This document lists 34 publications by Domenico Merante, MD from 1993 to 2006. The publications cover a range of topics including autonomic nervous system involvement in diabetic complications, evaluation of autonomic function in thyroid and Parkinson's diseases, cost analyses of diabetes management, evaluations of blood glucose monitoring devices, group psychotherapy for diabetic patients, improving foot care for diabetics, and various studies on the efficacy of different drug therapies for type 2 diabetes. Many of the publications appear to be from Italian journals and conferences on diabetes and related endocrine topics.

1. Domenico Merante, MD 11 January, 2017
Emails:nicomerante@hotmail.co.uk - nicomerante@hotmail.com
PUBLICATIONS: Abstracts as posters and presentations. Full papers and current submissions
1) A. Piaggesi, F. Sartucci, G. Tognoni, D. Pistolesi, F. Ponti, E. Castro Lopez, S. Viti, E. Schipani, L. Volpe, D. Merante,
L. Murri, R. Navalesi. `Evidence of central and autonomic nervous system involvement in neurogenic diabetic
impotence`. Journal of the Autonomic Nervous System. Volume 43, Supplement, April 1993, Pages 101-102.
Available online 27 March 2003.
2) A. Piaggesi, G. Iervasi, E. Castro Lopez, E. Schipani, S. Viti, D. Merante, R. Navalesi. `Autonomic function in newly
diagnosed hyper- and hypothyroidism`. Journal of the Autonomic Nervous System. Volume 43, Supplement, April
1993, Pages 101. Available online 27 March 2003.
3) A. Piaggesi, P. Del Dotto, P. Piccini, E. Castro Lopez, E. Schipani, S. Viti, L. Volpe , D. Merante, U. Bonuccelli, R.
Navalesi. `Autonomic function evaluation in De-novo Parkinson`s disease`. Journal of the Autonomic Nervous
System. Volume 43, Supplement, April 1993, Pages 101. Available online 27 March 2003.
4) A. Piaggesi, A. Tacchi, L. Bini, G. Di Cianni, E.C. Lopez, S. Viti, E. Schipani, D. Merante, L. Benzi, R. Cionini, L. Volpe,
R. Navalesi. “Quanto costa il diabete? Un’analisi dei costi di gestione della malattia nella USL n° 12 -Area Pisana-
della regione Toscana”. From the Abstracts Book of the IX° Italian Congress A.M.D. (Medical Association of Italian
diabetologists), May 1993: 441-6.
5) A. Piaggesi, E. Schipani, S. Viti, D. Merante, E.C. Lopez, R. Cionini, L. Volpe, L. Cruschelli, M. Andreozzi, R. Navalesi.
“Valutazione della precisione, accuratezza e gradimento da parte del paziente, di sei strumenti per la misurazione
della glicemia di recente introduzione sul mercato”. From the Abstracts Book of the IX° Italian Congress A.M.D.,
May 1993: 571-5
6) A. Piaggesi, F. Del Re, S. Viti, E. Schipani, D. Merante, L. Bini, R. Navalesi. `Beyond education: Group
psychotherapy for insulin-dependent diabetic patients (IDDM)`. Patient Education and Counseling. Volume 23,
Supplement 1, June 1994, Pages S90. International Congress on Treatment of Chronic Diseases. Available online 1
March 2004.
7) A. Piaggesi, S. Viti, E. Schipani, L. Bini, D. Merante, R. Navalesi. `Improving foot care organization in Tuscany:
outcomes of the first regional training course on diabetic foot care`. Patient Education and Counseling. Volume 23,
Supplement 1, June 1994, Pages S5-S6. International Congress on Treatment of Chronic Diseases. Available online
1 March 2004.
8) A. Piaggesi, L. Bini, E. Schipani, S. Viti, D. Merante, G. Di Cianni, R. Navalesi. `Cost of self-management for insulin-
dependent diabetic patients (IDDM)`. Patient Education and Counseling. Volume 23, Supplement 1, June 1994,
Pages S37-S38. International Congress on Treatment of Chronic Diseases. Available online 1 March 2004.
9) A. Piaggesi, E. Schipani, S. Viti, E. Castro Lopez, L. Bini, D. Merante, R. Navalesi. `Educative intervention on
diabetes in nurses of non-diabetological departments`. Patient Education and Counseling. Volume 23, Supplement
1, June 1994, Pages S74. International Congress on Treatment of Chronic Diseases. Available online 1 March
2004.
10) D. Merante, S. Viti, E. Schipani, L. Bini, L. Volpe, A. Piaggesi: “Organizzazione della cura del piede in Toscana:
risultati del primo corso regionale di aggiornamento sulle complicanze agli arti inferiori nel paziente diabetico”.
Il Diabete (The official journal of the Italian Society of Diabetes: S.I.D.), suppl. N° 1, March 1994, page 123.
11) A. Piaggesi, G. Siciliano, E. Schipani, A. Giorgetti, S. Viti, D. Merante, L. Bini, B. Rossi, R. Navalesi. “Caratteristiche
mioelettriche dei fenomeni di fatica muscolare nei diabetici tipo II con e senza polineuropatia sensitivo-motoria”.
Il Diabete, suppl. N° 1, March 1994, page 145.

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12) D. Casparis, P. Del Carlo, F. Branconi, A. Grossi, D. Merante and L. Gafforio. “Efficacia e tollerabilita’ del gluconato
ferroso orale liquido nell’anemia da carenza di ferro in gravidanza e nell’immediato post-partum: confronto con
altre formulazioni orali liquide o solide contenenti ferro bivalente o trivalente”. Abstracts Book of the Italian
Society of Gynecology and Obstetricians: S.I.G.O., September 1996, pag. 128-9.
13) R. D’Argenzio, P. Cavallo, D. Merante and A. Morelli. “Comparison of two treatment models in type II diabetic
patients with poor metabolic control: Preformed combination of glibenclamide 2,5 mg + metformin 400 mg or
mono-therapy with sulfonylureas at maximal doses? An evaluation at 6 months”. MEDLINE 1997. Minerva
Endocrinologica: Vol. 21, 1996: 1-10.
14) F. Gregorio, D. Merante, P. Filipponi. “Una popolazione in crescita per un crescente problema terapeutico”.
Medico & Diabete (Journal of Italian general practitioners) - Review n. 32, year 5°, Sept/Oct. 1996: 1-10.
15) D. Casparis, P. Del Carlo, F. Branconi, A. Grossi, D. Merante and L. Gafforio. “Effectiveness and tolerance of oral
doses of liquid ferrous gluconate in iron-deficiency anaemia during pregnancy and in the immediate post-natal
period: comparison with other liquid or solid formulations containing bivalent or trivalent iron”. MEDLINE 1997.
Minerva Ginecologica: Vol. 48, 1996: 1-8.
16) L. Pastore, D. Merante, A. Coppini, L. Morviducci, A. Giaccari, G. Tamburrano. “La terapia combinata
glibenclamide più metformina migliora la sensibilità insulinica in pazienti diabetici tipo II non obesi”. From the
Abstracts Book of the XI° Italian Congress A.M.D., May 1997: 603-612.
17) L. Pastore, L. Morviducci, D. Merante, A. Giaccari, G. Tamburrano. “Combined glibenclamide plus metformin
improves insulin sensitivity in non-obese NIDDM patients”. Diabetes 1997, Vol. 46 suppl. 1 - Abstract n. 0400,
page 101A.
18) D. Merante, A. Coppini, G. Bittolo Bon, Dr. C. Zambon, P. Brunetti, G. Perriello, F. Capani, A. Latorre, E.
Vitacolonna, D. Fedele, M. Lapolla, S. Marini, S. Gambardella, A. Caselli, S. Gentile, G. De Simone, I. Gaeta, G.
Ghirlanda, A. Manto, G. Marra, D. Pitocco, R. Navalesi, C. Arvia, S. Viti, A.E. Pontiroli, P. Piatti, G.L. Viviani, M.
Carrubba and G. Pagano. “Nel trattamento del diabete mellito non insulino dipendente la terapia glibenclamide +
metformina e` una realta` italiana ormai ben consolidata: risultati di uno studio multicentrico centralizzato in
doppio cieco cross-over”. Il Diabete, May 1998; Abstract n. 304.
19) F. Mariano, L. Benzi, P. Cecchetti, A. Rosatello, D. Merante, F. Goia, L. Capra, G. Lanza, V. Curto and P.L. Cavalli.
“Efficacy of continuous venous venous hemofiltration (CVVH) in treatment of severe phenformin-induced lactic
acidosis”. Nephrology Dialysis Transplantation, 1998; 13: 1012-15.
20) D. Merante, A. Coppini, C. Stocchiero, S. Lovise, L. Lora and G. Erle. “E` piu` utile trattare i pazienti diabetici non
insulino-dipendenti con dosaggi massimali di glibenclamide come monoterapia o impiegare una terapia che
prevede dosaggi medi dell`associazione precostituita glibenclamide 2,5 mg + metformina 400 mg? Valutazioni del
controllo glicometabolico dopo uno studio in doppio cieco- cross-over di un anno di terapia”. Il Diabete, May
1998; Abstract n. 330.
21) L. Pastore, L. Morviducci, D. Merante, A. Coppini, P. Sbraccia, M. D’Adamo, M. Mellozzi, A. Giaccari e G.
Tamburrano. “Combined glibenclamide plus metformin improves insulin sensitivity in non-obese Type 2 diabetic
patients”. Diabetes Nutrition & Metabolism - Clinical and Experimental August 1998, Vol. 11, N. 4: 225-231.
22) A. Ciccarone, P. Cecchetti, P. Orsini, G. Di Cianni, A. Coppini, D. Merante, R. Navalesi, and L. Benzi. “Effects of
gliquidone and glibenclamide on metabolic response and insulin receptor interaction in monocytes from patients
with Type 2 diabetes mellitus”. Current Therapeutic Research - Clinical and Exp. June 1999, Vol. 60, N. 6: 314-325.
23) G. Erle, S. Lovise, C. Stocchiero, L. Lora, A. Coppini, P. Marchetti and D. Merante. “A comparison of preconstituted,
fixed combinations of low-doses glyburide plus metformin versus high-dose glyburide alone in the treatment of
Type 2 diabetic patients”. Acta Diabetologica, July 1999; 36: 61-65.

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24) F. Gregorio, F. Ambrosi, S. Manfrini, M. Velussi, F. Carle, R. Testa, D. Merante and P. Filipponi. “Poorly controlled
elderly Type 2 diabetic patients under sulphonylureas: the effects of increasing dosages or adding metformin”.
Diabetic Medicine, Dec. 1999, Vol. 16, N. 12: 1016-1024.
25) P. Mereu, M.T. Contigiani, F. Flumene, L. De Luna, G. Fanciulli and D. Merante. “Immunological markers for Type
1 diabetes in celiac disease: effects on diet with lack of gluten. Results from an observational study”. Abstract
from the congress of the Italian Society of Gastroenterology - Bari, Italy 2002.
26) C. Lepore, G. Iacobellis, D. Merante and G. Antonucci. “Inadequacy of therapeutic education: a risk factor of
hypoglycaemia”. Diabetes Research and Clinical Practice, Oct. 2003; 62 (1): 61-62.
27) C. Coscelli, C. Calderini, R. Carleo, M. Gobbo, U. Di Mario, F. Leonetti, G. Iacobellis, A. Galluzzo, V. Pirrone, M.
Lunetta, P. Casale, F. Paleari, C. Falcelli, D. Valle, A. Camporeale and D. Merante. “Importance of premeal
injection time in insulin therapy: Humalog Mix25 is convenient for improved post-prandial glycemic control in
type 2 diabetic patients with Italian dietary habits”. Acta Diabetologica, Dec. 2003; 40 (4): 187-92.
28) S. Del Guerra, R. Lupi, M. Bugliani, S. Sbrana, S.Torri, U. Boggi, F.Mosca, S. Del Prato, D.Merante, P. Marchetti. “PKC
beta 2 in isole pancreatiche umane: effetto della gluco- e lipotossicità”. Il Diabete, suppl. al n. 1, March 2004 -
Abstract P116.
29) F. Bamfi, D. Merante, F. Arpinelli, G. Visonà and M. Novelli. “Drug utilization of glitazones in Italy”. Poster
presented at ISPOR, 7th Annual European Congress, Hamburg 24th-26th Oct. 2004.
30) E. Altobelli, A. Blasetti, R. Petrocelli, S. Tumini, R. Azzarone, S. Tiberti, C. Battistoni, D. Merante, A. Verrotti, M.A.
Fioroni, R. Iannarelli, G. Poccia, F. Papola. “HLA DR/DQ alleles and risk of type I diabetes in childhood: a
population-based case-control study”. Clin. Exp. Med. July 2005; 5 (2): 72-9.
31) F. Bamfi, D. Merante, V. Frizzo, A. Avallone. “Budget impact of the introduction of rosiglitazone in the treatment
of type 2 diabetes. The Italian NHS perspective”. Poster presented at ISPOR, 2005, 8th Annual European Congress,
6-8 Nov. 2005, Florence.
32) K. Esposito, M. Ciotola, D. Carleo, B. Schisano. F. Saccomanno. F.C. Sasso, D. Cozzolino, R. Assaloni, D. Merante, A.
Ceriello, D. Giugliano. “Effect of rosiglitazone on endothelial function and inflammatory markers in patients with
the metabolic sindrome”. Diabetes Care, Vol. 29, N. 5, May 2006: 1071-1076.
33) K. Esposito, M. Ciotola, D. Merante, D. Giugliano. “Rosiglitazone cools down inflammation in the metabolic
syndrome”. Arteriosclerosis, Thrombosis, and Vascular Biology. June 2006; 26 (6): 1413-1414.
34) M.C. Rossi, A. Nicolucci, M. Comaschi, C. Coscelli, D. Cucinotta, A. Ceriello, S. De Cosmo, C. Giorda, U. Valentini, P. Di
Blasi, D. Merante, G. Vespasiani. “Correlation between Structural and Organizational Characteristics, Process
Measures and Outcomes in type 2 diabetes. Rationale and design of the QUASAR study”. MeDia (scientific journal
of SIMG: Italian Society of General Practitioners and AMD: Associazione Italiana Medica Diabetologi). March
2007; 7: 42-48.
35) P. Tatti, F. Arrigoni, A. Longobardi, F. Costanza, P. Di Blasi and D. Merante. “Retrospective analysis of
rosiglitazone and macular edema in patients with type 2 diabetes mellitus”. Clin. Drug Invest. 2008: 28 (5): 327-
33.
36) L.D. Monti, E. Galluccio, P. Lucotti, E. Setola, S. Costa, B. Fontana, M. Oldani, D. Merante, P. Di Blasi, E. Bosi, P.M.
Piatti. “Beneficial role of L-arginine in cardiac matrix remodeling in insulin resistant rats”. Eur. J. Clin. Invest.
2008 Nov.; 38 (11): 849-56.
37) M.C. Rossi, M. Comaschi, C. Coscelli, D. Cucinotta, P. Di Blasi, D. Merante, F. Pellegrini, U. Valentini, G. Vespasiani,
A. Nicolucci. “Organizational characteristics influence quality of diabetes care. The QUASAR study (quality
assessment score and cardiovascular outcomes in Italian diabetic patients)”. 45th EASD Vienna, Diabetologia, Sep.
2009; 52, Supp.1; Poster n. 1034.

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38) K. E. Truitt, R. B. Goldberg, J. Rosenstock, H. Chou, D. Merante, J. Triscari and A. C. Wang. “A 26-Week, Placebo
and Pioglitazone-Controlled, Dose-Ranging Study of Rivoglitazone, a Novel Thiazolidinedione for the Treatment
of Type 2 Diabetes”. Current Medical Research and Opinion, Vol. 26, No 6, 2010: 1321-1331.
39) H.S. Chou, J. Moberly, Y. Mun, Y.Choi, D. Merante, K.E. Truitt: “Efficacy and Safety of Rivoglitazone as
Monotherapy for Type 2 Diabetes Mellitus”. Diabetes 2010, Vol. 59 suppl. 1 - Abs. n. 671-P; page: A183 - ADA
70th Scientific Sessions. June 25-29, 2010.
40) D. Merante, F. Menchini, K.E. Truitt and F.M. Bandello. “Diabetic macular edema: correlations with available
diabetes therapies. Evidence across a qualitative review of published literature from Medline and Embase”. Drug
Safety, Aug. 2010; 33 (8): 1-10.
41) D. Merante and A. Ceriello. `Diabetes Drugs: Historical Regulatory Decisions over the past 17 years`.
Pharmaceutical Medicine, Volume 25, Number 5, 1 Oct. 2011; page: 285-291.
42) H.S. Chou, K.E. Truitt, J.B. Moberly, D. Merante, Y. Choi, Y. Mun, A. Pfützner. “A 26-week, placebo- and
pioglitazone-controlled monotherapy study of rivoglitazone in subjects with type 2 diabetes mellitus”. Diabetes
Obes. Metab. June 2012 (11): 1-10.
43) D. Merante. `Challenges in conducting pain trials: a sponsor`s perspective`. Oral presentation at the Annual
Scientific Symposium 2012, Sep. 26, 2012 by MMS Holdings Inc., Canton/MI, USA,
http://blog.mmsholdings.com/annual-scientific-symposium-2012/
44) D. Merante. `Challenges in Painful Diabetic Peripheral Neuropathy clinical research`. Oral presentation at the
4th World Congress on Diabetes & Metabolism, Chicago, Aug. 14-16, 2013. Journal of Diabetes & Metabolism 2013,
Vol. 4, Issue 6: page 48.
45) D. Merante (Clinical Study Lead of a clinical phase 2 study posted at ClinTrials.Gov). `A Randomized, Double-
Blind, Placebo and Active Comparator-Controlled Study of DS-5565 for Treatment of Neuropathic Pain
Associated With Diabetic Peripheral Neuropathy`. ClinicalTrials.gov processed this record on Sep. 30, 2013.
http://clinicaltrials.gov/show/NCT01496365
46) D. Merante, G. Skouteris and R. Malik. `Developing new molecules for the treatment of Painful Diabetic
Peripheral Neuropathy: is it feasible given the magnitude of the placebo response in Proof of Concept clinical
studies? Journal of Diabetes & Metabolism, November 2013, Vol. 4 Issue 9: 1-4.
47) D. Merante, A. Currie and K. Feins. `Impact of the nocebo effect in clinical studies of Painful Diabetic Peripheral
Neuropathy and potential strategies to minimize this effect`. Journal of Diabetes & Metabolism, November, 2013,
Vol. 4 Issue 9: 1-3.
48) A. Vinik, U. Sharma, K. Feins, C. Hsu, D. Merante on behalf of the DS5565-A-U201 US Phase II Study Investigators.
`DS-5565 for the treatment of diabetic peripheral neuropathic pain: randomized, double-blind, placebo and
active comparator-controlled phase II study`. Abstract accepted for dual presentation as poster on Neurology and
as oral communication at the American Academy of Neurology, Philadelphia, 26 Apr.-3 May, 2014. The poster
was presented by Dr D. Merante on April 29th 2014.
49) A. Vinik, U. Sharma, K. Feins, C. Hsu, D. Merante on behalf of the DS5565-A-U201 US Phase II Study Investigators.
`Central nervous system safety and tolerability of DS-5565: a randomized, double-blind, placebo and active
comparator-controlled phase II study in diabetic peripheral neuropathic pain`. Abstract accepted as poster on
Neurology at the American Academy of Neurology, Philadelphia, 26 Apr.-3 May, 2014. The poster was presented
by Dr D. Merante on May 1st 2014.
50) D. Merante, U. Sharma, K. Feins, C. Hsu, A. Vinik on behalf of the DS-5565-A-U201 US Phase II Study Investigators
`Efficacy of mirogabalin (DS-5565) in diabetic peripheral neuropathic pain: pain assessment and correlations
with a numerical rating scale and visual analog scale`. Abstract accepted on Diabetes by the American Diabetes
Association, San Francisco, 13-17 June 2014. This was presented by Dr D. Merante as a guided audio tour
poster on June 14th and on June 16th 2014.

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51) A. Vinik, U. Sharma, K. Feins, C. Hsu, D. Merante on behalf of the DS-5565-A-U201 US Phase II Study Investigators.
`A randomized, double-blind, placebo- and active comparator (pregabalin)-controlled phase II study of
mirogabalin (DS-5565) for the treatment of diabetic peripheral neuropathic pain`. Abstract presented on
June14th and published on Diabetes by the American Diabetes Association, San Francisco, June 13-17, 2014.
52) A. Vinik, U. Sharma, K. Feins, C. Hsu, D. Merante on behalf of the DS-5565-A-U201 US Phase II Study Investigators.
`Safety/tolerability profile of mirogabalin (DS-5565): a new potent, specific alpha2-delta ligand for the treatment
of diabetic peripheral neuropathic pain`. Abstract accepted on Diabetes by the American Diabetes Association, San
Francisco, June 13-17, 2014. The poster was presented by Dr D. Merante on June 14th 2014.
53) A. Vinik, J. Rosenstock, U. Sharma, K. Feins, C. Hsu, and D. Merante on behalf of the DS-5565-A-U201 US Phase II
Study Investigators. `Efficacy and Safety of Mirogabalin (DS-5565) For the Treatment of Diabetic Peripheral
Neuropathic Pain: A Randomized, Double-Blind, Placebo and Active Comparator-Controlled, Adaptive Proof-of-
Concept Phase 2 Study`. Diabetes Care, December 2014, 37: 3253-3261.
54) O.Q.P. Yin, D. Merante, R. Miller. `Population Pharmacokinetic Modeling for Assessing Renal Impairment Effect
on the Pharmacokinetics of DS-5565`. Annual meeting of American College of Clinical Pharmacology, 14-16 Sept.
2014. Abstract presented as a poster on September 14, 2014.
55) A. Vinik, U. Sharma, K. Feins, C. Hsu, D. Merante on behalf of the DS-5565-A-U201 US Phase II Study
Investigators. `A randomized, double-blind, placebo- and active comparator (pregabalin)-controlled adaptive
phase 2 study of mirogabalin (DS-5565) for the treatment of diabetic peripheral neuropathic pain (DPNP)`.
Abstract accepted as oral presentation n.52 on page 5 of the Abstract Book by the NeuroDiab at the Annual
Meeting, Neuropathy Study Group of the EASD, 12-14 Sep 2014 Sopron (Hungary). The oral presentation was
made by Dr D. Merante on Sep. 12th 2014.
56) D. Merante, K. Truitt, S. Ohwada and C. Hsu. `Adaptive trial design for chronic pain: A randomized, double-blind,
placebo- and active comparator (pregabalin)-controlled adaptive phase 2 study of mirogabalin (DS-5565)`.
Abstract n. P-51 on page 35 of the Abstract Book accepted as poster by the NeuroDiab at the Annual Meeting,
Neuropathy Study Group of the EASD, 12-14 Sep. 2014 Sopron (Hungary). The poster was presented by Dr D.
Merante on September 13rd 2014.
57) D. Merante. `Impact of the nocebo effect in clinical studies of Painful Diabetic Peripheral Neuropathy. Can this
effect masquerade a safety signal of a new investigational compound? ` Oral presentation at the 5th World
Congress on Diabetes & Metabolism, Las Vegas, Nov 4 2014. Journal of Diabetes & Metabolism 2014 Vol 5, Issue
10: 79-80. Chairman of the scientific session: `Diabetes and its Complications` on November 4 and 5, 2014.
58) D. Merante (Clinical Study Lead of a clinical phase 3 study posted at ClinTrials.Gov). ` A Randomized, Double-
Blind, Placebo- and Active-Controlled Study of DS-5565 for Treatment of Pain Associated With Fibromyalgia`.
ClinicalTrials.gov processed this record on February 11, 2015. https://clinicaltrials.gov/ct2/show/NCT02146430
59) M.M. Hutmacher, B. Frame, R. Miller, K.Truitt, D. Merante. ` Exposure-Response Modeling of Average Daily Pain
Score, and Dizziness and Somnolence, for Mirogabalin (DS-5565) for the treatment of Diabetic Peripheral
Neuropathy Pain`. Abstract accepted as a poster (NEUPS 0323) on January 6, 2015 at the NeuPSIG, 5th
International Congress of Neuropathic Pain, May 14-17, 2015. The poster was presented on Friday, May 15th,
2015 at the Nice Acropolis Convention Center, Nice, France.
60) M. Jansen, D. Merante, A. Currie, M. Velinova, and H. Zahir. `Pharmacodynamics, pharmacokinetics, safety, and
tolerability of mirogabalin when coadministered with ethanol or lorazepam: results from two randomized,
double blind, drug-drug interaction studies `. Abstract accepted as a poster (NEUPS 0329) on January 6, 2015 at
the NeuPSIG, 5th International Congress of Neuropathic Pain, May 14-17, 2015. The poster was presented on
Friday, May 15th, 2015 at the Nice Acropolis Convention Center, Nice, France.
61) M. Jansen, D. Merante, A. Currie, M. Boyce, and H. Zahir. `Coadministration of mirogabalin and lorazepam in
healthy subjects: Results from a randomized, double-blind, drug-drug interaction study`. Abstract accepted as a
poster on January 18 2015 at the APS (American Pain Society`s 34th Annual Scientific Meeting) May 13-16, 2015.
The poster was presented on Thursday, May 14th, 2015 at the Palm Springs Convention Center, Palm Springs,CA.

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62) M. Jansen, D. Merante, A. Currie, M. Velinova, and H. Zahir. `Coadministration of mirogabalin and ethanol in
healthy subjects: Results from a randomized, double-blind, drug-drug interaction study`. Abstract accepted as a
poster on January 18 2015 at the APS (American Pain Society`s 34th Annual Scientific Meeting) May 13-16, 2015.
The poster was presented on Thursd., May 14th, 2015 at the Palm Springs Convention Center, Palm Springs, CA.
63) D. Merante. `Collaborate with patient groups, patient advocates and patient networks to drive forward clinical
research`. Patients Centric Clinical Trials Europe. Oral presentation on June 9th, 2015. Eyeforpharma.
http://www.eyeforpharma.com/patient-clinical-trials-europe/. Hilton Tower Bridge, London - June 8-9th, 2015.
64) J. Mendell-Harary, V. Warren, V. Dishy, J.-Fue Maa, D. Merante, and H. Zahir. Pharmacodynamics,
pharmacokinetics, safety and tolerability of mirogabalin when coadministered with tramadol: results from a
randomized, double blind, drug-drug interaction study. The poster n. 232 was presented by Dr Merante on
September 3, 2015 at the European Pain Federation EFIC, 2-5 September 2015, Vienna.
65) D. Merante, J. Rosenstock, U. Sharma, K. Feins, C. Hsu, A. Vinik on behalf of the DS-5565-A-U201 US Phase II Study
Investigators. Effect of mirogabalin on patient-reported pain and sleep: results from a randomized, double blind,
placebo and active (pregabalin) comparator-controlled adaptive phase 2 study. The poster n. 228 was
presented by Dr Merante on September 3, 2015 at the European Pain Federation EFIC, 2-5 Sept. 2015, Vienna.
66) K. Lash, Y. Wan, M. Yang, D. Merante, C. Hsu, F. Frech-Tamas. `Worst Pain Scores on the Modified Brief Pain
Inventory are Associated with Clinically Important Changes on the Patient Global Impression of Change`. The
poster n. 120 was presented by Dr Merante on September 4, 2015 at the European Pain Federation EFIC, 2-5
September 2015, Vienna.
67) O. Yin, D. Merante, K. Truitt, R. Miller. `Longitudinal exposure-response relationship for mirogabalin in patients
with diabetic peripheral neuropathic pain`. Abstract accepted by the American Conference on Pharmacometrics
(ACoP6 Main Conference Poster M-20) on July 15, 2015 Crystal City, VA, October 4-7, 2015.
68) M.M. Hutmacher, B. Frame, R. Miller, K. Truitt, D. Merante. `Exposure-response modeling of average daily pain
score, and dizziness and somnolence, for mirogabalin (DS-5565) in patients with diabetic peripheral neuropathic
pain`. Journal of Clinical Pharmacology 2016 Jan; 56 (1): 67-77.
69) O. Yin, D. Merante, K. Truitt, R. Miller. `Population Pharmacokinetic Modeling for Assessing Renal Impairment
Effect on the Pharmacokinetic of Mirogabalin`. Journal of Clinical Pharmacology. 2016 Feb; 56 (2): 203-12.
70) M. Jansen, D. Merante, A. Currie, M. Velinova, K. Brown and H. Zahir. "Co-administration of mirogabalin and
zolpidem in healthy subjects: results from a randomized, double-blind, drug-drug interaction study`. Presented as
a poster at the 35th Annual Scientific Meeting of the American Pain Society, May 11-14, 2016 at the Austin
Convention Center, Austin, Texas.
71) D. Merante, J. Rosenstock, U. Sharma, K. Feins, C. Hsu, and A. Vinik; on behalf of the DS-5565-A-U201 US Phase II
Study Investigators. `Efficacy of mirogabalin on patient-reported pain and sleep interference in patients with
diabetic neuropathic pain: Secondary outcomes of a phase 2 proof-of-concept study`. Abstract n. 3823 accepted
on May 20, 2016 and to be presented at the 16th World Congress of Pain 2016, Yokohama/Japan on 26-30
September 2016. The poster was presented by Dr D. Merante on 30 September 2016.
72) L. Arnold, A. Currie, R. Coll, C. Hsu, S. Whitaker, S. Patel, D. Merante. `The ALDAY Program: Three Randomized,
Double-blind, Placebo- and Active-controlled Trials, and an Open-label Extension Study, of Mirogabalin in
Subjects with Pain Associated with Fibromyalgia. Study Design and Preliminary Demographic Data`. Abstract n.
3789 accepted on May 20, 2016 to be presented at the 16th World Congress of Pain 2016, Yokohama/Japan on 26-
30 September 2016. The poster was presented by Dr D. Merante on 30 September 2016.
73) D. Merante, J. Rosenstock, U. Sharma, K. Feins, C. Hsu, and A. Vinik; on behalf of the DS-5565-A-U201 US Phase II
Study Investigators. ` Efficacy of Mirogabalin on Patient-Reported Pain and Sleep Interference in Patients With
Diabetic Neuropathic Pain: Secondary Outcomes of a Phase 2 Proof-of-Concept Study`. Abstract 59941 accepted
as poster presentation on 20 September 2016 at the ACR/ARHP Annual Meeting in Washington, DC; November
11-16, 2016

7. Domenico Merante, MD 11 January, 2017
7 | P a g e
74) D. Merante, J. Rosenstock, U. Sharma, K. Feins, C. Hsu, and A. Vinik; on behalf of the DS-5565-A-U201 US Phase II
Study Investigators. `Efficacy of mirogabalin (DS-5565) on patient-reported pain and sleep interference in
patients with diabetic neuropathic pain: secondary outcomes of a phase 2 proof-of-concept study`. Full
manuscript was submitted on 24 June, 2016 and was accepted for publication and is in press on Pain Medicine on
January 2017
75) D. Merante and S. Patel. `Impact of the placebo response in drug clinical setting for the treatment of
fibromyalgia`. Final abstract was submitted on 16 September 2016 to the British Pain Society (submission code:
AS000308), Annual Scientific Meeting 2017.
76) M. Jansen, J. Mendell, A. Currie, J. Dow, D. Merante, V. Dishy, K. Brown, H. Ishizuka, and H. Zahir.
`Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Mirogabalin When Coadminstered With
Lorazepam, Zolpidem, Tramadol or Ethanol: Results From Randomized, Double-Blind, Drug-Drug Interaction
Studies`. Full manuscript submitted of the American Journal of Pharmacology on September 30, 2016.
77) K. Lash, Y. Wan, M. Yang, F.F-Tamas, C. Hsu, D. Merante. `A Preliminary Evaluation of Clinically Important
Differences on the Worst Pain Severity Item of the Modified Brief Pain Inventory in Patients with Painful Diabetic
Peripheral Neuropathy`. Full manuscript submitted to the European Journal of Pain on September 30 2016.
78) D. Merante and S. Patel. `The phenomena of a strong placebo response in clinical studies in painful diabetic
neuropathy: An Achilles heel for future drug development`. Final abstract was submitted on 10 January 2017 to
NeuPSIG, 6th International Congress on Neuropathic Pain, Gothenburg 15-18 June, 2017