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1. Effect of atorvastatin in elderly patients with a recent stroke or transient ischemic attack

Author

Chaturvedi, S, Zivin, J, Breazna, A, Amarenco, P, Callahan, A, Goldstein, LB, Hennerici, M, Sillesen, H, Rudolph, A, Welch, MA, SPARCL Investigators, Crimmins D, Davis S, Dimmitt S, Donnan G, Frayne J, Freilich D, Zagami A, Mikocki J, Schmidauer C, Schmidt R, De Bleecker J, Deceuninck F, Tack P, Thijs V, Gomes Fernandes J, Beaudry M, Cote R, Hoyte K, Lebrun LH, Mackey A, Sahlas D, Selchen D, Shuaib A, Spence JD, Teal P, Winger M, Matamala G, Cifkova R, Kalita Z, Rektor I, Rosolova H, Stipal R, Vaclavik D, Boysen G, Klingenberg H, Iversen, Sillesen H, Hillbom M, Kaste M, Numminen H, Pilke A, Salmivaara A, Sivenius J, Alamowitch S, Amarenco P, Boulliat J, De Broucker T, Chollet F, Mahagne MH, Milandre L, Moulin T, Bogdahn U, Diener HC, Dichgans M, Glahn J, Haberl R, Harms L, Hennerici MG, Knecht S, Kroczek G, Lichy C, Sander D, Schneider D, Kazis A, Karageorgiou C, Milonas I, Stathis P, Vogiatzoglou D, Bornstein N, Honigman S, Lampl Y, Streifler J, Capurso A, Comi G, Gandolfo C, Poloni M, Senin U, Rangel Guerra R, Boon AM, De Keyser JH, De Kort PL, Haas JA, Kamphuis DJ, Koudstaal PJ, Anderson N, Scott R, Singh G, Czlonkowska A, Drozdowski W, Gralewski Z, Kozubski W, Kuczynska Zardzewialy A, Podemski R, Stelmasiak Z, Szczudlik A, Da Costa Correia C, Ferro J, Salgueiro e. Cunha L, Lietava J, Raslova K, Carr J, Gardiner J, Kruger A, Alvarez Sabin J, Chamorro A, Diez Tejedor E, Fernández O, Trejo Gabriel y. Galán J, González Marcos J, Egido Herrero J, Jiménez Martínez M, Lago Martin A, Mostacero Miguel E, Vivancos Mora J, Moltó J, Viguera Romero J, Cuartero Rodriguez E, Rodriguez F, Serena J, Laska AC, Leijd B, Strand T, Terent A, Waegner A, Wallén T, Baumgartner R, Bogousslavsky J, Hungerbühler H, Lyrer P, Mattle H, Bath PM, Ekpo EB, Freeman A, Lees KR, MacLeod MJ, MacWalter RS, Sharma AK, Shetty HG, Albers G, Altafullah I, Benavente O, Book D, Broderick J, Callahan A. 3rd, Calder C, Carlini W, Chaturvedi S, Chippendale T, Clark W, Coull B, Davis P, Devlin T, Dick A, Dooneief G, Duff R, Estronza N, Forteza A, Frankel M, Frey J, Friday G, Graham G, Goldstein J, Hammer M, Harris J, Harper W, Hendin B, Hendin D, Hinton R, Hollander J, Hughes R, Kasner S, Kent T, Kim L, Kirshner H, LaMonte M, Ledbetter L, Lee Kwen P, Levin K, Libman R, Matlock J, McDowell P, McGee F. Jr, Meyer B, Minagar A, Moussouttas M, Munson R, Nash M, Nassief A, Orr S, Ratinov G, Salanga V, Silliman S, Singer R, Smith D, Sullivan H, Tietjen G, Thaler D, Tuchman M, Uskavitch D, Verro P, Vicari R, Weinstein R, Wilterdink J, Zweifler R, De Bastos M., FERRARESE, CARLO, Chaturvedi, S, Zivin, J, Breazna, A, Amarenco, P, Callahan, A, Goldstein, L, Hennerici, M, Sillesen, H, Rudolph, A, Welch, M, Sparcl, I, Crimmins, D, Davis, S, Dimmitt, S, Donnan, G, Frayne, J, Freilich, D, Zagami, A, Mikocki, J, Schmidauer, C, Schmidt, R, De Bleecker, J, Deceuninck, F, Tack, P, Thijs, V, Gomes Fernandes, J, Beaudry, M, Cote, R, Hoyte, K, Lebrun, L, Mackey, A, Sahlas, D, Selchen, D, Shuaib, A, Spence, J, Teal, P, Winger, M, Matamala, G, Cifkova, R, Kalita, Z, Rektor, I, Rosolova, H, Stipal, R, Vaclavik, D, Boysen, G, Klingenberg, H, Iversen, Hillbom, M, Kaste, M, Numminen, H, Pilke, A, Salmivaara, A, Sivenius, J, Alamowitch, S, Boulliat, J, De Broucker, T, Chollet, F, Mahagne, M, Milandre, L, Moulin, T, Bogdahn, U, Diener, H, Dichgans, M, Glahn, J, Haberl, R, Harms, L, Knecht, S, Kroczek, G, Lichy, C, Sander, D, Schneider, D, Kazis, A, Karageorgiou, C, Milonas, I, Stathis, P, Vogiatzoglou, D, Bornstein, N, Honigman, S, Lampl, Y, Streifler, J, Capurso, A, Comi, G, Ferrarese, C, Gandolfo, C, Poloni, M, Senin, U, Rangel Guerra, R, Boon, A, De Keyser, J, De Kort, P, Haas, J, Kamphuis, D, Koudstaal, P, Anderson, N, Scott, R, Singh, G, Czlonkowska, A, Drozdowski, W, Gralewski, Z, Kozubski, W, Kuczynska Zardzewialy, A, Podemski, R, Stelmasiak, Z, Szczudlik, A, Da Costa Correia, C, Ferro, J, Salgueiro e., C, Lietava, J, Raslova, K, Carr, J, Gardiner, J, Kruger, A, Alvarez Sabin, J, Chamorro, A, Diez Tejedor, E, Fernández, O, Trejo Gabriel y., G, González Marcos, J, Egido Herrero, J, Jiménez Martínez, M, Lago Martin, A, Mostacero Miguel, E, Vivancos Mora, J, Moltó, J, Viguera Romero, J, Cuartero Rodriguez, E, Rodriguez, F, Serena, J, Laska, A, Leijd, B, Strand, T, Terent, A, Waegner, A, Wallén, T, Baumgartner, R, Bogousslavsky, J, Hungerbühler, H, Lyrer, P, Mattle, H, Bath, P, Ekpo, E, Freeman, A, Lees, K, Macleod, M, Macwalter, R, Sharma, A, Shetty, H, Albers, G, Altafullah, I, Benavente, O, Book, D, Broderick, J, Callahan A., 3, Calder, C, Carlini, W, Chippendale, T, Clark, W, Coull, B, Davis, P, Devlin, T, Dick, A, Dooneief, G, Duff, R, Estronza, N, Forteza, A, Frankel, M, Frey, J, Friday, G, Graham, G, Goldstein, J, Hammer, M, Harris, J, Harper, W, Hendin, B, Hendin, D, Hinton, R, Hollander, J, Hughes, R, Kasner, S, Kent, T, Kim, L, Kirshner, H, Lamonte, M, Ledbetter, L, Lee Kwen, P, Levin, K, Libman, R, Matlock, J, Mcdowell, P, McGee F., J, Meyer, B, Minagar, A, Moussouttas, M, Munson, R, Nash, M, Nassief, A, Orr, S, Ratinov, G, Salanga, V, Silliman, S, Singer, R, Smith, D, Sullivan, H, Tietjen, G, Thaler, D, Tuchman, M, Uskavitch, D, Verro, P, Vicari, R, Weinstein, R, Wilterdink, J, Zweifler, R, and De Bastos, M

Subjects
Male, medicine.medical_specialty, Atorvastatin, medicine.medical_treatment, Coronary Disease, Pyrrole, Revascularization, Risk Assessment, Cohort Studies, Coronary artery disease, Internal medicine, Anticholesteremic Agent, Myocardial Revascularization, medicine, Clinical endpoint, Humans, Pyrroles, Age Factor, cardiovascular diseases, Stroke, Aged, Cerebral infarction, business.industry, Anticholesteremic Agents, Hazard ratio, Age Factors, Cholesterol, LDL, Middle Aged, medicine.disease, Surgery, Heptanoic Acid, Heptanoic Acids, Ischemic Attack, Transient, Cohort, Cardiology, Female, Hydroxymethylglutaryl-CoA Reductase Inhibitor, Neurology (clinical), Hydroxymethylglutaryl-CoA Reductase Inhibitors, Cohort Studie, business, Human, medicine.drug
Abstract

BACKGROUND: It is unclear whether patients age 65 years and over with a recent stroke or TIA benefit from statin treatment to a similar degree as younger patients. METHODS: The 4,731 patient cohort in the SPARCL study was divided into an elderly group (65 and over) and a younger group. The primary endpoint (fatal or nonfatal stroke) and secondary endpoints were analyzed, with calculation of the hazard ratio (HR) and p values from a Cox regression model. RESULTS: There were 2,249 patients in the elderly group and 2,482 in the younger group. The baseline LDL (133 mg/dL) and total cholesterol were comparable in the two groups. The elderly and younger groups had a 61.4 mg/dL and 58.7 mg/dL decrease in mean LDL during the trial. The primary endpoint was reduced by 26% in younger patients (HR 0.74, 0.57-0.96, p = 0.02) and by 10% in elderly subjects (HR 0.90, 0.73-1.11, p = 0.33). A test of heterogeneity for a treatment-age interaction was not significant (p = 0.52). The risk of stroke or TIA (HR 0.79, p = 0.01), major coronary events (HR 0.68, p = 0.035), any coronary heart disease event (HR 0.61, p = 0.0006), and revascularization procedures (HR 0.55, p = 0.0005) was reduced in the elderly group. CONCLUSIONS: There was no heterogeneity in the stroke reduction seen with atorvastatin in the elderly and younger groups. Cardiac events and revascularization procedures were also lower in both the elderly and younger subgroups treated with atorvastatin. These results support the use of atorvastatin in elderly patients with recent stroke or TIA.

Published
2008
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2. Comparison of subcutaneous interferon beta-1a with glatiramer acetate in patients with relapsing multiple sclerosis (the REbif vs Glatiramer Acetate in Relapsing MS Disease [REGARD] study): a multicentre, randomised, parallel, open-label trial

Author

Mikol, Dd1, Barkhof, F, Chang, P, Coyle, Pk, Jeffery, Dr, Schwid, Sr, Stubinski, B, Uitdehaag, B, Ballario, Ch, Caceres, Fj, Correale, J, Cristiano, E, Garcea, Do, Leutic, Gg, Aicher, F, Barreira, Aa, Freedman, M, Grand'Maison, F, Jacques, F, Lee, L, Stefanelli, M, Edan, G, Pelletier, J, Berghoff, M, Keifer, R, Koehler, J, Hardiman, O, Comi, G, Mancardi, GIOVANNI LUIGI, Pozzilli, C, Trojano, Mp, Jongen, P, Uitdehaag, Bm, Belova, An, Boyko, An, Elchaninov, Ap, Kozlov, Va, Odinak, Mm, Shvarkov, Sb, Skoromets, Aa, Spirin, Nn, Stolyarov, Id, Vorobieva, Ov, Zavalishin, I, Arbizu, T, Fernandez, O, Izquierdo, G, Montalban, X, Goebels, N, Bates, D, Constantinescu, C, Turner, B, Bashir, K, Bever, Ct, Birnbaum, G, Brod, Sa, Carlini, W, Dunne, P, Elias, S, Estronza, N, Fox, E, Glyman, S, Gross, J, Guarnaccia, Jb, Gupta, A, Kaufman, M, Khan, O, Khatri, B, Kresa reahl, K, Lava, N, Leist, T, Markowitz, C, Mihai, C, Mikol, Dd, Miller, T, Panitch, H, Parry, G, Rammohan, Kw, Reder, A, Sheppard, C, Simsarian, Jp, Smiroldo, J, Spier, L, Thrower, B, Vollmer, T, Wendt, J, Wray, S, Wynn, D., Radiology and nuclear medicine, Epidemiology and Data Science, Neurology, and Neuroscience Campus Amsterdam 2008

Subjects
Adult, Male, medicine.medical_specialty, Multiple Sclerosis, Adolescent, Injections, Subcutaneous, Population, Placebo-controlled study, Relapsing-Remitting, drug therapy/pathology, Drug Administration Schedule, Injections, methods, law.invention, Disability Evaluation, Multiple Sclerosis, Relapsing-Remitting, Randomized controlled trial, law, Internal medicine, Adolescent, Adult, Confidence Intervals, Disability Evaluation, Disease Progression, Drug Administration Schedule, Female, Humans, Immunologic Factors, administration /&/ dosage, Injections, Subcutaneous, methods, Interferon-beta, administration /&/ dosage, Magnetic Resonance Imaging, methods, Male, Middle Aged, Multiple Sclerosis, drug therapy/pathology, Peptides, administration /&/ dosage, Retrospective Studies, Treatment Outcome, Confidence Intervals, medicine, Humans, Immunologic Factors, Glatiramer acetate, administration /&/ dosage, education, Retrospective Studies, education.field_of_study, Intention-to-treat analysis, business.industry, Interferon beta-1a, McDonald criteria, Glatiramer Acetate, Interferon-beta, Middle Aged, Magnetic Resonance Imaging, Treatment Outcome, Tolerability, Immunology, Disease Progression, Female, Neurology (clinical), Peptides, business, medicine.drug
Abstract

Summary Background Interferon beta-1a and glatiramer acetate are commonly prescribed for relapsing-remitting multiple sclerosis (RRMS), but no published randomised trials have directly compared these two drugs. Our aim in the REGARD (REbif vs Glatiramer Acetate in Relapsing MS Disease) study was to compare interferon beta-1a with glatiramer acetate in patients with RRMS. Methods In this multicentre, randomised, comparative, parallel-group, open-label study, patients with RRMS diagnosed with the McDonald criteria who had had at least one relapse within the previous 12 months were randomised to receive 44 μg subcutaneous interferon beta-1a three times per week or 20 mg subcutaneous glatiramer acetate once per day for 96 weeks to assess the time to first relapse. A subpopulation of 460 patients (230 from each group) also had serial MRI scans to assess T2-weighted and gadolinium-enhancing lesion number and volume. Treatments were assigned by a computer-generated randomisation list that was stratified by centre. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00078338. Findings Between February and December, 2004, 764 patients were randomly assigned: 386 to interferon beta-1a and 378 to glatiramer acetate. After 96 weeks, there was no significant difference between groups in time to first relapse (hazard ratio 0·94, 95% CI 0·74 to 1·21; p=0·64). Relapse rates were lower than expected: 258 patients (126 in the interferon beta-1a group and 132 in the glatiramer acetate group) had one or more relapses (the expected number was 460). For secondary outcomes, there were no significant differences for the number and change in volume of T2 active lesions or for the change in the volume of gadolinium-enhancing lesions, although patients treated with interferon beta-1a had significantly fewer gadolinium-enhancing lesions (0·24 vs 0·41 lesions per patient per scan, 95% CI −0·4 to 0·1; p=0·0002). Safety and tolerability profiles were consistent with the known profiles for both compounds. The overall number and severity of adverse events were similar between the treatments and were not an important cause for discontinuation of the trial during the 96 weeks. Interpretation There was no significant difference between interferon beta-1a and glatiramer acetate in the primary outcome. The ability to predict clinical superiority on the basis of results from previous studies might be limited by a trial population with low disease activity, which is an important consideration for ongoing and future trials in patients with RRMS. Funding EMD Serono; Pfizer.

Published
2008
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3. Effect of atorvastatin in elderly patients with a recent stroke or transient ischemic attack

Author

Chaturvedi, S, Zivin, J, Breazna, A, Amarenco, P, Callahan, A, Goldstein, L, Hennerici, M, Sillesen, H, Rudolph, A, Welch, M, Sparcl, I, Crimmins, D, Davis, S, Dimmitt, S, Donnan, G, Frayne, J, Freilich, D, Zagami, A, Mikocki, J, Schmidauer, C, Schmidt, R, De Bleecker, J, Deceuninck, F, Tack, P, Thijs, V, Gomes Fernandes, J, Beaudry, M, Cote, R, Hoyte, K, Lebrun, L, Mackey, A, Sahlas, D, Selchen, D, Shuaib, A, Spence, J, Teal, P, Winger, M, Matamala, G, Cifkova, R, Kalita, Z, Rektor, I, Rosolova, H, Stipal, R, Vaclavik, D, Boysen, G, Klingenberg, H, Iversen, Hillbom, M, Kaste, M, Numminen, H, Pilke, A, Salmivaara, A, Sivenius, J, Alamowitch, S, Boulliat, J, De Broucker, T, Chollet, F, Mahagne, M, Milandre, L, Moulin, T, Bogdahn, U, Diener, H, Dichgans, M, Glahn, J, Haberl, R, Harms, L, Knecht, S, Kroczek, G, Lichy, C, Sander, D, Schneider, D, Kazis, A, Karageorgiou, C, Milonas, I, Stathis, P, Vogiatzoglou, D, Bornstein, N, Honigman, S, Lampl, Y, Streifler, J, Capurso, A, Comi, G, Ferrarese, C, Gandolfo, C, Poloni, M, Senin, U, Rangel Guerra, R, Boon, A, De Keyser, J, De Kort, P, Haas, J, Kamphuis, D, Koudstaal, P, Anderson, N, Scott, R, Singh, G, Czlonkowska, A, Drozdowski, W, Gralewski, Z, Kozubski, W, Kuczynska Zardzewialy, A, Podemski, R, Stelmasiak, Z, Szczudlik, A, Da Costa Correia, C, Ferro, J, Salgueiro e., C, Lietava, J, Raslova, K, Carr, J, Gardiner, J, Kruger, A, Alvarez Sabin, J, Chamorro, A, Diez Tejedor, E, Fernández, O, Trejo Gabriel y., G, González Marcos, J, Egido Herrero, J, Jiménez Martínez, M, Lago Martin, A, Mostacero Miguel, E, Vivancos Mora, J, Moltó, J, Viguera Romero, J, Cuartero Rodriguez, E, Rodriguez, F, Serena, J, Laska, A, Leijd, B, Strand, T, Terent, A, Waegner, A, Wallén, T, Baumgartner, R, Bogousslavsky, J, Hungerbühler, H, Lyrer, P, Mattle, H, Bath, P, Ekpo, E, Freeman, A, Lees, K, Macleod, M, Macwalter, R, Sharma, A, Shetty, H, Albers, G, Altafullah, I, Benavente, O, Book, D, Broderick, J, Callahan A., 3, Calder, C, Carlini, W, Chippendale, T, Clark, W, Coull, B, Davis, P, Devlin, T, Dick, A, Dooneief, G, Duff, R, Estronza, N, Forteza, A, Frankel, M, Frey, J, Friday, G, Graham, G, Goldstein, J, Hammer, M, Harris, J, Harper, W, Hendin, B, Hendin, D, Hinton, R, Hollander, J, Hughes, R, Kasner, S, Kent, T, Kim, L, Kirshner, H, Lamonte, M, Ledbetter, L, Lee Kwen, P, Levin, K, Libman, R, Matlock, J, Mcdowell, P, McGee F., J, Meyer, B, Minagar, A, Moussouttas, M, Munson, R, Nash, M, Nassief, A, Orr, S, Ratinov, G, Salanga, V, Silliman, S, Singer, R, Smith, D, Sullivan, H, Tietjen, G, Thaler, D, Tuchman, M, Uskavitch, D, Verro, P, Vicari, R, Weinstein, R, Wilterdink, J, Zweifler, R, De Bastos, M, Goldstein, LB, Welch, MA, SPARCL Investigators, Crimmins D, Davis S, Dimmitt S, Donnan G, Frayne J, Freilich D, Zagami A, Mikocki J, Schmidauer C, Schmidt R, De Bleecker J, Deceuninck F, Tack P, Thijs V, Gomes Fernandes J, Beaudry M, Cote R, Hoyte K, Lebrun LH, Mackey A, Sahlas D, Selchen D, Shuaib A, Spence JD, Teal P, Winger M, Matamala G, Cifkova R, Kalita Z, Rektor I, Rosolova H, Stipal R, Vaclavik D, Boysen G, Klingenberg H, Sillesen H, Hillbom M, Kaste M, Numminen H, Pilke A, Salmivaara A, Sivenius J, Alamowitch S, Amarenco P, Boulliat J, De Broucker T, Chollet F, Mahagne MH, Milandre L, Moulin T, Bogdahn U, Diener HC, Dichgans M, Glahn J, Haberl R, Harms L, Hennerici MG, Knecht S, Kroczek G, Lichy C, Sander D, Schneider D, Kazis A, Karageorgiou C, Milonas I, Stathis P, Vogiatzoglou D, Bornstein N, Honigman S, Lampl Y, Streifler J, Capurso A, Comi G, Gandolfo C, Poloni M, Senin U, Rangel Guerra R, Boon AM, De Keyser JH, De Kort PL, Haas JA, Kamphuis DJ, Koudstaal PJ, Anderson N, Scott R, Singh G, Czlonkowska A, Drozdowski W, Gralewski Z, Kozubski W, Kuczynska Zardzewialy A, Podemski R, Stelmasiak Z, Szczudlik A, Da Costa Correia C, Ferro J, Salgueiro e. Cunha L, Lietava J, Raslova K, Carr J, Gardiner J, Kruger A, Alvarez Sabin J, Chamorro A, Diez Tejedor E, Fernández O, Trejo Gabriel y. Galán J, González Marcos J, Egido Herrero J, Jiménez Martínez M, Lago Martin A, Mostacero Miguel E, Vivancos Mora J, Moltó J, Viguera Romero J, Cuartero Rodriguez E, Rodriguez F, Serena J, Laska AC, Leijd B, Strand T, Terent A, Waegner A, Wallén T, Baumgartner R, Bogousslavsky J, Hungerbühler H, Lyrer P, Mattle H, Bath PM, Ekpo EB, Freeman A, Lees KR, MacLeod MJ, MacWalter RS, Sharma AK, Shetty HG, Albers G, Altafullah I, Benavente O, Book D, Broderick J, Callahan A. 3rd, Calder C, Carlini W, Chaturvedi S, Chippendale T, Clark W, Coull B, Davis P, Devlin T, Dick A, Dooneief G, Duff R, Estronza N, Forteza A, Frankel M, Frey J, Friday G, Graham G, Goldstein J, Hammer M, Harris J, Harper W, Hendin B, Hendin D, Hinton R, Hollander J, Hughes R, Kasner S, Kent T, Kim L, Kirshner H, LaMonte M, Ledbetter L, Lee Kwen P, Levin K, Libman R, Matlock J, McDowell P, McGee F. Jr, Meyer B, Minagar A, Moussouttas M, Munson R, Nash M, Nassief A, Orr S, Ratinov G, Salanga V, Silliman S, Singer R, Smith D, Sullivan H, Tietjen G, Thaler D, Tuchman M, Uskavitch D, Verro P, Vicari R, Weinstein R, Wilterdink J, Zweifler R, De Bastos M., FERRARESE, CARLO, Chaturvedi, S, Zivin, J, Breazna, A, Amarenco, P, Callahan, A, Goldstein, L, Hennerici, M, Sillesen, H, Rudolph, A, Welch, M, Sparcl, I, Crimmins, D, Davis, S, Dimmitt, S, Donnan, G, Frayne, J, Freilich, D, Zagami, A, Mikocki, J, Schmidauer, C, Schmidt, R, De Bleecker, J, Deceuninck, F, Tack, P, Thijs, V, Gomes Fernandes, J, Beaudry, M, Cote, R, Hoyte, K, Lebrun, L, Mackey, A, Sahlas, D, Selchen, D, Shuaib, A, Spence, J, Teal, P, Winger, M, Matamala, G, Cifkova, R, Kalita, Z, Rektor, I, Rosolova, H, Stipal, R, Vaclavik, D, Boysen, G, Klingenberg, H, Iversen, Hillbom, M, Kaste, M, Numminen, H, Pilke, A, Salmivaara, A, Sivenius, J, Alamowitch, S, Boulliat, J, De Broucker, T, Chollet, F, Mahagne, M, Milandre, L, Moulin, T, Bogdahn, U, Diener, H, Dichgans, M, Glahn, J, Haberl, R, Harms, L, Knecht, S, Kroczek, G, Lichy, C, Sander, D, Schneider, D, Kazis, A, Karageorgiou, C, Milonas, I, Stathis, P, Vogiatzoglou, D, Bornstein, N, Honigman, S, Lampl, Y, Streifler, J, Capurso, A, Comi, G, Ferrarese, C, Gandolfo, C, Poloni, M, Senin, U, Rangel Guerra, R, Boon, A, De Keyser, J, De Kort, P, Haas, J, Kamphuis, D, Koudstaal, P, Anderson, N, Scott, R, Singh, G, Czlonkowska, A, Drozdowski, W, Gralewski, Z, Kozubski, W, Kuczynska Zardzewialy, A, Podemski, R, Stelmasiak, Z, Szczudlik, A, Da Costa Correia, C, Ferro, J, Salgueiro e., C, Lietava, J, Raslova, K, Carr, J, Gardiner, J, Kruger, A, Alvarez Sabin, J, Chamorro, A, Diez Tejedor, E, Fernández, O, Trejo Gabriel y., G, González Marcos, J, Egido Herrero, J, Jiménez Martínez, M, Lago Martin, A, Mostacero Miguel, E, Vivancos Mora, J, Moltó, J, Viguera Romero, J, Cuartero Rodriguez, E, Rodriguez, F, Serena, J, Laska, A, Leijd, B, Strand, T, Terent, A, Waegner, A, Wallén, T, Baumgartner, R, Bogousslavsky, J, Hungerbühler, H, Lyrer, P, Mattle, H, Bath, P, Ekpo, E, Freeman, A, Lees, K, Macleod, M, Macwalter, R, Sharma, A, Shetty, H, Albers, G, Altafullah, I, Benavente, O, Book, D, Broderick, J, Callahan A., 3, Calder, C, Carlini, W, Chippendale, T, Clark, W, Coull, B, Davis, P, Devlin, T, Dick, A, Dooneief, G, Duff, R, Estronza, N, Forteza, A, Frankel, M, Frey, J, Friday, G, Graham, G, Goldstein, J, Hammer, M, Harris, J, Harper, W, Hendin, B, Hendin, D, Hinton, R, Hollander, J, Hughes, R, Kasner, S, Kent, T, Kim, L, Kirshner, H, Lamonte, M, Ledbetter, L, Lee Kwen, P, Levin, K, Libman, R, Matlock, J, Mcdowell, P, McGee F., J, Meyer, B, Minagar, A, Moussouttas, M, Munson, R, Nash, M, Nassief, A, Orr, S, Ratinov, G, Salanga, V, Silliman, S, Singer, R, Smith, D, Sullivan, H, Tietjen, G, Thaler, D, Tuchman, M, Uskavitch, D, Verro, P, Vicari, R, Weinstein, R, Wilterdink, J, Zweifler, R, De Bastos, M, Goldstein, LB, Welch, MA, SPARCL Investigators, Crimmins D, Davis S, Dimmitt S, Donnan G, Frayne J, Freilich D, Zagami A, Mikocki J, Schmidauer C, Schmidt R, De Bleecker J, Deceuninck F, Tack P, Thijs V, Gomes Fernandes J, Beaudry M, Cote R, Hoyte K, Lebrun LH, Mackey A, Sahlas D, Selchen D, Shuaib A, Spence JD, Teal P, Winger M, Matamala G, Cifkova R, Kalita Z, Rektor I, Rosolova H, Stipal R, Vaclavik D, Boysen G, Klingenberg H, Sillesen H, Hillbom M, Kaste M, Numminen H, Pilke A, Salmivaara A, Sivenius J, Alamowitch S, Amarenco P, Boulliat J, De Broucker T, Chollet F, Mahagne MH, Milandre L, Moulin T, Bogdahn U, Diener HC, Dichgans M, Glahn J, Haberl R, Harms L, Hennerici MG, Knecht S, Kroczek G, Lichy C, Sander D, Schneider D, Kazis A, Karageorgiou C, Milonas I, Stathis P, Vogiatzoglou D, Bornstein N, Honigman S, Lampl Y, Streifler J, Capurso A, Comi G, Gandolfo C, Poloni M, Senin U, Rangel Guerra R, Boon AM, De Keyser JH, De Kort PL, Haas JA, Kamphuis DJ, Koudstaal PJ, Anderson N, Scott R, Singh G, Czlonkowska A, Drozdowski W, Gralewski Z, Kozubski W, Kuczynska Zardzewialy A, Podemski R, Stelmasiak Z, Szczudlik A, Da Costa Correia C, Ferro J, Salgueiro e. Cunha L, Lietava J, Raslova K, Carr J, Gardiner J, Kruger A, Alvarez Sabin J, Chamorro A, Diez Tejedor E, Fernández O, Trejo Gabriel y. Galán J, González Marcos J, Egido Herrero J, Jiménez Martínez M, Lago Martin A, Mostacero Miguel E, Vivancos Mora J, Moltó J, Viguera Romero J, Cuartero Rodriguez E, Rodriguez F, Serena J, Laska AC, Leijd B, Strand T, Terent A, Waegner A, Wallén T, Baumgartner R, Bogousslavsky J, Hungerbühler H, Lyrer P, Mattle H, Bath PM, Ekpo EB, Freeman A, Lees KR, MacLeod MJ, MacWalter RS, Sharma AK, Shetty HG, Albers G, Altafullah I, Benavente O, Book D, Broderick J, Callahan A. 3rd, Calder C, Carlini W, Chaturvedi S, Chippendale T, Clark W, Coull B, Davis P, Devlin T, Dick A, Dooneief G, Duff R, Estronza N, Forteza A, Frankel M, Frey J, Friday G, Graham G, Goldstein J, Hammer M, Harris J, Harper W, Hendin B, Hendin D, Hinton R, Hollander J, Hughes R, Kasner S, Kent T, Kim L, Kirshner H, LaMonte M, Ledbetter L, Lee Kwen P, Levin K, Libman R, Matlock J, McDowell P, McGee F. Jr, Meyer B, Minagar A, Moussouttas M, Munson R, Nash M, Nassief A, Orr S, Ratinov G, Salanga V, Silliman S, Singer R, Smith D, Sullivan H, Tietjen G, Thaler D, Tuchman M, Uskavitch D, Verro P, Vicari R, Weinstein R, Wilterdink J, Zweifler R, De Bastos M., and FERRARESE, CARLO

Abstract

BACKGROUND: It is unclear whether patients age 65 years and over with a recent stroke or TIA benefit from statin treatment to a similar degree as younger patients. METHODS: The 4,731 patient cohort in the SPARCL study was divided into an elderly group (65 and over) and a younger group. The primary endpoint (fatal or nonfatal stroke) and secondary endpoints were analyzed, with calculation of the hazard ratio (HR) and p values from a Cox regression model. RESULTS: There were 2,249 patients in the elderly group and 2,482 in the younger group. The baseline LDL (133 mg/dL) and total cholesterol were comparable in the two groups. The elderly and younger groups had a 61.4 mg/dL and 58.7 mg/dL decrease in mean LDL during the trial. The primary endpoint was reduced by 26% in younger patients (HR 0.74, 0.57-0.96, p = 0.02) and by 10% in elderly subjects (HR 0.90, 0.73-1.11, p = 0.33). A test of heterogeneity for a treatment-age interaction was not significant (p = 0.52). The risk of stroke or TIA (HR 0.79, p = 0.01), major coronary events (HR 0.68, p = 0.035), any coronary heart disease event (HR 0.61, p = 0.0006), and revascularization procedures (HR 0.55, p = 0.0005) was reduced in the elderly group. CONCLUSIONS: There was no heterogeneity in the stroke reduction seen with atorvastatin in the elderly and younger groups. Cardiac events and revascularization procedures were also lower in both the elderly and younger subgroups treated with atorvastatin. These results support the use of atorvastatin in elderly patients with recent stroke or TIA.

Published
2009

4. Relative effects of statin therapy on stroke and cardiovascular events in men and women: Secondary analysis of the stroke prevention by aggressive reduction in cholesterol levels (SPARCL) study

Author

Goldstein, L, Amarenco, P, Lamonte, M, Gilbert, S, Messig, M, Callahan, A, Hennerici, M, Sillesen, H, Welch, K, Sparcl, I, Bogousslavsky, J, Zivin, J, Clark, W, Dávalos, A, Kaste, M, Leiter, L, Altafullah, I, Graham, G, Glahn, J, Jiménez Hernández, D, Macwalter, R, Scott, R, Shuaib, A, Sivenius, J, Stipal, R, Hart, R, Marsh, J, Norrving, B, Pocock, S, Sacco, R, Easton, J, Brown, M, Nagy, Z, Whisnant, J, O'Neill, B, Kleber, F, Lablanche, J, Welty, F, Crimmins, D, Davis, S, Dimmitt, S, Donnan, G, Frayne, J, Freilich, D, Zagami, A, Mikocki, J, Schmidauer, C, Schmidt, R, De Bleecker, J, Deceuninck, F, Tack, P, Thijs, V, Gomes Fernandes, J, Beaudry, M, Cote, R, Hoyte, K, Lebrun, L, Mackey, A, Sahlas, D, Selchen, D, Spence, J, Teal, P, Winger, M, Matamala, G, Cifkova, R, Kalita, Z, Rektor, I, Rosolova, H, Vaclavik, D, Boysen, G, Klingenberg, H, Hillbom, M, Numminen, H, Pilke, A, Salmivaara, A, Alamowitch, S, Boulliat, J, De Broucker, T, Chollet, F, Mahagne, M, Milandre, L, Moulin, T, Milonas, I, Stathis, P, Vogiatzoglou, D, Bornstein, N, Honigman, S, Lampl, Y, Streifler, J, Capurso, A, Comi, G, Ferrarese, C, Gandolfo, C, Poloni, M, Senin, U, Rangel Guerra, R, Boon, A, De Keyser, J, De Kort, P, Haas, J, Kamphuis, D, Koudstaal, P, Anderson, N, Singh, G, Czlonkowska, A, Drozdowski, W, Gralewski, Z, Kozubski, W, Kuczynska Zardzewialy, A, Podemski, R, Stelmasiak, Z, Szczudlik, A, Da Costa Correia, C, Ferro, J, Salgueiro e., C, Lietava, J, Raslova, K, Carr, J, Gardiner, J, Kruger, A, Alvarez Sabin, J, Chamorro, A, Diez Tejedor, E, Fernández, O, Trejo Gabriel y., G, González Marcos, J, Egido Herrero, J, Jiménez Martínez, M, Lago Martin, A, Mostacero Miguel, E, Vivancos Mora, J, Moltó, J, Viguera Romero, J, Cuartero Rodriguez, E, Rubio, F, Serena, J, Laska, A, Leijd, B, Strand, T, Terent, A, Waegner, A, Wallén, T, Baumgartner, R, Hungerbühler, H, Lyrer, P, Mattle, H, Bath, P, Ekpo, E, Freeman, A, Lees, K, Macleod, M, Sharma, A, Shetty, H, Albers, G, Benavente, O, Book, D, Broderick, J, Calder, C, Carlini, W, Chaturvedi, S, Chippendale, T, Coull, B, Davis, P, Devlin, T, Dick, A, Dooneief, G, Duff, R, Estronza, N, Forteza, A, Frankel, M, Frey, J, Friday, G, Goldstein, J, Hammer, M, Harris, J, Harper, W, Hendin, B, Hess, D, Hinton, R, Hollander, J, Hughes, R, Kasner, S, Kent, T, Kim, L, Kirshner, H, Ledbetter, L, Lee Kwen, P, Levin, K, Libman, R, Matlock, J, Mcdowell, P, McGee F., J, Meyer, B, Minagar, A, Moussouttas, M, Munson, R, Nash, M, Nassief, A, Orr, S, Ratinov, G, Salanga, V, Silliman, S, Singer, R, Smith, D, Sullivan, H, Tietjen, G, Thaler, D, Tuchman, M, Uskavitch, D, Verro, P, Vicari, R, Weinstein, R, Wilterdink, J, Zweifler, R, De Bastos, M, Goldstein, LB, Welch, KMA, SPARCL investigators, Bogousslavsky J, Goldstein LB, Zivin J, Clark W, Dávalos A, Kaste M, Leiter L, Altafullah I, Graham G, Glahn J, Jiménez Hernández D, MacWalter R, Scott R, Shuaib A, Sivenius J, Stipal R, Hart R, Marsh J, Norrving B, Pocock S, Sacco R, Easton J, Brown M, Nagy Z, Whisnant J, O'Neill B, Kleber F, LaBlanche JM, Welty F, Crimmins D, Davis S, Dimmitt S, Donnan G, Frayne J, Freilich D, Zagami A, Mikocki J, Schmidauer C, Schmidt R, De Bleecker J, Deceuninck F, Tack P, Thijs V, Gomes Fernandes J, Beaudry M, Cote R, Hoyte K, Lebrun LH, Mackey A, Sahlas D, Selchen D, Spence JD, Teal P, Winger M, Matamala G, Cifkova R, Kalita Z, Rektor I, Rosolova H, Vaclavik D, Boysen G, Klingenberg H, Sillesen H, Hillbom M, Numminen H, Pilke A, Salmivaara A, Alamowitch S, Amarenco P, Boulliat J, De Broucker T, Chollet F, Mahagne MH, Milandre L, Moulin T, Milonas I, Stathis P, Vogiatzoglou D, Bornstein N, Honigman S, Lampl Y, Streifler J, Capurso A, Comi G, Gandolfo C, Poloni M, Senin U, Rangel Guerra R, Boon AM, De Keyser JH, De Kort PL, Haas JA, Kamphuis DJ, Koudstaal PJ, Anderson N, Singh G, Czlonkowska A, Drozdowski W, Gralewski Z, Kozubski W, Kuczynska Zardzewialy A, Podemski R, Stelmasiak Z, Szczudlik A, Da Costa Correia C, Ferro J, Salgueiro e. Cunha L, Lietava J, Raslova K, Carr J, Gardiner J, Kruger A, Alvarez Sabin J, Chamorro A, Diez Tejedor E, Fernández O, Trejo Gabriel y. Galán J, González Marcos J, Egido Herrero J, Jiménez Martínez M, Lago Martin A, Mostacero Miguel E, Vivancos Mora J, Moltó J, Viguera Romero J, Cuartero Rodriguez E, Rubio F, Serena J, Laska AC, Leijd B, Strand T, Terent A, Waegner A, Wallén T, Baumgartner R, Hungerbühler H, Lyrer P, Mattle H, Bath PM, Ekpo EB, Freeman A, Lees KR, MacLeod MJ, MacWalter RS, Sharma AK, Shetty HG, Albers G, Benavente O, Book D, Broderick J, Calder C, Carlini W, Chaturvedi S, Chippendale T, Coull B, Davis P, Devlin T, Dick A, Dooneief G, Duff R, Estronza N, Forteza A, Frankel M, Frey J, Friday G, Goldstein J, Hammer M, Harris J, Harper W, Hendin B, Hess D, Hinton R, Hollander J, Hughes R, Kasner S, Kent T, Kim L, Kirshner H, LaMonte M, Ledbetter L, Lee Kwen P, Levin K, Libman R, Matlock J, McDowell P, McGee F. Jr, Meyer B, Minagar A, Moussouttas M, Munson R, Nash M, Nassief A, Orr S, Ratinov G, Salanga V, Silliman S, Singer R, Smith D, Sullivan H, Tietjen G, Thaler D, Tuchman M, Uskavitch D, Verro P, Vicari R, Weinstein R, Wilterdink J, Zweifler R, De Bastos M., FERRARESE, CARLO, Goldstein, L, Amarenco, P, Lamonte, M, Gilbert, S, Messig, M, Callahan, A, Hennerici, M, Sillesen, H, Welch, K, Sparcl, I, Bogousslavsky, J, Zivin, J, Clark, W, Dávalos, A, Kaste, M, Leiter, L, Altafullah, I, Graham, G, Glahn, J, Jiménez Hernández, D, Macwalter, R, Scott, R, Shuaib, A, Sivenius, J, Stipal, R, Hart, R, Marsh, J, Norrving, B, Pocock, S, Sacco, R, Easton, J, Brown, M, Nagy, Z, Whisnant, J, O'Neill, B, Kleber, F, Lablanche, J, Welty, F, Crimmins, D, Davis, S, Dimmitt, S, Donnan, G, Frayne, J, Freilich, D, Zagami, A, Mikocki, J, Schmidauer, C, Schmidt, R, De Bleecker, J, Deceuninck, F, Tack, P, Thijs, V, Gomes Fernandes, J, Beaudry, M, Cote, R, Hoyte, K, Lebrun, L, Mackey, A, Sahlas, D, Selchen, D, Spence, J, Teal, P, Winger, M, Matamala, G, Cifkova, R, Kalita, Z, Rektor, I, Rosolova, H, Vaclavik, D, Boysen, G, Klingenberg, H, Hillbom, M, Numminen, H, Pilke, A, Salmivaara, A, Alamowitch, S, Boulliat, J, De Broucker, T, Chollet, F, Mahagne, M, Milandre, L, Moulin, T, Milonas, I, Stathis, P, Vogiatzoglou, D, Bornstein, N, Honigman, S, Lampl, Y, Streifler, J, Capurso, A, Comi, G, Ferrarese, C, Gandolfo, C, Poloni, M, Senin, U, Rangel Guerra, R, Boon, A, De Keyser, J, De Kort, P, Haas, J, Kamphuis, D, Koudstaal, P, Anderson, N, Singh, G, Czlonkowska, A, Drozdowski, W, Gralewski, Z, Kozubski, W, Kuczynska Zardzewialy, A, Podemski, R, Stelmasiak, Z, Szczudlik, A, Da Costa Correia, C, Ferro, J, Salgueiro e., C, Lietava, J, Raslova, K, Carr, J, Gardiner, J, Kruger, A, Alvarez Sabin, J, Chamorro, A, Diez Tejedor, E, Fernández, O, Trejo Gabriel y., G, González Marcos, J, Egido Herrero, J, Jiménez Martínez, M, Lago Martin, A, Mostacero Miguel, E, Vivancos Mora, J, Moltó, J, Viguera Romero, J, Cuartero Rodriguez, E, Rubio, F, Serena, J, Laska, A, Leijd, B, Strand, T, Terent, A, Waegner, A, Wallén, T, Baumgartner, R, Hungerbühler, H, Lyrer, P, Mattle, H, Bath, P, Ekpo, E, Freeman, A, Lees, K, Macleod, M, Sharma, A, Shetty, H, Albers, G, Benavente, O, Book, D, Broderick, J, Calder, C, Carlini, W, Chaturvedi, S, Chippendale, T, Coull, B, Davis, P, Devlin, T, Dick, A, Dooneief, G, Duff, R, Estronza, N, Forteza, A, Frankel, M, Frey, J, Friday, G, Goldstein, J, Hammer, M, Harris, J, Harper, W, Hendin, B, Hess, D, Hinton, R, Hollander, J, Hughes, R, Kasner, S, Kent, T, Kim, L, Kirshner, H, Ledbetter, L, Lee Kwen, P, Levin, K, Libman, R, Matlock, J, Mcdowell, P, McGee F., J, Meyer, B, Minagar, A, Moussouttas, M, Munson, R, Nash, M, Nassief, A, Orr, S, Ratinov, G, Salanga, V, Silliman, S, Singer, R, Smith, D, Sullivan, H, Tietjen, G, Thaler, D, Tuchman, M, Uskavitch, D, Verro, P, Vicari, R, Weinstein, R, Wilterdink, J, Zweifler, R, De Bastos, M, Goldstein, LB, Welch, KMA, SPARCL investigators, Bogousslavsky J, Goldstein LB, Zivin J, Clark W, Dávalos A, Kaste M, Leiter L, Altafullah I, Graham G, Glahn J, Jiménez Hernández D, MacWalter R, Scott R, Shuaib A, Sivenius J, Stipal R, Hart R, Marsh J, Norrving B, Pocock S, Sacco R, Easton J, Brown M, Nagy Z, Whisnant J, O'Neill B, Kleber F, LaBlanche JM, Welty F, Crimmins D, Davis S, Dimmitt S, Donnan G, Frayne J, Freilich D, Zagami A, Mikocki J, Schmidauer C, Schmidt R, De Bleecker J, Deceuninck F, Tack P, Thijs V, Gomes Fernandes J, Beaudry M, Cote R, Hoyte K, Lebrun LH, Mackey A, Sahlas D, Selchen D, Spence JD, Teal P, Winger M, Matamala G, Cifkova R, Kalita Z, Rektor I, Rosolova H, Vaclavik D, Boysen G, Klingenberg H, Sillesen H, Hillbom M, Numminen H, Pilke A, Salmivaara A, Alamowitch S, Amarenco P, Boulliat J, De Broucker T, Chollet F, Mahagne MH, Milandre L, Moulin T, Milonas I, Stathis P, Vogiatzoglou D, Bornstein N, Honigman S, Lampl Y, Streifler J, Capurso A, Comi G, Gandolfo C, Poloni M, Senin U, Rangel Guerra R, Boon AM, De Keyser JH, De Kort PL, Haas JA, Kamphuis DJ, Koudstaal PJ, Anderson N, Singh G, Czlonkowska A, Drozdowski W, Gralewski Z, Kozubski W, Kuczynska Zardzewialy A, Podemski R, Stelmasiak Z, Szczudlik A, Da Costa Correia C, Ferro J, Salgueiro e. Cunha L, Lietava J, Raslova K, Carr J, Gardiner J, Kruger A, Alvarez Sabin J, Chamorro A, Diez Tejedor E, Fernández O, Trejo Gabriel y. Galán J, González Marcos J, Egido Herrero J, Jiménez Martínez M, Lago Martin A, Mostacero Miguel E, Vivancos Mora J, Moltó J, Viguera Romero J, Cuartero Rodriguez E, Rubio F, Serena J, Laska AC, Leijd B, Strand T, Terent A, Waegner A, Wallén T, Baumgartner R, Hungerbühler H, Lyrer P, Mattle H, Bath PM, Ekpo EB, Freeman A, Lees KR, MacLeod MJ, MacWalter RS, Sharma AK, Shetty HG, Albers G, Benavente O, Book D, Broderick J, Calder C, Carlini W, Chaturvedi S, Chippendale T, Coull B, Davis P, Devlin T, Dick A, Dooneief G, Duff R, Estronza N, Forteza A, Frankel M, Frey J, Friday G, Goldstein J, Hammer M, Harris J, Harper W, Hendin B, Hess D, Hinton R, Hollander J, Hughes R, Kasner S, Kent T, Kim L, Kirshner H, LaMonte M, Ledbetter L, Lee Kwen P, Levin K, Libman R, Matlock J, McDowell P, McGee F. Jr, Meyer B, Minagar A, Moussouttas M, Munson R, Nash M, Nassief A, Orr S, Ratinov G, Salanga V, Silliman S, Singer R, Smith D, Sullivan H, Tietjen G, Thaler D, Tuchman M, Uskavitch D, Verro P, Vicari R, Weinstein R, Wilterdink J, Zweifler R, De Bastos M., and FERRARESE, CARLO

Abstract

BACKGROUND AND PURPOSE: In SPARCL, treatment with atorvastatin 80 mg daily reduced stroke risk in patients with recent stroke or TIA and no known coronary heart disease by 16% versus placebo over 4.9 years of follow-up. The purpose of this secondary analysis was to determine whether men and women similarly benefited from randomization to statin treatment. METHODS: The effect of sex on treatment-related reductions in stroke and other cardiovascular outcomes were analyzed with Cox regression modeling testing for sex by treatment interactions. RESULTS: Women (n=1908) constituted 40% of the SPARCL study population. At baseline, men (n=2823) were younger (62.0+/-0.21 versus 63.9+/-0.27 years), had lower systolic BPs (138.1+/-0.35 versus 139.5+/-0.47 mm Hg), higher diastolic BPs (82.2+/-0.20 versus 81.0+/-0.25 mm Hg), more frequently had a history of smoking (73% versus 38%), and had lower total cholesterol (207.0+/-0.54 versus 218.9+/-0.67 mg/dL) and LDL-C levels (132+/-0.45 versus 134+/-0.57 mg/dL) than women. Use of antithrombotics and antihypertensives were similar. After prespecified adjustment for region, entry event, time since event, and age, there were no sex by treatment interactions for the combined risk of nonfatal and fatal stroke (treatment Hazard Ratio, HR=0.84, 95% CI 0.68, 1.02 in men versus HR=0.84, 95% CI 0.63, 1.11 in women; treatment x sex interaction P=0.99), major cardiac events (HR=0.61, 95% CI 0.42, 0.87 in men versus HR=0.76, 95% CI 0.48, 1.21 in women; P=0.45), major cardiovascular events (HR=0.78, 95% CI 0.65, 0.93 in men versus HR=0.84, 95% CI 0.65, 1.07 in women; P=0.63), revascularization procedures (HR=0.50, 95% CI 0.37, 0.67 in men versus HR=0.76, 95% CI 0.46, 1.24 in women; P=0.17), or any CHD event (HR=0.54, 95% CI 0.41, 0.72 in men versus 0.67 95% CI 0.46, 0.98 in women; P=0.40). CONCLUSIONS: Stroke and other cardiovascular events are similarly reduced with atorvastatin 80 mg/d in men and women with recent stroke or TIA.

Published
2008

5. Relative effects of statin therapy on stroke and cardiovascular events in men and women: secondary analysis of the Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) Study

Author

Goldstein, LB, Amarenco, P, Lamonte, M, Gilbert, S, Messig, M, Callahan, A, Hennerici, M, Sillesen, H, Welch, KMA, SPARCL investigators, Bogousslavsky J, Goldstein LB, Zivin J, Clark W, Dávalos A, Kaste M, Leiter L, Altafullah I, Graham G, Glahn J, Jiménez Hernández D, MacWalter R, Scott R, Shuaib A, Sivenius J, Stipal R, Hart R, Marsh J, Norrving B, Pocock S, Sacco R, Easton J, Brown M, Nagy Z, Whisnant J, O'Neill B, Kleber F, LaBlanche JM, Welty F, Crimmins D, Davis S, Dimmitt S, Donnan G, Frayne J, Freilich D, Zagami A, Mikocki J, Schmidauer C, Schmidt R, De Bleecker J, Deceuninck F, Tack P, Thijs V, Gomes Fernandes J, Beaudry M, Cote R, Hoyte K, Lebrun LH, Mackey A, Sahlas D, Selchen D, Spence JD, Teal P, Winger M, Matamala G, Cifkova R, Kalita Z, Rektor I, Rosolova H, Vaclavik D, Boysen G, Klingenberg H, Sillesen H, Hillbom M, Numminen H, Pilke A, Salmivaara A, Alamowitch S, Amarenco P, Boulliat J, De Broucker T, Chollet F, Mahagne MH, Milandre L, Moulin T, Milonas I, Stathis P, Vogiatzoglou D, Bornstein N, Honigman S, Lampl Y, Streifler J, Capurso A, Comi G, Gandolfo C, Poloni M, Senin U, Rangel Guerra R, Boon AM, De Keyser JH, De Kort PL, Haas JA, Kamphuis DJ, Koudstaal PJ, Anderson N, Singh G, Czlonkowska A, Drozdowski W, Gralewski Z, Kozubski W, Kuczynska Zardzewialy A, Podemski R, Stelmasiak Z, Szczudlik A, Da Costa Correia C, Ferro J, Salgueiro e. Cunha L, Lietava J, Raslova K, Carr J, Gardiner J, Kruger A, Alvarez Sabin J, Chamorro A, Diez Tejedor E, Fernández O, Trejo Gabriel y. Galán J, González Marcos J, Egido Herrero J, Jiménez Martínez M, Lago Martin A, Mostacero Miguel E, Vivancos Mora J, Moltó J, Viguera Romero J, Cuartero Rodriguez E, Rubio F, Serena J, Laska AC, Leijd B, Strand T, Terent A, Waegner A, Wallén T, Baumgartner R, Hungerbühler H, Lyrer P, Mattle H, Bath PM, Ekpo EB, Freeman A, Lees KR, MacLeod MJ, MacWalter RS, Sharma AK, Shetty HG, Albers G, Benavente O, Book D, Broderick J, Calder C, Carlini W, Chaturvedi S, Chippendale T, Coull B, Davis P, Devlin T, Dick A, Dooneief G, Duff R, Estronza N, Forteza A, Frankel M, Frey J, Friday G, Goldstein J, Hammer M, Harris J, Harper W, Hendin B, Hess D, Hinton R, Hollander J, Hughes R, Kasner S, Kent T, Kim L, Kirshner H, LaMonte M, Ledbetter L, Lee Kwen P, Levin K, Libman R, Matlock J, McDowell P, McGee F. Jr, Meyer B, Minagar A, Moussouttas M, Munson R, Nash M, Nassief A, Orr S, Ratinov G, Salanga V, Silliman S, Singer R, Smith D, Sullivan H, Tietjen G, Thaler D, Tuchman M, Uskavitch D, Verro P, Vicari R, Weinstein R, Wilterdink J, Zweifler R, De Bastos M., FERRARESE, CARLO, Goldstein, L, Amarenco, P, Lamonte, M, Gilbert, S, Messig, M, Callahan, A, Hennerici, M, Sillesen, H, Welch, K, Sparcl, I, Bogousslavsky, J, Zivin, J, Clark, W, Dávalos, A, Kaste, M, Leiter, L, Altafullah, I, Graham, G, Glahn, J, Jiménez Hernández, D, Macwalter, R, Scott, R, Shuaib, A, Sivenius, J, Stipal, R, Hart, R, Marsh, J, Norrving, B, Pocock, S, Sacco, R, Easton, J, Brown, M, Nagy, Z, Whisnant, J, O'Neill, B, Kleber, F, Lablanche, J, Welty, F, Crimmins, D, Davis, S, Dimmitt, S, Donnan, G, Frayne, J, Freilich, D, Zagami, A, Mikocki, J, Schmidauer, C, Schmidt, R, De Bleecker, J, Deceuninck, F, Tack, P, Thijs, V, Gomes Fernandes, J, Beaudry, M, Cote, R, Hoyte, K, Lebrun, L, Mackey, A, Sahlas, D, Selchen, D, Spence, J, Teal, P, Winger, M, Matamala, G, Cifkova, R, Kalita, Z, Rektor, I, Rosolova, H, Vaclavik, D, Boysen, G, Klingenberg, H, Hillbom, M, Numminen, H, Pilke, A, Salmivaara, A, Alamowitch, S, Boulliat, J, De Broucker, T, Chollet, F, Mahagne, M, Milandre, L, Moulin, T, Milonas, I, Stathis, P, Vogiatzoglou, D, Bornstein, N, Honigman, S, Lampl, Y, Streifler, J, Capurso, A, Comi, G, Ferrarese, C, Gandolfo, C, Poloni, M, Senin, U, Rangel Guerra, R, Boon, A, De Keyser, J, De Kort, P, Haas, J, Kamphuis, D, Koudstaal, P, Anderson, N, Singh, G, Czlonkowska, A, Drozdowski, W, Gralewski, Z, Kozubski, W, Kuczynska Zardzewialy, A, Podemski, R, Stelmasiak, Z, Szczudlik, A, Da Costa Correia, C, Ferro, J, Salgueiro e., C, Lietava, J, Raslova, K, Carr, J, Gardiner, J, Kruger, A, Alvarez Sabin, J, Chamorro, A, Diez Tejedor, E, Fernández, O, Trejo Gabriel y., G, González Marcos, J, Egido Herrero, J, Jiménez Martínez, M, Lago Martin, A, Mostacero Miguel, E, Vivancos Mora, J, Moltó, J, Viguera Romero, J, Cuartero Rodriguez, E, Rubio, F, Serena, J, Laska, A, Leijd, B, Strand, T, Terent, A, Waegner, A, Wallén, T, Baumgartner, R, Hungerbühler, H, Lyrer, P, Mattle, H, Bath, P, Ekpo, E, Freeman, A, Lees, K, Macleod, M, Sharma, A, Shetty, H, Albers, G, Benavente, O, Book, D, Broderick, J, Calder, C, Carlini, W, Chaturvedi, S, Chippendale, T, Coull, B, Davis, P, Devlin, T, Dick, A, Dooneief, G, Duff, R, Estronza, N, Forteza, A, Frankel, M, Frey, J, Friday, G, Goldstein, J, Hammer, M, Harris, J, Harper, W, Hendin, B, Hess, D, Hinton, R, Hollander, J, Hughes, R, Kasner, S, Kent, T, Kim, L, Kirshner, H, Ledbetter, L, Lee Kwen, P, Levin, K, Libman, R, Matlock, J, Mcdowell, P, McGee F., J, Meyer, B, Minagar, A, Moussouttas, M, Munson, R, Nash, M, Nassief, A, Orr, S, Ratinov, G, Salanga, V, Silliman, S, Singer, R, Smith, D, Sullivan, H, Tietjen, G, Thaler, D, Tuchman, M, Uskavitch, D, Verro, P, Vicari, R, Weinstein, R, Wilterdink, J, Zweifler, R, and De Bastos, M

Subjects
Male, Atorvastatin, Blood Pressure, Sex Factor, Pyrrole, Triglyceride, law.invention, Randomized controlled trial, law, Stroke, Sex Characteristics, Middle Aged, Heptanoic Acid, Cholesterol, Treatment Outcome, Data Interpretation, Statistical, Hypertension, Population study, Female, Cardiology and Cardiovascular Medicine, Human, medicine.drug, medicine.medical_specialty, Randomization, Logistic Model, Reproducibility of Result, Placebo, Sex Factors, Internal medicine, medicine, Humans, Pyrroles, Triglycerides, Advanced and Specialized Nursing, Apolipoprotein A-I, Proportional hazards model, business.industry, Reproducibility of Results, Sex Characteristic, medicine.disease, Surgery, Blood pressure, Logistic Models, Heptanoic Acids, Hydroxymethylglutaryl-CoA Reductase Inhibitor, Neurology (clinical), Hydroxymethylglutaryl-CoA Reductase Inhibitors, business
Abstract

Background and Purpose— In SPARCL, treatment with atorvastatin 80 mg daily reduced stroke risk in patients with recent stroke or TIA and no known coronary heart disease by 16% versus placebo over 4.9 years of follow-up. The purpose of this secondary analysis was to determine whether men and women similarly benefited from randomization to statin treatment. Methods— The effect of sex on treatment-related reductions in stroke and other cardiovascular outcomes were analyzed with Cox regression modeling testing for sex by treatment interactions. Results— Women (n=1908) constituted 40% of the SPARCL study population. At baseline, men (n=2823) were younger (62.0±0.21versus 63.9±0.27 years), had lower systolic BPs (138.1±0.35 versus 139.5±0.47 mm Hg), higher diastolic BPs (82.2±0.20 versus 81.0±0.25 mm Hg), more frequently had a history of smoking (73% versus 38%), and had lower total cholesterol (207.0±0.54 versus 218.9±0.67 mg/dL) and LDL-C levels (132±0.45 versus 134±0.57 mg/dL) than women. Use of antithrombotics and antihypertensives were similar. After prespecified adjustment for region, entry event, time since event, and age, there were no sex by treatment interactions for the combined risk of nonfatal and fatal stroke (treatment Hazard Ratio, HR=0.84, 95% CI 0.68, 1.02 in men versus HR=0.84, 95% CI 0.63, 1.11 in women; treatment×sex interaction P =0.99), major cardiac events (HR=0.61, 95% CI 0.42, 0.87 in men versus HR=0.76, 95% CI 0.48, 1.21 in women; P =0.45), major cardiovascular events (HR=0.78, 95% CI 0.65, 0.93 in men versus HR=0.84, 95% CI 0.65, 1.07 in women; P =0.63), revascularization procedures (HR=0.50, 95% CI 0.37, 0.67 in men versus HR=0.76, 95% CI 0.46, 1.24 in women; P =0.17), or any CHD event (HR=0.54, 95% CI 0.41, 0.72 in men versus 0.67 95% CI 0.46, 0.98 in women; P =0.40). Conclusion— Stroke and other cardiovascular events are similarly reduced with atorvastatin 80 mg/d in men and women with recent stroke or TIA.

Published
2008

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