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Curr Med Res Opin. 2011 Apr;27(4):821-33. doi: 10.1185/03007995.2011.555754. Epub 2011 Feb 10.

Proactive multiple cardiovascular risk factor management compared with usual care in patients with hypertension and additional risk factors: the CRUCIAL trial.

Collaborators (297)

Gamboa-Garro R, Cespedes-Vargas J, Sancez-Soto C, Moya-Rodriguez J, Gonzalez-Rojas L, Jones-Chacon MA, Ramirez LC, Cob-Sanchez A, Dengo-Sotela G, Apestegui IG, Sucaet B, Slon-Hitti C, Mesen G, Zumbado R, Tortos-Guzman J, Echeverri-McCandless A, Martinez-Elizondo M, Vinocour-Fornieri M, Duran-Ramirez M, Yung-Li G, Bokarica D, Bezdrov M, Car I, Cikac T, Cop R, Hrandek BH, Javoric J, Kotur G, Kranjcevic K, Lazic G, Maravic Z, Margetic S, Primorac L, Prlina M, Smiciklas NF, Grilec B, Stritof M, Smiciklas NF, Vivoda ZB, Vrdoljak D, Herle P, Kos P, Marek V, Miskovska Z, Miskovsky J, Moravcikova D, Motlikova E, Hanusova I, Nejedla A, Seifert B, Youngova A, Skala B, Vecerek M, Winklerova J, Almonte C, Diez Y, Nunez E, Gonzalez-Medina A, Suarez-Fuster L, Pichardo R, Rodriguez C, Sanchez A, Chandradin C, Wardoyo A, Harahap ML, Achyar A, Kusmana D, Dakota I, Radi B, Lukito AA, Eddy E, Makmun LH, Nasution SA, Martanto E, Achmad C, Antono E, Rifqi S, Herminingsih S, Yogiarto RM, Sumantri D, Subagjo A, Albatayneh A, Khatib N, Qaqa Z, Saleh AA, Baek SH, Baek JY, Jung HO, Kim PJ, Park MW, Yoon SG, Cho SY, Lee SH, Park SH, Hur SH, Cho YK, Kim HS, Kim KB, Nam CW, Jeong MH, Kang DH, Kim CH, Chae IH, Cho YS, Choi DJ, Kim KI, Youn TJ, Kim DS, Kim DK, Kim SM, Yang TH, Kim KS, Chang SG, Choi JY, Lee JB, Lee YS, Ryu JK, Kim MH, Cha KS, Koh KK, Kwon HM, Hong BK, Min PK, Rim SJ, Yoon YW, Lee SH, Kim JY, Lee MY, Shin YG, Yoo BS, Oh BH, Lee HY, Park JH, Lee JH, Park SW, Sung J, Seo HS, Kim EJ, Shim WJ, Park SM, Tahk SJ, Choi BJ, Choi SY, Choi UJ, Hwang JW, Kang SJ, Lim HS, Shin JH, Woo SI, Yoon MH, Akbar M, Petrovski P, Yassin K, Zubaid M, Ali A, Adhami A, El Bayeh H, Chouairi S, Sarkis AS, Aziz A, Ahmad S, Hashim NA, Kwa SK, Ismail M, Lee WY, Sathay S, Rajathurai C, Xavier G, Alvarado-Ruiz R, Reyes-Sanchez R, Sida-Perez P, Cabrera-Jardines R, Cruz-Diaz A, Rangel-Rojo FJ, Duarte-Vega M, Zamora-Angulo LE, Gonzalez-Ortiz M, Guerra-Guevaraq KP, Robles JA, Halley-Castillo ME, Aranza-Doniz C, Archundia-Cabanez HM, Lopez-Morales Cde J, Perez-Moreno D, Meaney-Martinez A, Rodriguez-Briones I, Delgado-Galicia EA, Quintero S, Trujillo R, Guardia C, Jaen Y, Lim-Abrahan MA, Fernando KK, Panelo A, Agra J, Punzalan FE, Aquino-Nablo MD, Jocson GB 3rd, Roasa EL, Garcia M, Sy RG, Chua PU, Vicaldo ER, Akhmedzhanov NM, Kachanova N, Aroutyunov GP, Chernyavskaya TK, Meskhidze EB, Bart BY, Mikhailusova MP, Runikhina NK, Egorova LP, Maslakova D, Sychova YA, Karpov YB, Garshin BB, Kosenko BV, Kurakova EN, Kostenko VA, Bokovin N, Tumarov F, Lopatin YM, Ilyukhin OV, Zavodchikova EN, Moiseyev VS, Kobalava Z, Korovina EP, Rubanova A, Villevalde SV, Petrov AA, Shubik YV, Aparina I, Solovieva Z, Vishnevskiy A, Bershtein L, Kositcyn DV, Molotkova EN, Smirnov GB, Terskikh M, Yusupov AS, Titkov YS, Zharkova LP, Andreeva IV, Ilyin DV, Zrazhevsky KN, Paltsman ZV, Rodina NA, Chen JF, Kuo MC, Chen ZC, Ko YL, Lai WT, Lee KT, Lin LJ, Ueng KC, Tseng CD, Jeng JS, Wang YC, Wang KY, Assawawitoontip S, Sakulsaengprapha T, Wadhanakul K, Thongouppakarn P, Bodur HA, Tunca M, Guler K, Akkaya V, Kumbasar A, Cengiz I, Ergen A, Sertkaya S, Akpolat A, Sonbahar M, Yildrim A, Tukek T, Cakirca M, Cikrikcioglu MA, Kurt T, Kurtulmus N, Tunckale A, Curgunlu A, Afendi B, El Houni A, Naeemi AA, Brek AS, Feiruz A, Gabroun A, Kaddaha G, Matto S, Antepara N, Jimenez A, Chazzim G, Martinez E, Delgado AJ, Guzman M, Delgado CL, Ribaldi JD.

Author information

1
Hospital Clinico San Carlos, Madrid, Spain. zamorano@secardiologia.es

Abstract

OBJECTIVE:

To investigate whether a proactive multifactorial risk factor intervention strategy using single-pill amlodipine/atorvastatin (5/10, 10/10 mg) in addition to other antihypertensive and lipid-lowering therapy, as required, resulted in greater reduction in calculated Framingham 10-year coronary heart disease (CHD) risk compared with usual care (UC) after 52-weeks treatment.

RESEARCH DESIGN AND METHODS:

Prospective, multinational, open-label, cluster randomized trial, with the investigator as the unit of randomization. Eligible hypertensive patients were 35-79 years of age, with ≥3 additional cardiovascular risk factors, but no history of CHD and baseline total cholesterol (TC) ≤6.5 mmol/l.

CLINICAL TRIAL REGISTRATION:

www.ClinicalTrials.gov ; trial identifier NCT00407537.

MAIN OUTCOME MEASURE:

The primary endpoint was calculated Framingham 10-year CHD risk at 52 weeks.

RESULTS:

Of the 140 randomized sites, 136 sites contributed 1461 patients. Mean baseline age and low-density lipoprotein cholesterol (LDL-C) were comparable between treatment arms. Mean baseline BP (150.3/89.7 vs. 144.3/86.5 mmHg) and Framingham CHD risk (20.0 vs. 18.1%) were higher in the proactive intervention versus the UC arm (p < 0.002 for both). At week 52, mean CHD risk was 12.5% in the proactive intervention arm and 16.3% in the UC arm (p < 0.001). The difference, observed at weeks 16 and 52, was primarily driven by significant differences in systolic BP and in TC between the two arms. Overall, adverse events (AEs) were reported in 48.8% and 44.0% of patients in the proactive intervention and the UC arm, respectively. Although there were differences in the incidence of AEs between the treatment arms, the AE profile in the proactive intervention arm was consistent with previous safety experience for this medication.

CONCLUSIONS:

A proactive multifactorial risk factor intervention strategy that simultaneously treated both BP and cholesterol regardless of individual risk factors per se, is more effective in reducing calculated Framingham 10-year CHD risk than UC in patients with hypertension and additional risk factors.

PMID:
21306285
DOI:
10.1185/03007995.2011.555754
[Indexed for MEDLINE]

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