Quality of life and efficacy of nebivolol in an open-label study in hypertensive patients. The QoLaN study

Figures & data

Table I. Questionnaire.

Over the last month, did you experience any of the following?	Over the last month, did you feel?	Does your current health status limit your daily activities?
Tiredness	Anxious	Climbing a flight of stairs
Dizziness	Satisfied with your personal life	Walking around the block several times
Facial redness	Depressed	Being satisfied with your sexual life
Cold hands and/or feet	Satisfied with your family life
Coughing	Satisfied performing daily activities
Tinnitus	Satisfied with your professional life
Breathing difficulty
Palpitations
Headache
Swollen legs and/or feet
□ never	□ never	□ no, not at all
□ once to twice	□ once to twice	□ no, not really
□ once to twice a week	□ once to twice a week	□ rather not
□ almost every day	□ almost every day	□ rather yes
□ at least once a day	□ at least once a day	□ yes, completely
Did you have to take leave from work for medical reasons over the previous month?	Are you satisfied with your current hypertension treatment?	Did you have to give up your usual leisure time activites?
□ no	□ no, not at all	□ no
□ one or two day(s)	□ no, not really	□ no, but I feel constrained
□ one week	□ rather not	□ yes, once or twice
□ two weeks	□ rather yes	□ yes, often
□ more than two weeks	□ yes, completely	□ yes, all the time
Do you feel better than one month ago? □ Yes □ No

Table II. Baseline characteristics.

	Nebivolol
	Monotherapy	Add-on	Switch
n	587	460	421
Age (years)	56.7±13.3	63.7±11.9	63.5±12.4
Sex ratio (M:F) (%)	52:48	48:52	45:55
BMI (kg/m^2)	26.9±4.5	28.6±5.3	27.6±4.7
Waist circumference (cm)	95±13	99±16	96±15
Within normal JNC-VII* BP levels (%)	1	1	15
Age at hypertension diagnosis (years)	55.6±13.2	57.3±12.0	56.5±11.8
Systolic BP** (mmHg)	161±14	162±15	152±17
Diastolic BP (mmHg)	98±7	96±8	89±10
Pulse pressure (mmHg)	63±14	66±15	63±15
Mean arterial pressure (mmHg)	119±8	118±9	110±11
Heart rate (bpm)	80±10	79±10	72±13
Diabetes mellitus (%)	5	20	12

Results are expressed as means±1 SD or as proportions (%).

M, Male; F, Female;

*Normal JNC-VII levels defined according to glucose tolerance status (see Methods);

** BP, Blood pressure.

Figure 1. Proportion (%) of controlled subjects and responders under nebivolol in each treatment category (monotherapy, add-on, switch) at visits 2 and 3: proportion of JNC-VII goal achievers (dark column), proportion of subjects with SBP/DBP decreased by more than 10/5 mmHg (white column), and proportion of responders defined by SBP/DBP decreased by more than 10/5 mmHg irrespective of JNC-VII target thresholds attainment and/or those who were considered as BP controlled (grey column)

Table III. Quantitative changes in Quality of life items.

Item		Monotherapy	Add-on	Switch	p
1	n	282	245	226
	v1	1.8±1.3	1.9±1.2	1.9±1.4	NS
	v3	0.91±1.0	1.0±1.1	1.1±1.2	NS
	D	–0.93±1.3*	–0.86±1.2*	–0.79±1.4*	NS
2	n	282	246	226
	v1	0.97±1.1	0.95±1.1	0.97±1.2	NS
	v3	0.37±0.67	0.37±0.72	0.42±0.76	NS
	D	–0.60±1.1*	–0.58±1.2*	–0.55±1.1*	NS
3	n	280	246	224
	v1	0.75±1.2	0.80±1.2	0.79±1.2	NS
	v3	0.32±0.67	0.30±0.65	0.33±0.79	NS
	D	–0.44±1.1*	–0.50±1.1*	–0.45±1.0*	NS
4	n	281	246	226
	v1	0.71±1.1	0.78±1.2	1.3±1.5	<0.0001
	v3	0.35±0.74	0.42±0.82	0.47±0.89	NS
	D	–0.36±0.99*	–0.37±0.98*	–0.85±1.5*	<0.0001
5	n	281	243	225
	v1	0.63±1.1	0.74±1.1	0.76±1.2	NS
	v3	0.39±0.83	0.42±0.86	0.44±0.94	NS
	D	–0.25±0.94*	–0.33±0.93*	–0.32±1.1*	NS
6	n	280	242	225
	v1	0.65±1.0	0.66±1.1	0.53±0.96	NS
	v3	0.23±0.68	0.21±0.55	0.25±0.70	NS
	D	–0.43±0.97*	–0.44±1.0*	–0.28±0.83*	NS
7	n	279	244	226
	v1	0.68±1.1	0.75±1.09	0.73±1.2	NS
	v3	0.39±0.77	0.49±0.88	0.45±0.90	NS
	D	–0.29±0.93*	–0.26±0.90*	–0.28±0.90*	NS
8	n	281	244	226
	v1	1.1±1.2	0.89±1.0	0.77±1.1	0.013
	v3	0.37±0.64	0.24±0.56	0.35±0.72	NS
	D	–0.69±1.1*	–0.65±1.0*	0.42±0.95*	0.0088
9	n	281	244	226
	v1	1.3±1.2	0.94±1.1	1.1±1.3	0.0043
	v3	0.54±0.84	0.51±0.77	0.57±0.84	NS
	D	–0.73±1.2*	–0.43±1.1*	–0.50±1.3*	0.0089
10	n	280	242	224
	v1	0.45±0.89	0.62±1.0	0.72±1.2	0.013
	v3	0.26±0.68	0.39±0.83	0.34±0.79	NS
	D	–0.19±0.91**	–0.22±0.93**	–0.38±1.3*	NS
11	n	280	245	225
	v1	1.3±1.4	1.2±1.3	1.1±1.3	NS
	v3	0.69±0.96	0.76±1.1	0.80±1.1	NS
	D	–0.61±1.2*	–0.44±1.1*	–0.32±1.0*
	n	280	245	225
	vl	1.3±1.4	1.2±1.3	1.1 ± 1.3	NS
	v3	0.69±0.96	0.76±1.1	0.80±1.1	NS
	D	–0.61±1.2^*	–0.44±1.1^*	–0.32±1.0^*	0.0095
12	n	280	244	222
	vl	2.6±1.2	2.5±1.1	2.6±1.1	NS
	v3	2.8±1.1	2.7±1.1	2.9±1.1	NS
	D	0.18±1.2**	0.25 ±1.3**	0.24±1.1**	NS
13	n	280	245	225
	vl	1.0±1.2	1.1 ± 1.2	1.0±1.3	NS
	v3	0.63±0.91	0.64±0.57	0.65 ±1.0	NS
	D	–0.40±1.2^*	–0.43±1.0^*	–0.36±1.2^*	NS
14	n	279	243	224
	vl	2.7±1.1	2.6±1.1	2.7±1.1	NS
	v3	2.8±1.1	2.8±1.1	2.9±1.1	NS
	D	0.17±1.1**	0.25±1.1**	0.15±1.1***	NS
15	n	280	243	221
	vl	2.5±1.2	2.5±1.0	2.5±1.2	NS
	v3	2.9±1.1	2.7±1.1	2.7±1.2	NS
	D	0.36±1.1^*	0.19±1.1**	0.19 ±1.2***	NS
16	n	252	191	178
	vl	2.3±1.3	2.3 ±1.2	2.3 ±1.3	NS
	v3	2.8±1.2	2.6±1.2	2.8±1.2	NS
	D	0.45 ±1.2^*	0.29±1.3**	0.50±1.3^*	NS
17	n	281	245	225
	vl	1.2±1.3	1.5±1.3	1.5±1.4	0.028
	v3	0.72±1.1	1.0±1.3	1.0±1.2	0.0035
	D	–0.52±1.2^*	–0.47±1.2^*	–0.52±1.0^*	NS
18	n	280	245	223
	vl	1.1 ± 1.3	1.5±1.3	1.4±1.4	0.0048
	v3	0.74±1.1	1.0±1.3	0.99±1.3	0.012
	D	–0.36±1.1^*	–0.42±1.3^*	–0.41±1.3^*	NS
19	n	269	238	219
	vl	0.75±1.1	0.94±1.3	0.86±1.2	NS
	v3	0.36±0.88	0.58±1.1	0.50±1.0	0.045
	D	–0.39±1.1^*	–0.36±1.1^*	–0.36 ±1.2^*	NS
20	n	259	206	184
	vl	0.53±1.1	0.56±1.2	0.66±1.3	NS
	v3	0.28±0.94	0.26±0.89	0.30±0.97	NS
	D	–0.25±1.1**	–30±1.1^*	–0.36±1.2^*	NS
21	n	264	215	188
	vl	2.5±1.2	2.1±1.4	2.3±1.4	0.0087
	v3	2.7±1.1	2.3±1.3	2.5±1.3	0.0008
	D	0.23 ±1.0**	0.16±1.3	0.27±1.1**	NS
22	n	236	244	222
	vl	2.3 ±1.4	2.3±1.1	2.1±1.1	NS
	v3	3.2±0.96	3.1±0.99	3.1±1.0	NS
	D	0.92±1.6^*	0.77±1.4^*	1.0±1.3^*	NS
Total	N	277	243	222
	vl	24.1 ±14.4	25.5±13.5	25.4±13.4	NS
	v3	14.4±11.2	16.3±10.5	15.9±10.3	NS
	D	–9.67±12.1^*	–9.15±12.2^*	–9.52±10.7^*	NS

Items are: 1, Tiredness; 2, Dizziness; 3, Facial redness; 4, Cold hands and/or feet; 5, Coughing; 6, Tinnitus; 7, Breathing difficulty; 8, Palpitations; 9, Headache; 10, Swollen legs and/or feet; 11, Anxiety; 12, Satisfaction with personal life, 13, Depression; 14, Satisfaction with family life; 15, Satisfaction in performing daily activities; 16, Satisfaction with professional life; 17, Climbing a flight of stairs; 18, Walking around the block several times; 19, Having to give up usual leisure time activites; 20, Having to take leave from work for medical reasons over the previous month; 21, Being satisfied with one's sexual life; 22, Satisfaction with current hypertension treatment. “D”, Difference in quality of life items between V3 and V1 in the three groups receiving nebivolol. A negative value is indicative of improvement, except for items 12, 14, 15, 16, 21 and 22, for which a positive value means improvement.

*p<0.0001;

**p≥0.0001 and p< 0.01;

***p≥0.01 and p<0.05.

Table IV. Qualitative changes in Quality of life (QoL) items.

Item		Monotherapy	Add-on	Switch	p
1	n	282	245	226	NS
	worsening	6.4%	7.4%	11.1%
	no change	33.3%	35.0%	34.9%
	improvement	60.3%	57.6%	54.0%
2	n	282	246	226	NS
	worsening	5.7%	9.4%	5.3%
	no change	52.8%	49.5%	57.1%
	improvement	41.5%	41.1%	37.6%
3	n	280	246	224	NS
	worsening	7.5%	5.7%	4.0%
	no change	61.8%	61.0%	67.8%
	improvement	30.7%	33.3%	28.2%
4	n	281	246	226	<0.0001
	worsening	6.8%	6.1%	8.3%
	no change	66.9%	66.7%	46.2%
	improvement	26.3%	27.2%	45.5%
5	n	281	243	225	NS
	worsening	7.5%	6.6%	9.3%
	no change	69.7%	68.7%	64.9%
	improvement	22.8%	24.7%	25.8%
6	n	280	242	225	NS
	worsening	5.4%	4.6%	4.9%
	no change	66.4%	65.6%	71.5%
	improvement	28.2%	29.8%	23.6%
7	n	279	244	226	NS
	worsening	7.2%	8.2%	7.1%
	no change	69.5%	67.2%	69.4%
	improvement	23.3%	24.6%	23.5%
8	n	281	244	226	NS
	worsening	5.0%	3.3%	5.8%
	no change	52.3%	54.1%	61.0%
	improvement	42.7%	42.6%	33.2%
9	n	281	244	226	0.007
	worsening	9.3%	9.8%	12.0%
	no change	39.1%	50.4%	51.7%
	improvement	51.6%	39.8%	36.3%
10	n	280	242	224	NS
	worsening	7.9%	8.7%	9.4%
	no change	73.2%	70.2%	66.0%
	improvement	18.9%	21.1%	24.6%
11	n	280	245	225	0.0023
	worsening	8.2%	10.2%	9.8%
	no change	49.3%	51.8%	61.8%
	improvement	42.5%	38.0%	28.4%
12	n	280	244	222	NS
	worsening	18.6%	15.6%	14.0%
	no change	52.5%	52.4%	56.7%
	improvement	28.9%	32.0%	29.3%
13	n	280	245	225	NS
	worsening	11.8%	9.4%	9.7%
	no change	54.6%	55.9%	59.8%
	improvement	33.6%	34.7%	30.5%
14	n	279	243	224	NS
	worsening	16.1%	16.5%	18.3%
	no change	59.5%	51.4%	56.2%
	improvement	24.4%	32.1%	25.5%
15	n	280	243	221	0.029
	worsening	10.0%	18.5%	18.6%
	no change	58.2%	50.6%	48.8%
	improvement	31.8%	30.9%	32.6%
16	n	252	191	178	NS
	worsening	11.5%	15.2%	9.0%
	no change	54.0%	52.3%	54.5%
	improvement	34.5%	32.5%	36.5%
17	n	281	245	225	NS
	worsening	7.1%	9.8%	5.8%
	no change	56.2%	53.1%	59.1%
	improvement	36.7%	37.1%	35.1%
18	n	280	245	223	NS
	worsening	8.6%	11.8%	10.3%
	no change	59.6%	47.8%	54.3%
	improvement	31.8%	40.4%	35.4%
19	n	269	238	219	NS
	worsening	4.8%	8.8%	7.8%
	no change	65.5%	63.9%	63.0%
	improvement	29.7%	27.3%	29.2%
20	n	259	206	184	NS
	worsening	5.0%	3.9%	4.4%
	no change	76.5%	76.2%	78.2%
	improvement	18.5%	19.9%	17.4%
21	n	264	215	188	NS
	worsening	15.5%	13.5%	16.0%
	no change	56.1%	58.1%	54.2%
	improvement	28.4%	28.4%	29.8%
22	n	236	244	222	NS
	worsening	12.3%	12.3%	9.0%
	no change	34.3%	30.7%	28.8%
	improvement	53.4%	57.0%	62.2%

Items are: 1, Tiredness; 2, Dizziness; 3, Facial redness; 4, Cold hands and/or feet; 5, Coughing; 6, Tinnitus; 7, Breathing difficulty; 8, Palpitations; 9, Headache; 10, Swollen legs and/or feet; 11, Anxiety; 12, Satisfaction with personal life; 13, Depression; 14, Satisfaction with family life; 15, Satisfaction in performing daily activities; 16, Satisfaction with professional life; 17, Climbing a flight of stairs; 18, Walking around the block several times; 19, Having to give up usual leisure time activites; 20, Having to take leave from work for medical reasons over the previous month; 21, Being satisfied with one's sexual life; 22, Satisfaction with current hypertension treatment. Changes in quality of life items between V1 and V3 in the the three groups receiving nebivolol. In cross-classification and symmetry analyses, all items were significantly improved at V3, except for items 10, 12, 14 (monotherapy), and for items 15, 20 and 21 (switch).