Revue neurologique · 2026
Real-world assessment of effectiveness and safety of candesartan in migraine prevention: Results of the French FHU InovPain registry.
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Ferrao-Malheiro S, Fabre R, Lanteri-Minet M
Аннотация
BACKGROUND: Candesartan is recommended for migraine prevention, but real-world data on effectiveness, persistence of response, and titration tolerability across episodic migraine (EM) and chronic migraine (CM) and treatment lines are limited.
METHODS: We analyzed consecutive adults starting candesartan for migraine prevention in the prospective French FHU InovPain registry. Visits occurred at month 3 (M3), month 9 (M9), and month 15 (M15). The primary endpoint was the M3≥50% responder rate, defined as≥50% reduction from baseline in monthly migraine days (MMD). The main analysis used a modified intention-to-treat/last-observation-carried-forward approach (modified ITT/LOCF; n=183), including patients who discontinued candesartan before M3 because of treatment-emergent adverse events as non-responders. Observed-case analyses were supportive. Exploratory analyses assessed EM versus CM, CM-to-EM conversion, and outcomes according to prior preventive exposure.
RESULTS: In the modified ITT/LOCF analysis, 77/183 patients achieved a≥50% MMD reduction at M3 (42.1 [95% CI 35.2;49.3]%). In a fully conservative analysis including all candesartan initiators, the M3≥50% responder rate was 77/207 (37.2 [30.9;44.0]%). In the observed-case analysis, 77/163 patients achieved≥50% response (47.2 [39.7;54.9]%). Mean MMD decreased from 14.1 to 9.7 and MHD from 17.3 to 11.2 at M3 (both P<0.001). Among patients remaining on treatment and under follow-up, observed-case≥50% responder rates were 75.6% at M9 and 78.9% at M15; these estimates reflect persistence of response among treatment continuers rather than population-level response rates. Corresponding modified ITT/LOCF≥50% responder rates were 44.8% and 43.2%. At M3, ≥50% responder rates were higher in EM than CM (66.2% vs. 31.5%), while 43.8% of baseline CM patients no longer met CM criteria. Outcomes were similar in prophylaxis-naive and previously treated patients. Treatment-attributed adverse events occurred in 29.0% and led to discontinuation in 15.8%, mainly during early titration. Systolic blood pressure decreased modestly, whereas diastolic blood pressure remained stable.
CONCLUSIONS: In this real-world observational cohort, candesartan was associated with clinically meaningful reductions in migraine burden by M3, including in conservative modified ITT/LOCF analyses. Longer-term observed-case data suggested persistence of response among treatment continuers, but should not be interpreted as population-level effectiveness. These findings support candesartan as a pragmatic oral preventive option across migraine phenotypes, while highlighting the need for cautious interpretation of observational data and for prospective comparative studies.
METHODS: We analyzed consecutive adults starting candesartan for migraine prevention in the prospective French FHU InovPain registry. Visits occurred at month 3 (M3), month 9 (M9), and month 15 (M15). The primary endpoint was the M3≥50% responder rate, defined as≥50% reduction from baseline in monthly migraine days (MMD). The main analysis used a modified intention-to-treat/last-observation-carried-forward approach (modified ITT/LOCF; n=183), including patients who discontinued candesartan before M3 because of treatment-emergent adverse events as non-responders. Observed-case analyses were supportive. Exploratory analyses assessed EM versus CM, CM-to-EM conversion, and outcomes according to prior preventive exposure.
RESULTS: In the modified ITT/LOCF analysis, 77/183 patients achieved a≥50% MMD reduction at M3 (42.1 [95% CI 35.2;49.3]%). In a fully conservative analysis including all candesartan initiators, the M3≥50% responder rate was 77/207 (37.2 [30.9;44.0]%). In the observed-case analysis, 77/163 patients achieved≥50% response (47.2 [39.7;54.9]%). Mean MMD decreased from 14.1 to 9.7 and MHD from 17.3 to 11.2 at M3 (both P<0.001). Among patients remaining on treatment and under follow-up, observed-case≥50% responder rates were 75.6% at M9 and 78.9% at M15; these estimates reflect persistence of response among treatment continuers rather than population-level response rates. Corresponding modified ITT/LOCF≥50% responder rates were 44.8% and 43.2%. At M3, ≥50% responder rates were higher in EM than CM (66.2% vs. 31.5%), while 43.8% of baseline CM patients no longer met CM criteria. Outcomes were similar in prophylaxis-naive and previously treated patients. Treatment-attributed adverse events occurred in 29.0% and led to discontinuation in 15.8%, mainly during early titration. Systolic blood pressure decreased modestly, whereas diastolic blood pressure remained stable.
CONCLUSIONS: In this real-world observational cohort, candesartan was associated with clinically meaningful reductions in migraine burden by M3, including in conservative modified ITT/LOCF analyses. Longer-term observed-case data suggested persistence of response among treatment continuers, but should not be interpreted as population-level effectiveness. These findings support candesartan as a pragmatic oral preventive option across migraine phenotypes, while highlighting the need for cautious interpretation of observational data and for prospective comparative studies.