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MS ID#: HYPERTENSION/2007/098475

EFFECTS OF CANDESARTAN COMPARED WITH AMLODIPINE IN HYPERTENSIVE PATIENTS WITH HIGH CARDIOVASCULAR RISKS: CASE-J TRIAL

Short Title: CASE-J: ARB vs. CCB for High-risk Hypertension

Authors: Toshio Ogihara1) M.D., Ph.D., Kazuwa Nakao2,3) M.D., Ph.D., Tsuguya Fukui4) M.D., Ph.D., Kohshiro Fukiyama5) M.D., Ph.D., Kenji Ueshima2) M.D., Ph.D., Koji Oba2) M.S., Tosiya Sato6) Ph.D., and Takao Saruta7) M.D., Ph.D., for the CASE-J Trial group

Affiliations:

1) Osaka University Graduate School of Medicine, Osaka, Japan

2) EBM Research Center, Kyoto University Graduate School of Medicine, Kyoto, Japan

3) Department of Medicine and Clinical Science, Kyoto University Graduate School of Medicine, Kyoto, Japan

4) St. Luke’s International Hospital, Tokyo, Japan

5) Japan Seaman’s Relief Association Moji hospital, Fukuoka, Japan

6) Department of Biostatistics, Kyoto University School of Public Health, Graduate School of Medicine, Kyoto, Japan

7) Keio University Graduate School of Medicine, Tokyo, Japan

Corresponding Author: Kazuwa Nakao, M.D., Ph.D.

Department of Medicine and Clinical Science and EBM Research Center, Kyoto University Graduate School of Medicine, Kyoto, Japan

54 Shogoin-Kawaracho, Sakyo-ku, Kyoto, 606-8507

Tel: 81-75-751-3168; Fax: 81-75-761-1195; E-mail:
Online Supplement

TABLE S1. Adverse events*

Adverse events / Candesartan
(n=2,333) / Amlodipine
(n=2,327) / P value†
Dizziness / 64 (2.7%) / 52 (2.2%) / 0.266
Headache / 26 (1.1%) / 26 (1.1%) / 0.991
Vomiting / 25 (1.1%) / 32 (1.4%) / 0.345
Palpitations / 40 (1.7%) / 30 (1.3%) / 0.288
Coughing / 30 (1.3%) / 20 (0.9%) / 0.158
Malaise / 28 (1.2%) / 23 (1.0%) / 0.488
Hot flush / 0 (0.0%) / 4 (0.2%) / 0.045
Edema / 26 (1.1%) / 35 (1.5%) / 0.241
Red cell decreased / 39 (1.7%) / 43 (1.8%) / 0.646
Haematocrit decreased / 33 (1.4%) / 45 (1.9%) / 0.166
White blood cell increased / 28 (1.2%) / 33 (1.4%) / 0.512
Serum ALT increased / 48 (2.1%) / 57 (2.5%) / 0.366
AL-P increased / 19 (0.8%) / 36 (1.5%) / 0.020
BUN increased / 39 (1.7%) / 37 (1.6%) / 0.827
Serum creatinine increased / 45 (1.9%) / 51 (2.2%) / 0.526
Serum colesterol increased / 25 (1.1%) / 37 (1.6%) / 0.122
Triglycerides increased / 36 (1.5%) / 42 (1.8%) / 0.485
Sugar fasting blood level increased / 26 (1.1%) / 31 (1.3%) / 0.498
Potassium increased / 23 (1.0%) / 8 (0.3%) / 0.007
Urinary protein positive / 19 (0.8%) / 30 (1.3%) / 0.112
Pneumonia / 3 (0.1%) / 12 (0.5%) / 0.020

*Participants were grouped according to the treatment that they actually received. Incidences > 1% in one of the treatment groups and P values < 0.05 are listed. Data are the number of patients (%).

†P values were obtained using χ2 tests.

2