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Rivaroxaban compared with enoxaparin for the prevention of venous thromboembolism in acutely ill medical patients. Alexander T Cohen On behalf of the MAGELLAN Steering Committee and Investigators. Potential conflicts.

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Rivaroxaban compared with enoxaparin for the prevention of venous thromboembolism in acutely ill medical patients

Alexander T Cohen

On behalf of the MAGELLAN Steering Committee and Investigators

potential conflicts
Potential conflicts
  • Dr AT Cohen is a medical consultant for and has received honoraria, consultancy and clinical trial funding from many pharmaceutical companies, including:
    • Astellas, AstraZeneca, Bayer, Boehringer Ingelheim, BMS, Daiichi Sankyo, GSK, Johnson and Johnson, Mitsubishi Pharma, Pfizer, Sanofi-Aventis, Schering Plough and Takeda
  • Dr Cohen is an advisor to the UK Government Health Select Committee, the All-party Working Group on Thrombosis, Department of Health, and the NHS on the prevention of venous thromboembolism
  • Dr Cohen is also an advisor to Lifeblood: The Thrombosis Charity and is the founder of the European educational charity the Coalition to Prevent Venous Thromboembolism

Presentation includes discussion of the following off-label use of a drug or medical device: No Rivaroxaban is not currently approved for use in the United States

attributable risk for deep vein thrombosis pulmonary embolism
Attributable risk for deep vein thrombosis/pulmonary embolism

Medicalpatients

Heit et al, 2002

3

contemporary studies of hospitalized patients
Contemporary studies of hospitalized patients

MEDENOX, all venous thromboembolism (VTE) Day 1 to Day 14; PREVENT, asymptomatic proximal deep vein thrombosis (DVT), symptomatic VTE and sudden death Day 1 to Day 21; ARTEMIS, all VTE Day 1 to Day 15; EXCLAIM, proximal DVT, symptomatic PE or fatal PE Day 10 to Day 38TE, treatment-emergent

1. Samama et al, 1999; 2. Leizorovicz et al, 2004; 3. Cohen et al, 2006; 4. Hull et al, 2010

4

background and study questions
Background and study questions

Background

  • The optimal duration of thromboprophylaxis (short or extended) and the acutely ill patient population most likely to benefit from extended thromboprophylaxis is not well characterized

Study question

  • Is 10 days of anticoagulation with rivaroxaban non-inferior to enoxaparin?
  • Is 35 days of anticoagulation with rivaroxaban superior to enoxaparin followed by placebo?

Cohen et al, 2011

5

magellan clinical trial design
MAGELLAN: clinical trial design

Day 90(83–97)

Day 10(6–14)

Day 35(31–39)

8,101 patients randomized

Oral rivaroxaban 10 mg od 35±4 days

Patients ≥40 years hospitalized for acute medical illness with decreased level of mobility

s.c. placebo 10±4 days

Follow-up periodto Day 90

R

Oral placebo 35±4 days

s.c. enoxaparin40 mg od 10±4 days

Ultrasonography on day 10±4

Ultrasonography on day 35±4

Primary efficacy outcome Day 10 (non-inferiority)

Primary efficacy outcome Day 35* (superiority)

*Events from Day 1 to Day 35

Cohen et al, 2011

6

magellan study outcomes
MAGELLAN: study outcomes

Primary efficacy outcome

  • Composite of:
    • Asymptomatic proximal DVT detected by mandatory ultrasonography
    • Symptomatic DVT (proximal or distal)
    • Symptomatic non-fatal pulmonary embolism (PE)
    • VTE-related death
  • At Day 10 (test for non-inferiority)
  • At Day 35 (test for superiority)

Main safety outcome

  • Composite of major bleeding and non-major clinically relevant bleeding observed not later than 2 days after the last intake of double-blind study medication (treatment emergent)

Cohen et al, 2011

7

sample size and assumptions
Sample size and assumptions
  • Sample size: 2,876 valid patients per group was estimated to obtain a joint power of at least 90%

Non-inferiority: Day 10

  • Assumptions: 2.2% event rate in control group; 1.4% event rate in the rivaroxaban group; relative risk reduction (RRR) ≥35%
  • Non-inferiority margin: 1.5

Superiority: Day 35

  • Assumptions: 4.0% event rate in the control group; 2.4% event rate in the rivaroxaban group; RRR ≥40%

Cohen et al, 2011

patient flow day 10 and day 35 endpoints
Patient flow: Day 10 and Day 35 endpoints

Enoxaparin/placebo

Rivaroxaban

Randomized (n=8,101)

4,050

4,051

Safety

3,997 (99%)

4,001 (99%)

Modified intent to treat (mITT)

Day 10

3,232 (80%)

3,271 (81%)

Day 35

2,967 (73%)

3,057 (75%)

Per-protocol (PP)

Day 10

2,993 (74%)

2,938 (73%)

Day 35

2,516 (62%)

2,586 (64%)

patient characteristics
Patient characteristics*

*Safety population; †some data missing

primary efficacy outcome day 10

0.968

1.334

0.713

Superior

Non-inferior

Inferior

Primary efficacy outcome: Day 10*

p=0.0025 for non-inferiority (one-sided)

0

1.50

1.00

Relative risk ratio

*PP population, events up to Day 10+5 days; ‡includes cases where PE cannot be ruled out

primary efficacy outcome day 35

Superior

Non-inferior

Inferior

Primary efficacy outcome: Day 35*

0.962

0.618

0.771

Absolute risk reduction:1.3% Relative risk reduction: 22.9%

p=0.0211 for superiority (two-sided)

0

1.00

Relative risk ratio

*mITT population, events up to Day 35+6 days; ‡4 confirmed fatal PEs but includes cases where PE cannot be ruled out

safety outcomes
Safety outcomes

*Major plus non-major clinically relevant bleedingSafety population; treatment-emergent bleeding

components of major bleeding
Components of major bleeding

*Patients could have more than 1 event

other outcomes day 35
Other outcomes: Day 35

*The composite of asymptomatic proximal DVT, symptomatic DVT, symptomatic non-fatal PE, VTE-related death, treatment-emergent major plus non-major clinically relevant bleeding in the mITT population‡Day 90+7 data

contemporary studies of hospitalized patients17
Contemporary studies of hospitalized patients

MEDENOX, all VTE Day 1 to Day 14; EXCLAIM, proximal DVT, symptomatic PE or fatal PE Day 10 to Day 38; MAGELLAN, asymptomatic proximal DVT, symptomatic VTE and VTE-related death Day 1 to Day 35TE, treatment-emergent

1. Samama et al, 1999; 2. Leizorovicz et al, 2004; 3. Cohen et al, 2006; 4. Hull et al, 2010

17

summary
Summary
  • MAGELLAN met its primary efficacy endpoints
    • Day 10: rivaroxaban was non-inferior to enoxaparin in reducing the risk of VTE
    • Day 35: extended thromboprophylaxis was superior to enoxaparin followed by placebo in reducing the risk of VTE
  • Overall bleeding rates were low, but significantly higher in the rivaroxaban arm across the entire study period
  • Rates of other adverse events, including liver and cardiovascular events, were similar in both arms

18

conclusion
Conclusion

MAGELLAN confirms that there is a continued risk of VTE beyond the initial period of hospitalization or immobilization in acutely ill patients

Based on the pre-specified net clinical benefit analysis, a consistently positive benefit-risk balance was not seen across the heterogeneous, acutely ill patient population studied, and further analysis is required to identify which groups of patients in MAGELLAN may derive benefit from thromboprophylaxis with rivaroxaban

19

acknowledgements
Acknowledgements

Steering Committee: Alexander Cohen MBBS (Chairman); Harry Büller MD PhD; Alexander Mebazaa MD PhD; Sebastian Schellong MD; Geno Merli MD; Victor Tapson MD; Russell Hull MBBS; Dayi Hu MD PhD; Lloyd Haskell MD; Theodore Spiro MD

Data Safety and Monitoring Board: Alain Leizorovicz MD (Chairman); Gordon Lowe MD; Charles Francis MD; Robin Roberts MT; Shotai Kobayashi MD PhD

Bayer:Global Clinical Leader, Theodore Spiro MD; Medical Experts:  Eva Mühlhofer MD & Melanie Hemmrich MD; Statistician: Dr. Horst Beckmann; Study Managers: Andrea Duszczyszyn, Lynda Fielding, Teresa Twomey; Study Data Manager: Karin Müller; Johnson & Johnson: Physician: Lloyd Haskell MD

Countries and individual sites: Argentina (7 sites); Australia (11 sites); Austria (14 sites); Belgium (10 sites); Brazil (8 sites); Bulgaria (8 sites); Canada (13 sites); Chile (2 sites); China (43 sites); Colombia (8 sites); Croatia (6 sites); Czech Republic (7 sites); Denmark (5 sites); Estonia (4 sites); Finland (2 sites); France (22 sites); Germany (27 sites); Greece (10 sites); Hong Kong (2 sites); Hungary (8 sites); India (14 sites); Indonesia (3 sites); Israel (10 sites); Italy (21 sites); Japan (32 sites); Korea (7 sites); Latvia (6 sites); Lithuania (10 sites); Luxembourg (2 sites); Malaysia (3 sites); Mexico (12 sites); The Netherlands (4 sites); New Zealand (3 sites); Norway (4 sites); Pakistan (3 sites); Peru (7 sites); Poland (14 sites); Portugal (10 sites); Russia (8 sites); Singapore (6 sites); Slovakia (5 sites); Slovenia (6 sites); South Africa (14 sites); Spain (11 sites); Sweden (9 sites); Switzerland (6 sites); Taiwan (5 sites); Thailand (3 sites); Turkey (6 sites); Ukraine (16 sites); UK (7 sites); US (72 sites)

acknowledgements21
Acknowledgements

INVESTIGATORS:DR. F BOTTARO, DR. H HENDLER, DR. B GRAND, DR. A MYKIETIUK, DR. M HOJMAN, DR. O CABERLOTTO, DR. R SALERNO, PROF. E PILGER, DR. N BAUER, PROF. P SIOSTRZONEK, PROF. R KIRCHMA, DR. W FORTUNAT, DR. C WENISCH, PROF. DR. A WELTERM, DR. L ERLACHEROA, DR. H-R SCHONR, DR. B BAUER, DR. E GRAFL, PROF. F KEIL, PROF. P BALCKE, PROF. F WEIDINGE, PROF. H SALEM, DR. M LEYDEN, PROF B CHONG, PROF B CHONG, DR. P CARROLL, DR. D COLQUHOUN, DR D JACKSONA, PROF. E GANA, PROF. S HALL, DR D SERISIERA, PROF R BAKER, PROF. D BLOCKMANS, DR. K HENDRICKX, DR. H STRIEKWOLD, DR. G VAN ROEY, DR. M-E VANDEN ABEELE, DR. C JACQUY, DR. A DELOBBE, PROF. A SOUPART, DR. L VAN ZANDWEGHE, DR. A VAN HOOF, PROF. V MINCHEVA, PROF. S MILANOV, DR. L LYUBENOV, DR. S NENKOVA, DR. D DIMOV, DR. M TASEVA, PROF. Y IVANOV, PROF. D POPOV, DR. B GARICOCHEA, DR. C CAVALHEIRO, DR D CHAMONE, DR. J BIZZACCHI, DR. E FISS, DR. A LOPES, DR. B VAN BELLEN, DR. R RDO MOREIRA, DR. A SHUAIB, DR. F DUBE, DR. D KUTSOGIANNIS, DR. S VERREAULT, DR. B BUCK, DR. A ROUSSIN, DR. G MODDEL, DR. G STOTTS, DR. H DESAI, DR. J-M BOULANGER, DR. F SILVER, DR. N DANEAULT, DR. C BERGERON, DR. M BANYAI, PROF. I BAUMGARTNER, PROF. A SCHIFFER, DR. A IMHOF, DR. C JEAN, DR. P NUSSBAUME, DR. G BUGEDO, DR. H TORRES, PROF. D HU, PROF C WANG, PROF. Y WANG, DR. Y YANG, PROF. Y CHEN, DR C SHEN, PROF. J LIU, PROF. S WU, PROF. W  LI, PROF Z ZHAO, DR. Q XIU, PROF. S-Y ZHANG, DR. T HU, PROF. X  YAN, DR. L GAI, DR. Y ZHAO, PROF. Q HUA, PROF. H LI, PROF. J LI, PROF. DP ZHANG, DR. B XU, PROF. Q WAN, PROF. R CHEN, PROF. S XIAN, DR. Y LIU, PROF. Q GAO, DR. C LIU, DR. G QI, PROF. P CHEN, PROF. S SUN, PROF. K YANG, DR. C WU, PROF. H WANG, PROF. L YANG, PROF. X QIN, DR. S GUO, PROF. Y SUN, DR. Y WANG, DR. Y-S LI, PROF. Y ZHOU, DR. K-N CHEN, DR. J WU, DR. J ZHANG, DR. D FAJARDO, DR. R BOTERO, DR. R RADA, DR. L GOMEZ, DR. L URIBE, DR. J CEDANO, DR. J VELASQUEZ, DR. C JARAMILLO, PROF. A LINHART, DR. O MAYER, DR. K GORICAN, DR. V PROCHAZKA, DR. J FIKSA, DR. I MACEL, DR. J SEDLACEK, PROF. W PETERMA, PROF. B MUHLBAUER, DR. J BARTH, DR. H LAWALL, PROF. C POHL, PROF. T KLOTZ, PROF. J-D. RINGE, PROF. J SCHMIDT LUCK, DR. T HEINTGES, DR. I SCHOFFAUER, DR. A DORMANN, DR. W THEELEN, DR. F-M. DROUVEN, PROF. C NIEDERAU, PROF. B SANNER, DR. H-R MILSTREY, DR. M BORST, PROF. J VOM DAHL, DR. H HINDAHL, DR. E STØLBEN, PROF. S SCHELL, DR. J BEYER-WESTENDORF, DR. R VELTKAMP, PROF. S MOBIUS-WINK, PROF. C ESPINO, PROF. M LESCHKE, PROF. I SCHARRER, DR. H NIELSEN, DR. S AVNSTRØM, DR. C TUXEN, DR. T NIELSEN, DR. O ØSTERGAARD, DR. T UUETOA, DR. T MARANDI, DR. M LEMBER, DR. O KOLBASSOVA, DR. M MONREAL, DR. A CASTRO, DR. C TOLOSA, DR. F CONGET, DR. J­A NIETO RODRIGU, DR. R TIRADO MIRANDA, DR. A MARIA GUIL, DR. J BISBE, DR. F CERETO CASTRO, DR. J TRUJILLO SANTOS, DR. J VILLALTA, DR. R LASSILA, DR. J KARMAKOSKI, PROF. P MISMETTI, PROF. D MOTTIER, PROF. J SCHMIDT, PROF. I QUERE, PROF. C LE JEUNNE, PROF. D VITAL-DURAND, PROF. I MAHE, DR. R RIHANI, PROF. J-F BERGM, PROF. P DEBOURDEAU, DR. M LAMBERT, PROF. D STEPHAN, PROF. B LORCERIE, PROF. P LACROIX, DR. A PROUST, PROF. D FARGE-BAN, PROF. C-H MARQUETTE, DR. D BRISOT, DR. C FOURNIER, DR. A DUCHEMIN, DR. S AQUILANTI, PROF. M GALINIER, DR. M SCULLY, DR. A COHEN, DR. P KESTEVEN, DR. M ELLIOTT, DR J LUCKIT, DR. P RAFFERTY, DR. R DURAIRAJ, PROF. H BASSARIS, PROF. A SKOUTELIS, DR. F VLASTOS, DR. M TOUBIS, DR. G PANOUTSOPOUL, DR. S APSOKARDOS, DR. D BABALIS, DR. A KARAFOULID, DR. A KATSIVAS, DR. S PATSILINAKOS, PROF. LKS WONG, DR. RSM WONG, PROF. M BERGOVEC, PROF. M SAMARZIJA, DR. S ZUPANCIC-SALEK DR. S HAJNSEK, DR. A KNEZEVIC, DR. R STEINER, DR. J NIKL, DR. I KONDAKOR, DR. G NYIRATI, DR. G JAKAB, DR. Z SZAKACS, DR. F NAGY, DR. N SZEGEDI, DR. Z FRANKFURTER, DR. K TAMBUNAN, PROF. HARMANI KALIM, DR. M MACHFØD, DR. D ZELTSER, PROF. S OREN DR. M LISHNER, PROF. R ZIMLICHMAN, DR. Z STHØGER, DR. H OSAMAH, DR. M ELIAS, PROF T HAYEK, DR. G TELMAN, DR. N ELIAS, DR. S BHAIRAPPA, DR. A CHEVIRI, DR. M GADKARI, DR. K PRADEEP KUMAR, DR. A NAIK, DR. A OOMMAN, DR. K KUCHIMANCHI, DR. A MAHAJAN, DR. D TALWAR, DR. P GRANT, DR. J WHIG, DR. G AVVARU, DR. RM PL RAMANATHAN, DR. C RAGHU, PROF. G AGNELLI, DR. W AGENO, DR. M GIORGI PIERFRANCESC, DR. C LODIGIANI, DR. M SILINGARDI, DR. R POGGIO, PROF. S SIRAGUSA, DR. E MORRA, DR. A DE BLASIO, DR. G CASTAMAN, DR. R BUZZONI, DR. A FONTANELLA, DR. A FALANGA, DR. R LANDOLFI, PROF. M PINI, DR. E DE GAUDENZI, PROF. P PARISE, DR. M BONDI, DR. M BERRETTINI, PROF. F VIOLI, DR. R QUINTAVALLA, DR. S NISHI, DR. K UTSUGISAWA, DR. T UCHIYAMA, DR. Y MOMIYAMA, DR. K FUKUI, DR. E TANAKA, DR. M NAGAOKA, DR. T OZAWA, DR. S SAKAGAMI, DR. T TSUJI, DR. N YAMADA, DR. O HATAJI, DR. A WADA, DR. T ICHINOSE, DR. J FUNADA, DR. Y NAKAMURA, DR. S ANDO, DR. K FUJIMOTO, DR. S MEKARU, DR. K OSHIRO, DR. Y SHIOHIRA, DR. O OKAZAKI, DR. A SHIMIZU, DR. M KATO, DR. H IBATA, DR. S IMAI, DR. H IKEFUJI, DR. T SAITO, DR. K ITO, DR. T MIO, DR. H KANI, DR. H NAKAGAWA, DR. D-W KANG, DR. C-S CHUNG, DR. B-W YOON, DR. Y-S LEE, DR. D YEUNOH, DR. S­M BANG, DR. Y-K KIM, DR. B ALEKNIENE, DR. Z BUTKIENE, DR. R PETRAUSKIENE, PROF. A BAGDONAS, DR. G GUMBREVICIUS, DR. A VITKAUSKAS, DR. V BASIJOKIENE, DR. S STONKUS, DR. V GRISKEVICIENE, DR. R NORVILIENE, DR. P MULLER, DR. S RAUH, DR. U KUPCS, DR. V ROZITIS, DR. I STUKENA, DR. D KRIEVINS, DR. N PONTAGA,DR. I AIZSILNIECE, DR. R PEREA SANCHEZ, DR. J GONZALEZ GARZA, DR. M GOMEZ LARA, DR. J CARDOZA AMADOR, DR. A TANAKA CHAVEZ, DR. V VELASCO RODRIGU, DR. F NARES OCHOA, DR. M VAZQUEZ LOPEZ, DR. C ROMERO LOPE, DR. J GALLEGOS MARTINEZ, DR. D HERNANDEZ GAETA, DR. M HERVER CABRERA, DR. S PIAW CHIN, DR K HAN SIM, DR. B WAN AHMAD WAN AZMAN, DR. R FIJNHEERD, DR. H CATE, DR. A DEES. DR. AM KREUK, DR. R TORP, DR. I STOKSTAD, DR. F SCHJESVOLD, DR. W GHANIMA, DR. S JACKSON, DR. D SIMPSON, DR. P OCKELFORD, DR. R COTRINA, DR. M SALAS PEREZ, DR. V ULLOA PEREZ, DR. Z MONCADA VILELA, DR. F ARRIETA DIAS, DR. O SALAZAR CANDIO, DR. R CASTILLO LEON, DR. Z AZIZ, DR. G UN NABI TAYYAB, DR. N RIZVI, PROF. A SZCZEKLIK, PROF. L WALASEK, DR. M  BOJARSKA­LOS, PROF. T PASIERSKI, DR M GUTOWSKA-JABLONS, DR. W KRYSIAK, DR. T ZECHOWICZ, PROF. K JAHNZ-ROZYK, DR. E MIREK-BRYNIARSKA, PROF. M GORSKA, DR. M BIEDRZYCKA, DR. A GOCH, DR M OGOREK, DR. A SYDOR, DR. K WRZESINSKI, DR. F FERREIRA, PROF. L PROVIDENCIA, DR. A MARTINS, DR. F GOMES, PROF. F SANTOS, PROF. P BETTENCOURT, PROF. J DUCLA SOARES, DR. A MELLO E SILVA, DR. T RODRIGUES, DR. A FERREIRA, DR. S KHATKOVA, DR A SOTNIKOV, PROF. T FEDOROVA, PROF. G AROUTYNOV, PROF. M GLEZER, PROF. VN MOISEEV, DR. N SHILKINA, DR. O ERSHOVA, DR. P SVENSSON, DR. I TORSTENSSON, DR. A SJAELANDER, DR. J OSTERGREN, DR. I TIMBERG, DR A-C LASKA, DR. PG WIKLUND, DR. E BERTHOLDS, DR. M CWIKIEL, DR. T HOW ONG, DR. R TAN, DR. A NG, DR. G CHUA, DR H WOOI GAN, PROF. O TENG TANG, DR. M JEREB, DR. B ZVAN, DR. M FLEZAR, DR. G TRATAR, DR. ML SOK, DR. V GORJUP, DR. L GASPAR, DR. J STEVLIK, DR. V SPISAK, DR. F KOVAR, DR. M SZENTIVANYI, PROF. C PERMPIKUL, DR. A WATTANATHUM, DR. C POTHIRAT, PROF.  S KUCUKOGLU, PROF. B ILERIGELEN, PROF. E GOKER, PROF. H SIRIN, PROF. U YILMAZ, PROF. S NALBANTGIL, DR. Y-H LIN, DR. B-F GUO, DR. C-L HAN, DR. K-G SHYU, DR. K YIN-CHING CHUANG, DR. V SKREBKOV, PROF. V SORKIN, PROF. Y SVYSHCHENKO, PROF. O KORZH, PROF. S GENYK, PROF. L VORONKOV, DR. V TSELUYKO, DR. O KARPENKO, PROF. I VAKALIUK, DR. M PEREPELIUK, PROF. O LEGKONOGOV, DR. V KOVAL, DR. A POLYAKOV, DR. Y GONCHAROVA, DR. T RYABICHENKO, PROF.  M VATUTIN, DR. A HEYDER, DR. R MURRAY, DR. P RASTOGI, DR. M PLAUTZ, DR. R YUSEN, DR. R LAVENDER, DR. G MERLI, DR. A JAFFER, DR. P MEHRA, DR. G JOHNSON, DR. P MANOS, DR. S KAATZ, DR. V NADAR, DR. T WUN, DR. J MASSON, DR. R LERNER, DR. A SEIBERT, DR. R MCLAFFERTY, DR. J WELKER, DR. P WRIGHT JR., DR. K RAJAMANI, DR. D SCHULLER, DR. A SHARMA, DR. J SIMMONS, DR. F WHITTIER, DR. J WARD, DR. N DABOUL, DR. S CHASTAIN, DR. J DEXTER, DR. J UPDEGROVE, DR. W REITER, DR. S STOLTZ, DR. S CONRAD, DR. M HAZELRIGG, DR. T LING, DR. D CHEN, DR. K MAYNOR, DR. W FRENCH, DR. D DIETRICH, DR. C LAWTON, DR. J BRENSILVER, DR. B HELLER, DR. C ALBRECHT III, DR. C COWLEY, DR. S MAHAL, DR. S ANDERSON, DR. W TØ, DR. P POKHAREL, DR. M FONTES, DR. H MINKOWITZ, DR. M CONCHA, DR. R STEIN, DR. M PEBERDY, DR. T BIRCH, DR. R LIGHT, DR. G SOFF, DR. M COX, DR. A NATHANSON, DR. R FEI, DR. J REYES, DR. M KAZIMIR, DR. D WILLIAMS, DR. T ZIEDALSKI, DR. G HILL JR, DR. J SUEN, DR. C GREENBERG, DR. P MEHTA, DR. K WAXMAN, DR. W PATTON, DR. A COMEROTA, DR. C THURM, DR. E GONZALES, DR. P JETTY, DR. M BENNINGHOFF, DR. M BIDAIR, DR. O QUINTANA, DR. D ADLER, PROF. L DREOSTI, DR. JOHAN ENGELBRECHT, DR. C KØGELENBERG, DR B RAPOPORT, DR. A ROODT, DR. C SMITH, DR. F STEENKAMP, DR. R SOMMERS, DR. H JANSE VAN RENSBURG, DR. B BLOY, DR. H NORTJE, DR. W RABIE, DR. E VAN NIEUWENHUIZEN, DR. L VAN ZYL