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Improvements in quality of life associated with insulin analogue therapies in people with type 2 diabetes: Results from the A1chieve observational study

Siddharth Shah, Alexey Zilov, Rachid Malek, Pradana Soewondo, Ole Bech and Leon Litwak

Diabetes Research and Clinical Practice, Issue 3, Volume 94, pages 364 - 370

Received 20 September 2011, Revised 10 October 2011, Accepted 13 October 2011, Published online Nov-2011


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4. Discussion

This analysis of HRQoL, measured by the validated EQ-5D questionnaire, in the international, 24-week A1chieve study found that people with T2DM starting insulin with, or switching to, insulin detemir, insulin aspart, or biphasic insulin aspart 30 experienced significantly increased overall HRQoL, with significant improvements across all five component health dimensions. Irrespective of people's previous insulin experience, the HRQoL significantly improved with the insulin analogues used in this study. Overall HRQoL also improved across all regions, although not in all individual health dimensions. That these changes were associated with large changes in HbA1c (overall reduction of −2.1 ± 1.7% from baseline), and despite this no marked weight gain (−0.1 ± 3.7 kg) or increase in hypoglycaemia (as reported in Home et al., submitted to Diabetes Res. Clin. Pract., this issue), suggests that the overall experience of these people in starting the insulin analogue was very positive, perhaps suggesting that overall engagement with healthcare also improved, as did self-management activities such as dietary control. This in turn would explain why the improvements in HRQoL were for the most part independent of insulin type chosen, and indeed of baseline insulin use or geographical region.

It is important to determine QoL when evaluating treatments, as physicians may otherwise make only subjective assessments about their patients’ QoL when taking clinical decisions. Measuring QoL is also of value as often there is only a modest difference in efficacy and/or safety outcomes between treatments when investigated in a clinical trial setting, and therefore choices taking QoL into account could beneficially aid management.

There are few randomised controlled trials looking at the effect on QoL of insulin analogues in insulin-naïve or insulin-experienced people with T2DM, in particular for the population studied by A1chieve, outside of western Europe or North America. More often, treatment satisfaction questionnaires are used, measuring something which may not reflect specific impact on QoL. In one 16-week, randomised controlled trial in 308 insulin-naïve people with T2DM, the Diabetes Health Profile and the World Health Organization's Diabetes Treatment Satisfaction Questionnaire (DTSQ) were used to measure the effect of twice- or three-times daily biphasic insulin aspart 30 plus metformin compared with OGLDs alone [12] x O. Ushakova, V. Sokolovskaya, A. Morozova, F. Valeeva, O. Zanozina, O. Sazonova, et al. Comparison of biphasic insulin aspart 30 given three times daily or twice daily in combination with metformin versus oral antidiabetic drugs alone in patients with poorly controlled type 2 diabetes: a 16-week, randomized, open-label, parallel-group trial conducted in Russia. Clin Ther. 2007;29(11):2374-2384 . Treatment satisfaction scores significantly improved for all groups from baseline, and all subjects experienced improvements in psychological distress and barriers to activity scores.

However, there are some prospective and retrospective observational data investigating insulin analogues and their effect on QoL in people with T2DM, and the results from the A1chieve study support the few findings from these studies [13], [14], and [15] x A.K. Mukherjee, V.S. Reddy, S. Shah, A.K. Jhingan, P. Ramakrishnan, V. Prusty, et al. Quality of life as a key indicator of patient satisfaction and treatment compliance in people with type 2 diabetes mellitus in the IMPROVE study: a multicentre, open label, non-randomised, observational trial. J Indian Med Assoc. 2009;107(7):464-470 x A. Esteghamati, R. Rajabian, M. Amini, A. Bahrami, M.E. Khamseh, M. Afkhami-Ardekani, et al. The safety and efficacy of biphasic insulin aspart 30 (BIAsp 30) in Iranians with type 2 diabetes: an open-label, non-randomised, multi-centre observational study—the Iran subgroup of the IMPROVE™ study. Endokrynol Pol. 2010;61(4):364-370 x T.R. Hajos, F. Pouwer, R. de Grooth, F. Holleman, J.W. Twisk, M. Diamant, et al. Initiation of insulin glargine in patients with Type 2 diabetes in suboptimal glycaemic control positively impacts health-related quality of life. A prospective cohort study in primary care. Diabet Med. 2011;28(9):1096-1102 . For example, in the Indian cohort of the 26-week IMPROVE observational study, QoL was measured using the DiabMedSat questionnaire in 349 people with T2DM being treated with biphasic insulin aspart 30 [13] x A.K. Mukherjee, V.S. Reddy, S. Shah, A.K. Jhingan, P. Ramakrishnan, V. Prusty, et al. Quality of life as a key indicator of patient satisfaction and treatment compliance in people with type 2 diabetes mellitus in the IMPROVE study: a multicentre, open label, non-randomised, observational trial. J Indian Med Assoc. 2009;107(7):464-470 . Overall QoL score and the sub-parameters of relief of burden, relief of symptoms, and effectiveness significantly increased from baseline. Similar observations were made in the Iranian cohort of the IMPROVE™ study, with a significantly higher DiabMedSat score, including significant increases in all three subscale scores, at study end in 478 people who were insulin naïve or insulin experienced [14] x A. Esteghamati, R. Rajabian, M. Amini, A. Bahrami, M.E. Khamseh, M. Afkhami-Ardekani, et al. The safety and efficacy of biphasic insulin aspart 30 (BIAsp 30) in Iranians with type 2 diabetes: an open-label, non-randomised, multi-centre observational study—the Iran subgroup of the IMPROVE™ study. Endokrynol Pol. 2010;61(4):364-370 .

There appear to be no other data on the effect of QoL by starting insulin with, or switching to, insulin analogues, given prior insulin status, and across a wide range of populations, as in A1chieve. It is thus reassuring to see that starting such insulin in insulin-naïve people is not detrimental to QoL, at least in a population with poor blood glucose control at baseline. Likewise, QoL in people being treated with a potentially more complex insulin aspart and basal insulin regimen was not lower than other insulin regimens by study end, even where there were differences at baseline.

It is difficult to compare overall HRQoL values and those observed in the regions of the A1chieve study with those of general or other T2DM populations, as HRQoL data should be country-specific and no HRQoL papers have been published in these regions. Measured QoL did appear to vary by region at baseline, but some care is required in interpreting these and other aspects of the findings. A1chieve is an observational study, which can generate useful data from routine clinical practice, but is naturally subject to study effects, which cannot be distinguished from either the effect of the insulins themselves, or the circumstances in which the insulin was started. Furthermore, the interaction between QoL and diabetes is complicated and it is difficult to ascertain which features of management or treatment are responsible for any changes in QoL. In A1chieve, QoL significantly improved for people irrespective of prior insulin status, and it is known that improvements in glycaemic control are associated with improvements in QoL [8] x A.M. Jacobson. Impact of improved glycemic control on quality of life in patients with diabetes. Endocr Pract. 2004;10(6):502-508 . It is also recognised that hypoglycaemia has an impact on QoL [16] x Barendse S, Singh H, Frier BM, Speight J. The impact of hypoglycaemia on quality of life and related patient-reported outcomes in type 2 diabetes: a narrative review. Diabet Med, in press. , and it is possible that the reduction in events seen in previous insulin users in this study also contributed to an improvement in score.

There could also be some limitations regarding the comparative validity of the EQ-5D questionnaire over such diverse geographical regions as were investigated in A1chieve, or the implausibility of the results in the pain/mobility sub-dimensions. However, the EQ-5D questionnaire is known to be a validated, reliable and responsive instrument in T2DM [17] x M.F. Janssen, E.I. Lubetkin, J.P. Sekhobo, A.S. Pickard. The use of the EQ-5D preference-based health status measure in adults with Type 2 diabetes mellitus. Diabet Med. 2011;28(4):395-413 , and is thus a reasonable choice for the purposes of the current study. It will be used alongside other measures in a major upcoming European prospective observational study [18] x Bradley C, de Pablos-Velasco P, Parhofer KG, Eschwège E, Gönder-Frederick L, Simon D. PANORAMA: a European study to evaluate quality of life and treatment satisfaction in patients with type-2 diabetes mellitus—study design. Primary Care Diabetes doi:10.1016/j.pcd.2011.04.004, in press. .

In summary, observations from the A1chieve study provide new insights and support previous findings regarding the beneficial effect on HRQoL of starting insulin analogues in people with neglected blood glucose control, whether insulin naïve or insulin experienced, in routine clinical practice across diverse geographical regions.

References

Label Authors Title Source Year
[8]

References in context

  • Indeed, it is known that measured QoL improves with better glycaemic control [8].
    Go to context

  • In A1chieve, QoL significantly improved for people irrespective of prior insulin status, and it is known that improvements in glycaemic control are associated with improvements in QoL [8].
    Go to context

A.M. Jacobson Impact of improved glycemic control on quality of life in patients with diabetes Endocr Pract. 2004;10(6):502-508 2004
[12]

References in context

  • In one 16-week, randomised controlled trial in 308 insulin-naïve people with T2DM, the Diabetes Health Profile and the World Health Organization's Diabetes Treatment Satisfaction Questionnaire (DTSQ) were used to measure the effect of twice- or three-times daily biphasic insulin aspart 30 plus metformin compared with OGLDs alone [12].
    Go to context

O. Ushakova, V. Sokolovskaya, A. Morozova, F. Valeeva, O. Zanozina, O. Sazonova, et al. Comparison of biphasic insulin aspart 30 given three times daily or twice daily in combination with metformin versus oral antidiabetic drugs alone in patients with poorly controlled type 2 diabetes: a 16-week, randomized, open-label, parallel-group trial conducted in Russia Clin Ther. 2007;29(11):2374-2384 2007
[13]

References in context

  • For example, in the Indian cohort of the 26-week IMPROVE observational study, QoL was measured using the DiabMedSat questionnaire in 349 people with T2DM being treated with biphasic insulin aspart 30 [13].
    Go to context

A.K. Mukherjee, V.S. Reddy, S. Shah, A.K. Jhingan, P. Ramakrishnan, V. Prusty, et al. Quality of life as a key indicator of patient satisfaction and treatment compliance in people with type 2 diabetes mellitus in the IMPROVE study: a multicentre, open label, non-randomised, observational trial J Indian Med Assoc. 2009;107(7):464-470 2009
[14]

References in context

  • Similar observations were made in the Iranian cohort of the IMPROVE™ study, with a significantly higher DiabMedSat score, including significant increases in all three subscale scores, at study end in 478 people who were insulin naïve or insulin experienced [14].
    Go to context

A. Esteghamati, R. Rajabian, M. Amini, A. Bahrami, M.E. Khamseh, M. Afkhami-Ardekani, et al. The safety and efficacy of biphasic insulin aspart 30 (BIAsp 30) in Iranians with type 2 diabetes: an open-label, non-randomised, multi-centre observational study—the Iran subgroup of the IMPROVE™ study Endokrynol Pol. 2010;61(4):364-370 2010
[16]

References in context

  • It is also recognised that hypoglycaemia has an impact on QoL [16], and it is possible that the reduction in events seen in previous insulin users in this study also contributed to an improvement in score.
    Go to context

Barendse S, Singh H, Frier BM, Speight J. The impact of hypoglycaemia on quality of life and related patient-reported outcomes in type 2 diabetes: a narrative review. Diabet Med, in press.
[17]

References in context

  • However, the EQ-5D questionnaire is known to be a validated, reliable and responsive instrument in T2DM [17], and is thus a reasonable choice for the purposes of the current study.
    Go to context

M.F. Janssen, E.I. Lubetkin, J.P. Sekhobo, A.S. Pickard The use of the EQ-5D preference-based health status measure in adults with Type 2 diabetes mellitus Diabet Med. 2011;28(4):395-413 2011
[18]

References in context

  • It will be used alongside other measures in a major upcoming European prospective observational study [18].
    Go to context

Bradley C, de Pablos-Velasco P, Parhofer KG, Eschwège E, Gönder-Frederick L, Simon D. PANORAMA: a European study to evaluate quality of life and treatment satisfaction in patients with type-2 diabetes mellitus—study design. Primary Care Diabetes doi:10.1016/j.pcd.2011.04.004, in press.

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