Examining correlates of treatment satisfaction for injectable insulin in type 2 diabetes: lessons learned from a clinical trial comparing biphasic and basal analogues

Meryl Brod, David Cobden, Morten Lammert, Donald Bushnell, Philip Raskin, Meryl Brod, David Cobden, Morten Lammert, Donald Bushnell, Philip Raskin

Abstract

Background: Successfully managing diabetes is a complex process that includes addressing issues of drug efficacy, safety and treatment satisfaction. Additionally, the combined impact of patient/disease characteristics and treatment outcomes on treatment satisfaction is not well understood. The purpose of this study was to examine the impact of age, weight, gender, co-morbid conditions, diabetes history, treatment burden, efficacy (HbA1c) and side effects (weight gain, hypoglycemic events) on patients' appraisal of treatment satisfaction using linear regression models.

Methods: Data from a multi-center, randomized clinical trial comparing the efficacy/safety of biphasic insulin aspart 70/30 (BIAsp 70/30) vs. glargine (Glar) among insulin naïve type 2 patients were analyzed. Subjects were between ages 18-75, with baseline HbA1c > 8% and BMI < or = 40 kg/m2 (N = 233). Treatment satisfaction was assessed by the Insulin Treatment Satisfaction Questionnaire (ITSQ).

Results: When factors were examined independently, multiple significant relationships (age, co-morbidity, hypoglycemic events, and weight gain) with overall and/or domains of treatment satisfaction were found. However, when all significant relationships were examined together, only neuropathy, treatment efficacy, and number of hypoglycemic events maintained their previous significance.

Conclusion: By examining predictors independently, significant relationships were identified. However, not all findings remained significant when examined in combination with each other. Thus, to more accurately characterize the impact of factors on treatment satisfaction, a more comprehensive approach may be necessary. By improving patient treatment satisfaction, the efficacy of treatments, as well as critical treatment outcomes such as compliance and cost of care should be improved.

References

    1. Weaver M, Patrick DL, Markson LE, Martin D, Frederic I, Berger M. Issues in the measurement of satisfaction with treatment. Am J Man Care. 1997;3:579–594.
    1. Albrecht G, Hoogstraten J. Satisfaction as determination of compliance. Community Dent Oral Epidemiol. 1998;26:139–146. doi: 10.1111/j.1600-0528.1998.tb01940.x.
    1. Atkinson MJ, Kumar R, Cappelleri JC, Hass SL. Hierarchical construct validity of the treatment Satisfaction Questionnaire for Medication (TSQM Version ll) among outpatient pharmacy consumers. Value Health. 2005;8:S9–S24. doi: 10.1111/j.1524-4733.2005.00066.x.
    1. Menzin J, Langley-Hawthorne C, Friedman M, Boulanger L, Cavanaugh R. Potential short-term economic benefits of improved glycemic control: a managed care perspective. Diabetes Care. 2001;24:51–55.
    1. Hogan P, Dall T, Nikolov P, American Diabetes Association Economic Costs of Diabetes in the U.S. in 2002. Diabetes Care. 2003;26:917–932.
    1. Anderson RT, Marrero D, Skovlund SE, Cramer J, Schwartz S. Self-reported compliance with insulin injection therapy in subjects with type 1 and 2 diabetes. Diabetologia. 2003;46:A275. doi: 10.1007/s00125-003-1112-x.
    1. Rosenstock J, Cappelleri JC, Bolinder B, Gerber RA. Patient satisfaction and glycemic control after 1 year with inhaled insulin (Exubera) in patients with type 1 or type 2 diabetes. Diabetes Care. 2004;27:1318–1323.
    1. Clark CM, Jr, Snyder JW, Meek RL, Stutz LM, Parkin CG. A systematic approach to risk stratification and intervention within a managed care environment improves diabetes outcomes and patient satisfaction. Diabetes Care. 2001;24:1079–1086.
    1. Colman SS, Brod MI, Krishnamurthy A, Rowland CR, Jirgens KJ, Gomez-Mancilla B. Treatment satisfaction, functional status and health related quality of life of patients with migraine randomly assigned to almotriptan or aumatriptan. Clin Ther. 2001;23:127–145. doi: 10.1016/S0149-2918(01)80036-9.
    1. Weijman I, Ros WJ, Rutten GE, Schaufeli WB, Schabracq MJ, Winnubst JA. Frequency and perceived burden of diabetes self-management activities in employees with insulin-treated diabetes: relationships with health outcomes. Diabetes Res Clin Pract. 2005;68:56–64. doi: 10.1016/j.diabres.2004.08.004.
    1. Anderson RT, Skovlund SE, Marrero D, Levine DW, Meadows K, Brod M, Balkrishnan R. Development and validation of the insulin treatment satisfaction questionnaire. Clin Ther. 2004;26:565–578. doi: 10.1016/S0149-2918(04)90059-8.
    1. Testa M. Improving diabetes therapy: improving satisfaction. Diabetes Voice. 2003;48:23–25.
    1. Brod M, Skovlund SE, Wittrup-Jensen KU. Measuring the impact of diabetes through patient report of treatment satisfaction, productivity and symptom experience. Qual Life Res. 2006;15:481–491. doi: 10.1007/s11136-005-1624-6.
    1. Atkinson MJ, Sinha A, Hass SL, Colman SS, Kumar RN, Brod M, Rowland CR. Validation of a general measure of treatment satisfaction, the Treatment Satisfaction Questionnaire for Medication (TSQM), using a national panel study of chronic disease. Health Qual Life Outcomes. 2004;2:12. doi: 10.1186/1477-7525-2-12.
    1. Greenfield S, Kaplan SH, Kahn R, Ninomiya J, Griffith JL. Profiling care provided by different groups of physicians: effects of patient case-mix (bias) and physician-level clustering on quality assessment results. Ann Intern Med. 2002;136:111–121.
    1. Cappelleri JC, Gerber RA, Kourides IA, Gelfand RA. Development and factor analysis of a questionnaire to measure patient satisfaction with injected and inhaled insulin for type 1 diabetes. Diabetes Care. 2000;23:1799–1803.
    1. Redekop WK, Koopmanschap MA, Stolk RP, Rutten GE, Wolffenbuttel BH, Niessen LW. Health-related quality of life and treatment satisfaction in Dutch patients with Type 2 diabetes. Diabetes Care. 2002;25:458–463.
    1. Taylor MD, Frier BM, Gold AE, Deary IJ, Edinburgh Prospective Diabetes Study Psychosocial factors and diabetes-related outcomes following diagnosis of type 1 diabetes in adults: the Edinburgh prospective diabetes study. Diabet Med. 2003;20:135–146. doi: 10.1046/j.1464-5491.2003.00887.x.
    1. Petterson T, Lee P, Hollis S, Young B, Newton P, Dornan T. Well-being and treatment satisfaction in older people with diabetes. Diabetes Care. 1998;21:930–935.
    1. Bech P, Moses R, Gomis R. The effect of prandial glucose regulation with repaglinide on treatment satisfaction, wellbeing and health status in patients with pharmacotherapy naive Type 2 diabetes: a placebo-controlled, multicentre study. Qual Life Res. 2003;12:413–425. doi: 10.1023/A:1023495106160.
    1. Herman WH, Ilag LL, Johnson SJ, Martin CL, Sinding J, Al Harthi A, Plunkett CD, LaPorte FB, Burke R, Brown MB, Halter JB, Raskin P. A clinical trial of continuous subcutaneous insulin infusion versus multiple daily injections in older adults with type 2 diabetes. Diabetes Care. 2005;28:1568–1573.
    1. Wilson M, Moore MP, Lunt H. Treatment satisfaction after commencement of insulin in Type 2 diabetes. Diabetes Res Clin Pract. 2004;66:263–267. doi: 10.1016/j.diabres.2004.04.010.
    1. Brod M, Lammert M, Raskin P. Comparison of treatment satisfaction of twice-daily BIAsp 70/30 with once-daily insulin glargine in patients with type 2 diabetes. Poster presented at the 65th Scientific Session of the American Diabetes Association Meeting – San Diego, California, 2005 of the American Diabetes Association Meeting – San Diego, California. 2005.
    1. Bradley C, Plewe G, Kliebe-Frisch Treatment satisfaction with a basal insulin added to oral agents versus twice-daily premixed insulin alone in patients with Type 2 diabetes. Diabetes. 2005;54:A304.
    1. Raskin P, Bode PW, Marks JB, Hirsch IB, Weinstein RL, McGill JB, Peterson GE, Mudaliar SR, Reinhardt RR. Continuous subcutaneious insulin infusion and multiple daily injection therapy are equally effective in type 2 diabetes: a randomized, parallel-group, 24 week study. Diabetes Care. 2003;26:2598–2603.
    1. Hoogma RP, Spijker AJ, van Doorn-Scheele M, van Doorn TT, Michels RP, van Doorn RG, Levi M, Hoekstra JB. Quality of Life and metabolic control in patients with diabetes mellitus type 1 treated by continuous subcutaneous insulin infusion of multiple daily insulin injections. Neth J Med. 2004;62:383–387.
    1. Raskin P, Allen E, Hollander P, Lewin A, Gabbay RA, Hu P, Bode B, Garber A, INITIATE Study Group Initiating insulin therapy in type 2 diabetes. Diabetes Care. 2005;28:260–265.
    1. Korytkowski M, Bell D, Jacobsen C, Suwannasari R, FlexPen Study Team 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. Clin Ther. 2003;25:2836–2848. doi: 10.1016/S0149-2918(03)80337-5.
    1. Rubin RR, Peyrot M. Quality of life, treatment satisfaction and treatment preference associated with use of a pen device delivering a pemixed 70/30 insulin aspart suspension (aspart protamine suspension/soluble aspart) versus alternative treatment strategies. Diabetes Care. 2004;27:2495–2497.
    1. Summers KH, Szeinbach SL, Lenox SM. Preference for insulin delivery systems among current users and nonusers. Clin Ther. 2004;26:1498–1505. doi: 10.1016/j.clinthera.2004.09.009.
    1. Peyrot M, Rubin RR, Lauritzen T, Skovlund SE, Snoek FJ, Matthews DR, Landgraf R, Kleinebreil L, The International DAWN Advisory Panel Resistance to insulin therapy among patients and providers: results of the cross-national Diabetes Attitudes, Wishes, and Needs (DAWN) study. Diabetes Care. 2005;28:2673–2679.
    1. Garber AJ, Wahlen J, Wahl T, Bressler P, Braceras R, Allen E, Jain R. Attainment of glycaemic goals in type 2 diabetes with once-twice, or thrice-daily dosing with biphasic insulin aspart 70/30 (The 1-2-3 study) Diabetes Obes Metab. 2006;8:58–66. doi: 10.1111/j.1463-1326.2005.00563.x.
    1. Kann P, Wascher T, Zackova V, Moeller J, Medding J, Szocs A, Mokan M, Mrevlje F, Regulshki M. Starting insulin therapy in type 2 diabetes: twice-daily biphasic insulin Aspart 30 plus metformin versus once-daily insulin glargine plus glimepiride. Exp Clin Endocrinol Diabetes. 2006;114:527–32. doi: 10.1055/s-2006-949655.
    1. Goudswaard AN, Stolk RP, Zuithoff P, de Valk HW, Rutten GE. Starting insulin in type 2 diabetes: continue oral hypoglycemic agents? A randomized trial in primary care. The J Fam Pract. 2004;53:393–399.
    1. Shaw WS, Zaia A, Pransky G, Winters T, Patterson WB. Perceptions of provider communication and patient satisfaction for treatment of acute low back pain. J Occup Environ Med. 2005;47:1036–1043. doi: 10.1097/01.jom.0000172863.26222.14.
    1. Hirsh AT, Atchison JW, Berger JJ, Waxenberg LB, Lafayette-Lucey A, Bulcourf BB, Robinson ME. Patient satisfaction with treatment for chronic pain: predictors and relationship to compliance. Clin J Pain. 2005;21:302–310. doi: 10.1097/01.ajp.0000113057.92184.90.
    1. McCracken LM, Klock PA, Mingay DJ, Asbury JK, Sinclair DM. Assessment of satisfaction with treatment for chronic pain. J Pain Symptom Manage. 1997;14:292–299. doi: 10.1016/S0885-3924(97)00225-X.
    1. Niskanen L, Jensen EJ, Rastam J, Nygaard-Pedersen L, Erichsen K, Vora JP. Randomized, multinational open-label, 2-period, crossover comparison of biphasic insulin aspart 30 and biphasic insulin lispor 25 and pen devices in adult patients with Type 2 diabetes mellitus. Clin Ther. 2004;26:531–540. doi: 10.1016/S0149-2918(04)90055-0.
    1. Asakura T, Seino H. Assessment of dose selection attributes with audible notification in insulin pen devices. Diabetes Technol Ther. 2005;7:620–626. doi: 10.1089/dia.2005.7.620.
    1. Ray JA, Valentine J, Nicklasson L, Cobden D, Raskin P, Garber A, Palmer AJ. Insulin therapy in type 2 diabetes patients failing oral agents: cost-effectiveness of biphaic insulin aspart 70/30 vs. insulin glargine in the US. Diabetes Obes Metab. 2007;9:103–113. doi: 10.1111/j.1463-1326.2006.00581.x.
    1. Valentine WJ, Palmer AJ, Lammert M, Nicklasson L, Foos V, Roze S. Long-term clinical and cost outcomes of treatment with biphasic insulin aspart 30/70 versus insulin glargine in insulin naive type 2 diabetes patients: cost-effectiveness analysis in the UK setting. Curr Med Res Opin. 2005;21:2063–2071. doi: 10.1185/030079905X74989.
    1. Hurwitz EL, Morgenstern , Yu F. Satisfaction as a predictor of clinical outcomes among chiropractic and medical patients enrolled in the UCLA low back pain study. Spine. 2005;30:2121–2128. doi: 10.1097/01.brs.0000180639.67008.d0.

Source: PubMed

Sponsoren und Mitarbeiter

Krankheiten

Drogeninterventionen

3
Abonnieren