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 | ||||||
p < 0.001 versus baseline.
p = 0.006.
57 ± 10 years in other treatment arm.
Values for first 4-week treatment period (p < 0.01 versus baseline).
Dosages doubled after 4 weeks if unsatisfactory response (2 weeks in Cherubini et al, 8 weeks in James et al).
p < 0.01 versus baseline.
p < 0.05.
Values for first 4 weeks of treatment (p < 0.001 versus baseline).
Sustained sympathetic activation with chronic NG therapy (p < 0.05 versus baseline).
Ankle edema significantly greater with NG (p < 0.001 versus L).
Values for first 8 weeks of treatment (p < 0.001 versus baseline).
Neither drug affected insulin resistance.
Values for first 6 weeks of treatment.
p < 0.001 between treatment groups in numbers of responding and normalized patients.
Incidence of adverse drug reactions was lowest for L.
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.
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.