CandeSpartan Study. Candesartan Spanish Response-prediction and Tolerability Study

Launched by HOSPITAL CLÍNICO UNIVERSITARIO DE VALLADOLID · Oct 22, 2019

Keywords

ClinConnect Summary

CandeSpartan Study Candesartan Spanish Response-prediction and Tolerability study

Observational study on response predictors and tolerability of Candesartan in usual clinical practice

INTRODUCTION:

Migraine is a neurological disease with a prevalence of 14% of the population 1, 2. It is the second most disabling disease in terms of years of life lived with disability, especially in the age group between 15 and 49 years3. Migraine is also the headache the most frequently seen in neurology consultations and headache units4.

Since the 1970s, numerous preventive drugs have been developed. O...

Gender

ALL

Eligibility criteria

• Inclusion criteria:
• • Diagnosis of migraine (episodic or chronic) according to the International Classification of headache Disorders (ICHD), 3rd version, criteria10.
• • Being treated with Candesartan under the criteria of the physician and according to local guidelines.
• • Age \>18 years. More than 4 days of headache per month in the preceding 3 months. More than 1 year of migraine evolution. Beginning of migraine before the age of 50. Ability to provide informed consent.
• Exclusion criteria:
• • Previous failure of three or more preventive drugs in accordance with the definition provided below.
• • Concomitant use of another preventive drug or use of it in less than 5-half lives of the drug.
• • History of another active primary headache with a periodicity considered frequent according to the International Classification of Headache disorders, that is, more than 10 days per month at the time of screening or the basal period.
• • Continuous or daily headache in the month prior to inclusion in the study. Pregnancy or breastfeeding. Any relevant cardiovascular conditions. Kidney diseases. Hyperkaliemia. Use of another concomitant preventive. Previous use of candesartan. Current use of another Angiotensin Conversing Enzime Inhibitor or Angiotensin-II receptor antagonist.
• • Alcoholism or drug use.
• Concomitant treatment:
• • The study will not interfere in the current practice, participants will receive the candesartan in the same manner and intensity if they were not enrolled in the study.
• • Patients will be allowed to use their usual symptomatic treatment as usual. The number of days of symptomatic treatment and the number of use of triptans will be reflected.
• • The concomitant drugs with potential use as a preventive according to National Clinical Practice guidelines (gabapentin, pregabalin, tricyclic antidepressants, duloxetine, valproic acid, phenytoin, lamotrigine, topiramate, botulinum toxin, anti-CGRP antibodies, beta-blockers, lisinopril) will not be permitted.
• • Treatment failure shall be defined as insufficient efficacy at a sufficient dose and for an adequate duration or withdrawal due to adverse effects of a drug present in the national headache guidelines.