Aggrenox®

Filipinos Headache Study

Tolerance Study among Filipinos on Acetylsalicylic Acid and Dipyridamole

Background and purpose

This study was done to document the frequency, severity and pattern of headache experienced by Filipino patients given combination of acetylsalicylic acid and dipyridamole in order for physicians to assess practicability of high-dose dipyridamole in the secondary prevention of stroke.

Methods

Open non-comparative study carried out among 105 Filipinos, 18 years old or above with transient ischaemic attack or completed stroke within past three months. Patients with history of peptic ulcer disease, gastrointestinal bleeding or hypersensitivity to study drugs were excluded. Subjects were given 25 mg of acetylsalicylic acid and 200 mg of dipyridamole twice a day for 2 weeks. Number of dropouts due to headache was the primary outcome measure. Incidence, severity, duration and timing of headaches and the need for an analgesic were documented in patients’ diary. Evaluation was done after 7 and 14 days of treatment.

Characteristics of Study Patients

One hundred and five patients with mean age of 56 years participated in the study. Sixty five percent were male. Baseline characteristics of patients included in the study are shown in the table.

(N=105)
Mean age (s.d.) in years 56 (11)
Sex, percentage of male: female 65 : 35
Mean weight (s.d.) in kg 62 (9.6)
Diagnosis
Transient ischaemic attack 6%
Stroke 94%
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