Lercanidipine in Hypertension

Figures & data

Figure 1 Evolution of dihydropyridine calcium antagonists for improved clinical efficacy and tolerability. Abbreviations: GITS, gastrointestinal therapeutic system.

Table 1 Efficacy and tolerability of lercanidipine compared with other antihypertensive drugs in patients with mild-to-moderate hypertension

Study	Study design/duration (w)	N/Age (y)	Dosages (mg/day)	SBP/DBP at baseline (mmHg)	SBP/DBP at study end (mmHg)	Responding (normalized) at 4 weeks (%)	Overall efficacy	Adverse events
Comparison with calcium antagonists
Pedrinelli et al 2003	sb, co/2	22/48 ± 5	L 20	L 146 ± 16/93 ± 13	L 138 ± 9/86 ± 9a	NR	L≡A	L < A (leg edema)b
			A 10	A 148 ± 17/95 ± 11	A 137 ± 13/84 ± 9a
De Giorgio et al 1999	db, co/4	20/55 ± 9c	L 20	L 162 ± 20/101 ± 5	L 141 ± 24/88 ± 10d	L 86 (86) (33)	L≡A	L≡A
			A 10	A 166 ± 19/104 ± 6	A 152 ± 16/94 ± 9d	A 56
Romito et al 2003	db, p/8e	325/31–74	L 10	L 155 ± 11/99 ± 3	L 141 ± 13/87 ± 7f	L≡NG≡F	L≡NG≡F	L≡NG < Fg
			NG 30	NG 155 ± 12/99 ± 3	NG 142 ± 10/86 ± 7f
			F 10	F 155 ± 12/99 ± 3	F 138 ± 10/85 ± 7f
Policicchio et al 1997	db, p/8e	130/18–70	L 10	L 163 ± 12/101 ± 5	L 151 ± 13/91 ± 9h	L 58 (51)	L≡NS	L≡NS
			NS 40	NS 163 ± 14/101 ± 4	NS 151 ± 14/91 ± 8h	NS 63 (53)
Fogari et al 2003	db, p/48e	60/30–65	L 10	L 159 ± 11/101 ± 6	L 137/85a	NR	L≡NG	NRi
			NG 30	NG 159 ± 10/101 ± 5	NG 21/15a
Fogari et al 2000a	db, p/12e	60/36–70	L 10	L 163 ± 5/98 ± 4	L 144 ± 5/86 ± 4a	NR	L≡NG	L < NG (ankle edema)j
			NG 30	NG 162 ± 6/97 ± 4	NG 144 ± 5/86 ± 3a
Comparison with other antihypertensive drug classes
Morisco et al 1997	db, p/8e	217/18–70	L 10	L 157 ± 11/100 ± 3	L 145 ± 12/90 ± 8d	L 71 (65)	L≡AT	L≡AT
			AT 50	AT 157 ± 11/100 ± 4	AT 142 ± 13/88 ± 7d	AT 78 (76)
Sangiorgi et al 1997	db, p/12e	115/18–80	L 10	L 161 ± 10/100 ± 3	L 147 ± 10/89 ± 7d	L 75 (81)	L≡C	L≡C
			C 50	C 159 ± 10/100 ± 3	C 148 ± 11/91 ± 7d	C 73 (74)
Notarbartolo et al 1999	db, p/24e	52/18–70	L 10	L 159 ± 13/105 ± 5	L 143 ± 7/92 ± 7d	L 65 (54)	L≡H	L < H (lipid changes)
			H 12.5	H 158 ± 14/103 ± 5	H 146 ± 10/93 ± 7d	H 58 (54)
James et al 2002	db, p/16e	562/18–75	L 10	L 163 ± 15/101 ± 5	L 148 ± 16/88 ± 7	L ≈ 80 (71) (16w)	L≡LO	L≡LO
			LO 50	LO 162 ± 13/101 ± 5	LO 144 ± 15/88 ± 8	LO ≈ 80 (65) (16w)
Sarafidis et al 2004	NR/16	20/53 ± 9	L 10	L 165 ± 8/102 ± 2	L 151 ± 9/97 ± 4k	L NR (20) (8w)	L≡T	NRl
			T 80	T 166 ± 8/103 ± 5	T 152 ± 8/96 ± 4k	T NR (20) (8w)
Aranda et al 2000	open/32	338/55	L 10	L 162 ± 11/97 ± 9	L 135/82m	NR	L≡CA	L≡CA
			CA 16	CA 161 ± 10/96 ± 7	CA 133/82m
Comparative studies in the elderly
Cherubini et al 2003	db, p/24e	324/≥65	L 5	L 167 ± 11/98 ± 5	L 140/80f	L/NG > LA (24w)n	L≡LA≡NG	L≡LA/NGo
			LA 2	LA 168 ± 12/98 ± 4	LA 142/81f
			NG 30	NG 167 ± 11/97 ± 4	NG 138/79f
Leonetti et al 1999	db, p/26–104e	828/≥60	L 10	L 170 ± 10/97 ± 6	L 140/83p	L≡LA≡A	L≡LA≡A	L≡LA < Aq
			LA 2	LA 170 ± 10/97 ± 6	LA 141/83p
			A 5	A 171 ± 11/97 ± 7	A 141/82p

a p < 0.001 versus baseline.

b p = 0.006.

c 57 ± 10 years in other treatment arm.

d Values for first 4-week treatment period (p < 0.01 versus baseline).

e Dosages doubled after 4 weeks if unsatisfactory response (2 weeks in Cherubini et al, 8 weeks in James et al).

f p < 0.01 versus baseline.

g p < 0.05.

h Values for first 4 weeks of treatment (p < 0.001 versus baseline).

i Sustained sympathetic activation with chronic NG therapy (p < 0.05 versus baseline).

j Ankle edema significantly greater with NG (p < 0.001 versus L).

k Values for first 8 weeks of treatment (p < 0.001 versus baseline).

l Neither drug affected insulin resistance.

m Values for first 6 weeks of treatment.

n p < 0.001 between treatment groups in numbers of responding and normalized patients.

o Incidence of adverse drug reactions was lowest for L.

p Values are at 6 months (p < 0.01 versus baseline). AT or enalapril (plus diuretic, if required) was added after 8 weeks in 22%–29% of patients with an unsatisfactory response.

q Higher rates of edema, edema-related symptoms, and early edema-related discontinuation with A compared with L and LA (p < 0.001).

Abbreviations: A, amlodipine; AT, atenolol; BP, blood pressure; co, crossover; C, captopril; CA, candesartan; DBP, diastolic BP; db, double blind; H, hydrochlorothiazide; LA, lacidipine; L, lercanidipine; LO, losartan; NE, norepinephrine; NG, nifedipine gastrointestinal therapeutic system; NR, not reported; NS, nifedipine slow-release formulation; p, parallel; sb, single blind; SBP, systolic BP; T, telmisartan.

Figure 2 Amlodipine produces significantly more leg edema than lercanidipine after 2 weeks therapy in patients with mild to moderate hypertension (p = 0.006) (Pedrinelli et al 2003).

Figure 3 Clinical summary of lercanidipine in hypertension. All features and comments are derived from referenced information in the text. Abbreviations: ACE, angiotensin converting enzyme; AEs, adverse events; DHP, dihydropyridine; ISH, isolated systolic hypertension.

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