Polytechnic Institute of Coimbra, Coimbra Health School, Pharmacy, Portugal 2
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1 EspaComp TH ANNUAL MEETING OF THE EUROPEAN SOCIETY FOR PATIENT ADHERENCE, COMPLIANCE AND PERSISTENCE NOVEMBER 2016 / LISBON - PORTUGAL Patient-Reported Perceptions of Adverse Events with Oral Antidiabetic s agents and Adherence to Medication in Persons with Type 2 Diabetes Mellitus Rui Santos Cruz 1, Ana Filipa Cardoso 2, Luiz Miguel Santiago 3, Carlos Fontes Ribeiro 4 1 Polytechnic Institute of Coimbra, Coimbra Health School, Pharmacy, Portugal 2 Nursing School of Coimbra, Health Sciences Research Unit: Nursing. Portugal 3 Invited Associate Professor, University of Beira Interior, Portugal 4 Department of Pharmacology and Experimental Therapeutics, University of Coimbra, Portugal
2 The authors declare no conflict of interest.
3 Background Diabetes Mellitus- It s a Problem around the World Estimated number of people with diabetes worldwide and per region in 2015 and 2040 (20 79 years) (IDF, 7 th edition 2015) 3
4 Background The leading causes of NCD deaths in Europe: 1. Cardiovascular diseases; 2. Cancers, 3. Respiratory diseases, including asthma and chronic obstructive pulmonary disease (COPD); 4. Diabetes Mellitus In Europe, noncommunicable diseases (NCD) account for almost 86% of deaths and 77% of disease burden, placing increasing pressure on health systems, economic development and the well-being of a large part of the population, particularly people With 50 or more years. Action Plan for Implementation of the European Strategy for the Prevention and Control of Noncommunicable Diseases
5 Background Diabetes in Portugal: 2015 Undiagnosed prevalence Diagnosed prevalence Overall prevalence 5,7% 7,4% 13,1% (1 million people) years (Relatório Anual do Observatório Nacional da Diabetes. SPD, 2015) 5
6 Background Diabetes Mellitus Type 2 diabetes accounts for at least 90% of all cases of diabetes. (Nature vol may 2012) Diabetes Therapeutic Strategies Diet Physical activity Medication JABFM, Volume 22, Number 3: May-June
7 Background Medication No drug which is pharmacologically effective is without hazard. Furthermore not all hazards can be know before a drug is marketed. Derrick Dunlop (mid-1970) UK s Committee on Safety of Drugs 7
8 Background Medication Adverse drug reactions (ADR) are health problems associated with the use of medicines. ADRs to the oral antidiabetic agents (OA), contribute to poor adherence in the treatment of Type 2 diabetes Tolerability with Oral Antidiabetic agents Adherence 8 (Annette Winkler et al., 2002; Karen S. Ingersoll, 2008; Heisler et al., 2010)
9 Objectives This study aims to determine the adverse events of OAs perceived and experienced by patients and the association between the adverse events and adherence to medication regimens in the primary health care. 9
10 Material & Methods EXCLUSION CRITERIA STATISTICAL ANALYSIS CROSS- SECTIONAL STUDY Primary Health Care Centers Jan Dec ELIGIBILITY CRITERIA DM2 > 1 ano Oral medication Age 18 years Informed consent DM2 <1 ano Insulin and GLP-1 Analogues Age <18 anos Degenerative diseases Psychological disorders and with commitment physical Neurological Disorders Institutionalized patients Descriptive statistics and inferential statistics techniques like Spearman's correlation coefficient; Mann- Whitney U tests. Statistical tests level at 0,05 10
11 Material & Methods MEASUREMENTS Questionnaire design Adverse Drug Reaction 1. Weight gain 2. Reduced weight 3. Impotence 4. Anemia 5. Low blood sugar (hypoglycaemia) 6. Bruising (Amendment coagulation) 7. Hair loss (alopecia) 8. Clinical and socialdemographic information Questionnaire for adverse events to OA Skin blemishes, without allergies (Skin Reactions) 9. Allergic reactions (itchy skin, nose or eyes, itching, hives, skin rash) 10. Belching much (aerophagia) 11. Diarrhoea 12. Swollen belly (abdominal distension) 13. Stomach pain (Pain Epigastric) 14. Gases (Flatulence) 15. Feeling sick (nausea) 16. Vomiting 17. Changes in the liver (Increase of transaminases) 18. Joint pain (Arthralgia) 19. Lack of strength 20. Loss of appetite (anorexia) 21. Headache (Headache) 22. Tingling (paraesthesia) 23. Somnolence 24. Dizziness 25. Changes in vision 26. Shortness of breath (dyspnea) 27. Respiratory Infections 28. Cold (nasopharyngitis) 29. Blood in the urine (hematuria) 30. Swelling of legs (Peripheral Edema) 31. Other Events (What?) Never Rarely Often Always Suspended or reduced the dose of medicine? Improved with discontinuati on or dose reduction? Not Just intense Very intense Yes Yes No Yes No Rui S. Cruz et al. A NEW TOOL FOR DETECTING ADVERSE EVENTS ASSOCIATED WITH ORAL ANTIDIABETIC AGENTS. I J L R S & T. Vol. 5, Issue 1: Page No , minutes Morisky Green adapted questionnaire 11
12 Results Social-demographic information Sample Type 2 Diabetes Age Mean age: 67,5 years Std. Deviation: 9,5 357 patients 197 (55,2%) 160 (44,8%) Min: 35 Max: 94 Table 1: Distribution of the sample clinical information Clinical information Mean ± SD Duration DM2 (yrs) 9,10± 7,2 Oral Antidiabetic Agents 357 (100%) BMI (kg/m2) 30,57 ± 4,85 HbA1c 6,65 ± 0,88 Total cholesterol (mg/dl) 181,27 ± 36,28 LDL (mg/dl) 105,68 ± 33,78 HDL (mg/dl) 49,73 ± 11,45 Education Level Primary: 199 (55,7%) Occupational Status Retired: 279 (78,2%) Economic Level Average: 182 (51%) Low: 171 (47,9%) 12
13 Results Therapeutic information Biguanides Table 2: Distribution of the sample according to the OA therapeutic classes OA therapeutic classes Overall Monotherapy n % n % , ,74 Sulfonylureas ,1 25 7,0 Metformin + Vildagliptin (fixed dose) 60 16,8 28 7,84 Metformin + Sitagliptin (fixed dose) 43 12,0 13 3,64 DPP-4 Inhibitors 36 10,1 10 2,8 Alpha-Glucosidase Inhibitors 18 5,0 5 1,4 Thiazolidinediones 5 1,4 0 0 Total ,43 13
14 Results Therapeutic and Adverse Events Table 3, 4: Prevalence of adverse events according to main therapeutic classes of OA OA therapeutic classes Biguanides Adverse events n തx 215 5,04 Sulfonylureas DPP-4 Inhibitors Metformin + Sitagliptin Metformin + Vildagliptin ,68 5,25 5,19 5,40 OA therapeutic classes Adverse events n തx ord തx Md 2 p One OA class Two OA classes Three or more OA classes
15 T2DM % Results Patients and Adverse Events Advers Events ,2 36,1 29, < > 6 15
16 Results Adverse Events Table 5: Distribution of adverse events. Adverse Events തx Md d.p. x min x máx Weight gain 1,31 1,00 0, Bruising (Amendment coagulation) 1,15 1,00 0, Hair loss (alopecia) 1,13 1,00 0, Allergic reactions (itchy skin, nose or eyes, itching, hives, skin rash) 1,36 1,00 0, Belching much (aerophagia) 1,24 1,00 0,46 1 Diarrhoea 1,13 1,00 0, Swollen belly (abdominal distension) 1,27 1,00 0, Stomach pain (Pain Epigastric) 1,11 1,00 0, Gases (Flatulence) 1,52 1,00 0, Feeling sick (nausea) 1,09 1,00 0, Vomiting 1,09 1,00 0, Joint pain (Arthralgia) 1,84 2,00 0, Lack of strength 1,30 1,00 0, Loss of appetite (anorexia) 1,13 1,00 0, Headache 1,30 1,00 0, Tingling (paraesthesia) 1,54 1,00 0, Somnolence 1,14 1,00 0, Dizziness 1,25 1,00 0, Shortness of breath (dyspnoea) 1,09 1,00 0, Cold (nasopharyngitis) 1,18 1,00 0, Swelling of legs (Peripheral Oedema) 1,31 1,00 0,
17 Results Adverse Events Table 6: Classification with System Organ Classes (SOCs) Disorders/SOC Lowest Level Term തx Md d.p. x min x máx Musculoskeletal Arthralgias Immune System Allergic reactions Nervous system Gastrointestinal disorders Headaches Paresthesias Somnolence Dizziness Aerophagia Diarrhea Abdominal distension Epigastric pain Flatulence Nausea Vomiting General disorders Peripheral edema ICH. (2014). MedDRA Version London. 17
18 Results Adherence to Oral Antidiabetic Agents 100% Adherence (Morisky Green adapted questionnaire) 80% 60% 40% 20% 0% Questions Always Often Frequently Sometimes Rarely Never Legend: 1. Do you sometimes forget to take your pills? 2. Are you careless at times about taking your medicine? 3. Have you ever cut back or stopped taking your medicine without telling your doctor because you felt worse when you took it? 4. When you travel or leave home, do you sometimes forget to bring along your medicine? 5. Did you take all your medicine yesterday? 6. When you feel like your symptoms are under control, do you sometimes stop taking your 7. Taking medicine every day is a real inconvenience for some people. Do you ever feel hassled about sticking to your treatment plan? 18
19 Results Adherence to Oral Antidiabetic Agents 8,4 % Adherence 91,6 % Adherent ( 5) Nonadherent (< 5) 19
20 Results Adherence and Adverse Events Table 6, 7: Relation of Adherence and Adverse Events. Morisky Green adapted questionnaire Adherence to treatment (Sum of scores - Likert items) Adherence to treatment (Sum of scores - dichotomous items) Adverse Events n r s p 357-0,21 0, ,17 0,001 (р < 0,001) OA therapeutic classes DPP-4 Inhibitors Metformin+Sitagliptin Adverse Events No Yes No Yes Adherence to treatment n തx ord തx Md z p ,45 38,97 40, ,26 38,31 38,50-1,906 0, ,24 38,99 40, ,05 38,30 39,00-2,122 0,034 (р < 0,05) 20
21 Conclusions This sample of type 2 diabetics has a high Adherence to therapy and a good metabolic control; The adverse events perceived by patients, either in Oral Antidiabetic agents in Monotherapy or in Combination therapy; That patients who show greater number of Adverse Events tend to show poor Adherence to Oral Antidiabetic agents. 21
22 End of Presentation Thank You. Rui Santos Cruz - Polytechnic Institute of Coimbra, Coimbra Health School, Pharmacy, Portugal ruic@estescoimbra.pt 22
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