Table 1.
Comparison of study designs
| Study | Disease | Study dates | Design
|
Treatmenta
|
Ratiob | Number of centers | ||||
|---|---|---|---|---|---|---|---|---|---|---|
| Baseline | Dose adjustment | Treatment | Withdrawal | Placebo, n | Pregabalin (n) | |||||
| 1008-01410 | DPN | Mar 1998–Mar 1999 | 1 week | 2 week | 4 week | – | 85 | 150 mg/d (79) 600 mg/d (82) |
2:1 | 29 |
| 1008-02911 | DPN | Aug 1998–Jun 1999 | 1 week | 1 week | 4 week | – | 97 | 75 mg/d (77) 300 mg/d (81) 600 mg/d (82) |
3:1 | 45 |
| 1008-04012 | DPN | Sep 1999–Dec 2000 | 1 week | 2 week | 6 week | 1 week | 81 | 600 mg/d (86) Amit 75 mg/d (87)c |
2:1 | 49 |
| 1008-13116 | DPN | Dec 1999–May 2000 | 1 week | – | 8 week | – | 70 | 300 mg/d (76) | 1:1 | 25 |
| 1008-14917 | DPN | Nov 2000–May 2002 | 1 week | 1 week | 11 week | – | 96 | 150 mg/d (99) 300 mg/d (99) 300/600 mg/dd (101) |
3:1 | 58 |
| A0081030 | DPN | Jan 2005–Apr 2006 | 1 week | 6 week | 6 week | 1 week | 135 | 150–600 mg/de (271) | 2:1 | 47 |
| A008106020 | DPN | Sep 2004–Oct 2005 | 1 week | 1 week | 12 week | – | 85 | 600 mg/day (82) | 1:1 | 23 |
| A0081071 | DPN | May 2005–May 2007 | 1–2 week | 1 week | 12 week | 1 week | 151 | 300 mg/d (153) 600 mg/d (152) |
2:1 | 50 |
| A008116322 | DPN | Oct 2007–Mar 2009 | 1 week | 1 week | 12 week | 1 week | 135 | 300 mg/d (134) 600 mg/d (45) |
1:1 | 62 |
| 1008-03012 | PHN | Oct 1998–Jul 1999 | 1 week | – | 5 week | – | 88 | 75 mg/d (84) 150 mg/d (84) |
2:1 | 29 |
| 1008-04513 | PHN | Feb 1999–Jun 2000 | 1 week | 1 week | 7 week | – | 81 | 150 mg/d (81) 300 mg/d (76) |
2:1 | 53 |
| 1008-12715 | PHN | Dec 1999–May 2000 | 1 week | 1 week | 7 week | – | 84 | 300 mg/d (30) 600 mg/d (59) |
1:1 | 29 |
| 1008-19618 | PHN | Nov 2001–Oct 2002 | 1 week | 1 week | 12 week | – | 93 | 150 mg/d (87) 300 mg/d (98) 300/600 mg/dd (90) |
3:1 | 76 |
| A008100419 | PHN | Oct 2004–Jun 2006 | 1 week | – | 4 week | 1 week | 90 | 300 mg/d (88) 150–600 mg/de (92) |
2:1 | 42 |
| 1008-15514 | DPN and PHN | Jul 2001–Dec 2002 | 1 week | – | 12 week | – | 65 | 600 mg/d (132) 150–600 mg/de (141) |
4:1 | 60 |
| A008108121 | DPN and PHN | Feb 2006–Sept 2007 | 1 week | – | 8 week | 1 week | 102 | 150–600 mg/de (206) | 2:1 | 11 |
a
Notes: Treatment groups in each study, including number of patients receiving at least one dose of treatment;
b
ratio of patients receiving active treatment to those receiving placebo;
c
included an active comparator arm with 87 patients randomized to amitriptyline;
d
patients received 300 mg/day if creatinine clearance was higher than 30 but 60 mL/min or less, and 600 mg/day if creatinine clearance was higher than 60 mL/min;
e
escalating doses of 150, 300, 450, and 600 mg/day, titrated in weekly intervals based on patient’s individual response and tolerability.
Abbreviations: Amit, amitriptyline; DPN, diabetic peripheral neuropathy; PHN, postherpetic neuralgia.