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Pharmacy 482 Literature Review of Oral Treatment Med. Surg. J. – Rev. Med. Chir. Soc. Med. Nat., Iaşi – 2020 – vol. 124, no. 3 PHARMACY REVIEWS LITERATURE REVIEW OF ORAL TREATMENT OF TYPE 2 DIABETES MELLITUS Mousa Sha’at1, Cristina Mihaela Ghiciuc2, Alexandra Bujor1*, D. V. Timofte2, Alina Ștefanache1, Lăcrămioara Ochiuz1 “Grigore T. Popa” University of Medicine and Pharmacy Iasi 1. Faculty of Pharmacy 2. Faculty of Medicine *Corresponding author. E-mail: [email protected] LITERATURE REVIEW OF ORAL TREATMENT OF TYPE 2 DIABETES MELLITUS (Abstract): Type 2 non-insulin-dependent diabetes mellitus (T2DM), the most common form of diabetes that affects more than 90% of diabetic patients, is characterized by insulin re- sistance, β-pancreatic cells dysfunction, and increased hepatic glucose synthesis. The aim of the present paper was to review data on the efficacy of conventional oral dosage forms com- pared to controlled oral drug delivery systems for treating diabetes. Although the number of oral antidiabetic drugs has significantly increased in recent years, clinically there are still important limitations in terms of therapeutic efficacy, tolerability, and adverse effects, par- ticularly regarding weight gain and medium and long-term glucose control. The last genera- tion of oral pharmaceutical formulations such as modified-release tablets overcame some limitations, while injectable formulations with glucagon-like peptide-1 receptor agonists sig- nificantly increased the effectiveness of anti-diabetic medication and significantly reduced diabetes-specific comorbidities. Metformin extended-release formulation seems to be more effective than metformin conventional-release formulation in improving glyco-metabolic control, lipid profile, and levels of some adipocytokines in T2DM. Sustained-release glipiz- ide formulation increases the compliance compared to immediate-release glipizide because it seems to achieve similar glucose control with decreased insulin secretion and to decrease the frequency of hypoglycemic episodes. Gliclazide modified release formulation seems to be effective and safe in T2DM with suboptimal glycemic control. Modified release formula- tions generate other advantages such as increasing treatment compliance, lowering the dose of drug substance, and even reducing side effects. Keywords: NON-INSULIN- DEPENDENT DIABETES MELLITUS, CONVENTIONAL RELEASE ORAL PHARMA- CEUTICAL DOSAGE FORMS, MODIFIED RELEASE ORAL PHARMACEUTICAL DOSAGE FORMS. Diabetes mellitus is a metabolic genet- al metabolism. The diagnostic criteria ically or inherited disorder, with chronic defined by the standard diagnostic criteria evolution, characterized initially by dis- proposed by IDF and World Health Or- ruption of glucose metabolism, subse- ganization (WHO) for the patient with quently associated with suffering and diabetes mellitus include a venous blood disturbance of lipidic, protidic and miner- glucose higher than 126 mg/dL or 7.0 482 Literature review of oral treatment of type 2 diabetes mellitus mmol/L at fasting (fasting for at least 8 rently living with diabetes and 700 million hrs.) obtained for two separate tests or by adults are estimated with diabetes for 2045 more than 200 mg/dL (11.1 mmol/L) (5). It is important to mention that the inci- measured at any time of the day in pa- dence of diabetes has significantly in- tients with symptoms of hyperglycemia or creased in developing countries compared hyperglycemic crisis. Another diagnostic to the developed ones. According to the criterion is the glucose tolerance test, results of the PREDATORR study finalized which requires the administration of a in 2014, which aimed to assess the preva- defined amount of glucose (75 g) followed lence of diabetes in the adult population of by blood glucose level test after two Romania, more than 11% of Romania's hours; in this case, a glycemia higher than population is affected by diabetes. In 2014, 200 mg/dL confirms the diagnosis of dia- there were registered over 875,000 diabetic betes mellitus. Last but not least, glyco- patients and in 2015 there was an increase sylated hemoglobin value above 6.5% (48 with 8.73% in the number of patients, mmol/mol) completes the biochemical reaching approximately one million diag- status of the diabetic patient (1-3). Diabe- nosed patients (6). tes mellitus, according to its etiopatholo- This fact has contributed to the approval gy, is classified as: type 1 diabetes (auto- of innovative antidiabetic molecules, thus immune β-pancreatic cells destruction), ensuring effective monitoring of antidiabet- type 2 diabetes (progressive loss of insulin ic medication, especially in patients for secretion), gestational diabetes (usually whom conventional antidiabetic medication diagnosed in the second or third trimester does not provide a rigorous and stable gly- of pregnancy in previously clinically cemic control. Nowadays, the pharmaco- healthy patients). There are also other logical therapy of T2DM includes the fol- types of diabetes such as neonatal diabe- lowing therapeutic classes: insulin, bigua- tes due to exocrine pancreatic disorders nides, sulphonylureas (hypoglycemic sul- (cystic fibrosis and pancreatitis) and iat- famides), methylglinides, thiazolidinedi- rogenic diabetes as a result of chronic ones (glitazones), α-glucosidase inhibitors, glucocorticoid administration in transplant dipeptidyl peptidase 4 (DPP-4), sodium- patients and HIV/AIDS immunosup- glucose co-transporter 2 inhibitors (SGLT2 pressed patients (2, 3). inhibitors) and glucagon-like peptide 1 T2DM is the metabolic disorder with (GLP-1) receptor agonists (4, 7). the highest incidence and is considered a Most conventional pharmaceutical dos- worldwide public health issue. According age forms of oral antidiabetic drugs are to World Health Organization (WHO) sta- characterized by low bioavailability, short tistics, the number of diabetes patients half-life, and the need to be taken more increased from 108 million in 1980 to 422 times a day, resulting in poor patient ad- million in 2014 and it is estimated to in- herence. Therefore, more research has been crease to 642 million diabetic patients in made in developing new controlled oral 2040 (4). According to the 2019 edition of drug delivery systems. The aim of the pre- the International Diabetes Federation (IDF) sent paper was to review data on the effica- Diabetes Atlas, 463 million adults are cur- cy of conventional oral dosage forms com- 483 Mousa Sha’at et al. pared to controlled oral drug delivery sys- The current dosage forms for oral anti- tems for treating diabetes. diabetic drugs are presented in first table. TABLE I Dosage forms for oral antidiabetic drugs Therapeutic Strength Pharmaceutical Renal Hepatic ANMDMR EMA Drug name Brand name Elderly class (mg) form impairment impairment approval approval film-coated 1000 SIOFOR® tablet 500; prolonged- 750; SIOFOR® release tablet 1000 film-coated 1000 METFOGAMMA® tablet Biguanides Metformin film-coated SRI NO YES 500 MEGUAN® tablet 500; film-coated 850; GLUCOPHAGE® tablet 1000 500; GLUCOPHAGE prolonged- 750; XR® release tablet 1000 1,75; GLIBENCLAMID tablet Glibenclamide 3,5; 5 ARENA SRI SLD YES 3,5 MANINIL® tablet modified 60 DIAPREL MR® release tablet 80 ESQUEL® tablet Sulfonylureas Gliclazide prolonged- SRI SLD YES derivatives 30 GLYCLADA® release tablet modified 60; 90 GLYCLADA® release tablet 1; 2; 3; Glimepiride AMARYL® tablet SRI SLD YES 4; 6 Gliquidone 30 GLURENORM® tablet YES SLD YES Lobeglitazone 0,5 DUVIE® tablet Thiazolidine- PIOGLITAZONE 15 tablet diones TORRENT Pioglitazone YES NO YES (glitazones) 15; 30; ACTOS® tablet 45 Alpha- glucosidase Acarbose 50; 100 GLUCOBAY® tablet SRI YES YES inhibitors MRI=12,5 mg Dipeptidyl 6,25; film-coated Alogliptin VIPIDIA® ESRD; YES YES Peptidase-4 12,5; 25 tablet SRI=6,25 (DPP-4) mg Inhibitors film-coated Linagliptin 5 TRAJENTA® YES YES YES tablet 484 Literature review of oral treatment of type 2 diabetes mellitus Therapeutic Strength Pharmaceutical Renal Hepatic ANMDMR EMA Drug name Brand name Elderly class (mg) form impairment impairment approval approval film-coated Saxagliptin 2,5; 5 ONGLYZA® ESRD YES YES tablet 25; 50; film-coated Sitagliptin JANUVIA® ESRD YES YES 100 tablet MRI; SRI; Vildagliptin 50 GALVUS® tablet ESRD= NO YES 50 mg 5; 10 GLUFAST® tablet Mitiglinide orally disinte- - - - 5; 10 GLUFAST OD® grating tablet Methylglinides 60; 120; film-coated Nateglinide STARLIX® YES SLD YES 180 tablet Repaglinide 0,5; 1; 2 RENEOS® tablet YES YES YES 100; film-coated ≥75 Canagliflozin INVOKANA® YES YES 300 tablet years film-coated Dapagliflozin 5; 10 FORXIGA® YES YES YES SGLT-2 tablet Inhibitors film-coated Empagliflozin 10; 25 JARDIANCE® YES YES YES tablet film-coated ≥75 Ertugliflozin 5; 15 STEGLATRO® ESRD YES tablet years ANMDMR: National Agency for Medicines and Medical Devices of Romania; EMA: European Medicines Agency; ESRD: end-stage renal disease; MR: modified-release; MRI: moderate renal impairment; SRI: severe renal impairment; SLD: severe liver disease; XR: extended-release. Biguanides - from conventional gees/sugar-coated pills (100 mg bufor- formulations to modified release min/dragee) by the German pharmaceutical Since the active substance called phen- company Grünenthal. Unfortunately, this formin (fig. 1a) was firstly discovered in the active molecule did not offer maximum 1920s in the Galega officinalis plant extract therapeutic results, being responsible for the (French lilac), the biguanides became the same adverse effects as the phenformin first therapeutic class
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