In this high/very-high CV risk population in Germany, statin utilization was low; suggesting that LLTs are not prescribed as per European guidelines. These results highlight the need to increase LLT use among high-risk patients.

A high proportion of patients had asymptomatic atherosclerotic disease and a considerable risk of recurrent stroke according to the ABI and ESRS category. The prognostic accuracy as well as the potential benefit of various risk stratification scores in secondary stroke prevention require validation in a larger prospective study.

BackgroundPharmacological and clinical differences between insulin glargine and NPH insulin may translate into differences in patient reported outcomes, but existing data are equivocal.MethodsIn this 48-week, open-label, randomized, multi-center, crossover phase IV trial, insulin naïve type 2 diabetes patients with blood glucose not at target on oral hypoglycemic agents had basal insulin added to their treatment regimen. A total of 343 patients were randomized to either receive insulin glargine (n = 176; sequence A) or neutral protamine Hagedorn (NPH) insulin (n = 167; sequence B) in period 1 (weeks 1–24) and vice versa in period 2 (weeks 25–48). The primary objective was to assess patient reported outcomes using a composite Diabetes Related Quality of Life (DRQoL) score based on an unweighted Insulin Treatment Experience Questionnaire (ITEQ) score, a Problem Areas in Diabetes (PAID) questionnaire score, and the mental health score in the Short Form (SF)-12® Health Survey, analyzed by analysis of covariance (ANCOVA).ResultsPatients (mean age 62.3 ± 9.0; 39.5 % female) had a mean diabetes duration of 9.6 ± 5.9 years, a mean baseline HbA1c of 8.15 ± 0.72 %, and a mean fasting blood glucose (FBG) level of 9.37 ± 2.19 mmol/L. A total of 229 patients were available for primary endpoint evaluation (modified intention to treat population). Combining all data from both periods for each insulin treatment, on a 0–100 scale, the mean DRQoL score was 69.6 (±9.04) with insulin glargine and 70.0 (±9.40) with NPH insulin. Neither an effect of treatment with insulin glargine vs NPH insulin (p = 0.31) nor a period effect (p = 0.96), nor a sequence effect (p = 0.76) was observed using ANCOVA.ConclusionsThe results show that in a patient population with sub-optimal glycemic control at baseline, and a low target achievement rate together with a low rate of hypoglycemia, differences in the patient reported outcomes evaluated in this study were negligible between insulin glargine and NPH insulin.Trial registrationClinicaltrials.gov identifier: NCT00941369

Early benefit assessment in Germany under the legislative framework of AMNOG (Arzneimittelmarktneuordnungsgesetz) requires direct comparisons of the new drug with appropriate comparators determined by the Federal Joint Committee (G-BA). In case no head-to-head studies are available for direct comparisons, the submission of indirect comparisons is permitted to assess the additional benefit of the new drug. However, the Institute for Quality and Efficiency in Health Care (IQWiG) states a clear preference for head-to-head trials and defines strict requirements for indirect comparisons to be considered in the benefit assessment. Similar requirements also exist in other countries with mandatory health technology assessments (HTA), like France, England and Scotland. Our evaluation shows that a comparison of the different HTA regarding indirect comparisons is difficult. Overall, external preconditions and methodological requirements are demanding and hardly to fulfill by pharmaceutical companies for implementation of indirect comparisons in early benefit assessment. The determination of the appropriate comparators, outcomes, patient subgroups and study choice are the main target within indirect comparisons for the future. To compare and assess submitted indirect comparisons it would be desirable that a transparent process was established, including the mandatory publication of HTA-reports within Europe and international guidelines, accepted by a large number of HTA-agencies.

This study shows that glulisine, lispro and RHI have similar effects on S(EGP), GU, FFA, glycerol and lactate levels, providing evidence for similar end-organ metabolic effects.