Clinical trial NCT00437775: ACEIs and ARBs Treatment in Diabetic Patients -Drug Interactions and Adverse Drug Effects
Official title: Angiotensin Converting Enzyme Inhibitors & Angiotensin Receptor Blocker in the Treatment of Type 2 Diabetic Patients Adverse Drug Effects and Drug Interactions- a Survey in an Internal Medicine Department.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetes Mellitus Type 2
Keywords: Diabetes Mellitus type 2
ACE Inhibitors
ARBs
Adverse drug effect
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2007-02-21
Enrollment: 300
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: Proteinuria is an expression of diabetic nephropaty in type 1 and type 2 patients. Hypertenshion treatment and decreasing urine protein excretion, slow down renal deterioration. Treating diabetic ,hypertensive patients with Angiotensin Converting Enzyme inhibitors (ACEi), Angiotensin receptor blockers (ARBs)is common practice. The aim of our work is to examine 1.The prevalence of ACE and ARB treatment in diabetic patients with or without hypertension.2. Adverse drug reactions of ACEi and ARBs alone or in combination.

Detailed description: The study group- men and women with diabetes mellitus type 2,who were hospitalized in the department of internal medicine in Assaf- Harofeh Medical Center.

During hospitalization, data regarding the clinical history,chronic diseases and drugs were collected from the medical files. Blood tests results were recorded during hospitalization .The patients were asked about adverse drug effects.

Eligibility criteria: Inclusion Criteria:

* Type 2 diabetic patients admitted to department of Internal Medicine in Assaf Harofeh Medical Center

Exclusion Criteria:

* Type 1 diabetes mellitus

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Zerifin
country: Israel
facility: Assaf Harofeh Medical Center
Study officials:
affiliation: Sackler School of Medicine, Tel-Aviv University
name: Ahuva Golik, Assoc. Prof.
role: STUDY_DIRECTOR
affiliation: Assaf-Harofeh Medical Center
name: Alina Alperovich, B.Pharm
role: PRINCIPAL_INVESTIGATOR
affiliation: Assaf-Harofeh Medical Center
name: Lila Akivison, MSc.Pharm
role: STUDY_CHAIR
affiliation: Assaf-Harofeh Medical Center
name: Sofia Berkovitch, MSc. Pharm
role: STUDY_CHAIR
affiliation: Assaf- Hrofech Medical Senter
name: Gabby Elbaz, MD
role: STUDY_CHAIR
References:
citation: Winkelmayer WC, Zhang Z, Shahinfar S, Cooper ME, Avorn J, Brenner BM. Efficacy and safety of angiotensin II receptor blockade in elderly patients with diabetes. Diabetes Care. 2006 Oct;29(10):2210-7. doi: 10.2337/dc06-0570.
citation: Andros V, Egger A, Dua U. Blood pressure goal attainment according to JNC 7 guidelines and utilization of antihypertensive drug therapy in MCO patients with type 1 or type 2 diabetes. J Manag Care Pharm. 2006 May;12(4):303-9. doi: 10.18553/jmcp.2006.12.4.303.
citation: Burnier M, Zanchi A. Blockade of the renin-angiotensin-aldosterone system: a key therapeutic strategy to reduce renal and cardiovascular events in patients with diabetes. J Hypertens. 2006 Jan;24(1):11-25. doi: 10.1097/01.hjh.0000191244.91314.9d.