Efficacy of n-3 polyunsaturated fatty acids and feasibility of optimizing preventive strategies in patients at high cardiovascular risk: rationale, design and baseline characteristics of the Rischio and Prevenzione study, a large randomised trial in general practice
Genre
Journal ArticleMulticenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Date
2010-05-28Author
Avanzini, FBarlera, S
Caimi, V
Longoni, P
Marchioli, R
Roncaglioni, MC
Silletta, MG
Tognoni, G
Tombesi, M
Tombesi, M
Tognoni, G
Massa, E
Marrocco, W
Micalella, M
Caimi, V
Longoni, P
Aprile, L
Avanzini, F
Franzosi, MG
Geraci, E
Giansiracusa, N
Rocchetti, L
Decarli, A
Satolli, R
Alli, C
Beghi, E
Volpi, V Bertele' A
Roncaglioni, MC
Monesi, L
Marzona, I
Baviera, M
Barlera, S
Milani, V
Nicolis, E
Casola, C
Clerici, F
Palumbo, A
Sgaroni, G
Marchioli, R
Silletta, MG
Pioggiarella, R
Scarano, M
Marfisi, RM
Flamminio, A
Mancino, L
Ferri, B
Pera, C
Polidoro, A
Abbatino, D
Acquati, M
Addorisio, G
Adinolfi, D
Adreani, L
Agistri, MR
Agneta, A
Agnolio, ML
Agostini, N
Agostino, G
Airo, A
Alaimo, N
Albano, M
Albano, N
Alecci, G
Alemanno, S
Alexanian, A
Alfarano, M
Alfe, L
Alonzo, N
Alvino, S
Ancora, A
Andiloro, S
Andreatta, E
Angeli, S
Angiari, F
Angilletti, V
Annicchiarico, C
Anzivino, M
Aprea, R
Aprile, A
Aprile, E
Aprile, I
Aprile, L
Armellani, V
Arnetoli, M
Aronica, A
Autiero, V
Bacca, G
Baccalaro, AM
Bacci, M
Baglio, G
Bagnani, M
Baiano, A
Baldari, A
Ballarini, L
Banchi, G
Bandera, R
Bandini, F
Baratella, M
Barbieri, A
Vita, A Barbieri
Bardi, M
Barlocchi, M
Baron, P
Bartoli, M
Basile, A
Basile, F
Basile, S
Battaggia, A
Battaglia, A
Bau, A
Beconcini, G
Beggio, R
Belfiore, PA
Belicchi, M
Bellamoli, S
Bellini, C
Bellomo, M
Benetollo, C
Benetti, R
Beretta, E
Bertalero, P
Bertaso, FG
Bertolani, U
Bettelli, G
Biagiotti, G
Bianchi, S
Bianco, G
Biccari, F
Bigioli, F
Bindi, M
Bisanti, G
Bitetti, EM
Blasetti, MP
Blesi, F
Boato, V
Boga, S
Boidi, E
Boldrin, G
Bollati, A
Bolzan, L
Bolzonella, S
Bonardi, P
Bonato, GB
Bonci, M
Bonfitto, G
Bonincontro, E
Boninsegna, F
Bonissone, D
Bono, L
Bonollo, E
Borghi, M
Borioli, N
Borsatto, M
Bosco, T
Pioltelli, M Bosisio
Botarelli, C
Botassis, S
Bottini, F
Bottos, C
Bova, G
Bova, V
Bozzani, A
Bozzetto, RM
Braga, VT
Braglia, M
Bramati, E
Brazzoli, C
Breglia, G
Brescia, A
Briganti, D
Brigato, G
Brocchi, A
Brosio, FA
Bruni, E
Buscaglia, E
Bussini, MD
Bussotti, A
Buzzaccarini, F
Buzzatti, A
Caccamo, G
Cacciavillani, C
Caggiano, G
Caimi, V
Calciano, FP
Calderisi, M
Calienno, S
Caltagirone, P
Calzolari, I
Cammisa, M
Campanaro, M
Campanella, GB
Campese, F
Canali, G
Candiani, DEL
Canepa, R
Canini, D
Canino, A
Cantoro, EA
Capilupi, V
Capotosto, P
Cappelli, B
Capraro, G
Carafa, FA
Carano, Q
Carcaterra, V
Carriero, D
Carrozzo, G
Cartanese, M
Casalena, M
Casarola, M
Caso, C
Casotto, M
Castaldi, F
Castegnaro, R
Castellani, G
Castri, S
Catalano, E
Catinello, N
Caturano, G
Cavallaro, R
Cavallo, AM
Cavallo, G
Cavion, MT
Cavirani, G
Cazzaniga, F
Cazzetta, D
Cecconi, V
Cefalo, A
Celebrano, M
Celora, A
Centonze, P
Cerati, D
Cesaretti, D
Checchia, G
Checchin, A
Cherubini, M
Chianese, L
Chiappa, A
Chiappa, MV
Chiariello, G
Chiavini, G
Chicco, M
Chiumeo, F
Ciacciarelli, A
Ciaci, D
Ciancaglini, R
Cicale, C
Cicale, S
Cipolla, A
Ciruolo, A
Citeri, AL
Citterio, G
Clerici, M
Coazzoli, E
Collecchia, G
Colletta, F
Colombo, I
Colorio, P
Coluccia, S
Comerio, M
Comoretto, P
Compagni, M
Conte, O
Contri, S
Contrisciani, A
Coppetti, T
Corasaniti, F
Corradi, MT
Corsano, A
Corsini, A
Corti, N
Costantini, G
Costantino, A
Cotroneo, S
Cozzi, D
Cravello, MG
Cristiano, E
Cucchi, R
Cusmai, L
D'Errico, GB
D'Agostino, P
D'Agostino, P
Dal Bianco, L
Dal Mutto, U
Dal Pozzo, G
Dallapiccola, P
Dallatorre, G
Molle, G Dalle
Dalloni, E
D'Aloiso, A
D'Amicis, G
Danese, R
Danieli, D
Danisi, G
D'Anna, MA
Danti, G
D'Ascanio, S
Davidde, G
De Angeli, D
De Bastiani, R
De Battisti, A
De Bellis, A
De Bellis, A
De Berardinis, G
De Carlo, F
De Giorgi, D
De Gobbi, R
De Lorenzis, E
De Luca, P
De Martini, G
De Marzi, M
De Matteis, D
De Padova, S
De Polo, P
De Sabato, N
De Stefano, T
De Vita, MT
De Vito, U
De Zolt, V
Debernardi, F
Del Carlo, A
Del Re, G
Del Zotti, F
D'Elia, R
Della Giovanna, P
Dell'Acqua, L
Dell'Orco, RL
Demaria, G
Di Benedetto, MG
Di Chiara, G
Di Corcia, V
Di Domizio, O
Di Donato, P
Di Donato, S
Di Fermo, G
Di Franco, M
Di Giovannantonio, G
Di Lascio, G
Di Lecce, G
Di Lorenzo, N
Di Maro, T
Di Mattia, Q
Di Michele, E
Di Modica, RS
Di Murro, D
Di Noi, MC
Di Paoli, V
Di Santi, M
Di Sanzo, A
Di Turi, C
Diazzi, A
Dileo, I
D'Ingianna, AP
Dolci, A
Dona, G
Donato, C
Donato, P
Donini, A
Donna, ME
Donvito, TV
Esposito, L
Esposito, N
Evangelista, M
Faita, G
Falco, M
Falcone, DA
Falorni, F
Fanciullacci, A
Fanton, L
Fasolo, L
Fassina, R
Fassone, A
Fatarella, P
Fedele, F
Fera, I
Fera, L
Ferioli, S
Ferlini, MG
Ferlino, R
Ferrante, G
Ferrara, FN
Ferrarese, MF
Ferrari, G
Ferrari, O
Ferreri, A
Ferroni, M
Fezzi, G
Figaroli, C
Fina, MG
Fioretta, A
Fiorucci, C
Firrincieli, R
Fischetti, M
Fischietti, G
Fiume, DC
Flecchia, G
Forastiere, G
Fossati, B
Franceschi, PL
Franchi, L
Franzoso, F
Frapporti, G
Frasca, G
Frisotti, A
Fumagalli, G
Fusco, D
Gabriele, P
Gabrieli, A
Gagliano, D
Galimberti, G
Galli, A
Gallicchio, N
Gallio, F
Gallipoli, T
Gallo, P
Galopin, T
Gambarelli, L
Garbin, A
Garozzo, GM
Gasparri, R
Gastaldo, M
Gatti, E
Gazzaniga, P
Gennachi, N
Gentile, RV
Germani, P
Gesualdi, F
Gherardi, E
Ghezzi, C
Ghidini, MG
Ghionda, F
Giacci, L
Gialdini, D
Giampaolo, C
Giancane, R
Giannanti, A
Giannese, S
Giannini, L
Giaretta, M
Giaretta, R
Giavardi, L
Giordano, P
Giordano, E
Giordano, B
Gioria, GM
Giugliano, R
Grassi, EA
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Gualtieri, L
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Altomonte, M
Anelli, N
Angio, F
Annale, P
Antonacci, S
Anzilotta, R
Bano, F
Basadonna, O
Beduschi, L
Becagli, P
Bellotti, G
Blotta, C
Bruno, G
Cappuccini, A
Caramatti, S
Cariolato, MP
Castellana, M
Castellani, L
Catania, R
Chielli, A
Chinellato, A
Ciaccia, A
Clerici, E
Cocci, A
Costanzo, G
D'Ercole, F
De Stefano, G
Dece, F
Di Cicco, N
Di Marco, A
Sarti, C Donati
Draghi, E
Dusi, G
Esposito, V
Ferraro, L
Ferretti, A
Ferri, E
Foggetti, L
Foglia, A
Fonzi, E
Frau, G
Fuoco, MR
Furci, G
Gallo, L
Garra, V
Giannini, A
Gris, A
Iacovino, R
Interrigi, R
Joppi, R
Laner, B
La Fortezza, G
La Padula, A
Lista, MR
Lupi, G
Maffei, D
Maggioni, G
Magnani, L
Marrazzo, E
Marcon, L
Marino, V
Maroni, A
Martinelli, C
Mastandrea, E
Mastropierro, F
Meo, AT
Mero, P
Minesso, E
Moschetta, V
Mosele, E
Nanni, C
Negretti, A
Nistico, C
Orsini, A
Osti, M
Pacilli, MC
Pennestre, C
Picerno, G
Piol, K
Pivano, L
Pizzuti, E
Poggi, L
Poidomani, I
Pozzetto, M
Presti, ML
Ravani, R
Recalenda, V
Romagnuolo, F
Rossignoli, S
Rossin, E
Sabatella, C
Sacco, F
Sanita, F
Sansone, E
Servadei, F
Sisto, MT
Sorio, A
Sorrentino, A
Spinelli, E
Spolaor, A
Squillacioti, A
Stella, P
Talerico, A
Todisco, C
Vadino, M
Zuliani, C
Investigators, Rischio Prevenzione
Subject
AgedCardiotonic Agents
Cardiovascular Diseases
Diabetes Mellitus
Family Practice
Fatty Acids, Omega-3
Feasibility Studies
Female
Follow-Up Studies
Humans
Italy
Male
Middle Aged
Risk Factors
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10.1186/1745-6215-11-68Abstract
BACKGROUND: The optimization of preventive strategies in patients at high risk of cardiovascular events and the evaluation of bottlenecks and limitations of transferring current guidelines to the real world of clinical practice are important limiting steps to cardiovascular prevention. Treatment with n-3 polyunsaturated fatty acids improves prognosis after myocardial infarction, but evidence of this benefit is lacking in patients at high cardiovascular risk, but without a history of myocardial infarction. METHODS/DESIGN: Patients were eligible if their general practitioner (GP) considered them at high cardiovascular risk because of a cardiovascular disease other than myocardial infarction, or multiple risk factors (at least four major risk factors in non-diabetic patients and one in diabetics).Patients were randomly allocated to treatment with n-3 polyunsaturated fatty acids (1 g daily) or placebo in a double-blind study and followed up for five years by their GPs to assess the efficacy of the treatment in preventing cardiovascular mortality (including sudden death) and hospitalization for cardiovascular reasons. The secondary, epidemiological, aim of the study is to assess whether it is feasible to adopt current guidelines in everyday clinical practice, with a view to optimizing all the available preventive strategies in people at high cardiovascular risk.A nation-wide network of 860 GPs admitted 12,513 patients to the study between February 2004 and March 2007. The mean age was 64 years and 62% were males. Diabetes mellitus plus one or more cardiovascular risk factors was the main inclusion criterion (47%). About 30% of patients were included because of a history of atherosclerotic cardiovascular disease, 21% for four or more risk factors, and less than 1% for other reasons. DISCUSSION: The Rischio and Prevenzione (R&P) project provides a feasible model to test the efficacy of n-3 polyunsaturated fatty acid therapy in patients at high cardiovascular risk with no history of myocardial infarction, and to assess how to implement recommended preventive strategies in general practice. TRIAL REGISTRATION: ClinicalTrials.gov NCT00317707.Citation to related work
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Distinct Subpopulations in Biofilms of Streptococcus mutans and their Response to Sugar Starvation and RestorationPiggot, Patrick; Buttaro, Bettina A.; Tsygankov, Alexander Y.; Grubmeyer, Charles; Stevens, Roy H. (Temple University. Libraries, 2012)Streptococcus mutans is a secondary colonizer of the dental plaque biofilm and is the primary causative agent of dental caries. Sugar metabolism is central to S. mutans growth and survival. S. mutans produces lactic acid as an end product of sugar metabolism, which results in dissolution of the tooth enamel, leading to dental cavities. Sucrose metabolism also results in the formation of extracellular dextrans that are a key component of the extracellular matrix that encases the bacteria in the biofilm. The availability of sugars is dependent on diet, on competition with other bacteria and on the location of the bacteria within the dental plaque. I hypothesize there are distinct subpopulations of S. mutans within biofilms that respond differently to environmental conditions. I have identified several genetic markers that are helping us identify and characterize some of these subpopulations, and how they react to starvation and to the restoration of nutrients in single species biofilms of S. mutans. Two of the loci that were identified as markers via microarray analysis are rpsT and pdh. rpsT encodes a small ribosomal protein which is strongly expressed during exponential growth, when the cells are producing high levels of ribosomes. The other marker, pdh, is a four-gene operon encoding the pyruvate dehydrogenase complex; pdh is upregulated in late stationary phase. Our laboratory has recently shown that expression of the pdh operon is important for long-term survival in stationary phase, where a subpopulation (~0.5%) is dividing, forms long chains and expresses pdh. In the current studies, rpsT and pdh promoters driving expression of gfp were used to identify the exponential phase subpopulation (rpsT) and a subpopulation capable of surviving in late stationary phase (pdh). In addition, I developed an unstable variant of GFP by fusing a proteolytic tag sequence to the C-terminus of GFP (encoded by ugfp). When the rpsT promoter was inserted upstream, uGFP was produced and subsequently degraded within about 1.5 hours of translation. This behavior allowed us to distinguish exponentially growing cells, as the signal diminishes once the cells entered stationary phase. In biofilms that had been starved for 10 days, there was no expression of PrpsTugfp. I observed that when sucrose was added to these biofilms, some bacteria within the biofilm microcolonies underwent fast exponential-like growth indicated by expression of PrpsT-ugfp. Within 24 hours of the sucrose addition, most growth had ceased and fluorescence had decreased. Using a Ppdh-gfp construct in bacteria in 10-day starved biofilms, fluorescence was observed in long chains of cells within the biofilms indicating slow growth. I hypothesized that the pdh-expressing cells were capable of responding to sucrose restoration and would be one of the principal subpopulations to do so. However, when sucrose was added, these fluorescing chains did not exhibit any growth, while other non-fluorescing bacteria within the biofilm clearly responded to the sucrose by growing. This was unexpected since inactivating the pdh operon leads to drastically reduced survival. It is concluded that pdh plays a role in long term survival, but pdhexpressers do not appear to respond to sugar restoration. This led me to hypothesize that the pdh-expressing population is interacting with other populations of cells in some capacity, enabling them to survive. To determine if this was the case, we performed a mixed culture experiment with wild-type S. mutans and the pdh null mutant. I observed that when these two strains were grown in co-culture, the pdh null mutant survived at low levels, for over 30 days, while this mutant by itself typically did not survive past ten days. This result indicates that the wild-type strain was able to interact with the mutant, leading to increased survival. In biofilms, it seems possible that the pdh-expressing cells secrete a substance or directly interact with other cells, somehow promoting their survival in the starved biofilm. The fluorescent constructs appear to mark distinct populations of cells that respond in different ways to sugar availability, suggesting that S. mutans forms a mixed population of cells able to grow in the presence of sugar or survive prolonged sugar starvation. These studies demonstrate that indeed subpopulations of cells do exist within biofilms, and their interactions may be more complex than previously thought.
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An Evaluation of Meaningful Learning in a High School Chemistry CourseSchmuckler, Joseph S., 1927-; Fitt, David; Caldwell, Corrinne A.; Shapiro, Joan Poliner; Ketelhut, Diane Jass (Temple University. Libraries, 2008)This study utilized an action research methodology to examine students' understandings of science knowledge, and meaningful learning using the SLD (Science Lecture Demonstration) and laboratory instructional method in a high school chemistry classroom. This method was a modification of the Science Lecture Demonstration Method as developed by Majerich and Schmuckler (2004, in press), the modification due to the addition of a laboratory component. The participants in this study represented a convenience sample which included one class of twenty-two, middle to high socio-economic status students (Mean family income over $75,000/year in 2005 U.S. dollars) in an honors chemistry course at a public high school in the state of New Jersey. These participants included nine girls and thirteen boys. The results of this study indicated what the students' understandings of science knowledge were, how the understandings differed among students, and to what extent those understandings were indicative of meaningful learning. These results were obtained by careful analysis of student generated concept maps, narratives from demonstration quizzes, laboratory reports, and test questions, as well as a teacher/researcher reflection upon the classroom experience. A simple taxonomy for analyzing students' understandings of science knowledge was developed, based upon the work of Majerich (2004). Findings indicated that the students' understanding of science knowledge, as well as the extent of meaningful learning that occurs in the chemistry classroom may be influenced by the roles of : explicit directions, pre-existing knowledge from elementary and middle school science classes, using examples vs. non-examples, macroscopic vs. microscopic views of nature, time for reflection, and everyday vs. scientific language. Results obtained from high school student responses confirmed Novak's observation of elementary students' lack of differentiation between the terms vapor and gas (Novak, 1998).
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The Effects of Massage Therapy on Immune Functioning of Inner-City Adults Living with HIV/AIDSNelson, Deborah B.; Komaroff, Eugene; Bass, Sarah Bauerle (Temple University. Libraries, 2011)Background/Objective: Massage therapy has moderate empirical support for enhancing immunological functioning. This study examined the effects of massage on 144 inner-city HIV/AIDS-positive men/women. It was hypothesized that adults electing massage would have greater improvement in immune functioning compared to adults declining massage. This study has Temple IRB approval. Methods: 48 HIV/AIDS-positive adults who elected to receive one or more massage sessions from the licensed massage therapist at Congreso were compared to 96 sex-matched HIV/AIDS-positive adults who declined massage over one year. Pre/Post massage CD4+ counts were measured as proxies for immune functioning. Mean immune functioning change was compared between the massage and control group to identify differences Pre/Post the massage/control window and within the massage group to test for dose-dependent effects. Results: No significant differences in age, education, race/ethnicity, language, income, mental health or substance-abuse history were found between the massage and control group. The massage group had lower immune functioning at baseline (394.5±279.7) compared to control group (467.3±283.8); however, this 16.9% difference in baseline mean CD4+ counts between the two groups was non-significant (p=0.23). ANOVA analyses found no difference in CD4+ change (Post-Pre) between the groups (p=0.70). Further ANCOVA analyses found the effects of massage on mean CD4+ counts non-significant after adjusting for baseline differences (p=0.75). However, the trends were in the hypothesized direction with an increase of 36.9 (±148.6) in CD4+ counts for the massage group compared to an increase of 22.5 (±183.4) in the control group. The presence of a dose-dependent effect within the massage group was also non-significant (p=0.95). Pre/Post differences among subjects who received only one massage were found significant (p=0.04), but not for subjects receiving more than one massage (p=0.51). Conclusion: These trends highlight that massage therapy effects may be an important non-pharmacological modality to complement standard-of-care to improve or sustain immune functioning.