Postmarketing surveillance of adverse drug reactions: A correlational study approach using multiple data sources

Pharmacoepidemiology and Drug Safety

Volumn 7, Issue 1, 1998, Pages 51-57

  Rathmann, W ^a,c   Haastert, B ^a   Delling, B ^b   Gries, F A ^a   Giani, G ^a  

^a HEINRICH HEINE UNIVERSITY   (Germany)

^b Institute for Medical Statistics   (Germany)

^c LEIBNIZ CENTER FOR DIABETES RESEARCH AT HEINRICH HEINE UNIVERSITY DÜSSELDORF   (Germany)

Author keywords

Alpha lipoic acid; Diabetes mellitus; Pharmacoepidemiology; Postmarketing surveillance; Prescription drug use; Thioctic acid

Indexed keywords

THIOCTIC ACID;

ADULT; AGED; ARTICLE; DATA BASE; DIABETIC NEUROPATHY; DRUG MONITORING; FEMALE; HUMAN; INTRAVENOUS DRUG ADMINISTRATION; MAJOR CLINICAL STUDY; MALE; ORAL DRUG ADMINISTRATION; PHARMACOEPIDEMIOLOGY; POSTMARKETING SURVEILLANCE; PRIORITY JOURNAL; SIDE EFFECT;

EID: 0031886141     PISSN: 10538569     EISSN: None     Source Type: Journal    
DOI: 10.1002/(SICI)1099-1557(199801/02)7:1<51::AID-PDS319>3.0.CO;2-B     Document Type: Article

References (17)

1. Lenler-Petersen, P., Hansen, D., Andersen, M., Toft Sorensen, H. and Bille, H. Drug-related fatal anaphylactic shock in Denmark 1968-1990. A study based on notifications to the committee on adverse drug reactions. Journal of Clinical Epidemiology 1995; 48: 1185-1188.
2. Dukes, M. N. G. (Ed.). Drug Utilization Studies. Methods and Uses. WHO Regional Publications, European Series, No. 45, 1993.
3. Jick, H., Miettinen, O. S., Shapiro, S., Lewis, G. P., Siskind, V. and Slone, D. Comprehensive drug surveillance. Journal of the American Medical Association 1970; 213: 1455-1460.
4. Gifford, L. M., Aeguie, M. E., Myerson, R. M., et al. Cimetidine postmarket outpatient surveillance program. Journal of the American Medical Association 1980; 243: 1532-1535.
5. Herings, R. M. C., Bakker, A., Stricker, B. H. C. and Nap, G. Pharmaco-morbidity linkage: a feasibility study comparing morbidity in two pharmacy based exposure cohorts. Journal of Epidemiology and Community Health 1992; 46: 136-140.
6. Ray, W. A. and Griffin, M. R. Use of medicaid data for pharmacoepidemiology. American Journal of Epidemiology 1989; 129: 837-849.
7. Jick, H., Madsen, S., Nudelman, P. M., et al. Postmarketing follow-up at Group Health Cooperative of Puget Sound. Pharmacotherapy 1984; 4: 99-100.
8. Schwabe, U. and Paffrath, D. (Eds). Arzneiverordnungsreport '95. G. Fischer, Stuttgart, 1995.
9. Harris, M., Eastman, R. and Cowie, C. Symptoms of sensory neuropathy in adults with NIDDM in the US population. Diabetes Care 1993; 16: 1446-1452.
10. Ziegler, D., Hanefeld, M., Ruhnau, K.J., et al. Treatment of symptomatic diabetic peripheral neuropathy with the anti-oxidant α-lipoic acid. A 3-week multicentre randomized controlled trial (ALADIN Study). Diabetologia 1995; 38: 1425-1433.
11. Ziegler, D., Schatz, H., Conrad, F., Gries, F. A., Ulrich, H., The DEKAN Study Group and Reichel, G. Effects of treatment with the antioxidant α-lipoic acid on cardiac autonomic neuropathy in NIDDM patients. A 4-month randomized controlled multicenter trial (DEKAN study). Diabetes Care 1997; 20: 369-373.
12. Wessel, K. Personal communication, 1995.
13. Bundesanzeiger, Monographie: Alpha-Liponsäure. Nr. 205, 1990.
14. Schwabe, U. and Paffrath, D. (Eds). Arzneiverordnungsreport '94. G. Fischer, Stuttgart, 1994.
15. Schwabe, U. and Paffrath, D. (Eds). Arzneiverordnungsreport '96. G. Fischer, Stuttgart, 1996.
16. ASTA Medica. Adverse Event Report (Integrated Summary of Safety), 1995.
17. Jacob, S., Henriksen, E. J. and Schiemann, A. L. Enhancement of glucose disposal in patients with Type 2 diabetes by alpha-lipoic acid. Arzneimittel-Forschung/Drug Research 1995; 45: 872-874.