Patient adherence to and tolerability of treatment with metformin extended-release formulation in patients with type 2 diabetes. GLUCOMP study

Introduction. Appropriate treatment of diabetes requires regular intake of recommended drugs. Multifactorial therapy, which necessitates the concomitant use of many medications, may decrease patient adherence. The purpose of the study was to assess type 2 diabetic patients’ adherence to and tolerability of metformin extended-release formulation in the outpatient setting. Materials and methods. This non-interventional study was conducted in a group of 4737 patients [including 2468 (52%) women] with mean age of 60.6 ± 9.4 years, diabetes duration of 5.6 ± 4.4 years, duration of treatment with metformin extended release formulation of 8.3 ± 12 months at an average dose of 1667 ± 350 mg. The study enrolled patients aged over 18 years with type 2 diabetes if they were treated with metformin extended- release formulation at a dose of 1500–2000 mg for less than 1 year prior to the study enrollment. The exclusion criteria included: pregnancy, breast-feeding and any contraindications for metformin treatment. Treatment adherence was assessed by a tablet count (percentage of prescribed tablets taken) and using the Morisky-Green scale. Treatment adherence was defined as follows: excellent patient adherence if > 90% of prescribed tablets were taken; good: 76–90%; moderate: 51–75%; poor: ≤ 50%. Treatment tolerability was also evaluated based on the medical history focused on gastrointestinal symptoms, as well as patient preference for using specific types of metformin. Other patient data, clinical data and laboratory test results were recorded at the beginning of the study and after 3 months. Results. After 3 months of treatment with metformin extended release formulation 96% of study subjects demonstrated excellent or good adherence. Treatment adherence was significantly lower with 2 or 3 concomitant medications as compared to one (p < 0.001). Adverse events occurred in 715 patients (15% out of 4758 patients undergoing safety analysis). The occurrence of adverse events significantly decreased treatment adherence (p < 0.001). Approximately 90% of patients declared they had preferred the use of metformin extended-release formulation. Conclusions. Metformin extended-release formulation is a suitable, well tolerated therapeutic option which helps to obtain good patient cooperation based on good adherence.

Patient adherence to and tolerability of treatment with metformin extended-release formulation in patients with type 2 diabetes. GLUCOMP study

Wstęp. Prawidłowe leczenie cukrzycy wymaga regularnego zażywania zalecanych leków. Wieloczynnikowa terapia, w której konieczne jest przyjmowanie wielu preparatów, może powodować spadek stopnia stosowania się do zaleceń terapeutycznych. Celem badania była ocena przestrzegania zaleceń terapeutycznych przez pacjentów oraz tolerancji leczenia u chorych na cukrzycę typu 2, leczonych w warunkach ambulatoryjnych preparatem metforminy o przedłużonym uwalnianiu. Materiał i metody. Badanie przeprowadzono w grupie 4737 chorych [w tym 2468 (52%) kobiet] w wieku średnio 60,6 ± 9,4 roku; czas trwania cukrzycy: 5,6 ± 4,4 roku; czas trwania leczenia metforminą o przedłużonym uwalnianiu 8,3 ± 12 miesięcy w średniej dawce 1667 ± 350 mg. Do badania włączono pacjentów w wieku powyżej 18. rż. z cukrzycą typu 2, jeśli przyjmowali metforminę o przedłużonym uwalnianiu w dawce 1500–2000 mg przez mniej niż 1 rok przed włączeniem do badania. Kryteria wykluczenia z badania obejmowały: ciążę, karmienie piersią, występowanie jakichkolwiek przeciwwskazań do stosowania metforminy. Przestrzeganie zaleceń oceniano w zależności od liczby zażywanych leków oraz stosując skalę Morisky’ego-Greena. Przestrzeganie zaleceń zdefiniowano w następujący sposób: bardzo dobre przestrzeganie zaleceń przez pacjenta, jeśli > 90% przepisanych tabletek zostało spożytych; dobre: 76–90%; średnie: 51–75%; złe: £ 50%. Oceniano także tolerancję leczenia na podstawie wywiadu w kierunku objawów żołądkowo-jelitowych oraz preferencji pacjentów dotyczących stosowania poszczególnych rodzajów metforminy. Inne dane pacjentów, dane kliniczne i wyniki badań laboratoryjnych rejestrowano na początku badania oraz po 3 miesiącach. Wyniki. Po 3 miesiącach leczenia metforminą o przedłużonym uwalnianiu u 96% uczestników stwierdzono bardzo dobre lub dobre przestrzeganie zaleceń terapeutycznych. Przestrzeganie zaleceń było istotnie gorsze w przypadku zażywania 2 lub 3 leków w porównaniu z 1 lekiem (p < 0,001). Działania niepożądane wystąpiły u 715 pacjentów. Ich obecność istotnie pogarszała  przestrzeganie zaleceń terapeutycznych (p < 0,001). Około 90% pacjentów stwierdziło, że preferuje stosowanie metforminy o przedłużonym uwalnianiu. Wnioski. Forma metforminy o przedłużonym uwalnianiu jest odpowiednią opcją terapeutyczną stosowaną w celu uzyskania pożądanej współpracy z pacjentem opartej na dobrym przestrzeganiu zaleceń terapeutycznych.Introduction. Appropriate treatment of diabetes requires regular intake of recommended drugs. Multifactorial therapy, which necessitates the concomitant use of many medications, may decrease patient adherence. The purpose of the study was to assess type 2 diabetic patients’ adherence to and tolerability of metformin extended-release formulation in the outpatient setting. Materials and methods. This non-interventional study was conducted in a group of 4737 patients [including 2468 (52%) women] with mean age of 60.6 ± 9.4 years, diabetes duration of 5.6 ± 4.4 years, duration of treatment with metformin extended release formulation of 8.3 ± 12 months at an average dose of 1667 ± 350 mg. The study enrolled patients aged over 18 years with type 2 diabetes if they were treated with metformin extended-release formulation at a dose of 1500–2000 mg for less than 1 year prior to the study enrollment. The exclusion criteria included: pregnancy, breast-feeding and any contraindications for metformin treatment. Treatment adherence was assessed by a tablet count (percentage of prescribed tablets taken) and using the Morisky-Green scale. Treatment adherence was defined as follows: excellent patient adherence if > 90% of prescribed tablets were taken; good: 76–90%; moderate: 51–75%; poor: ≤ 50%. Treatment tolerability was also evaluated based on the medical history focused on gastrointestinal symptoms, as well as patient preference for using specific types of metformin. Other patient data, clinical data and laboratory test results were recorded at the beginning of the study and after 3 months. Results. After 3 months of treatment with metformin extended release formulation 96% of study subjects demonstrated excellent or good adherence. Treatment adherence was significantly lower with 2 or 3 concomitant medications as compared to one (p < 0.001). Adverse events occurred in 715 patients (15% out of 4758 patients undergoing safety analysis). The occurrence of adverse events significantly decreased treatment adherence (p < 0.001). Approximately 90% of patients declared they had preferred the use of metformin extended-release formulation. Conclusions. Metformin extended-release formulation is a suitable, well tolerated therapeutic option which helps to obtain good patient cooperation based on good adherence

Metformin prevents the development of severe chronic kidney disease and its associated mineral and bone disorder

International audienceChronic kidney disease (CKD) causes dysregulation of mineral metabolism, vascular calcification and renal osteodystrophy, an entity called `CKD-Mineral and Bone Disorder' (CKD-MBD). Here we determine whether metformin, an anti-diabetic drug, exerts favorable effects on progressive, severe CKD and concomitant mineral metabolism disturbances. Rats with CKD-MBD, induced by a 0.25% adenine diet for eight weeks, were treated with 200 mg/kg/day metformin or vehicle from one week after CKD induction onward. Severe, stable CKD along with marked hyperphosphatemia and hypocalcemia developed in these rats which led to arterial calcification and high bone turnover disease. Metformin protected from development toward severe CKD. Metformin-treated rats did not develop hyperphosphatemia or hypocalcemia and this prevented the development of vascular calcification and inhibited the progression toward high bone turnover disease. Kidneys of the metformin group showed significantly less cellular infiltration, fibrosis and inflammation. To study a possible direct effect of metformin on the development of vascular calcification, independent of its effect on renal function, metformin (200 mg/kg/day) or vehicle was dosed for ten weeks to rats with warfarin-induced vascular calcification. The drug did not reduce aorta or small vessel calcification in this animal model. Thus, metformin protected against the development of severe CKD and preserved calcium phosphorus homeostasis. As a result of its beneficial impact on renal function, associated comorbidities such as vascular calcification and high bone turnover disease were also prevented