Exploring design-related bias in clinical studies on receptor genetic polymorphism of hypertension

Journal of Clinical Epidemiology

Volumn 60, Issue 1, 2007, Pages 1.e1-1.e11

  Farahani, Pendar ^a   Dolovich, Lisa ^a   Levine, Mitchell ^a  

^a CENTRE FOR EVALUATION OF MEDICINES   (Canada)

Author keywords

Bias; Clinical studies; Pharmacogenetics; Pharmacogenomics; Renin Angiotensin Aldosterone System; Study design

Indexed keywords

ANGIOTENSIN 2 RECEPTOR ANTAGONIST; ATENOLOL; DIPEPTIDYL CARBOXYPEPTIDASE INHIBITOR;

CLINICAL TRIAL; DRUG METABOLISM; EMBASE; ENVIRONMENTAL FACTOR; GENE FREQUENCY; GENE INTERACTION; GENETIC POLYMORPHISM; HETEROZYGOSITY; HOMOZYGOTE; HUMAN; HYPERTENSION; MEDLINE; PATIENT SELECTION; PHARMACOGENOMICS; POPULATION GENETICS; PRIORITY JOURNAL; RECEPTOR GENE; REVIEW; SINGLE NUCLEOTIDE POLYMORPHISM; SYSTEMATIC REVIEW;

EID: 33845202134     PISSN: 08954356     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jclinepi.2006.04.002     Document Type: Review

References (55)

1. Wolf-Maier K., Cooper R.S., Banegas J.R., Giampaoli S., Hense H.W., Joffres M., et al. Hypertension prevalence and blood pressure levels in 6 European Countries, Canada, and the United States. JAMA 289 (2003) 2363-2369
2. Fields L.E., Burt V.L., Cutler J.A., Hughes J., Roccella E.J., and Sorlie P. The burden of adult hypertension in the United States 1999 to 2000: a rising tide. Hypertension 44 (2004) 398-404
3. Fischer M.A., and Avorn J. Economic implications of evidence-based prescribing for hypertension: can better care cost less?. JAMA 291 (2004) 1850-1856
4. Materson B.J. Variability in response to antihypertensive drug treatment. Hypertension 43 (2004) 1166-1167
5. Venter J.C., Adams M.D., Myers E.W., Li P.W., Mural R.J., Sutton G.G., et al. The sequence of the human genome. Science 291 (2001) 1304-1351
6. Sachidanandam R., Weissman D., Schmidt S.C., Kakol J.M., Stein L.D., Marth G., et al. A map of human genome sequence variation containing 1.42 million single nucleotide polymorphisms. Nature 409 (2001) 928-933
7. Hedgecoe A., and Martin P. The drugs don't work: expectations and the shaping of pharmacogenetics. Soc Stud Sci 33 (2003) 327-364
8. Lesko L.J., Salerno R.A., Spear B.B., Anderson D.C., Anderson T., Brazell C., et al. Pharmacogenetics and pharmacogenomics in drug development and regulatory decision making: report of the first FDA-PWG-PhRMA-DruSafe Workshop. J Clin Pharmacol 43 (2003) 342-358
9. Sadee W. Pharmacogenomics: the implementation phase. AAPS PharmSci 4 (2002) E5
10. Phillips K.A., Veenstra D.L., Oren E., Lee J.K., and Sadee W. Potential role of pharmacogenomics in reducing adverse drug reactions: a systematic review. JAMA 286 (2001) 2270-2279
11. Lifton R.P., Gharavi A.G., and Geller D.S. Molecular mechanisms of human hypertension. Cell 104 (2001) 545-556
12. Michel M.C., and Insel P.A. Receptor gene polymorphisms: lessons on functional relevance from the beta 1-adrenoceptor. Br J Pharmacol 138 (2003) 279-282
13. Mellen P.B., and Herrington D.M. Pharmacogenomics of blood pressure response to antihypertensive treatment. J Hypertens 23 (2005) 1311-1325
14. Moher D., Schulz K.F., and Altman D.G. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials. Lancet 357 (2001) 1191-1194
15. STROBE Statement. Strengthening the reporting of observational studies in epidemiology (2005). http://www.strobe-statement.org/Index.html
16. Little J. Reporting and review of human genome epidemiology studies. In: Khoury M.J., Little J., and Burke W. (Eds). Human genome epidemiology (2004), Oxford University Press, New York
17. Ortlepp J.R., Hanrath P., Mevissen V., Kiel G., Borggrefe M., and Hoffmann R. Variants of the CYP11B2 gene predict response to therapy with candesartan. Eur J Pharmacol 445 (2002) 151-152
18. Hoh J., and Ott J. Mathematical multi-locus approaches to localizing complex human trait genes. Nat Rev Genet 4 (2003) 701-709
19. Marchini J., Donnelly P., and Cardon L.R. Genome-wide strategies for detecting multiple loci that influence complex diseases. Nat Genet 37 (2005) 413-417
20. Hingorani A.D., Jia H., Stevens P.A., Hopper R., Dickerson J.E., and Brown M.J. Renin-angiotensin system gene polymorphisms influence blood pressure and the response to angiotensin converting enzyme inhibition. J Hypertens 13 (1995) 1602-1609
21. McVean G., Spencer C.C., and Chaix R. Perspectives on human genetic variation from the HapMap Project. PLoS Genet 1 (2005) e54
22. Li X., Du Y., Du Y., and Huang X. Correlation of angiotensin-converting enzyme gene polymorphism with effect of antihypertensive therapy by angiotensin-converting enzyme inhibitor. J Cardiovasc Pharmacol Ther 8 (2003) 25-30
23. Harrap S.B., Tzourio C., Cambien F., Poirier O., Raoux S., Chalmers J., et al. The ACE gene I/D polymorphism is not associated with the blood pressure and cardiovascular benefits of ACE inhibition. Hypertension 42 (2003) 297-303
24. Zheng G., Freidlin B., and Gastwirth J.L. Robust genomic control for association studies. Am J Hum Genet 78 (2006) 350-356
25. Pritchard J.K., Stephens M., Rosenberg N.A., and Donnelly P. Association mapping in structured populations. Am J Hum Genet 67 (2000) 170-181
26. Devlin B., and Roeder K. Genomic control for association studies. Biometrics 55 (1999) 997-1004
27. Kelly P.J., Stallard N., and Whittaker J.C. Statistical design and analysis of pharmacogenetic trials. Stat Med 24 (2005) 1495-1508
28. Van Gestel S., Houwing-Duistermaat J.J., Adolfsson R., van Duijn C.M., and Van Broeckhoven C. Power of selective genotyping in genetic association analyses of quantitative traits. Behav Genet 30 (2000) 141-146
29. Roeder K., Bacanu S.A., Wasserman L., and Devlin B. Using linkage genome scans to improve power of association in genome scans. Am J Hum Genet 78 (2006) 243-252
30. Pfeiffer R.M., and Gail M.H. Sample size calculations for population- and family-based case-control association studies on marker genotypes. Genet Epidemiol 25 (2003) 136-148
31. De La Vega F.M., Gordon D., Su X., Scafe C., Isaac H., Gilbert D.A., et al. Power and sample size calculations for genetic case/control studies using gene-centric SNP maps: application to human chromosomes 6, 21, and 22 in three populations. Hum Hered 60 (2005) 43-60
32. Ioannidis J.P., Trikalinos T.A., Ntzani E.E., and Contopoulos-Ioannidis D.G. Genetic associations in large versus small studies: an empirical assessment. Lancet 361 (2003) 567-571
33. Colhoun H.M., McKeigue P.M., and Davey S.G. Problems of reporting genetic associations with complex outcomes. Lancet 361 (2003) 865-872
34. O'Hely M., and Slatkin M. The loss of statistical power to distinguish populations when certain samples are ambiguous. Theor Popul Biol 64 (2003) 177-192
35. Ranade K., Hinds D., Hsiung C.A., Chuang L.M., Chang M.S., Chen Y.T., et al. A genome scan for hypertension susceptibility loci in populations of Chinese and Japanese origins. Am J Hypertens 16 (2003) 158-162
36. Koopmans R.P., Insel P.A., and Michel M.C. Pharmacogenetics of hypertension treatment: a structured review. Pharmacogenetics 13 (2003) 705-713
37. O'Toole L., Stewart M., Padfield P., and Channer K. Effect of the insertion/deletion polymorphism of the angiotensin-converting enzyme gene on response to angiotensin-converting enzyme inhibitors in patients with heart failure. J Cardiovasc Pharmacol 32 (1998) 988-994
38. Haas M., Yilmaz N., Schmidt A., Neyer U., Arneitz K., Stummvoll H.K., et al. Angiotensin-converting enzyme gene polymorphism determines the antiproteinuric and systemic hemodynamic effect of enalapril in patients with proteinuric renal disease. Austrian Study Group of the Effects of Enalapril Treatment in Proteinuric Renal Disease. Kidney Blood Press Res 21 (1998) 66-69
39. Kurland L., Liljedahl U., Karlsson J., Kahan T., Malmqvist K., Melhus H., et al. Angiotensinogen gene polymorphisms: relationship to blood pressure response to antihypertensive treatment. Results from the Swedish Irbesartan Left Ventricular Hypertrophy Investigation vs Atenolol (SILVHIA) trial. Am J Hypertens 17 (2004) 8-13
40. Yang Q., Cui J., Chazaro I., Cupples L.A., and Demissie S. Power and type I error rate of false discovery rate approaches in genome-wide association studies. BMC Genet 6 Suppl 1 (2005) S134
41. Dudoit S., Shaffer J.P., and Boldrick J. Multiple hypothesis testing in microarray experiments. Stat Sci 18 (2003) 71-103
42. Storey J.D., and Tibshirani R. Statistical significance for genomewide studies. Proc Natl Acad Sci 100 (2003) 9440-9445
43. Ohmichi N., Iwai N., Uchida Y., Shichiri G., Nakamura Y., and Kinoshita M. Relationship between the response to the angiotensin converting enzyme inhibitor imidapril and the angiotensin converting enzyme genotype. Am J Hypertens 10 (1997) 951-955
44. Katsuya T., Iwashima Y., Sugimoto K., Motone M., Asai T., Fukuda M., et al. Effects of antihypertensive drugs and gene variants in the renin-angiotensin system. Hypertens Res 24 (2001) 463-467
45. Freidlin B., Zheng G., Li Z., and Gastwirth J.L. Trend tests for case-control studies of genetic markers: power, sample size and robustness. Hum Hered 53 (2002) 146-152
46. Dudley C., Keavney B., Casadei B., Conway J., Bird R., and Ratcliffe P. Prediction of patient responses to antihypertensive drugs using genetic polymorphisms: investigation of renin-angiotensin system genes. J Hypertens 14 (1996) 259-262
47. Carlberg B., Lindholm L.H., and Samuelsson O. Atenolol in hypertension: is it a wise choice?. Lancet 364 (2004) 1684-1689
48. Lehtinen S., Lehtimaki T., Sisto T., Salenius J.P., Nikkila M., Jokela H., et al. Apolipoprotein E polymorphism, serum lipids, myocardial infarction and severity of angiographically verified coronary artery disease in men and women. Atherosclerosis 114 (1995) 83-91
49. Maitland-van der Zee A.H., Stricker B.H., Klungel O.H., Mantel-Teeuwisse A.K., Kastelein J.J., Hofman A., et al. Adherence to and dosing of beta-hydroxy-beta-methylglutaryl coenzyme A reductase inhibitors in the general population differs according to apolipoprotein E-genotypes. Pharmacogenetics 13 (2003) 219-223
50. Redon J., Luque-Otero M., Martell N., and Chaves F.J. Renin-angiotensin system gene polymorphisms: relationship with blood pressure and microalbuminuria in telmisartan-treated hypertensive patients. Pharmacogenomics J 5 (2005) 14-20
51. Bozec E., Fassot C., Tropeano A.I., Boutouyrie P., Jeunemaitre X., Lacolley P., et al. Angiotensinogen gene M235T polymorphism and reduction in wall thickness in response to antihypertensive treatment. Clin Sci (Lond) 105 (2003) 637-644
52. Yu H., Zhang Y., and Liu G. Relationship between polymorphism of the angiotensin-converting enzyme gene and the response to angiotensin-converting enzyme inhibition in hypertensive patients. Hypertens Res 26 (2003) 881-886
53. Stavroulakis G.A., Makris T.K., Krespi P.G., Hatzizacharias A.N., Gialeraki A.E., Anastasiadis G., et al. Predicting response to chronic antihypertensive treatment with fosinopril: the role of angiotensin-converting enzyme gene polymorphism. Cardiovasc Drugs Ther 14 (2000) 427-432
54. Benetos A., Cambien F., Gautier S., Ricard S., Safar M., Laurent S., et al. Influence of the angiotensin II type 1 receptor gene polymorphism on the effects of perindopril and nitrendipine on arterial stiffness in hypertensive individuals. Hypertension 28 (1996) 1081-1084
55. Sasaki M., Oki T., Iuchi A., Tabata T., Yamada H., Manabe K., et al. Relationship between the angiotensin converting enzyme gene polymorphism and the effects of enalapril on left ventricular hypertrophy and impaired diastolic filling in essential hypertension: M-mode and pulsed Doppler echocardiographic studies. J Hypertens 14 (1996) 1403-1408