Simvastatin and Vitamin D for migraine prevention: A randomized, controlled trial

Annals of Neurology

Volumn 78, Issue 6, 2015, Pages 970-981

  Buettner, Catherine ^a   Nir, Rony Reuven ^b   Bertisch, Suzanne M ^a   Bernstein, Carolyn ^a   Schain, Aaron ^a   Mittleman, Murray A ^c   Burstein, Rami ^a  

^a HARVARD MEDICAL SCHOOL   (United States)

^b TECHNION ISRAEL INSTITUTE OF TECHNOLOGY   (Israel)

^c HARVARD SCHOOL OF PUBLIC HEALTH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

PLACEBO; SIMVASTATIN; VITAMIN D; COLECALCIFEROL; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR;

ADULT; ARTHRALGIA; ARTICLE; CARDIOVASCULAR RISK; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG TOLERABILITY; ENDOTHELIAL DYSFUNCTION; EPISODIC MIGRAINE; FEMALE; GASTROINTESTINAL SYMPTOM; HUMAN; INTERVENTION STUDY; MAJOR CLINICAL STUDY; MALE; MYALGIA; MYOSITIS; OUTCOME ASSESSMENT; PRIORITY JOURNAL; PRURITUS; RANDOMIZED CONTROLLED TRIAL; RASH; TREATMENT DURATION; TREATMENT RESPONSE; COMBINATION DRUG THERAPY; MIDDLE AGED; MIGRAINE DISORDERS; YOUNG ADULT;

ADULT; CHOLECALCIFEROL; DOUBLE-BLIND METHOD; DRUG THERAPY, COMBINATION; FEMALE; HUMANS; HYDROXYMETHYLGLUTARYL-COA REDUCTASE INHIBITORS; MALE; MIDDLE AGED; MIGRAINE DISORDERS; OUTCOME ASSESSMENT (HEALTH CARE); SIMVASTATIN; YOUNG ADULT;

EID: 84954411567     PISSN: 03645134     EISSN: 15318249     Source Type: Journal    
DOI: 10.1002/ana.24534     Document Type: Article

References (50)

1. Lipton RB, Stewart WF., Migraine in the United States: a review of epidemiology and health care use. Neurology 1993; 43 (6 suppl 3): S6-S10.
2. Vos T, Flaxman AD, Naghavi M, et al., Years lived with disability (YLDs) for 1160 sequelae of 289 diseases and injuries 1990-2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet 2012; 380: 2163-2196.
3. Gilmore B, Michael M,. Treatment of acute migraine headache. Am Fam Phys 2011; 83: 271-280.
4. Wilkinson M,. Migraine treatment: the British perspective. Headache 1994; 34: S13-S16.
5. Hazard E, Munakata J, Bigal ME, Rupnow MF, Lipton RB,. The burden of migraine in the United States: current and emerging perspectives on disease management and economic analysis. Value Health 2009; 12: 55-64.
6. Lipton RB, Bigal ME, Diamond M, et al., Migraine prevalence, disease burden, and the need for preventive therapy. Neurology 2007; 68: 343-349.
7. Dahlof CG, Solomon GD,. The burden of migraine to the individual sufferer: a review. Eur J Neurol 1998; 5: 525-533.
8. Terwindt GM, Ferrari MD, Tijhuis M, et al., The impact of migraine on quality of life in the general population: the GEM study. Neurology 2000; 55: 624-629.
9. Dodick DW, Silberstein SD,. Migraine prevention. Pract Neurol 2007; 7: 383-393.
10. Silberstein SD, Holland S, Freitag F, et al.,; Quality Standards Subcommittee of the American Academy of Neurology and the American Headache Society. Evidence-based guideline update: pharmacologic treatment for episodic migraine prevention in adults: report of the Quality Standards Subcommittee of the American Academy of Neurology and the American Headache Society. Neurology 2012; 78: 1337-1345.
11. Hepp Z, Bloudek LM, Varon SF,. Systematic review of migraine prophylaxis adherence and persistence. J Manag Care Pharm 2014; 20: 22-33.
12. Blumenfeld AM, Bloudek LM, Becker WJ, et al., Patterns of use and reasons for discontinuation of prophylactic medications for episodic migraine and chronic migraine: results from the second international burden of migraine study (IBMS-II). Headache. 2013; 53: 644-655.
13. Bigal ME, Kurth T, Santanello N, et al., Migraine and cardiovascular disease: a population-based study. Neurology 2010; 74: 628-635.
14. Kurth T, Gaziano JM, Cook NR, et al., Migraine and risk of cardiovascular disease in women. JAMA 2006; 296: 283-291.
15. Kurth T, Schurks M, Logroscino G, Gaziano JM, Buring JE,. Migraine, vascular risk, and cardiovascular events in women: prospective cohort study. BMJ 2008; 337: a636.
16. Sacco S, Ricci S, Carolei A,. Migraine and vascular diseases: a review of the evidence and potential implications for management. Cephalalgia 2012; 32: 785-795.
17. Sacco S, Ripa P, Grassi D, et al., Peripheral vascular dysfunction in migraine: a review. J Headache Pain 2013; 14: 80.
18. Scher AI, Terwindt GM, Picavet HS, et al., Cardiovascular risk factors and migraine: the GEM population-based study. Neurology 2005; 64: 614-620.
19. Stam AH, Haan J, van den Maagdenberg AM, Ferrari MD, Terwindt GM,. Migraine and genetic and acquired vasculopathies. Cephalalgia 2009; 29: 1006-1017.
20. Aird WC,. Endothelial cell heterogeneity. Cold Spring Harb Perspect Med 2012; 2: a006429.
21. Mattace-Raso FU, van der Cammen TJ, Hofman A, et al., Arterial stiffness and risk of coronary heart disease and stroke: the Rotterdam Study. Circulation 2006; 113: 657-663.
22. Sandoo A, van Zanten JJ, Metsios GS, Carroll D, Kitas GD,. The endothelium and its role in regulating vascular tone. Open Cardiovasc Med J 2010; 4: 302-312.
23. Schindler TH, Nitzsche EU, Olschewski M, et al., Chronic inflammation and impaired coronary vasoreactivity in patients with coronary risk factors. Circulation 2004; 110: 1069-1075.
24. Versari D, Daghini E, Virdis A, Ghiadoni L, Taddei S,. Endothelial dysfunction as a target for prevention of cardiovascular disease. Diabetes Care 2009; 32 (suppl 2): S314-S321.
25. Antoniades C, Bakogiannis C, Leeson P, et al., Rapid, direct effects of statin treatment on arterial redox state and nitric oxide bioavailability in human atherosclerosis via tetrahydrobiopterin-mediated endothelial nitric oxide synthase coupling. Circulation 2011; 124: 335-345.
26. Everett BM, Glynn RJ, MacFadyen JG, Ridker PM,. Rosuvastatin in the prevention of stroke among men and women with elevated levels of C-reactive protein: justification for the Use of Statins in Prevention: an Intervention Trial Evaluating Rosuvastatin (JUPITER). Circulation 2010; 121: 143-150.
27. Forero-Pena DA, Gutierrez FR,. Statins as modulators of regulatory T-cell biology. Mediators Inflamm 2013; 2013: 167086.
28. Liao JK, Laufs U,. Pleiotropic effects of statins. Annu Rev Pharmacol Toxicol 2005; 45: 89-118.
29. Tousoulis D, Psarros C, Demosthenous M, et al., Innate and adaptive inflammation as a therapeutic target in vascular disease: the emerging role of statins. J Am Coll Cardiol 2014; 63: 2491-2502.
30. Yanuck D, Mihos CG, Santana O,. Mechanisms and clinical evidence of the pleiotropic effects of the hydroxy-methyl-glutaryl-CoA reductase inhibitors in central nervous system disorders: a comprehensive review. Int J Neurosci 2012; 122: 619-629.
31. Musial J, Undas A, Gajewski P, et al., Anti-inflammatory effects of simvastatin in subjects with hypercholesterolemia. Int J Cardiol 2001; 77: 247-253.
32. Ridker PM, Rifai N, Clearfield M, et al., Measurement of C-reactive protein for the targeting of statin therapy in the primary prevention of acute coronary events. N Engl J Med 2001; 344: 1959-1965.
33. Schonbeck U, Libby P,. Inflammation, immunity, and HMG-CoA reductase inhibitors: statins as antiinflammatory agents? Circulation 2004; 109 (21 suppl 1): II18-II26.
34. Wolfrum S, Jensen KS, Liao JK,. Endothelium-dependent effects of statins. Arteriosclerosis, thrombosis, and vascular biology. 2003; 23: 729-736.
35. Zhou Q, Liao JK,. Pleiotropic effects of statins. Basic research and clinical perspectives. Circ J 2010; 74: 818-826.
36. Millar PJ, Floras JS,. Statins and the autonomic nervous system. Clin Sci (Lond) 2014; 126: 401-415.
37. Buettner C, Burstein R,. Association of statin use and risk for severe headache or migraine by serum vitamin D status: a cross-sectional population-based study. Cephalalgia 2015; 35: 757-766.
38. Christakos S, Hewison M, Gardner DG, et al., Vitamin D: beyond bone. Ann N Y Acad Sci 2013; 1287: 45-58.
39. Hewison M, Freeman L, Hughes SV, et al., Differential regulation of vitamin D receptor and its ligand in human monocyte-derived dendritic cells. J Immunol 2003; 170: 5382-5390.
40. Jeffery LE, Wood AM, Qureshi OS, et al., Availability of 25-hydroxyvitamin D(3) to APCs controls the balance between regulatory and inflammatory T cell responses. J Immunol 2012; 189: 5155-5164.
41. Ahmed W, Khan N, Glueck CJ, et al., Low serum 25 (OH) vitamin D levels (<32 ng/mL) are associated with reversible myositis-myalgia in statin-treated patients. Transl Res 2009; 153: 11-16.
42. Palamaner Subash Shantha G, Ramos J, Thomas-Hemak L, Pancholy SB,. Association of vitamin D and incident statin induced myalgia-a retrospective cohort study. PLoS One 2014; 9: e88877.
43. Morioka TY, Lee AJ, Bertisch S, Buettner C,. Vitamin D status modifies the association between statin use and musculoskeletal pain: a population based study. Atherosclerosis 2014; 238: 77-82.
44. Buettner C, Rippberger MJ, Smith JK, et al., Statin use and musculoskeletal pain among adults with and without arthritis. Am J Med 2012; 125: 176-182.
45. Headache Classification Committee of The International Headache Society. The International Classification of Headache Disorders (second edition). Cephalalgia 2004; 24 (suppl 1): 1-160.
46. Schafer JL,. Multiple imputation: a primer. Stat Methods Med Res 1999; 8: 3-15.
47. Linde M, Mulleners WM, Chronicle EP, McCrory DC,. Topiramate for the prophylaxis of episodic migraine in adults. Cochrane Database Syst Rev 2013; 6: CD010610.
48. Finegold JA, Manisty CH, Goldacre B, Barron AJ, Francis DP,. What proportion of symptomatic side effects in patients taking statins are genuinely caused by the drug?. Systematic review of randomized placebo-controlled trials to aid individual patient choice. Eur J Prev Cardiol 2014; 21: 464-474.
49. Ashina S, Bendtsen L, Lyngberg AC, et al., Prevalence of neck pain in migraine and tension-type headache: a population study. Cephalalgia 2015; 35: 211-219.
50. Hauser W, Hansen E, Enck P,. Nocebo phenomena in medicine: their relevance in everyday clinical practice. Dtsch Arztebl Int 2012; 109: 459-465.