2012 Зміст Члени Групи з розробки настанови Відбір клінічних настанов для адаптації Синтез настанови Вступ 1 Передумови 2 Визначення 3 Поширеність Цільова аудиторія

Mix50 injected three times daily: crossover comparison with human insulin 30/70. Hormone & Metabolic

Research 2004;36(3):188–193.

190 Ligthelm RJ, Mouritzen U, Lynggaard H et al. Biphasic insulin aspart given thrice daily is as efficacious as

a basal-bolus insulin regimen with four daily injections: a randomised open-label parallel group four

months comparison in patients with type 2 diabetes. Experimental & Clinical Endocrinology & Diabetes

2006;114(9):511–519.

191 Joshi SR, Kalra S, Badgandi M et al. Designer insulins regimens in clinical practice – pilot multicenter

Indian study. Journal of the Association of Physicians of India 2005;53(Sept):775–779.

192 Davies M, Storms F, Shutler S. Initiation of Insulin Glargine in type 2 patients with suboptimal glycaemic

control on twice-daily premix insulin: results from the AT.LANTUS trial. Diabetologia 2004;47(Suppl 1):

319.

194 Rosenstock J, Dailey G, Massi-Benedetti M et al. Reduced hypoglycemia risk with insulin glargine: a metaanalysis

comparing insulin glargine with human NPH insulin in type 2 diabetes. Diabetes Care 2005;

28(4):950–955.

195 Horvath K, Jeitler K, Berghold A et al. Long-acting insulin analogues versus NPH insulin (human isophane

insulin) for type 2 diabetes mellitus. Cochrane Database of Systematic Reviews 2007;(2):CD005613.

196 Yki JH, Kauppinen MR, Tiikkainen M et al. Insulin glargine or NPH combined with metformin in type 2

diabetes: the LANMET study. Diabetologia 2006;49(3):442–451.

197 Herman WH, Ilag LL, Johnson SL et al. A clinical trial of continuous subcutaneous insulin infusion versus

multiple daily injections in older adults with type 2 diabetes. Diabetes Care 2005;28(7):1568–1573.

198 Raskin P, Allen E, Hollander P et al. Initiating insulin therapy in type 2 diabetes: a comparison of biphasic

and basal insulin analogs. Diabetes Care 2005;28(2):260–265.

Діабет 2 типу.

199 Eliaschewitz FG, Calvo C, Valbuena H et al. Therapy in type 2 diabetes: insulin glargine vs. NPH insulin

both in combination with glimepiride. Archives of Medical Research 2006;37(4):495–501.

200 Rosskamp R. Safety and efficacy of insulin glargine (HOE 901) versus NPH insulin in combination with

oral treatment in type 2 diabetic patients. Diabetic Medicine 2003;20(7):545–551.

201 Malone JK, Kerr LF, Campaigne BN et al. Combined therapy with insulin lispro mix 75/25 plus metformin

or insulin glargine plus metformin: a 16-week, randomized, open-label, crossover study in patients with

type 2 diabetes beginning insulin therapy. Clinical Therapeutics 2004;26(12):2034–2044.

202 Malone JK, Bai S, Campaigne BN et al. Twice-daily pre-mixed insulin rather than basal insulin therapy

alone results in better overall glycaemic control in patients with type 2 diabetes. Diabetic Medicine

2005;22(4): 374–381.

203 Jacober SJ, Scism BJ, Zagar AJ. A comparison of intensive mixture therapy with basal insulin therapy in

insulin-naive patients with type 2 diabetes receiving oral antidiabetes agents. Diabetes, Obesity &

Metabolism 2006;8(4):448–455.

204 Kann PH, Wascher T, Zackova V et al. Starting insulin therapy in type 2 diabetes: twice-daily biphasic

insulin aspart 30 plus metformin versus once-daily insulin glargine plus glimepiride. Experimental &

Clinical Endocrinology & Diabetes 2006;114(9):527–532.

205 Kazda C, Hulstrunk H, Helsberg K et al. Prandial insulin substitution with insulin lispro or insulin lispro

mid mixture vs. basal therapy with insulin glargine: a randomized controlled trial in patients with type 2

diabetes beginning insulin therapy. Journal of Diabetes & its Complications 2006;20(3):145–152.

206 Pan CY, Sinnassamy P, Chung KD et al. Insulin glargine versus NPH insulin therapy in Asian type 2

diabetes patients. Diabetes Research & Clinical Practice 2007;76(1):111–118.

207 Raskin PR, Hollander PA, Lewin A et al. Basal insulin or premix analogue therapy in type 2 diabetes

patients. European Journal of Internal Medicine 2007;18(1):56–62.

208 Yokoyama H, Tada J, Kamikawa F et al. Efficacy of conversion from bedtime NPH insulin to morning

insulin glargine in type 2 diabetic patients on basal-prandial insulin therapy. Diabetes Research & Clinical

209 Standl E, Maxeiner S, Raptis S et al. Once-daily insulin glargine administration in the morning compared

to bedtime in combination with morning glimepiride in patients with type 2 diabetes: an assessment of

treatment flexibility. Hormone & Metabolic Research 2006;38(3):172–177.

210 Gerstein HC, Yale JF, Harris SB et al. A randomized trial of adding insulin glargine vs. avoidance of insulin

in people with type 2 diabetes on either no oral glucose-lowering agents or submaximal doses of

metformin and/or sulphonylureas. The Canadian INSIGHT (Implementing New Strategies with Insulin

Glargine for Hyperglycaemia Treatment) Study. Diabetic Medicine 2006;23(7):736–742.

211 Fritsche A, Schweitzer MA, Haring HU et al. Glimepiride combined with morning insulin glargine,

bedtime neutral protamine hagedorn insulin, or bedtime insulin glargine in patients with type 2 diabetes.

A randomized, controlled trial. Annals of Internal Medicine 2003;138(12):952–959.

212 Massi BM, Humburg E, Dressler A et al. A one-year, randomised, multicentre trial comparing insulin

glargine with NPH insulin in combination with oral agents in patients with type 2 diabetes. Hormone &

Metabolic Research 2003;35(3):189–196.

213 Riddle MC, Rosenstock J, Gerich J et al. The treat-to-target trial: randomized addition of glargine or

human NPH insulin to oral therapy of type 2 diabetic patients. Diabetes Care 2003;26(11):3080–3086.

214 Rosenstock J, Schwartz SL, Clark CM Jr et al. Basal insulin therapy in type 2 diabetes: 28-week comparison

of insulin glargine (HOE 901) and NPH insulin. Diabetes Care 2001;24(4):631–636.

215 Warren E, Weatherley-Jones E, Chilcott J et al. Systematic review and economic evaluation of a longacting

insulin analogue, insulin glargine. Health Technology Assessment 2004;8(45):iii, 1–57.

216 McEwan P, Poole CD, Telow T et al. Evaluation of the cost-effectiveness of insulin glargine versus NPH

insulin for the treatment of type 1 diabetes in the UK. Current Medical Research & Opinion 2007;23(1):

S7–S19.

218 Little RR, Rohilfing CL, Wiedmeyer HM et al. The National Glycohaemoglobin Standardization Program

(NGSP): a five-year progress report. Clinical Chemistry 2001;47:1985–1992.

219 Coscelli C. Safety, efficacy, acceptability of a pre-filled insulin pen in diabetic patients over 60 years old.

220 Fox C, McKinnon C, Wall A et al. Ability to handle, and patient preference for, insulin delivery devices in

visually impaired patients with type 2 diabetes. Practical Diabetes International 2002;19(4):104–107.

221 Kadiri A, Chraibi A, Marouan F et al. Comparison of NovoPen 3 and syringes/vials in the acceptance of

insulin therapy in NIDDM patients with secondary failure to oral hypoglycaemic agents. Diabetes Research

& Clinical Practice 1998;41(1):15–23.

222 Korytkowski M, Bell D, Jacobsen C et al. A multicenter, randomized, open-label, comparative, two-period

crossover trial of preference, efficacy, and safety profiles of a prefilled, disposable pen and conventional

vial/syringe for insulin injection in patients with type 1 or 2 diabetes mellitus. Clinical Therapeutics

2003;25(11):2836–2848.

223 Shelmet J. Preference and resource utilization in elderly patients: InnoLet versus vial/syringe. Diabetes

224 Stockl K, Ory C, Vanderplas A et al. An evaluation of patient preference for an alternative insulin delivery

system compared to standard vial and syringe. Current Medical Research & Opinion 2007;23(1):133–146.

225 Asakura T, Seino H. Assessment of dose selection attributes with audible notification in insulin pen

devices. Diabetes Technology & Therapeutics 2005;7(4):620–626.

226 Turner R, Holman R, Stratton I et al. Tight blood pressure control and risk of macrovascular and

microvascular complications in type 2 diabetes (UKPDS 38). British Medical Journal 1998;317:703–713.

227 Sibal L, Law HN, Gebbie J et al. Cardiovascular risk factors predicting the development of distal

symmetrical polyneuropathy in people with type 1 diabetes: A 9-year follow-up study. Annals of the New

York Academy of Sciences 2006;1084:304–318.

228 Pohl MA, Blumenthal S, Cordonnier DJ et al. Independent and additive impact of blood pressure control

and angiotensin II receptor blockade on renal outcomes in the irbesartan diabetic nephropathy trial:

clinical implications and limitations. Journal of the American Society of Nephrology 2005;16(10):3027–3037.

229 Berl T, Hunsicker LG, Lewis JB et al. Impact of achieved blood pressure on cardiovascular outcomes in the

Irbesartan Diabetic Nephropathy Trial. Journal of the American Society of Nephrology 2005;16(7):2170–2179.

230 Matthews DR, Stratton IM, Aldington SJ et al. Risks of progression of retinopathy and vision loss related

to tight blood pressure control in type 2 diabetes mellitus (UKPDS 69). Archives of Opthalmology

2004;122(11):1631–1640.

231 Bakris GL, Weir MR, Shanifar S et al. Effects of blood pressure level on progression of diabetic

nephropathy: results from the RENAAL study. Archives of Internal Medicine 2003;163(13):1555–1565.

232 Estacio RO, Coll JR, Tran ZV et al. Effect of intensive blood pressure control with valsartan on urinary

albumin excretion in normotensive patients with type 2 diabetes. American Journal of Hypertension

2006;19(12):1241–1248.

233 Schrier RW, Estacio RO, Esler A et al. Effects of aggressive blood pressure control in normotensive type 2

diabetic patients on albuminuria, retinopathy and strokes. Kidney International 2002;61(3):1086–1097.

234 Turnbull F, Neal B, Algert C et al. Effects of different blood pressure-lowering regimens on major

cardiovascular events in individuals with and without diabetes mellitus: results of prospectively designed

overviews of randomized trials. Archives of Internal Medicine 2005;165(12):1410–1419.

235 Torffvit O, Agardh CD. A blood pressure cut-off level identified for renal failure, but not for macrovascular

complications in type 2 diabetes: a 10-year observation study. Hormone & Metabolic Research

2002;34(1):32–35.

236 Strippoli GF, Craig M, Craig JC. Antihypertensive agents for preventing diabetic kidney disease. Cochrane

Database of Systematic Reviews 2005;(4):CD004136.

237 Strippoli GF, Bonifati C, Craig M et al. Angiotensin converting enzyme inhibitors and angiotensin II

receptor antagonists for preventing the progression of diabetic kidney disease. Cochrane Database of

Systematic Reviews 2006;(4):CD006257.
Діабет 2 типу.

238 Casas JP, Chua W, Loukogeorgakis S et al. Effect of inhibitors of the renin-angiotensin system and other

antihypertensive drugs on renal outcomes: systematic review and meta-analysis. Lancet 2005;366(9502):

2026–2033.

239 Mann JF, Gerstein HC, Yi QL et al. Progression of renal insufficiency in type 2 diabetes with and without

microalbuminuria: results of the Heart Outcomes and Prevention Evaluation (HOPE) randomized study.

240 Mann JF, Gerstein HC, Yi QL et al. Development of renal disease in people at high cardiovascular risk:

results of the HOPE randomized study. Journal of the American Society of Nephrology 2003;14(3):641–647.

241 Bosch J. Long-term effects of ramipril on cardiovascular events and on diabetes: results of the HOPE study

extension. Circulation 2005;112(9):1339–1346.

242 Barnett AH, Bain SC, Bouter P et al. Angiotensin-receptor blockade versus converting-enzyme inhibition

in type 2 diabetes and nephropathy. New England Journal of Medicine 2004;351(19):1952–1961.

243 Sengul AM, Altuntas Y, Kurklu A et al. Beneficial effect of lisinopril plus telmisartan in patients with type

2 diabetes, microalbuminuria and hypertension. Diabetes Research & Clinical Practice 2006;71(2):210–219.

244 Dalla VM, Pozza G, Mosca A et al. Effect of lercanidipine compared with ramipril on albumin excretion rate

in hypertensive type 2 diabetic patients with microalbuminuria: DIAL study (diabete, ipertensione,

albuminuria, lercanidipina). Diabetes, Nutrition & Metabolism – Clinical & Experimental 2004;17(5):259–266.

245 Fogari R, Preti P, Zoppi A et al. Effects of amlodipine fosinopril combination on microalbuminuria in

hypertensive type 2 diabetic patients. American Journal of Hypertension 2002;15(12):1042–1049.

246 Ruggenenti P, Perna A, Ganeva M et al. Impact of blood pressure control and angiotensin-converting

enzyme inhibitor therapy on new-onset microalbuminuria in type 2 diabetes: a post hoc analysis of the

BENEDICT trial. Journal of the American Society of Nephrology 2006;17(12):3472–3481.

247 Whelton PK, Barzilay J, Cushman WC et al. Clinical outcomes in antihypertensive treatment of type 2

diabetes, impaired fasting glucose concentration, and normoglycemia: Antihypertensive and Lipid-Lowering

Treatment to Prevent Heart Attack Trial (ALLHAT). Archives of Internal Medicine 2005;165(12): 1401–1409.

248 Fernandez R, Puig JG, Rodriguez PJ et al. Effect of two antihypertensive combinations on metabolic

control in type-2 diabetic hypertensive patients with albuminuria: a randomised, double-blind study.

249 Holzgreve H, Nakov R, Beck K et al. Antihypertensive therapy with verapamil SR plus trandolapril versus

atenolol plus chlorthalidone on glycemic control. American Journal of Hypertension 2003;16(5:Pt 1):381–386.

250 Derosa G, Cicero AF, Gaddi A et al. Effects of doxazosin and irbesartan on blood pressure and metabolic

control in patients with type 2 diabetes and hypertension. Journal of Cardiovascular Pharmacology

2005;45(6):599–604.

251 Derosa G, Cicero AF, Bertone G et al. Comparison of the effects of telmisartan and nifedipine

gastrointestinal therapeutic system on blood pressure control, glucose metabolism, and the lipid profile in

patients with type 2 diabetes mellitus and mild hypertension: a 12-month, randomized, double-blind

study. Clinical Therapeutics 2004;26(8):1228–1236.

252 Viberti G, Wheeldon NM, MicroAlbuminuria Reduction With VALsartan (MARVAL) Study

Investigators. Microalbuminuria reduction with valsartan in patients with type 2 diabetes mellitus: a blood

pressure-independent effect. Circulation 2002;106(6):672–678.

253 Appel GB, Radhakrishnan J, Avram MM et al. Analysis of metabolic parameters as predictors of risk in the

RENAAL study. Diabetes Care 2003;26(5):1402–1407.

254 Remuzzi G, Ruggenenti P, Perna A et al. Continuum of renoprotection with losartan at all stages of type 2

diabetic nephropathy: a post hoc analysis of the RENAAL trial results. Journal of the American Society of

Nephrology 2004;15(12):3117–3125.

255 Andersen S, Bröchner-Mortensen J, Parving HH et al. Kidney function during and after withdrawal of

long-term irbesartan treatment in patients with type 2 diabetes and microalbuminuria. Diabetes Care

2003;26(12):3296–3302.

256 Lindholm LH, Ibsen H. Cardiovascular morbidity and mortality in patients with diabetes in the Losartan

Intervention For Endpoint reduction in hypertension study (LIFE): a randomised trial against atenolol.

257 Lewis EJ, Hunsicker LG, Clarke WR et al. Renoprotective effect of the angiotensin-receptor antagonist

irbesartan in patients with nephropathy due to type 2 diabetes. New England Journal of Medicine 2001;

345(12):851–860.

258 Zanchetti A, Julius S, Kjeldsen S et al. Outcomes in subgroups of hypertensive patients treated with

regimens based on valsartan and amlodipine: an analysis of findings from the VALUE trial. Journal of

259 Pepine CJ, Handberg EM, Cooper-DeHoff RM et al. A calcium antagonist vs a non-calcium antagonist

hypertension treatment strategy for patients with coronary artery disease. The International Verapamil-

Trandolapril Study (INVEST): a randomized controlled trial. The Journal of the American Medical

260 Bakris GL, Fonseca V. Metabolic effects of carvedilol vs metoprolol in patients with type 2 diabetes mellitus

and hypertension: a randomized controlled trial. The Journal of the American Medical Association

2004;292(18):2227–2236.

261 Black HR, Elliott WJ, Grandits G et al. Principal results of the Controlled Onset Verapamil Investigation

of Cardiovascular End Points (CONVINCE) trial. The Journal of the American Medical Association 2003;

289(16):2073–2082.

262 Dahlöf B. Prevention of cardiovascular events with an antihypertensive regimen of amlodipine adding

perindopril as required versus atenolol adding bendroflumethiazide as required, in the Anglo-Scandinavian

Cardiac Outcomes Trial-Blood Pressure Lowering Arm (ASCOT-BPLA): a multicentre randomised

controlled trial. Lancet 2005;366(9489):895–906.

263 Beard SM, Gaffney L, Backhouse ME. An economic evaluation of ramipril in the treatment of patients at

high risk for cardiovascular events due to diabetes mellitus (structured abstract). Journal of Medical

Economics 2001;4:199–205.

264 Schadlich PK, Brecht JG, Rangoonwala B et al. Cost effectiveness of ramipril in patients at high risk for

cardiovascular events: economic evaluation of the HOPE (Heart Outcomes Prevention Evaluation) study

for Germany from the Statutory Health Insurance perspective. Pharmacoeconomics 2004;22(15):955–973.

265 Gray A, Clarke P, Raikou M et al. An economic evaluation of atenolol vs. captopril in patients with type 2

diabetes (UKPDS 54). Diabetic Medicine 2001;18(6):438–444.

266 Palmer AJ, Annemans L, Roze S et al. An economic evaluation of the Irbesartan in Diabetic Nephropathy

Trial (IDNT) in a UK setting. Journal of Human Hypertension 2004;18:733–738.

267 Rodby RA, Chiou CF, Borenstein J et al. The cost-effectiveness of irbesartan in the treatment of

hypertensive patients with type 2 diabetic nephropathy. Clinical Therapeutics 2003;25(7):2102–2119.

268 Coyle D, Rodby RA. Economic evaluation of the use of irbesartan and amlodipine in the treatment of

diabetic nephropathy in patients with hypertension in Canada. Canadian Journal of Cardiology

2004;20(1):71–79.

269 Vora J, Carides G, Robinson P. Effects of losartan-based therapy on the incidence of end-stage renal

disease and associated costs in type 2 diabetes mellitus: A retrospective cost-effectiveness analysis in the

United Kingdom. Current Therapeutic Research, Clinical & Experimental 2005;66(6):475–485.

270 Smith DG, Nguyen AB, Peak CN et al. Markov modeling analysis of health and economic outcomes of

therapy with valsartan versus amlodipine in patients with type 2 diabetes and microalbuminuria. Journal

271 International currency rates. Available from: Financial Times. Last accessed on: 13 March 2007.

272 National Institute for Health and Clinical Excellence. Hypertension: management of hypertension in adults

in primary care (CG34). London: NICE, 2006.

273 Haffner SM, Lehto S, Ronnemaa T et al. Mortality from coronary heart disease in subjects with type 2

diabetes and in nondiabetic subjects with and without prior myocardial infarction. New England Journal

of Medicine 1998;339(4):229–234.

274 Eddy DM, Schlessinger L. Validation of the archimedes diabetes model. Diabetes Care 2003;26(11):

3102–3110.
Діабет 2 типу.

275 Song SH, Brown PM. Coronary heart disease risk assessment in diabetes mellitus: comparison of UKPDS

risk engine with Framingham risk assessment function and its clinical implications. Diabetic Medicine

2004;21(3):238–245.

276 Stephens JW, Ambler G, Vallance P et al. Cardiovascular risk and diabetes. Are the methods of risk prediction

satisfactory? European Journal of Cardiovascular Prevention and Rehabilitation 2004;11(6): 521–528.

277 Guzder RN, Gatling W, Mullee MA et al. Prognostic value of the Framingham cardiovascular risk equation

and the UKPDS risk engine for coronary heart disease in newly diagnosed type 2 diabetes: results from a

United Kingdom study. Diabetic Medicine 2005;22(5):554–562.

278 Coleman RL, Stevens RJ, Renakaran R et al. Framington, SCORE and DECODE do not provide reliable

cardiovascular risk estimates in type 2 diabetes. Diabetes Care 2007;30(5):1292–1293.

279 Stevens RJ, Kothari V, Adler AI et al. The UKPDS risk engine: a model for the risk of coronary heart disease

in type II diabetes (UKPDS 56). Clinical Science 2001;101(6):671–679.

280 Tuomilehto J, Rastenyte D. Epidemiology of macrovascular disease and hypertension in diabetes mellitus.

281 Baigent C, Keech A, Kearney PM et al. Efficacy and safety of cholesterol-lowering treatment: prospective

meta-analysis of data from 90,056 participants in 14 randomised trials of statins. Lancet 2005;366(9493):

1267–1278.

282 Vijan S, Hayward RA, American College of Physicians. Pharmacologic lipid-lowering therapy in type 2

diabetes mellitus: background paper for the American College of Physicians. Annals of Internal Medicine

2004;140(8):650–658.

283 National Institute for Health and Clinical Excellence. Statins for the prevention of cardiovascular events in

(TA94). London: NICE, 2006.