What is the best strategy for converting from twice-daily divalproex to a once-daily divalproex ER regimen? Examinations and answers via computer simulations

Clinical Drug Investigation

Volumn 24, Issue 9, 2004, Pages 509-521

  Reed, Ronald C ^a   Dutta, Sandeep ^a  

^a ABBOTT LABORATORIES   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

VALPROATE SEMISODIUM; VALPROIC ACID;

ARTICLE; COMPUTER SIMULATION; DISSOCIATION CONSTANT; DRUG BINDING; DRUG BLOOD LEVEL; DRUG DOSE REGIMEN; DRUG FORMULATION; DRUG METABOLISM; ENZYME INDUCTION; EXTENDED RELEASE FORMULATION; MONOTHERAPY; PRIORITY JOURNAL; STEADY STATE;

EID: 4644313418     PISSN: 11732563     EISSN: None     Source Type: Journal    
DOI: 10.2165/00044011-200424090-00002     Document Type: Article

References (28)

1. Browne TR, Holmes GL. Epilepsy. N Engl J Med 2001; 344 (15): 1145-51
2. Perucca E. Pharmacological and therapeutic properties of valproate: a summary after 35 years of clinical experience. CNS Drugs 2002; 16 (10): 695-714
3. Mathew NT, Saper JR, Silberstein SD, et al. Migraine prophylaxis with divalproex. Arch Neurol 1995; 52 (3): 281-6
4. Becker WJ. Evidence based migraine prophylactic drug therapy. Can J Neurol Sci 1999; 26 Suppl. 3: S27-32
5. Bowden CL, Brugger AM, Swann AC, et al. Efficacy of divalproex vs. lithium and placebo in the treatment of mania. The Depakote Mania Study Group. JAMA 1994; 271 (12): 918-24
6. Gugler R, von Unruh GE. Clinical pharmacokinetics of valproic acid. Clin Pharmacokinet 1980; 5: 67-83
7. Zaccara G, Messori A, Moroni F. Clinical pharmacokinetics of valproic acid. Clin Pharmacokinet 1988; 15: 367-89
8. Levy RH, Shen DD, Abbott FS, et al. Valproic acid: chemistry, biotransformation, and pharmacokinetics. In: Levy RH, Mattson RH, Meldrum BS, et al., editors. Antiepileptic drugs. 5th ed. Philadelphia (PA): Lippincott, Williams & Wilkins, 2002: 808-17
9. Abdel-Rahman SM, Leeder JS. Phenobarbital, phenytoin, and carbamazepine. In: Levy RH, Thummel KE, Trager WF, et al., editors. Metabolic drug interactions. Philadelphia (PA): Lippincott, Williams & Wilkins, 2000: 673-90
10. Mulleners WM, Whitmarsch TE, Steiner TJ. Noncompliance may render migraine prophylaxis useless, but once-daily regimens are better. Cephalgia 1998; 18: 52-6
11. Cramer JA, Mattson RH, Prevey ML, et al. How often is medication taken as prescribed? A novel assessment technique. JAMA 1989; 261: 3273-7
12. Freitag F, Collins SD, Carlson HA, et al. A randomized trial of divalproex sodium extended-release tablets in migraine prophylaxis. Neurology 2002; 58: 1652-9
13. Depakote® ER Tablets Product Information. Divalproex sodium extended-release tablets. North Chicago (IL): Abbott Laboratories Inc, 2003
14. Thibault M, Blume WT, Saint-Hilaire JM, et al. Divalproex extended-release versus the original divalproex tablet: results of a randomized, crossover study of well-controlled epileptic patients with primary generalized seizures. Epilepsy Res 2002; 50: 243-9
15. Cavanaugh JH, Granneman R, Lamm J, et al. Effect of food on the bioavailability of a controlled-release formulation of Depakote under multiple-dose conditions. Epilepsia 1997; 38 (Suppl. 8): 54
16. Dutta S, Zhang Y, Selness DS, et al. Comparison of the bioavailability of unequal doses of divalproex sodium extended-release formulation relative to the delayed-release formulation in healthy volunteers. Epilepsy Res 2002; 49: 1-10
17. Sommerville KW, Dutta S, Biton V, et al. Bioavailability of a divalproex extended-release formulation versus the conventional divalproex formulation in adult patients receiving enzyme-inducing antiepileptic drugs. Clin Drug Invest 2003; 23 (10): 661-70
18. Dutta S, Reed RC, Cavanaugh J. Absolute bioavailability and absorption characteristics of divalproex sodium extended-release tablets in healthy volunteers. J Clin Pharmacol 2004 Jul; 44 (7): 737-42
19. Dutta S, Cloyd JC, Granneman GR, et al. Oral/intravenous maintenance dosing of valproate following intravenous loading: a simulation. Epilepsy Res 2003; 53: 29-38
20. Cloyd JC, Dutta S, Cao G, et al. Valproate unbound fraction and distribution volume following rapid infusions in patients with epilepsy. Epilepsy Res 2003; 53: 19-27
21. Dutta S, Reed RC. Comparison of pharmacokinetics and safety of divalproex sodium extended-release tablets following morning versus evening dosing. Am J Health Syst Pharm. In press
22. Beydoun A, Sackellares JC, Shu V. Safety and efficacy of divalproex sodium monotherapy in partial epilepsy: a double-blind, concentration-response design clinical trial. Neurology 1997; 48: 182-8
23. Willmore JL, Shu V, Wallin B. Efficacy and safety of add-on divalproex sodium in the treatment of complex partial seizures. Neurology 1996; 46: 49-53
24. Perucca E, Dulac O, Shorvon S, et al. Harnessing the clinical potential of antiepileptic drug therapy: dosage optimization. CNS Drugs 2001; 15 (8): 609-21
25. Bourgeois BF. Valproic acid: clinical efficacy and use in epilepsy. In: Levy RH, Mattson RH, Meldrum BS, et al., editors. Antiepileptic drugs. 5th ed. Philadelphia (PA): Lippincott Williams & Wilkins, 2002: 808-17
26. Cloyd JC, Fischer JH, Kriel RL, et al. Valproic acid pharmacokinetics in children. IV. Effects of age and antiepileptic drugs on protein binding and intrinsic clearance. Clin Pharmacol Ther 1993; 53: 22-9
27. Kriel RL, Fischer JH, Cloyd JC, et al. Valproic acid pharmacokinetics in children. III. Very high dosage requirements. Pediatr Neurol 1986; 2: 202-8
28. Felix S, Sproule BA, Hardy BG, et al. Dose-related pharmacokinetics and pharmacodynamics of valproate in the elderly. J Clin Psychopharmacol 2003; 23: 471-8