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Abstract

Background

Migraine is a prevalent neurological disorder affecting 14% to 29% of the Indian population, with significant regional variations. The selection of pharmacological agents for the acute management of migraine remains largely subjective, guided by individual patient preferences, economic considerations, and an empirical, trial-and-error approach. Although international guidelines are frequently referenced by neurologists in India, they provide limited direction on essential considerations such as medication tolerability, management of comorbid conditions, and patient-centered outcomes including satisfaction, restoration of functional ability, and individual preferences. Clinical approaches to acute migraine management differ widely, especially in the utilization of triptans and the criteria employed to determine insufficient therapeutic response. These consensus statements aim to establish a standardized framework for defining response assessment criteria and inadequate response to acute migraine therapy within the Indian clinical context.

Methods

A modified Delphi method was employed to develop consensus-based recommendations for defining response assessment criteria and inadequate response to acute migraine therapy in India. Statements were drafted following a literature review, and a steering committee of headache experts validated them using the Content Validity Index (CVI) for clinical relevance and clarity. Statements scoring >0.80 were deemed valid. The Delphi round involved a larger group of neurologists to achieve consensus, with statements achieving >75% consensus included in the final consensus.

Results

Fifteen statements were drafted under five themes: treatment response assessment criteria and timepoint, defining non-response to therapy, triptan usage, tolerability, and comorbidities. The steering committee validated these statements. A CVI score of 0.80 was achieved for 11 statements; four were modified, and one was added. A Delphi round with 19 headache experts helped achieve consensus (>75%) on 14/16 statements, with strong agreement on early treatment initiation, nasal triptan use in patients with nausea, and markers for inadequate response. The panel emphasized caution in prescribing NSAIDs and triptans to patients with comorbid conditions.

Conclusion

These consensus statements provide the first India-specific framework to standardize acute migraine care, reduce practice variability, and guide future research and health policy.

Graphical abstract

This is a visual representation of the abstract.

Keywords

migraine tolerability triptans triptan cycling comorbidities

Introduction

Migraine is a debilitating neurological disorder that affects approximately 1.16 billion individuals worldwide, accounting for 14.7% of the global population.^1,2 In India, the prevalence of migraine was recorded at 14.9% in 2021,¹ with significant regional variations. Community-based studies report prevalence rates ranging from 14.1% to 25.2% across the country.^3–5 Hospital-based studies indicate even higher prevalence rates, with 29% in Rajasthan³ and 67.7% in North India among primary headache patients.⁴ The high prevalence in India, underscores the severity of migraine as a public health concern, while the main challenge lies in providing acute therapy using non-steroidal anti-inflammatory drugs (NSAIDs), acetaminophen, and migraine-specific medications, such as triptans, ditans, and calcitonin gene-related peptide (CGRP)-targeting drugs.^5,6 However, selecting a drug for acute attack remains predominantly subjective, influenced by factors such as patient preference, cost considerations, and a trial-and-error approach.⁵

As many as 50% of individuals suffering from migraine may not achieve complete relief from acute medications.⁵ This inadequate response can lead to medication overuse, increased healthcare utilization, and an elevated risk of developing chronic migraine.^5,7 Quick and effective pain control is important for lowering disability and improving quality of life.^6,8 Guidelines for managing acute migraine attacks have been issued by the International Headache Society (IHS),⁶ American Headache Society (AHS),⁹ European Headache Federation (EHF),¹⁰ and several other headache societies.^11–13 However, they offer limited direction on important aspects such as tolerability, comorbidities, and patient-centered outcomes, including satisfaction, functional recovery, and patient preference.

Data collected from Indian neurologists reveal considerable differences in clinical practice, particularly regarding triptan usage and the criteria used for identifying insufficient responses to medications. Many specialists advocate using one triptan for three to four migraine attacks before considering a switch, often if two formulations have not been helpful with inadequate response observed in 10% to >30% individuals. These findings emphasize the lack of defined criteria for assessing treatment outcomes. To address these gaps, expert consensus statements have been formulated utilizing a modified Delphi method. These statements provide clinically relevant and patient-centered definitions of therapeutic response (or inadequate response), as well as recommendations for triptan use, medication tolerance, and comorbidity management. The objective is to establish standardized practices, improve outcomes, and support future research and policy regarding acute migraine treatment.

Methods

Study design and participants

This study utilized a modified Delphi model to achieve consensus on response evaluation criteria and definitions of inadequate response to acute migraine therapy in India, conducted over three rounds from 1st April to 15th June 2025.

A thorough search of PubMed and Embase databases (2011–2025) was initiated, focusing on English-language publications, to identify global and Indian-specific knowledge gaps in acute migraine management, using a detailed search string (Supplementary S1). The targeted literature screening was conducted to inform initial statement development for the Delphi process; this was not intended as a systematic review and therefore PRISMA guidelines were not applied. Drafted statements were presented by the study lead to a steering committee (SC) of six headache specialists. To ensure comprehensive representation of clinical expertise and regional diversity, the SC members were identified from a predefined cohort of headache specialists affiliated with the provisional Headache Society of India (HSI) and have at least one peer reviewed publication, employment at a headache or neurology center or have been invited experts at national and international headache forums. The SC validated statements and ensured adherence to the methodological approach. All SC members and panelists provided informed consent to be a part of the study.

The sampling frame included neurologists experienced in migraine management from various regions of India, purposively selected for diverse clinical practices. Of 21 neurologists approached, 19 participated, who were randomly selected and contacted through email to participate in the study. Geographic and practice-related diversity was prioritized to enhance consensus relevance. Panelists represented private, institutional, and governmental hospital practices throughout India. The panel size, consistent with previous studies involving 10 to 20 experts, was deemed sufficient for validity and diverse perspectives.

Data collection

The Delphi process comprised of three rounds:

Round 1: A targeted literature review guided the drafting of 15 preliminary statements across five different areas: (i) treatment response assessment and timepoints, (ii) defining non-response, (iii) triptan cycling, (iv) tolerability, and (v) comorbidities. The SC reviewed and refined these statements. (April 2025)

Round 2: Validation by the steering committee (11^th May 2025)—The SC used the Content Validity Index (CVI) rating scale to evaluate the statement's clarity and relevance. The rating scale was as follows: 1 = not clear/relevant, 2 = somewhat clear/relevant, 3 = quite clear/relevant, and 4 = very clear/relevant. A CVI value of ≥ 0.80 indicates that the statements are both clear and relevant (Bull et al.).¹⁴ Statements that did not meet this criterion were revised or eliminated. Revised statements were sent back to the SC for inputs and validation.

Round 3: Final statements were distributed to all 19 participants electronically (25th May–15th June). A consensus was considered when there was ≥75% agreement among the respondents. The statement that failed to satisfy this criterion underwent further discussion and revision.

The Delphi survey was conducted entirely online, utilizing secure platforms to facilitate participation.

Data management and analysis

The 19 experts answered a survey consisting mostly of closed-ended questions and chose their favorite alternative from a list of options, which were collected and processed quantitatively to compute the average agreement score for each statement. A consensus criterion of ≥75% agreement was established based on the Delphi approach and research by Anukoolwittaya et al. (2025). Statements with <75% agreement required further discussion and modification, while those reaching this level were kept.

Results

In the first validation round, 15 draft statements were developed under the study lead's guidance (Figure 1). The SC evaluated these, with 11 statements surpassing the CVI score of 0.80. Four statements were revised after further SC discussions, and an additional statement (Statement 1) was added regarding treatment response evaluation criteria and time points. Following feedback from the SC and revisions, 16 statements were finalized. Of the 21 experts identified, 19 consented to participate in the Delphi procedure. These finalized statements were circulated for the Delphi round, where experts rated and commented via an online survey. Consensus was defined as ≥75% agreement.

Figure 1.

A modified Delphi method was adopted to develop consensus-based recommendations for defining response assessment criteria and inadequate response to acute treatment of migraine in India.

Figure 2 illustrates the consensus statement development process. Fourteen of the 16 statements met the consensus threshold (>75%) (Table 1), with six achieving full consensus (100%), including themes on function restoration within 2 hours post-treatment, inadequate response to acute therapy, and triptan contraindications.

Figure 2.

Summary of consensus statement development method.

Table 1.

Expert consensus recommendations on response assessment and inadequate response in acute migraine attack.

Theme	Statement	Agreement n (%)
I. Treatment response assessment criteria and timepoints	1. Patients with migraine (with/without aura) should take treatment as soon as the headache phase starts.	18 (94.7%)
	2. Response to acute migraine therapy should be assessed based on pain freedom at 2 hours post-dose.	10 (52.6%)
	3. Response can be assessed by the ability to restore function within 2 hours of treatment.	19 (100%)
II. Defining non-response to therapy in acute migraine	4. Headache recurrence and need for rescue medication within 24 hours (no sustained pain relief) is a valid marker of non-response.	15 (78.9%)
	5. Lack of efficacy with appropriate oral treatment (right dose, right time) in ≥2 of 3 attacks is a marker of inadequate response.	19 (100%)
	6. Lack of efficacy after switching formulations within the same drug class (e.g., oral to nasal triptan) in ≥2 episodes is a marker of inadequate response.	18 (94.7%)
	7. Lack of efficacy after switching to a new drug class in ≥2 of 3 episodes is a marker of inadequate response.	19 (100%)
III. Triptan cycling	8. A patient is defined as a triptan non-responder if they fail to respond to 2 triptans (as monotherapy or in combination with analgesics/anti-emetics).	17 (89.5%)
III. Triptan cycling	9. A trial with nasal triptans is advisable in patients with nausea and/or vomiting.	18 (94.7%)
IV. Tolerability	10. Patients with good pain relief after abortive treatment who experience mild adverse events (not requiring medical intervention) may continue therapy unless adverse events worsen in severity or frequency.	18 (94.7%)
	11. Patients with good pain relief but moderate or severe adverse events (requiring medical intervention) should switch to an alternate therapy class.	9 (47.4%)
	12. Patients with cardiovascular adverse events while on triptans should switch to an alternate therapy class for subsequent episodes.	19 (100%)
	13. Patients with CNS adverse events while on triptans should switch to an alternate therapy class for subsequent attacks.	17 (89.5%)
V. Comorbidities and acute migraine management	14. Patients with peptic ulcer disease or kidney disease should not receive NSAIDs for acute migraine management.	18 (94.7%)
	15. Patients with a history of hypertension, CAD, myocardial infarction, or other cardiovascular comorbidities should not receive triptans.	19 (100%)
	16. Patients with peripheral vascular disease (venous or arterial disease) should not receive triptans or ergots.	19 (100%)

Two statements did not reach consensus: defining treatment response as pain freedom versus relief at 2 hours and managing patients who experienced good relief from abortive treatment but with moderate-to-severe adverse effects (AEs). Despite not meeting the ≥75% threshold, these were retained for their clinical relevance and expert panel recommendations. Detailed rationale for each recommendation is in the discussion section.

Discussion

International guidelines for migraine management often overlook the specific needs of diverse populations, especially in India, where cultural, socioeconomic, and healthcare infrastructure factors differ. To address these discrepancies, a panel of Indian headache experts used a modified Delphi methodology to establish patient-centered criteria for defining treatment response and inadequate response to therapy in acute migraine management. Consensus was reached on 14 statements across five domains: treatment response assessment, non-response to therapy, triptan cycling, tolerability, and comorbidities. There was strong agreement on early treatment initiation, using nasal triptan formulations for patients with nausea, and identifying markers for inadequate response. The panel advised caution in prescribing NSAIDs and triptans for patients with comorbid conditions. These consensus statements provide the first India-specific framework to standardize acute migraine care, reduce variability in practice, and guide future research and health policy.

Theme I: Treatment response assessment criteria and timepoints

Recommended time to take the prescribed treatment

Statement 1.

In our study, 94.7% of experts agree that individuals experiencing migraine, whether accompanied by aura or not, should initiate their treatment as soon as the headache phase starts.

The IHS recommends that patients with migraine without aura start treatment while the pain is mild, and those with aura should begin treatment at the headache phase onset. Pathophysiological evidence supports this, as cutaneous allodynia (CA), a marker of central sensitization, affects up to 60% of migraineurs and 90% of those with chronic migraine.¹⁵ Allodynia reduces response to medications like triptans, NSAIDs, opioids, and barbiturates.¹⁵ Early triptan intervention has been found to be more effective before allodynia develops, preventing central sensitization.^15,16

“Act when Mild” (AwM) study and PRODROME trial supports early treatment.^17,18 Almotriptan during mild pain increased pain-free rates in AwM,¹⁷ whereas ubrogepant during the prodrome phase decreased headache onset and impairment in PRODROME.¹⁸ Gepants offer an advantage as they are not linked to medication overuse headache, supporting safe early use.^19,20

Several studies have confirmed that administering triptans early improves effectiveness. Taking sumatriptan, rizatriptan, almotriptan, zolmitriptan, or eletriptan at mild pain stages enhances pain relief, reduces rescue medicine need, and improves outcomes compared to delayed therapy.^21–30 The TEMPO study showed early triptan dosing led to more patients achieving pain freedom at 2 hours (52.8% vs. 30.2%).²¹

In conclusion, starting acute migraine treatment at the headache phase onset enhances effectiveness, reduces central sensitization risk, and decreases reliance on rescue medications.

Treatment response assessment criteria: pain and return to function

Statement 2.

Response to acute migraine therapy should be assessed based on pain freedom/pain relief at 2 hours post-dose.

Statement 3.

Response can be assessed by the ability to restore function within 2 hours of treatment.

Freedom from pain at 2 hours post-dose is the gold standard for acute migraine treatments, endorsed by the IHS, US-FDA, and EMA.^31–33 Early pain relief is linked to increased patient satisfaction and reduced need for rescue medication.^34–36 Satisfaction correlates with pain relief; over 90% of patients achieving pain freedom at 2 hours report high satisfaction, while satisfaction is lower among those with mild or moderate pain.³⁶ In our study, slightly more than half of the experts identified pain freedom as the primary goal, whereas others considered pain relief acceptable. Consensus was reached on restoring function at 2 hours as a key response indicator, highlighting therapy assessment complexity due to clinical experience variations and patient expectations.

Achieving pain freedom within 2 hours is ideal, but pain relief with functional recovery is a practical objective. The EHF guidelines emphasize pain relief and symptom management, with pain reduction as a reasonable goal.³⁷ The French headache society guidelines propose pain freedom within 2 hours as a primary goal, with significant pain relief as an acceptable goal.¹² The guidelines also emphasize the relief of associated symptoms and the ability to resume activities.¹² The AHS also outlines patient-centered goals, including consistent pain freedom, functional recovery, reduced resource use and minimal adverse events.³⁸

Patient-reported outcomes highlight that nausea, photophobia, phonophobia, and ability to function are as relevant as pain.^39,40 Migraine is linked to cognitive challenges, including difficulties with memory, attention, and slower processing speed.⁴¹ Consequently, regulatory authorities advocate most bothersome symptoms (MBS) as a co-primary goal alongside pain freedom for clinical trials.^31,32 Real-world evidence supports a multidimensional approach to migraine treatment. The rimegepant study demonstrated that 32.1% of patients achieved pain freedom at 2 hours, approximately 50% experienced pain relief, and 59% were able to return to everyday activities.⁴² The COURAGE (ubrogepant ± onabotulinumtoxinA) study reported meaningful pain relief in 51.3% of patients and a return to normal function in 32.2% at 2 hours post-dose, emphasizing the significance of both pain relief and functional restoration.⁴³ Evaluating treatment effectiveness should align with patient expectations, considering factors like daily activity return, side effect minimization, and episode frequency reduction.^36,44–47 Integrating patient-reported outcomes balances clinical efficacy with real-world effectiveness, enhancing satisfaction and adherence.^44,48,49

In summary, while pain freedom within 2 hours is ideal, a comprehensive therapeutic response should include pain alleviation, function restoration, resolution of MBS and cognitive impairment, and patient preferences, improving satisfaction and adherence.

Theme II: Defining non-response to therapy in acute migraine

Statement 4. In our study, 78.9% of experts agree that headache recurrence or need for rescue medication within 24 hours (no sustained pain relief) is a valid marker of non-response

Sustained pain relief is defined as headache absence 2 hours post-dose, with no recurrence over 24 hours.^50,51 The EHF suggests including pain recurrence and rescue medication use in assessing acute medication response.³⁷ The IHS identifies sustained pain freedom and absence of other migraine symptoms at 24 or 48 hours as relevant outcomes.³¹ The US FDA recognizes the proportion of patients requiring additional medication within 24 hours as a secondary endpoint, supporting the use of these criteria as markers of non-response.³²

Houts et al. found that headache recurrence and rescue medication use are commonly used outcomes in studies, with 47.0% examining headache recurrence and 64.9% examining rescue medication use.³⁴ Malik et al. study showed that only 38.5% of patients achieved sustained pain relief, while 56.9% of patients experienced headache recurrence despite initial pain freedom.⁵² Santanello et al. found that patients with sustained pain freedom have the highest quality of life scores, 5–6 points higher than those with no relief. Pain-free patients without recurrence score 1–2 points higher than those who experience headache recurrence, while patients with headache relief but no recurrence score 2–3 points higher than those with recurrent migraine attacks.⁵³ These data affirm recurrence and rescue medicine use within 24 hours as indicators of non-response to acute migraine treatment.

Defining an inadequate response to acute migraine treatment

Statement 5.

Lack of efficacy with appropriate oral treatment (right dose, right time) in ≥2 of 3 attacks is a marker of inadequate response.

Statement 6.

Lack of efficacy after switching formulations within the same drug class (e.g., oral to nasal triptan) in ≥2 episodes is a marker of inadequate response.

Statement 7.

Lack of efficacy after switching to a new drug class in ≥2 of 3 episodes is a marker of inadequate response

The experts concurred with consensus statements 5 (100%), 6 (94.7%), and 7 (100%), defining inadequate response as failure to effectively respond to two out of three appropriately treated attacks, whether through oral formulation, a change within the same class, or a switch to a different class, respectively. This highlights the significance of consistency in acute therapy.^54,55 The EMA and IHS emphasize intra-patient consistency across various attacks as a key measure of treatment effectiveness.^31,33 They recommend that clinical trials should assess both immediate symptoms relief and the sustained pain freedom across multiple episodes as essential goals for migraine treatment.^31,33 The British, IHS, EHF, and the European Academy of Neurology (EAN) guidelines establish thresholds of two out of three attacks repeated over 2 or 3 drugs for transitioning to a different drug class.^11,56 Nierenburg et al. define consistent response as efficacy in at least 50% of treated attacks.⁵⁷ Placebo-controlled studies show that pain freedom in ≥2 of 3 attacks occurs in 14% to 42% of patients receiving a triptan, compared to 3% to 13% receiving placebo.⁵⁴ These studies support the consensus that a consistent lack of response in 2 out of 3 attacks is a reliable indicator of treatment inadequacy.

Theme III: Triptan cycling

Defining triptan non-responders

Statement 8.

In our study, 89.5% of experts agree that a patient is defined as triptan non-responder with failure to respond to 2 triptans (either as monotherapy or in combination with analgesics and/or anti-emetics).

Despite their role in acute migraine therapy, 30% to 40% of patients fail to achieve satisfactory outcomes with triptans due to inadequate efficacy or tolerability.^57,58 Approximately 30–60% do not experience a 2-hour response, and up to 40% relapse after initial pain freedom.⁵⁹ Response is influenced by route of administration and timing of intake relative to attack onset.^57,60,61

The lack of efficacy of a single triptan does not imply a failure of the entire class, as people can demonstrate positive responses to alternative agents.^39,62 Those with inadequate triptan response or tolerability often have more severe symptoms, higher frequency, and greater disability. Ruscheweyh et al. reported that 42.5% of those studied experienced failure with at least one triptan, while 13.1% had failure with two or more triptans.⁶⁰ The EHF categorizes triptan non-response as the inability to respond to one triptan, triptan resistance as the inability to respond to at least two, and triptan refractoriness as the inability to respond to three, including subcutaneous (SC) formulations. Contraindications indicate triptan ineligibility.³⁷ SC administration of sumatriptan has been identified to provide relief for acute episodes of cluster headaches.⁶³ It has been recognized as the most rapidly acting agent among the triptan class, reaching peak concentration (t_max) in 12 minutes and having an onset of action as early as 10 minutes. About 82% of patients experience headache relief within 2 hours. However, less than 10% of eligible migraine patients use SC sumatriptan, mainly due to its suboptimal tolerability profile.^64–67 The IHS suggests switching to another triptan if the first at appropriate dose, route, and timing, does not provide relief in two out of three attacks repeating up to three different triptans before considering a different drug class.⁶ Viana et al. suggest assessing triptan efficacy by achieving pain freedom at 2 hours in two out of three attacks.⁶⁸ This consensus defines non-response as failure with two triptans, aligning with clinical evidence. New options for triptan non-responders include ditans (5-HT-1F agonists) and gepants (CGRP receptor antagonists), such as lasmiditan and rimegepant.^37,69

Patient profile for nasal triptans

Statement 9:

A trial with nasal formulation of triptans is advisable in patients suffering with nausea and/or vomiting

Based on both evidence and clinical experience, 94.7% of experts in our study recommended nasal triptans for migraine patients with nausea and/or vomiting.^58,70 Studies report nausea in 60% to 95% and vomiting in 50% to 70% of patients. In the American Migraine Study II, 73% experienced nausea and 29% vomiting. Some studies indicate that nausea appears in over 90% of patients, with roughly a third getting it during each episode. Vomiting is observed in as many as 70% of cases, frequently occurring in recurrent episodes. These symptoms can impair drug absorption and hinder oral therapy. 30.5% of patients with nausea reported difficulty consuming oral migraine medication.⁷¹ Nausea and vomiting often occur concurrently with the onset of a headache, typically manifesting within an hour correlating with severity of migraine pain. SC sumatriptan is an effective abortive treatment for acute migraine attacks, providing rapid relief from pain as well as headache-associated symptoms such as nausea, photophobia, and phonophobia. Its efficacy in alleviating nausea makes it particularly beneficial for patients experiencing migraine with significant gastrointestinal symptoms.^63,67,72 For patients dealing with intense headaches or nausea and vomiting, subcutaneous sumatriptan is recommended due to its rapid onset of action.⁷³ Intranasal triptan formulations are an effective alternative for patients with nausea, vomiting, gastroparesis, rapidly progressing headaches, or poor response to oral agents. Clinical trials, including those by Lipton, et al., show nasal sprays are efficacious, well tolerated, and safe. Placebo-controlled trials confirm these benefits.^58,70 SC administration of sumatriptan is considered as the gold standard for rapid and highly effective relief of acute migraine, especially relative to intranasal formulations. It demonstrates superior efficacy and faster onset compared to the 20 mg intranasal spray, although its use is associated with a higher incidence of adverse events.^63,72 However, limited availability of nasal as well as subcutaneous formulations may restrict use for such patients. Considering an out-patient management for migraine in India, patients must bear the cost of treatment without any provision for reimbursement. This further limit the use of costlier nasal or subcutaneous formulations in a resource-limited country like India. Alternatively, injectable anti-inflammatory formulations/analgesics which are relatively cheap and easily available can be used in such cases with limitations for use of intranasal formulations.

Theme-4: Tolerability

Adverse events with acute treatment

Statement 10.

Patients with good pain relief after abortive treatment who experience mild adverse events (not requiring medical intervention) may continue therapy unless adverse events worsen in severity or frequency.

Majority of the experts (94.7%) concurred with the statement that for patients with good pain relief after abortive treatment, experiencing mild adverse events (not requiring medical intervention) may continue therapy unless adverse events worsen in severity or frequency. Migraine attacks occur on average 34 times per year in men and 37 times in women.⁷⁴ Most available therapies are not disease-specific, do not address underlying mechanisms, and can be limited by safety concerns, comorbidities, and tolerability issues, reducing compliance. Abortive treatments include nonspecific agents, such as analgesics (aspirin, NSAIDs, opioids), anti-emetics, sedatives, intranasal lidocaine, corticosteroids⁷⁵—and migraine-specific drugs such as ergotamine derivatives and triptans. The treatment should be tailored to the patient's tolerability, comorbidities, symptoms, frequency, and severity of the attack.

Mild AEs, often not necessitating medical intervention, are prevalent but should not lead to cessation unless they worsen in severity or frequency.^76–79 These findings emphasize continuing effective therapy despite mild AEs to prevent worsening of migraine burden ensuring adequate symptom control as per patient preference.

Statement 11.

Patients with good pain relief but moderate or severe adverse events (requiring medical intervention) should switch to an alternate therapy class.

In this study, only 47.4% of panelists agreed that patients with good pain relief after abortive therapy should continue treatment despite moderate or severe adverse events, especially non-cardiovascular adverse events, after managing the incident adverse events. Although consensus was not achieved, the statement was retained, reflecting real-world practice, shared decision making, and variability in physician comfort and treatment goals. Acute migraine can be managed through step care across attacks (starting with lower-cost or better-tolerated agents, escalating in future attacks), step care within attacks (beginning with simple analgesics and escalating within the same episode), or stratified care (tailoring initial therapy to attack severity). Evidence indicates that stratified care provides faster 2-hour relief but carries a higher risk of AEs. Step care within attacks may be most useful for prolonged or variable episodes.

NSAIDs are consistently more effective than placebo, though direct comparative trials are lacking. The choice of agent should therefore depend on availability and tolerability.⁷⁸ More broadly, therapy selection should be individualized, considering the severity, comorbidities, contraindications, and adverse effect profiles. Severe adverse events with acute migraine therapy are rare, though fatigue, dizziness, paresthesias, and chest tightness may occur, particularly with triptans. Balancing efficacy with tolerability remains central to optimizing patient outcomes through shared decision making to allow considerations for patient preference along with the physician's treatment goals.

Specific AEs of interest: CVS and CNS

Statement 12.

Patients with cardiovascular adverse events while on triptans should switch to an alternate therapy class for subsequent episodes.

Statement 13.

Patients with CNS adverse events while on triptans should switch to an alternate therapy class for subsequent attacks.

According to 89.5% of the experts, patients that experience cardiovascular adverse events or CNS adverse events while being on triptans, should switch to an alternate therapy class for subsequent attacks. Triptans and ditans (5-HT1B/1D/1F agonists) are commonly used as first-line therapy for acute migraine. They are contraindicated in patients with ischemic heart disease or a history of myocardial infarction and should be used cautiously in individuals with vascular risk factors,^59–61^,68,80 Although triptans cause minimal vasoconstriction of cerebral arteries in vivo, they remain contraindicated in patients with prior stroke or transient ischemic attack due to concerns about cerebral ischemia. Observational studies suggest that migraine with aura itself increases stroke risk, though whether triptans independently contribute remains debated. Based on these factors and expert clinical experience, 100% of the panel consensus supported discontinuation of triptans in patients with cardiovascular adverse events.

Because 5-HT1B/1D receptors are widely distributed throughout the central nervous system, triptans may also have AEs on the central nervous system.⁵⁹ Lipid solubility of some triptans and the disruption of the blood-brain barrier during a migraine attack may facilitate the penetration of anti-migraine drugs into the CNS. Reversible cerebral vasoconstriction syndrome has been reported with some agents.⁷⁴ Based on these considerations, 89.5% of panelists agreed that patients experiencing CNS AEs should avoid using triptans in subsequent attacks. Although generally non-serious, CNS adverse events such as dizziness, somnolence, or vertigo may be functionally limiting and influence treatment adherence. Given inter-triptan variability in CNS tolerability, recurrent or bothersome CNS effects may reasonably prompt a switch to an alternative acute therapy class.⁸⁰

Theme 5: Comorbidities and acute migraine management

NSAIDs/triptans/ ergots as a treatment option

Statement 14.

Patients with peptic ulcer disease or kidney disease should not receive NSAIDs for acute migraine management

Statement 15.

Patients with a history of hypertension, CAD, myocardial infarction, or other cardiovascular comorbidities should not receive triptans.

Statement 16.

Patients with peripheral vascular disease (venous or arterial disease) should not receive triptans or ergots.

Majority of the experts concurred with consensus statements 14 (94.7%), 15 (100%), and 16 (100%), which focused on the use of NSAIDs, triptans and ergots as a treatment plan in acute migraine patients with associated comorbidities. Multiple studies, indicate that individuals with migraine, especially those with aura has an elevated risk of ischemic stroke (relative risk 1.73–2.41) and adverse cardiovascular outcomes such as hypertension, myocardial infarction, angina, and atrial fibrillation (hazard ratios 1.37–1.49).⁸¹ A study from Hyderabad highlighted a highly significant association between migraine and any cardiovascular diseases [RR – 12.35(7.12–21.4)] in women.⁸² Controlled hypertension is generally associated with a reduced risk of migraine progression and severity, whereas uncontrolled hypertension is strongly linked to increased frequency, greater severity, and the potential transformation of episodic migraine into chronic daily headaches.^83,84 While long-standing controlled hypertension may be associated with a higher likelihood of migraine with aura, therefore, effective blood pressure management mitigates the risk of chronicity and severe migraine outcomes.^83,84 The triptan label does not clearly define “uncontrolled” hypertension; it simply notes that significant increases in blood pressure, including hypertensive crisis, have rarely been reported with serotonin (5-HT)1 agonists.^83–85 As a result, the interpretation of “uncontrolled” hypertension is often left to the prescriber's judgment.^83,84

NSAIDs pose significant risks for individuals with certain health conditions, including peptic ulcer disease, renal disease, and cardiovascular disease.⁸⁶ Additional risks include hypertension, bleeding, hypersensitivity (anaphylactoid reactions including skin and respiratory system), and hepatotoxicity. Concomitant use of strong CYP3A4 inhibitors further increase the risk of NSAID toxicity.⁸⁶ A thorough patient evaluation is essential before initiating NSAID therapy to weigh the benefits against these potential risks.

Triptans, despite their efficacy, are contraindicated in patients with ischemic vascular disease, vasospastic angina, uncontrolled hypertension, or cerebrovascular disorders due to their vasoactive effects.⁷⁵ Additionally, triptans have demonstrated both efficacy and safety across multiple clinical trials. However, because of their vasoconstrictive properties, they are contraindicated in individuals with uncontrolled hypertension, as well as those with coronary, cerebrovascular, or peripheral vascular disease. Recent meta-analyses have demonstrated the efficacy of gepants, including rimegepant and ubrogepant, in patients with an inadequate response to triptans or those who are unable to tolerate them. Based on these findings, the EHF consensus panel recommended gepants as a treatment option for patients who are ineligible, intolerant, or insufficient responders to triptans and other standard agents.³⁷ By contrast, ergotamine derivatives exhibit stronger vasoconstrictive properties, with risks of serious complications such as ergotism.⁸⁷ In agreement with these concerns, our study panel reached unanimous consensus not to recommend triptans or NSAIDs for acute migraine patients with insufficient response or relevant comorbidities.

Triptans and ergot alkaloids both treat migraine by causing vasoconstriction of cranial blood vessels, but differ in mechanism of action, receptor selectivity, and safety profiles. However, ergots have a higher risk profile due to their prolonged and widespread peripheral vasoconstriction, whereas triptans act more selectively and has a shorter duration of action.^88–90 This study has several limitations, notably a small expert pool of 21 participants from four Indian zones, which may not fully represent the country's diversity. Although generalizability is limited, the consensus seeks to standardize migraine care nationwide. Future broader studies could strengthen these recommendations. Additionally, two statements did not reach the ≥75% consensus threshold but were retained for their clinical relevance and expert panel recommendations.

Conclusion

This expert consensus has defined response assessment criteria and inadequate response to therapy in acute migraine attack and may further help to establish uniform clinical practice in India which will further improve patient outcomes.

Public health relevance

A Delphi round with 19 headache experts helped achieve consensus on 14 statements.

The consensus statements were organized under five themes: treatment response assessment criteria and timepoint, defining non-response to therapy, triptan usage, tolerability, and comorbidities.

A standardized framework was established for defining response assessment criteria and inadequate response to acute migraine therapy within the Indian clinical context.

Supplemental Material

sj-docx-1-rep-10.1177_25158163261444610 - Supplemental material for Defining response assessment criteria and inadequate response in acute migraine attack: A Delphi expert consensus from headache experts in India

Supplemental material, sj-docx-1-rep-10.1177_25158163261444610 for Defining response assessment criteria and inadequate response in acute migraine attack: A Delphi expert consensus from headache experts in India by Debashish Chowdhury, K. Ravishankar, Sanjay Prakash, M.V. Francis, Sumit Singh, Girish Kulkarni, Sanjith Aaron, Ishan Patel, Ashish Bondia and Amod Madhav Tilak in Cephalalgia Reports

Footnotes

Acknowledgments

The authors would like to acknowledge Ms. Shrestha Priyadarsini (Medical Communications and Content Manager, IMCC, Pfizer (Asia) and Ms. Dimpal Thakkar Medical Communications and Content Specialist, IMCC, Pfizer (Asia) for their medical writing and editorial support in preparing this manuscript. Pfizer's generative artificial intelligence (AI) assisted technology, MAIA (Medical Artificial Intelligence Assistant) was used for language editing and refinement of this manuscript. All scientific content, analysis, and conclusions were independently developed by the authors.

Portions of this manuscript were presented at the 22nd Congress of the International Headache Society, Sao Paulo, Brazil, 10–13 September, 2025 (Poster ID: 1116622; Presentation ID - IHC25-LBAPO-053).

Permissions: No pre-published information/material was used in the development of this manuscript.

ORCID iDs

Debashish Chowdhury

Sanjay Prakash

Ishan Patel

Ashish Bondia

Amod Madhav Tilak

Ethical considerations

Ethics committee approval was not required for this study because it involved a Delphi consensus process with healthcare professionals providing expert opinion in a non-interventional context and without the collection of personal or patient-related data.

Consent to participate

Participation was voluntary, and informed consent was implied through completion of the Delphi rounds.

Consent for publication

The authors agree to transfer, assign, or otherwise convey all copyright ownership, including all rights incidental thereto, exclusively to Cephalalgia Reports journal.

Author contributions

Debashish Chowdhury and Amod Tilak conceptualized the study and finalized the methodology for the Delphi exercise. Amod Tilak undertook targeted literature search to identify themes for the consensus statements and compiled data. Subsequently, they worked with Debashish Chowdhury to formulate the statements. Ishan Patel is a former Pfizer employee and was involved in conceptualizing and designing the study, targeted literature search to identify themes for the statements and thoroughly reviewing the manuscript including the latest draft prepared for submission. All authors contributed to finalizing the statements based on clarity and clinical relevance. After the Delphi rounds, all authors contributed to analysis and interpretation of the results. Dr Sanjay Prakash prepared the initial draft of the manuscript. All authors critically reviewed the draft and approved the final version of the manuscript.

Funding

This study did not receive any specific grant from funding agencies in the public, commercial, or non-profit sectors.

Declaration of conflicting interests

The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article. Ashish Bondia, Ishan Patel and Amod Tilak report on a relationship with Pfizer Ltd that includes employment and hold stocks.

Data availability statement

There is no original data.

Supplemental material

Supplemental material for this article is available online.

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