB, angiotensin receptor blocker; COX, cyclo-oxygenase; FDC, fixed-dose combination; NSAID, nonsteroidal anti-inflammatory drug.

Figure 1 Frequency of adverse drug reactions (n=5,831, safety set).

Notes: (A) Age, (B) diabetes mellitus, (C) cardiovascular risk, and (D) concomitant medications.
Abbreviations: ADRs, adverse drug reactions; Con, concomitant.

Table 4 Frequency of adverse drug reactions (n=5,831, safety set) overall and according to primary organ system, including all individual ADRs reported by more than two patients

Type of ADR		Number of patients (%)
At least one ADR		75 (1.23)
At least one serious ADR		5 (0.09)
At least one ADR that led to study discontinuation		48 (0.82)
ADRs by primary organ system	Number of ADRs	Number of patients with at least one ADR (%)
Cardiac disorders	2	2 (0.03)
Ear and labyrinth disorders	2	2 (0.03)
Gastrointestinal conditions	7	6 (0.10)
General disorders and administration site conditions	35	34 (0.6)
Infections and infestations	3	3 (0.05)
Laboratory investigations	2	2 (0.03)
Metabolism and nutrition disorders	2	2 (0.03)
Musculoskeletal and connective tissue disorders	5	5 (0.09)
Nervous system disorders	12	10 (0.17)
Psychiatric disorders	1	1 (0.017)
Renal and urinary disorders	2	1 (0.017)
Respiratory, thoracic, and mediastinal disorders	2	1 (0.017)
Skin and subcutaneous tissue disorders	13	11 (0.19)
Vascular disorders	9	9 (0.15)

Abbreviation: ADR, adverse drug reaction.

Figure 2 Mean change in systolic and diastolic blood pressure from baseline to the 24-week follow-up (n=5,818, full analysis set).

Note: Mean differences between SBP and DBP are significant with a P-value of <0.0001.
Abbreviations: SBP, systolic blood pressure; DBP, diastolic blood pressure.

Figure 3 Change in the severity of hypertension from baseline to the 24-week follow-up according to the 2007 ESC/ESH classification (n=5,818, full analysis set).

Notes: “Normal” includes all patients with optimal systolic/diastolic BP (<120/80 mmHg), normal BP (120–129 and/or 80–85 mmHg), and normal-high BP (130–139 and/or 85–89 mmHg). Grades 1, 2, and 3 hypertension were defined as systolic and/or diastolic BPs of 140–159 and/or 90–99 mmHg, respectively, 160–179 and/or 100–109 mmHg, respectively, and ≥180 and/or ≥110 mmHg, respectively. “Systolic only” corresponds to isolated systolic hypertension (≥140 mmHg for systolic BP and <90 mmHg for diastolic BP).
Abbreviations: ESC, European Society of Cardiologists; ESH, European Society of Hypertension; BP, blood pressure.