Effect of rosuvastatin on diabetic polyneuropathy: a randomized, double-blind, placebo-controlled Phase IIa study

Figures & data

Table 1 Treatment of diabetes mellitus

	Rosuvastatin (n=17)		Placebo (n=17)		P-value
Sex
Male	3	17.6%	2	11.8%	0.628
Female	14	82.4%	15	88.2%
Diabetes treatment
Glyburide	1	5.9%	6	35.3%	0.085
Metformin	0	0.0%	2	11.8%
Glyburide + metformin	7	41.2%	5	29.4%
Insulin	1	5.9%	1	5.9%
Insulin + other oral antidiabetic agents	8	47.1%	3	17.6%
Symptomatic treatment
Anti-inflammatory drugs	0	0.0%	2	11.8%	0.15
None	17	100%	15	88.2%

Notes: More women than men were included in the study; 47.1% of patients were managed with insulin and oral hypoglycemic agents, followed by glyburide + metformin. The selection of patients in both groups showed homogeneity.

Table 2 Stage, type, and degree of diabetic neuropathy

	Rosuvastatin (n=17) (%)		P-value	Placebo (n=17) (%)		P-value
	Baseline	Final		Baseline	Final
Stage
1b	0.0	41.2	0.03	0.0	11.8	0.2
2a	88.2	52.9		64.7	70.6
2b	11.8	5.9		35.3	17.6
Type
Motor	11.8	23.5	0.1	5.9	17.6	0.3
Sensory	0.0	0.0		0.0	0.0
Mixed	88.2	76.5		94.1	83.4
Degree
Mild	52.9	70.6	0.04	64.7	70.6	0.7
Moderate	41.2	17.6		29.4	23.5
Severe	5.9	11.8		5.9	5.9

Notes: Patients with diabetic neuropathy treated with rosuvastatin showed a significant improvement in stage and degree of diabetic neuropathy; in the placebo group, there was no significant change in stage, type, or degree of diabetic neuropathy. The values in bold are statistically significant.

Table 3 Nerve conduction studies

Nerves	Rosuvastatin (n=17)		P-value	Placebo (n=17)		P-value
	Baseline	Final		Baseline	Final
Leg
Amplitude (μV)	14.0±9.7	15.6±5.8	0.1	19.8±8.8	19.4±13.3	0.9
Latency (msec)	2.9±0.6	3.0±0.5	0.6	3.1±0.4	3.3±0.7	0.7
Peroneal
Ankle width (mV)	4.1±2.2	3.8±2.1	0.9	3.3±2.1	3.5±2.3	0.8
Amplitude at fibula (mV)	3.2±1.9	4.1±2.4	0.8	3.6±2.3	4.0±2.0	0.2
Conduction velocity (m/sec)	40.8±2.2	42.1±1.6	0.03	41.2±4.4	41.9±4.5	0.5
Tibial
Amplitude ankle (mV)	5.3±3.3	6.9±5.3	0.4	7.5±5.1	8.5±4.6	0.7
Amplitude in popliteal fossa (mV)	3.4±2.4	4.8±4.4	0.08	5.7±4.8	6.4±3.9	0.2
Conduction velocity (m/sec)	41.8±5.7	43.1±5.9	0.5	40.4±4.2	41.0±4.6	0.2
F-wave latency (msec)	48.2±6.5	49.0±7.7	0.5	47.8±4.9	47.6±5.4	0.9
Arm
Median
Amplitude on wrist (μV)	23.6±9.2	24.5±8.5	0.5	25.5±17.3	30.5±17.7	0.3
Elbow breadth (μV)	14.4±7.2	12.5±6.4	0.4	16.2±9.1	16.4±10.7	0.8
Conduction velocity (m/sec)	49.3±5.2	50.1±4.4	0.08	51.2±4.5	50.4±7.5	0.6
Ulnar
Amplitude on wrist (mV)	8.1±2.7	8.0±2.2	0.8	8.2±2.4	8.7±2.6	0.4
Amplitude below the elbow (mV)	7.4±4.2	6.6±2.2	0.7	6.9±2.5	7.1±2.7	0.7
Amplitude above the elbow (mV)	7.2±5.3	6.6±1.9	0.5	6.7±2.0	7.0±2.4	0.6
Amplitude of armpit (mV)	7.8±1.6	7.0±3.3	0.1	7.3±4.1	6.8±3.0	0.7
Supraclavicular amplitude (mV)	6.5±2.5	5.7±2.0	0.5	5.9±2.6	6.3±1.7	0.5
Velocity below the wrist (m/sec)	48.9±6.2	51.2±6.2	0.3	49.5±6.5	50.0±6.6	0.9
Velocity below and above the elbow (m/sec)	50.6±8.5	48.9±11.6	0.3	50.4±6.1	50.0±9.2	0.2
Velocity above the elbow-armpit (m/sec)	50.4±2.7	51.6±7.0	0.5	50.8±6.5	51.9±6.1	0.5
Supraclavicular velocity axillary fossa (m/sec)	54.5±9.1	53.6±5.7	0.5	52.1±8.9	51.7±4.7	0.4
F-wave latency (msec)	26.5±1.7	26.3±2.1	0.9	26.9±3.2	27.0±3.5	0.7

Notes: There was a significant increase in conduction velocity of the peroneal nerve in the rosuvastatin group and a tendency towards significance in amplitude of the tibial nerve in the popliteal fossa and conduction velocity of the median nerve (P<0.08). There was no significant difference between baseline and final nerve conduction studies in the control group. The bold P-value indicates statistical significance.

Table 4 Lipid and hepatic profile

	Rosuvastatin (n=17)	Placebo (n=17)	P-value	Rosuvastatin (n=17)	Placebo (n=17)	P-value
	Baseline	Baseline		Final	Final
Lipid profile
Total cholesterol (mg/dL)	213.1±49.8	219.1±25.9	0.5	152.2±36.9	211.7±26.0	0.001
LDL cholesterol (mg/dL)	124.4±44.1	132.1±26.2	0.5	69.1±28.9	134.7±29.4	0.001
HDL cholesterol (mg/dL)	46.6±10.6	48.4±8.9	0.4	45.8±11.5	45.3±8.0	0.8
Triglycerides (mg/dL)	210.4±108.5	192.4±88.7	0.7	166.6±71.3	156.1±73.8	0.7
Hepatic profile
GGT (U/L)	44.2±29.4	57.4±44.2	0.2	58.7±70.4	43.4±35.9	0.5
Total bilirubin (U/L)	0.6±0.3	0.6±0.2	0.9	0.7±0.3	0.7±0.2	0.6
Direct bilirubin (U/L)	0.2±0.2	0.2±0.1	0.8	0.2±0.1	0.2±0.1	0.5
Indirect bilirubin (U/L)	0.4±0.2	0.4±0.2	0.8	0.5±0.2	0.5±0.2	0.7
Albumin (U/L)	4.1±0.3	3.8±0.3	0.1	4.7±0.6	3.9±0.4	0.1
ALT (U/L)	23.4±8.3	20.9±9.1	0.4	22.7±7.7	20.6±9.6	0.4
AST (U/L)	20.0±9.2	21.2±6.1	0.5	22.8±8.9	19.6±7.6	0.3
Alkaline phosphatase (U/L)	96.9±23.9	115.3±39.4	0.3	82.6±14.2	98.1±45.6	0.5

Notes: As expected, we found a significant decrease in total cholesterol and low-density lipoprotein cholesterol. There was no significant increase in liver enzymes, which supports the fact that rosuvastatin is a safe drug with few adverse events. The values in bold are statistically significant.

Abbreviations: ALT, alanine transaminase; AST, aspartate transaminase; GGT, gamma-glutamyl transferase; HDL, high-density lipoprotein; LDL, low-density lipoprotein.