Diabetes mellitus and comorbid depression: improvement of both diseases with milnacipran. A replication study (results of the Austrian Major Depression Diabetes Mellitus study group)

Figures & data

Table 1 Characteristics at baseline of patients completing the study

Patients (n)	135
Sex distribution: M/F (%)	61/74 (45%/55%)
Median age: years (range)	63 (18–85)
Naïve to depression treatment	111 (82%)
Naïve to diabetes treatment	77 (57%)

Table 2 Metabolic parameters at baseline and after 6 months treatment with milnacipran of patients completing the study

Parameter	Baseline	6 months	P
FBG (mg/dL)	163	128	<0.001
HbA1c (% of total Hb)	7.8	7.0	<0.001
HbA1c (mmol/mol)	61.7	53.0	<0.001
Body weight (kg)	89.2	86.2	<0.001
BMI (kg/m^2)	30.8	29.8	<0.001
BP systolic	140.3	134.2	<0.001
BP diastolic	82.8	79.6	<0.001
Total chol (mg/dL)	207	190	<0.001
LDL-chol (mg/dL)	120	116	NS
HDL-chol (mg/dL)	51.6	53.3	<0.05
Triglycerides (mg/dL)	173	158	<0.01

Notes: All values are given as the mean. P is the significance of the difference between baseline and 6 month values.

Abbreviations: FBG, fasting blood glucose; HbA_1c, glycated hemoglobin; BMI, body mass index; BP, blood pressure; chol, cholesterol; LDL, low-density lipoprotein; HDL, high-density lipoprotein.

Figure 1 Evolution of Beck Depression Inventory scores and patients responders and remitters during the study.

Notes: Mean Beck Depression Inventory (BDI) scores are given as triangles connected by a blue line. Percentage of patient responders (decrease of ≥50% of baseline BDI score) and remitters (BDI score ≤ 12) are represented as orange and dark red bars respectively.

Table 3 Evolution of Beck Depression Inventory scores throughout the study

	Baseline	3 months	6 months
Total	28.9	16.9	11.5
Responders	30.0	16.0	9.0
Nonresponders	26.9	20.2	17.5

Note: Values are means of the 135 patients who completed the study with a complete dataset.

Table 4 Mean doses of drugs administered throughout the study

Metformin	Met (mg/day)
	Months 0–3		Months 3–6	Final evaluation
Responders (n = 98)	1632		1728	1707
Nonresponders (n = 37)	1661		1707	1702
Milnacipran	Miln (mg/day)
	Days 0–7	Week 2 to 3 months	Months 3–6	Final evaluation
Responders (n = 98)	47	73	82	80
Nonresponders (n = 37)	48	80	84	83

Abbreviations: Miln, milnacipran; Met, metformin.

Table 5 Change of metabolic and anthropometric parameters in depression responders and nonresponders during milnacipran treatment

	Responders n = 98			Nonresponders n = 37
	Baseline	6 months	Δ	Baseline	6 months	Δ
FBG	164	126***	−38	158	134**	−24
HbA1c
(%)	7.9	7.0***	−0.9	7.7	6.8***	−0.9
(mmol/mol)	62.8	53.0***	−9.8	60.6	50.8***	−9.8
Body weight	89.9	86.3***	−3.6	87.5	85.9**	−1.6§§
BMI	31.2	30.0***	−1.2	29.8	29.3**	−0.5§§
Total cholesterol	212	188***	−24	193	193	0§§
LDL	120	116	−4	119	116	−3
HDL	51.4	52.7	+1.3	52.2	55.1	+2.9
Triglycerides	180	153***	−27	157	169	+12§§§

Notes: All values are given as the mean. Units are the same as those given in Table 2.

** P < 0.01;

*** P < 0.001 for the difference between baseline and 6-month values;

§§ P < 0.01;

§§§ P < 0.001 for the difference between Δ for responders and Δ for nonresponders.

Abbreviations: FBG, fasting blood glucose; HbA_1c, glycated hemoglobin; BMI, body mass index; LDL, low-density lipoprotein cholesterol; HDL, high-density lipoprotein cholesterol.