Wikipedia

Randomiserade strokestudier i Sverige

Flera randomiserade kontrollerade (RCT) strokestudier har genomförts i Sverige. Vissa studier initierats inom landet medan andra har inletts utanför Sveriges gränser.

Randomiserade kontrollerade studier initierade inom Sverige redigera

Den hittills största RCT-strokestudien är SALT-studien [1], som undersökte effekten av en låg dos acetylsalisylsyra (ASA) jämfört med en hög dos efter en cerebrovaskulär händelse. Studien publicerades 1991 i tidskriften Lancet. Vid den tidpunkten var det känt att en högre dos av ASA på ca 300 mg/dag var effektiv, samtidigt som det var känt att en så låg dos som 50 mg/dag kunde hämma alla blodplättar och troligen vara lika effektiv men med färre biverkningar. SALT-studien visade att 75 mg/dag av ASA var lika effektivt och den dosen har sedan dess varit standardmedicinering efter ischemisk stroke och TIA.

Den näst största studien är från Umeå och undersökte om atenolol (en medicin som dämpar hjärtats frekvens) minskade risken för hjärtkärlsjukdom efter en stroke [2]. Studien inkluderade 720 individer vid 18 olika centerar. De 15 största RCT-studierna listas i tabellen nedan. Som framgår av kolumnen sponsor är samtliga studier akademikerdrivna, dvs startade och ledda av forskare.

Tabell 1. Randomiserade kontrollerade strokestudier initierade i Sverige
Sponsor Referens Antal individer Antal center
Läkemedelsverket, Hjärt-Lungfonden, Vetenskapsrådet Swedish Aspirin Low-Dose Trial (SALT) of 75 mg aspirin as secondary prophylaxis after cerebrovascular ischaemic events [1] 1 360 16
Umeå universitet Atenolol in Secondary Prevention after Stroke [2] 720 18
Swedish Medical Research Council (Project no. 19X-07192), Pharmacia AB, Queen Victoria's and King Gustav V's 80th Anniversary Fund, the Swedish National Association Against Heart and Lung Diseases, and Umeå University Multicenter trial of hemodilution in acute ischemic stroke. I. Results in the total patient population [3] 373 15
Sahlgrenska akademien Effect of acute stroke unit care integrated with care continuum versus conventional treatment: A randomized 1-year study of elderly patients: the Göteborg 70+ Stroke Study [4] 249 1
Lunds universitet Anticoagulant vs anti-platelet therapy as prophylactic against cerebral infarction in transient ischemic attacks [5] 156 5
Lunds universitet Acupuncture and transcutaneous nerve stimulation in stroke rehabilitation: a randomized, controlled trial [6] 150 7
Karolinska Institutet Double-blind comparison of sertraline and placebo in stroke patients with minor depression and less severe major depression [7] 123 4
Karolinska Institutet A randomized controlled trial on very early speech and language therapy in acute stroke patients with aphasia [8] 123 1
Norrlands Universitetssjukhus A randomized controlled trial of hemodilution therapy in acute ischemic stroke [9] 102 1
Karolinska Institutet A randomized controlled trial evaluating the effect of a support and education programme for spouses of people affected by stroke [10] 100 1
Karolinska Institutet A randomized controlled trial of early supported discharge and continued rehabilitation at home after stroke: five-year follow-up of patient outcome [11] 83 1
Uppsala universitet Short-term and long-term effects of a progressive resistance and balance exercise program in individuals with chronic stroke: a randomized controlled trial [12] 67 1
Karolinska Institutet Randomized assessment of imatinib in patients with acute ischaemic stroke treated with intravenous thrombolysis [13] 60 5
Linköpings universitet Effects of Twice-Weekly Intense Aerobic Exercise in Early Subacute Stroke: A Randomized Controlled Trial [14] 56 1
Lunds universitet Can sensory stimulation improve the functional outcome in stroke patients? [15] 40 1

Randomiserade kontrollerade studier initierade utanför Sverige redigera

Den största RCT strokestudien med den högsta andelen svenska patienter, är SCAST-studien [16], som leddes från Norge. Andelen svenska individer i denna studie var 617 vilket utgjorde drygt 30 % av det totala antalet (N=2 029). SCAST studerade det blodtryckssänkande läkemedel, kandesatran, och syftet var att undersöka om det lönade sig att påbörja blodtryckssänkande behandling i det akuta skedet. Resultatet av studien var att det inte lönade sig att påbörja behandlingen akut.

PRoFESS är den nästa största studien [17] med 503 individer från Sverige av de totalt 20 332 i studien. Studien undersökte effekten av ASA plus dipyridamol med klopidogrel och telmisartan på funktionsnedsättning och kognitiv funktion efter ischemisk stroke.

De flesta strokestudierna har studerat olika blodförtunnande läkemedel för att förebygga stroke på grund av förmaksflimmer och effekten av propplösande läkemedel vid akut ischemisk stroke.

Tabell 2. Randomiserade kontrollerade strokestudier initierade utanför Sverige
Sponsor Namn på studien Acronym Totalantalet individer i studien Andelen individer i Sverige
Oslo University Hospital The angiotensin-receptor blocker candesartan for treatment of acute stroke [16] SCAST 2 029 617
Boehringer Ingelheim Effects of aspirin plus extended-release dipyridamole versus clopidogrel and telmisartan on disability and cognitive function after recurrent stroke in patients with ischaemic stroke in the Prevention Regimen for Effectively Avoiding Second Strokes [17] PRoFESS 20 332 503
Edinburgh University The third international stroke trial [18] IST-3 3 035 297
Astra Zeneca Stroke prevention with the oral direct thrombin inhibitor ximelagatran compared with warfarin in patients with non-valvular atrial fibrillation [19] SPORTIF 3 410 297
Boehringer Ingelheim Randomized evaluation of long-term anticoagulant therapy, warfarin, compared with dabigatran [20] RE-LY 18 113 277
Daiichi Sankyo PharmaDevelopment Edoxaban versus warfarin in patients with atrial fibrillation [21] ENGAGE 21 105 252
Bristol-Myers Squibb and Pfizer Apixaban compared with warfarin in patients with atrialfibrillation and previous stroke or transient ischaemic attack [22] ARISTOTLE 18 206 217
Astra Zeneca Acute Stroke or Transient Ischemic Attack Treated with Aspirin or Ticagrelor and Patient Outcomes [23] SOCRATS 13 600 211
Servier, France The Prevention of cerebrovascular and cardiovascular Events of ischemic origin witht eRutroban in patients with a history oF ischemic strOke or tRansient ischeMic attack [24] PERFORM 19 119 128
Boehringer Ingelheim Randomised double-blind placebo-controlled trial of thrombolytic therapy with intravenous alteplase in acute ischaemic stroke [25] ECASS II 800 36
Boehringer Ingelheim The European Cooperative Acute Stroke Study [26] ECASS 620 35
Johnson & Johnson Pharmaceutical Research Rivaroxaban-oncedaily, oral, directfactorXa inhibition compared with vitamin K antagonism for prevention of stroke and Embolism Trial in Atrial Fibrillation [27] ROCKET 14 000 28
University of Nottingham Efficacy of Nitric Oxide in Stroke [28] ENOS 4 011 14
Boehringer Ingelheim Thrombolysis with Alteplase 3 to 4.5 Hours after Acute Ischemic Stroke [29] ECASS III 821 14

Referenser redigera

  1. ^ [a b] ”Swedish Aspirin Low-Dose Trial (SALT) of 75 mg aspirin as secondary prophylaxis after cerebrovascular ischaemic events. The SALT Collaborative Group”. Lancet (London, England) 338 (8779): sid. 1345–1349. ISSN 0140-6736. https://www.ncbi.nlm.nih.gov/pubmed/1682734. Läst 21 maj 2017. 
  2. ^ [a b] Eriksson, Sture; Olofsson, Bert-Ove; Wester, Per-Olov. ”Atenolol in Secondary Prevention after Stroke”. Cerebrovascular Diseases 5 (1): sid. 21–25. doi:10.1159/000107813. http://www.karger.com/?doi=10.1159/000107813. Läst 22 juni 2017. 
  3. ^ Garraway, Isla P; Sun, Wenyi; Tran, Chau P; Perner, Sven; Zhang, Bao; Goldstein, Andrew S. ”Human Prostate Sphere-Forming Cells Represent a Subset of Basal Epithelial Cells Capable of Glandular Regeneration in Vivo”. The Prostate 70 (5): sid. 491–501. doi:10.1002/pros.21083. ISSN 0270-4137. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2885946/. Läst 22 juni 2017. 
  4. ^ Fagerberg, B.; Claesson, L.; Gosman-Hedström, G.; Blomstrand, C.. ”Effect of acute stroke unit care integrated with care continuum versus conventional treatment: A randomized 1-year study of elderly patients: the Göteborg 70+ Stroke Study”. Stroke 31 (11): sid. 2578–2584. ISSN 1524-4628. https://www.ncbi.nlm.nih.gov/pubmed/11062278. Läst 17 april 2017. 
  5. ^ Olsson, J. E.; Brechter, C.; Bäcklund, H.; Krook, H.; Müller, R.; Nitelius, E.. ”Anticoagulant vs anti-platelet therapy as prophylactic against cerebral infarction in transient ischemic attacks”. Stroke 11 (1): sid. 4–9. ISSN 0039-2499. https://www.ncbi.nlm.nih.gov/pubmed/7355429. Läst 22 juni 2017. 
  6. ^ Johansson, B. B.; Haker, E.; von Arbin, M.; Britton, M.; Långström, G.; Terént, A.. ”Acupuncture and transcutaneous nerve stimulation in stroke rehabilitation: a randomized, controlled trial”. Stroke 32 (3): sid. 707–713. ISSN 1524-4628. https://www.ncbi.nlm.nih.gov/pubmed/11239191. Läst 18 april 2017. 
  7. ^ Murray, Veronica; von Arbin, Magnus; Bartfai, Aniko; Berggren, Anna-Lena; Landtblom, Anne-Marie; Lundmark, Jöns. ”Double-blind comparison of sertraline and placebo in stroke patients with minor depression and less severe major depression”. The Journal of Clinical Psychiatry 66 (6): sid. 708–716. ISSN 0160-6689. https://www.ncbi.nlm.nih.gov/pubmed/15960563. Läst 18 april 2017. 
  8. ^ Laska, A. C.; Kahan, T.; Hellblom, A.; Murray, V.; von Arbin, M.. ”A randomized controlled trial on very early speech and language therapy in acute stroke patients with aphasia”. Cerebrovascular Diseases Extra 1 (1): sid. 66–74. doi:10.1159/000329835. ISSN 1664-5456. https://www.ncbi.nlm.nih.gov/pubmed/22566984. Läst 25 maj 2017. 
  9. ^ Strand, T.; Asplund, K.; Eriksson, S.; Hägg, E.; Lithner, F.; Wester, P. O.. ”A randomized controlled trial of hemodilution therapy in acute ischemic stroke”. Stroke 15 (6): sid. 980–989. ISSN 0039-2499. https://www.ncbi.nlm.nih.gov/pubmed/6209832. Läst 3 juni 2017. 
  10. ^ Franzén-Dahlin, Å.; Larson, J.; Murray, V.; Wredling, R.; Billing, E.. ”A randomized controlled trial evaluating the effect of a support and education programme for spouses of people affected by stroke” (på engelska). Clinical Rehabilitation 22 (8): sid. 722–730. doi:10.1177/0269215508090161. ISSN 0269-2155. http://journals.sagepub.com/doi/abs/10.1177/0269215508090161. Läst 25 maj 2017. 
  11. ^ Thorsén, Ann-Mari; Holmqvist, Lotta Widés; de Pedro-Cuesta, Jesús; von Koch, Lena. ”A randomized controlled trial of early supported discharge and continued rehabilitation at home after stroke: five-year follow-up of patient outcome”. Stroke 36 (2): sid. 297–303. doi:10.1161/01.STR.0000152288.42701.a6. ISSN 1524-4628. https://www.ncbi.nlm.nih.gov/pubmed/15618441. Läst 25 maj 2017. 
  12. ^ Vahlberg, Birgit; Cederholm, Tommy; Lindmark, Birgitta; Zetterberg, Lena; Hellström, Karin. ”Short-term and long-term effects of a progressive resistance and balance exercise program in individuals with chronic stroke: a randomized controlled trial”. Disability and Rehabilitation 39 (16): sid. 1615–1622. doi:10.1080/09638288.2016.1206631. ISSN 1464-5165. https://www.ncbi.nlm.nih.gov/pubmed/27415645. Läst 25 maj 2017. 
  13. ^ Wahlgren, N.; Thorén, M.; Höjeberg, B.; Käll, T.-B.; Laska, A.-C.; Sjöstrand, C.. ”Randomized assessment of imatinib in patients with acute ischaemic stroke treated with intravenous thrombolysis”. Journal of Internal Medicine 281 (3): sid. 273–283. doi:10.1111/joim.12576. ISSN 1365-2796. https://www.ncbi.nlm.nih.gov/pubmed/27862464. Läst 25 maj 2017. 
  14. ^ Sandberg, Klas; Kleist, Marie; Falk, Lars; Enthoven, Paul. ”Effects of Twice-Weekly Intense Aerobic Exercise in Early Subacute Stroke: A Randomized Controlled Trial”. Archives of Physical Medicine and Rehabilitation 97 (8): sid. 1244–1253. doi:10.1016/j.apmr.2016.01.030. ISSN 1532-821X. https://www.ncbi.nlm.nih.gov/pubmed/26903147. Läst 25 maj 2017. 
  15. ^ Johansson, K.; Lindgren, I.; Widner, H.; Wiklund, I.; Johansson, B. B.. ”Can sensory stimulation improve the functional outcome in stroke patients?”. Neurology 43 (11): sid. 2189–2192. ISSN 0028-3878. https://www.ncbi.nlm.nih.gov/pubmed/8232927. Läst 22 juni 2017. 
  16. ^ [a b] Sandset, Else Charlotte; Bath, Philip M. W.; Boysen, Gudrun; Jatuzis, Dalius; Kõrv, Janika; Lüders, Stephan. ”The angiotensin-receptor blocker candesartan for treatment of acute stroke (SCAST): a randomised, placebo-controlled, double-blind trial”. Lancet (London, England) 377 (9767): sid. 741–750. doi:10.1016/S0140-6736(11)60104-9. ISSN 1474-547X. https://www.ncbi.nlm.nih.gov/pubmed/21316752. Läst 25 maj 2017. 
  17. ^ [a b] Diener, Hans-Christoph; Sacco, Ralph L.; Yusuf, Salim; Cotton, Daniel; Ounpuu, Stephanie; Lawton, William A.. ”Effects of aspirin plus extended-release dipyridamole versus clopidogrel and telmisartan on disability and cognitive function after recurrent stroke in patients with ischaemic stroke in the Prevention Regimen for Effectively Avoiding Second Strokes (PRoFESS) trial: a double-blind, active and placebo-controlled study”. The Lancet. Neurology 7 (10): sid. 875–884. doi:10.1016/S1474-4422(08)70198-4. ISSN 1474-4422. https://www.ncbi.nlm.nih.gov/pubmed/18757238. Läst 25 maj 2017. 
  18. ^ IST-3 collaborative group; Sandercock, Peter; Wardlaw, Joanna M.; Lindley, Richard I.; Dennis, Martin; Cohen, Geoff. ”The benefits and harms of intravenous thrombolysis with recombinant tissue plasminogen activator within 6 h of acute ischaemic stroke (the third international stroke trial [IST-3): a randomised controlled trial”]. Lancet (London, England) 379 (9834): sid. 2352–2363. doi:10.1016/S0140-6736(12)60768-5. ISSN 1474-547X. https://www.ncbi.nlm.nih.gov/pubmed/22632908. Läst 25 maj 2017. 
  19. ^ Olsson, S. Bertil; Executive Steering Committee of the SPORTIF III Investigators. ”Stroke prevention with the oral direct thrombin inhibitor ximelagatran compared with warfarin in patients with non-valvular atrial fibrillation (SPORTIF III): randomised controlled trial”. Lancet (London, England) 362 (9397): sid. 1691–1698. ISSN 1474-547X. https://www.ncbi.nlm.nih.gov/pubmed/14643116. Läst 25 maj 2017. 
  20. ^ Ezekowitz, Michael D.; Connolly, Stuart; Parekh, Amit; Reilly, Paul A.; Varrone, Jeanne; Wang, Susan. ”Rationale and design of RE-LY: randomized evaluation of long-term anticoagulant therapy, warfarin, compared with dabigatran”. American Heart Journal 157 (5): sid. 805–810, 810.e1–2. doi:10.1016/j.ahj.2009.02.005. ISSN 1097-6744. https://www.ncbi.nlm.nih.gov/pubmed/19376304. Läst 26 maj 2017. 
  21. ^ Giugliano, Robert P.; Ruff, Christian T.; Braunwald, Eugene; Murphy, Sabina A.; Wiviott, Stephen D.; Halperin, Jonathan L.. ”Edoxaban versus warfarin in patients with atrial fibrillation”. The New England Journal of Medicine 369 (22): sid. 2093–2104. doi:10.1056/NEJMoa1310907. ISSN 1533-4406. https://www.ncbi.nlm.nih.gov/pubmed/24251359. Läst 26 maj 2017. 
  22. ^ Lopes, Renato D.; Alexander, John H.; Al-Khatib, Sana M.; Ansell, Jack; Diaz, Raphael; Easton, J. Donald. ”Apixaban for reduction in stroke and other ThromboemboLic events in atrial fibrillation (ARISTOTLE) trial: design and rationale”. American Heart Journal 159 (3): sid. 331–339. doi:10.1016/j.ahj.2009.07.035. ISSN 1097-6744. https://www.ncbi.nlm.nih.gov/pubmed/20211292. Läst 26 maj 2017. 
  23. ^ Amarenco, Pierre; Albers, Gregory W.; Denison, Hans; Easton, J. Donald; Evans, Scott R.; Held, Peter. ”Efficacy and safety of ticagrelor versus aspirin in acute stroke or transient ischaemic attack of atherosclerotic origin: a subgroup analysis of SOCRATES, a randomised, double-blind, controlled trial”. The Lancet. Neurology 16 (4): sid. 301–310. doi:10.1016/S1474-4422(17)30038-8. ISSN 1474-4465. https://www.ncbi.nlm.nih.gov/pubmed/28238711. Läst 26 maj 2017. 
  24. ^ Bousser, M. G.; Amarenco, P.; Chamorro, A.; Fisher, M.; Ford, I.; Fox, K.. ”The Prevention of cerebrovascular and cardiovascular Events of ischemic origin with teRutroban in patients with a history oF ischemic strOke or tRansient ischeMic attack (PERFORM) study: baseline characteristics of the population”. Cerebrovascular Diseases (Basel, Switzerland) 27 (6): sid. 608–613. doi:10.1159/000216835. ISSN 1421-9786. https://www.ncbi.nlm.nih.gov/pubmed/19407444. Läst 26 maj 2017. 
  25. ^ Hacke, W.; Kaste, M.; Fieschi, C.; von Kummer, R.; Davalos, A.; Meier, D.. ”Randomised double-blind placebo-controlled trial of thrombolytic therapy with intravenous alteplase in acute ischaemic stroke (ECASS II). Second European-Australasian Acute Stroke Study Investigators”. Lancet (London, England) 352 (9136): sid. 1245–1251. ISSN 0140-6736. https://www.ncbi.nlm.nih.gov/pubmed/9788453. Läst 26 maj 2017. 
  26. ^ Hacke, W.; Kaste, M.; Fieschi, C.; Toni, D.; Lesaffre, E.; von Kummer, R.. ”Intravenous thrombolysis with recombinant tissue plasminogen activator for acute hemispheric stroke. The European Cooperative Acute Stroke Study (ECASS)”. JAMA 274 (13): sid. 1017–1025. ISSN 0098-7484. https://www.ncbi.nlm.nih.gov/pubmed/7563451. Läst 26 maj 2017. 
  27. ^ ROCKET AF Study Investigators. ”Rivaroxaban-once daily, oral, direct factor Xa inhibition compared with vitamin K antagonism for prevention of stroke and Embolism Trial in Atrial Fibrillation: rationale and design of the ROCKET AF study”. American Heart Journal 159 (3): sid. 340–347.e1. doi:10.1016/j.ahj.2009.11.025. ISSN 1097-6744. https://www.ncbi.nlm.nih.gov/pubmed/20211293. Läst 26 maj 2017. 
  28. ^ ENOS Investigators. ”Baseline characteristics of the 4011 patients recruited into the ‘Efficacy of Nitric Oxide in Stroke’ (ENOS) trial”. International Journal of Stroke: Official Journal of the International Stroke Society 9 (6): sid. 711–720. doi:10.1111/ijs.12308. ISSN 1747-4949. https://www.ncbi.nlm.nih.gov/pubmed/25043647. Läst 26 maj 2017. 
  29. ^ Hacke, Werner; Kaste, Markku; Bluhmki, Erich; Brozman, Miroslav; Dávalos, Antoni; Guidetti, Donata. ”Thrombolysis with alteplase 3 to 4.5 hours after acute ischemic stroke”. The New England Journal of Medicine 359 (13): sid. 1317–1329. doi:10.1056/NEJMoa0804656. ISSN 1533-4406. https://www.ncbi.nlm.nih.gov/pubmed/18815396. Läst 26 maj 2017. 
Hämtad från ”https://sv.wikipedia.org/w/index.php?title=Randomiserade_strokestudier_i_Sverige&oldid=45203761”