Abstract
Background/objective:
The START study was a large general practice observational study involving 400 patients with migraine. Given the large sample size, a sub-analysis was planned to ascertain whether any patient characteristics/behaviors might help predict/explain the responses observed in this study, which demonstrated that almotriptan administered early when pain was mild significantly improved pain-related outcomes compared with non-early/non-mild treatment.
Methods:
This pre-planned sub-analysis assessed the impact of predictors of patient satisfaction, medication history, delayed drug intake, etc. on the primary pain endpoints of the START study.
Results:
Patients had previously tried an average of 2.5 drugs for migraine relief and were currently taking a mean of 1.4 drugs. Almotriptan had been tried by 21% of the sample and was still being used by 83% of this sub-group. Treatment satisfaction was higher in the subset of patients taking almotriptan than in almotriptan-naїve individuals (p < 0.001) and this may explain why this group had the highest continuation rate of all drugs evaluated. On completion of the study, patient satisfaction was higher in the early/mild treatment group than the non-early/non-mild group (p = 0.049). Many patients delayed taking almotriptan, despite being instructed otherwise. Patients reported that this was primarily because they believed that they should only take the medication in the case of a severe migraine attack and/or to ensure that the symptoms were definitely due to migraine headache. The limitations of the trial include its open, observational design, and the small number of individuals who managed to treat their migraine attack within 1 hour when it was still mild.
Conclusions:
Almotriptan was associated with increased patient satisfaction, particularly when taken early. Further action is required to increase patient compliance with early treatment regimens to improve clinical outcomes.
Transparency
Declaration of funding
The study was funded by Laboratorios Almirall, Barcelona, Spain.
Declaration of financial/other relationships
S.D.I. has disclosed that he has acted as a consultant to Allergan, Almirall, GSK, Janssen-Cilag, Lundbeck, Menarini, Merck, UCB-Pharma. C.V. has disclosed that he is an employee of Laboratorios Almirall, S.A., Spain. C.C.M. has disclosed that she is an editorial consultant at ContentEdNet, a company that received funding from Laboratorios Almirall for this service.
CMRO Peer Reviewers have disclosed that they have no relevant financial relationships to disclose.
Acknowledgments
This research was a substudy of the original START study. The authors are indebted to the investigators and participating centers, and the study coordination board, for their invaluable help with this clinical study.
Investigators of START Study include: Dr Cayetano Alarcón, Alicante, Spain; Dr Manuel Aleo Capelo, Alicante, Spain; Dr Julio Lahoz Ferrer, Alicante, Spain; Dr Margarita Anula Silva, Margarita, Alicante, Spain; Dr Manuel Cercós Aparisi, Aldaia, Spain; Dr Juan Ebri Brou, Castellón, Spain; Lorenzo Edu Mackuy, Gandia, Spain; Dr Jesús Enriquez Barbé, Valencia, Spain; Dr Luis Estal Andrés, Valencia, Spain; Dr Carmen Fenoll Palomares, Valencia, Spain; Dr Joaquin Ferrandiz Miquel, Alcoy, Spain; Dr María Angeles Goterris Pinto, Castellón, Spain; Dr Enrique Guinot Martínez, Valencia, Spain; Dr Cayetano Gómez Gálvez, La Ribera, Spain; Dr Antonio López Almenar, Valencia, Spain; Dr José María Mateo Limiaña, Elche, Spain; Dr Luis Miquel García, Valencia, Spain; Dr Renata Monsonís Andreu, La Plana, Spain; Dr Amparo Moreno Pla, Valencia, Spain; Dr Roberto Muñoz Sarmiento, Orihuela, Spain; Dr Antonio Palacios del Cerro, Elda, Spain; Dr José Vicente Vaquer Pérez Elda, Spain; Dr Manuel Pineda Cuenca, Orihuela, Spain; Dr Javier Montoro Martí, Aldaia, Spain; Dr Amparo Pallardó Palau, Valencia, Spain; Dr Luis Sánchez Vadillo, Elche, Spain; Dr María Dolores Tur Cotanda, Gandia, Spain; Dr Ignacio Verdú Jorda, Alicante, Spain; Dr Charles Baranes, Paris, France; Dr Giles Baudesson, Colombes, France; Dr Jean Gabriel Bechier, Nimes, France; Dr Philippe Cazin, Coudekerque Branche, France; Dr Sebastien Cornu, Chapelle les Marais, France; Dr Alain Dasse, Château-Gontier, France; Dr Michel Dizin, Paris, France; Dr Gérard Duclos, Villemomble, France; Dr Daniel Elkrieff, Paris, France; Dr Philippe Giraud, Saint Cyr sur Loire, France; Dr Xavier Grossemy, Amiens, France; Dr Jean-Pierre Kolodziejczyk, Les Mees, France; Dr Christiane Kouji, Nice, France; Dr Jean-Pierre Lacoste, Paris, France; Dr Christiane Laffond, Nevers, France; Dr Bruno Mannessier, Quarouble, France; Dr Jean-Louis Navarre, Manduel, France; Dr Francis Philippe, Dijon, France; Dr Francois Philippe, Albi, France; Dr Christian Ravier, Marseille, France; Dr Philippe Remaud, Angers, France; Dr André Sebbah, Paris, France; Dr Franck Séropian, Uzes, France; Dr Antonio Abbate, Messina, Italy; Dr Franco Pianorsi, Firenze, Italy; Dr Coletta, Empoli, Italy; Dr Ovidio Brignoli, Brescia, Italy; Dr Fanciullacci, Empoli, Italy; Dr Pietro Giorgianni, Messina, Italy; Dr Fabrizio Carugi, Firenze, Italy; Dr Franco Ciampa, Firenze, Italy; Dr Silvio Di Loreto, Vasto, Italy; Dr Filippo Foti, Reggio Calabria, Italy; Dr Galli, Empoli, Italy; Dr Antonio Sandullo, Agrigento, Italy; Dr Ferreri, Empoli, Italy; Dr Riccardo Liso, Bari, Italy; Dr Cammisa, Empoli, Italy; Dr Roberto Palmieri, Milano, Italy; Dr Emanno Pertosa, Foggia, Italy; Dr Logli, Empoli, Italy; Dr Caciagli, Empoli, Italy; Dr Antonio Pizzimenti, Reggio Calabria, Italy; Dr Marco Poggioni, Firenze, Italy; Dr Mirta Silvia De Nuccio, Merano, Italy; Dr Luigi Rubino, Merano, Italy, Dr Peter Von Sontagg, Merano, Italy.