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Metabolic effects of Olanzapine versus Iloperidone: A 24 weeks randomized, prospective, interventional study.

INTRODUCTIONV

Psychosis is a symptom of mental illness characterized by distorted or non-existent sense of reality. Psychotic disorders have different etiologies, each of which demands a unique treatment approach. (1) The ICD-10, F20-F29 group of psychiatric disorders includes mental and behavioral disorders characterized by prominent disturbances of thought, perception, affect and behavior. The disorders in this section include schizophrenia, schizotypal disorder, persistent delusional disorders, acute and transient psychotic disorders, induced delusional disorder and schizoaffective disorders. (2)

Psychosis is primarily treated with antipsychotic drugs. Antipsychotic drugs are classified as typical and atypical agents. Atypical antipsychotic agents, in addition to their moderate potencies at dopamine receptors, interact with varying affinities at several other classes of receptors like alpha1 and alpha2 adrenergic, 5-HT1A, 5-HT2A, 5-HT2C, M and H1. (3) The clinically effective doses of atypical antipsychotics compared with typical antipsychotic exhibit markedly reduced extrapyramidal symptoms risk. (3) Atypical antipsychotics possess the advantage of treating negative symptoms. Yet there have been increased concerns over metabolic effects like weight gain, hyperglycemia, diabetes mellitus and lipid abnormalities. (3)

A comparative evaluation between olanzapine versus iloperidone has not been investigated thoroughly. A few studies have assessed the adverse effect profile of olanzapine with iloperidone, though not in an Indian population. The aims of the present study were to comparatively evaluate olanzapine (OLZ) which is a more commonly used antipsychotic for the treatment of psychosis with iloperidone (ILO) with regard to metabolic profile and assess whether there exists any major advantage of one drug over the other for the Indian population.

METHODOLOGY

A prospective, randomized, observational study of 6months duration (October 2013 to March 2014) was conducted to comparatively evaluate the metabolic safety profile of iloperidone versus olanzapine in the departments of pharmacology and psychiatry of Rohilkhand Medical College and Hospital, Bareilly, Uttar Pradesh. Approval for the study protocol was obtained from the institutional ethics committee. The CTRI registration number of the study is CTRI/2014/10/005144. Each subject signed an informed consent form and could withdraw without prejudice at any time. Patients 18-65 years and of both genders attending the psychiatry outpatient department during the study period diagnosed with psychosis falling under the group (F20-F29) as per ICD-10 criteria and prescribed monotherapy with olanzapine or iloperidone were eligible to participate in the study. The exclusion criteria included history of diabetes mellitus, severe cardiovascular disease, hepatic, renal or untreated thyroid disease, current medication such as antiepileptics (valproate or carbamazepine), antiparkinsonian agents (levodopa), birth control pills, steroids, propranolol and thiazide diuretics and agents that induce weight loss, pregnancy or breast-feeding and irregular compliance. A total of 62 patients (OLZ=31 and ILO=31) comprised the sample; of these two patients dropped out of the olanzapine group (n= 29) due to extrapyramidal side effects. All patients were allotted a reference number; the odd numbers were assigned to the olanzapine and even numbers to the iloperidone group. A predesigned, structured and pretested questionnaire was used to collect demographic information.

A complete clinical examination was conducted on all study subjects to rule out any chronic ailments referred to in the exclusion criteria. Data regarding age, sex, socio-economic status, family history, and other demographic parameters were recorded. For calculating BMI, the patient's height and weight were recorded. Blood pressure was measured using a standard protocol. Other relevant investigations were also performed. The patient's bodyweight (BW), body mass index BMI, fasting blood sugar (FBS) and lipid profile (TC, LDL, TG, HDL) was estimated at baseline and on each subsequent follow-up.

Flexible doses of both iloperidone (8-12 mg/day) and olanzapine (10-20mg/day) were administered. No other anti-psychiatric drug therapy was given during the study period though rescue medications like tablets/injections of lorazepam, tablet trihexyphenidyl, tablet clonazepam were administered for managing emergency and side effects, if any.

Patients were subsequently monitored and reassessed after one, three and six months with respect to alterations in biochemical parameters and adverse effects. Blood pressure was recorded to evaluate orthostatic hypotension. The consultant psychiatrist performed psychiatric evaluation of the patients during each visit.

Statistical analysis was performed using the software SPSS, Windows version 20. Mean values of change in BW, BMI, FBS and lipid profile at baseline and after one, three and six months were compared between two groups by using unpaired ttest and, in the groups, by paired t-test.

RESULT

Table 1 shows demographic characteristics. Out of 62 cases of psychosis (31 patients in each group), 45 (72.58%) were males and 17 (27.42%) females. M: F ratio is 2.65:1. The mean age in the olanzapine group was 29.4 [+ or -] 9.55 years and the mean age in iloperidone group was 30.81[+ or -] 11.62.

Fifty (80.64%) patients out of 62 cases belonged to rural areas whereas 12 (19.35%) were from urban areas (rural:urban ratio 4.17:1). Thirty-four patients (54.83%)were illiterate while 28 (45.16%) were literate. Thirty-two (51.61%) patients had low socioeconomic status while 30 (48.38%) belonged to the middle class.

Table 2 shows BW, BMI, FBS, TC, TG, LDL, and HDL levels after one, three and six months with olanzapine. All the parameters were significantly altered. There was statistically significant increase (p<0.0001) in BW (upto7kg), BMI (2.49 kg/[m.sup.2]), FBS (8.18 mg/dl), TC (9.86 mg/dl), TG (8.89 mg/dl) and LDL (5.48 mg/dl) after six months of therapy. HDL values were significantly decreased (p<0.05) after three and six months from baseline. Table 3 depicts a statistically significant rise in body weight (upto 1 kg) and BMI (0.43 kg/[m.sup.2]) overtime with iloperidone treatment (p<0.05 after 6 months). However, there were no significant alterations (p>0.05) between the baseline values and follow-up values of FBS, TC, LDL and HDL. Only TG showed a statistically significant decrease (p<0.05) after one, three and six months.

Table 4 shows the comparative values of BW and BMI between olanzapine and iloperidone in followups. The two groups were well matched at baseline (p>0.05). After one month, treatment bodyweight showed no significant change (p=0.1179). After three months, the olanzapine group showed a statistically significant increase in bodyweight (p=0.0109) and bodyweight recorded a further more significant rise (p=0.0006) after six months. In short, olanzapine showed an increase of approximately 7kg over six months compared to 1kg with iloperidone.

Regarding BMI, there was comparatively no significant changes after one month and three months of therapy (p=0.9581 and p=0.1115, respectively). However, after 6 months there was markedly significant increase in BMI with olanzapine as compared to iloperidone (p=0.0025).

Table 5 compares the alterations in FBS between olanzapine and iloperidone treated groups from baseline to one, three and six months. Both groups were comparable at baseline (p>0.05) and after 1 month (p>0.05). However after 3 months statistically marked significant increase in FBS (p = 0.0048, 88.72[+ or -]7.41 mg/dl in olanzapine group versus 83.77[+ or -]5.60 mg/dl in iloperidone) was noted, FBS after 6 months became statistically highly significant (p<0.0001, 92.90[+ or -]1.72 mg/dl in the olanzapine group versus 83.90[+ or -]5.34 mg/dl in the iloperidone group).

Table 6 shows comparative changes in lipid profile between olanzapine versus iloperidone. Statistically no significant difference in LDL and HDL levels (p>0.05) was noted. Though, TC and TG levels were comparable at baseline after one month and three months (p>0.05), yet the olanzapine group showed statistically significant increase in TC (150[+ or -] 24.68 mg/dl, p<0.05) and TG (134.41[+ or -] 16.66 mg/dl, P<0.05) after six months.

DISCUSSION

Workers in the field have documented that most atypical antipsychotic agents, except a few, cause significant rapid increase in bodyweight ranging from 2-14 kg which occurs within 12 weeks of treatment and is one of the important adverse effects leading to drop out from the study. (4-7) In the present study, a rapid markedly significant increase in bodyweight was noted with olanzapine, after one (p<0.0001) three (p<0.0001), and six months (p<0.0001) whereas iloperidone caused comparatively less increase in weight during similar periods. The mean change in weight from baseline to endpoint was 7kg with olanzapine compared to 1 kg with iloperidone.

Allison et al (8) and Conley et al (4) observed that olanzapine caused weight gain of 4.15 kg at 10 weeks from baseline and 3.26 kg at 8 weeks respectively. Similarly, in the CATIE trial, (5) patients taking olanzapine gained an average of 0.9kg/month and a greater proportion of these patients gained 7% or more of their body weight at 18 months. Besides, Ganguli et al (9), Garyfallos et al (10), Volavka et al (6), Bobes et al (7), Brier et al (11) also observed significant weight gain and BMI increase after treatment with olanzapine and risperidone. Atmaca et al (12) have also noted that olanzapine and clozapine caused marked increase in weight. In a meta-analysis of 48 studies, Rummel-Kluge et al (13) have noted that olanzapine produced more weight gain than all other second generation antipsychotic agents. The results of the present study with respect to olanzapine are in line with previous findings.

De Hert et al (14) in a meta-analysis observed statistically significant weight gain with iloperidone (p<0.001) greater than placebo. Cutler et al (15) in a 25-week clinical trial with iloperidone (12 mg BD) noted weight gain (9.2%). Weiden et al (16) observed that iloperidone caused a mild weight increase (1.5-2.1 kg) similar to risperidone (1.5kg). Hochfeld et al (17) in a meta-analysis of 3200 patients who were administered iloperidone noted an average weight gain of about 2kg following treatment for greater than one year and most weight gain occurred within first six weeks of the studies. Thus, the results of the present study are comparable with these studies for iloperidone and that weight gain has been noticed after 1month of therapy (p=0.0019).

The precise mechanism of weight gain due to atypical antipsychotics is not clearly understood and appears to be a multifactorial phenomenon involving basically effects on receptors and neuroendocrine pathways (hypothalamic neurotransmitters and neuropeptides). Serotonin enhances satiety by stimulating Proopiomelanocortin (POMC) secretion by an effect mediated by 5-HT2c receptors; antagonists of 5HT2c receptors prevent or delay the onset of satiety, thereby increasing the size of the meal. Histamine H1 receptor blockade activates hypothalamic AMP-activated protein kinase (AMPK), increasing appetite. Additionally, D2 receptor antagonism has also been implicated in antipsychotic associated weight gain. Further cells in the arcuate nucleus of the hypothalamus express neuropeptide Y (NPY) and Agouti-related protein (AgRP), two highlyorexigenic (appetite enhancing) peptides whose expression is increased by ghrelin and inhibited by leptin. (18)

In the present study we observed a highly significant increase in body mass index (BMI) after one, three and six months (p<0.0001) with olanzapine. In contrast iloperidone caused statistically significant increase in BMI only after three (p=0.0089) and six months (p=0.0229). Thus, comparatively iloperidone has shown a lower and delayed increase in BMI than olanzapine.

Allison et al (8) have noted that olanzapine also increased mean BMI by 1.1 kg/m (2) . Robinson et al (19) have noted that the estimate of adjusted mean of BMI increased from 24.3 (95%, CI= 22.8-22.7) at baseline to 28.2 (95%, CI= 26.7-29.7) at 4 months with olanzapine. Ingole et al (20) in a short term trial have similarly observed that bodyweight and BMI show significant increase from baseline with both olanzapine and risperidone. Besides, other workers in the field (6-12) also have observed that an increase in BMI occurred after treatment with olanzapine. Thus the findings in our study on BMI in respect to olanzapine are consistent with that of the above noted workers. Data pertaining to iloperidone are not available.

In our study mean FBS values with olanzapine have shown statistically significant rise in each follow-up and (p< 0.0001) after six months. While iloperidone showed no significant alterations in FBS even after 6 months, Lindenmayer et al (21) and Atmaca et al (12) noted that olanzapine produced more increase in glucose levels than risperidone, ziprasidone and aripiprazole. Ingole et al (21) observed that mean blood sugar significantly increased in a short term trial with olanzapine (p<0.0001). The results of the present study are in line with the above studies. Fuller et al (22) and Farewell et al (23) also demonstrated that after one year of therapy, olanzapine use was a significant predictor of developing new onset diabetes and that development of diabetes mellitus takes more than 15 months.

In Phase I of the CATIE trial (5), olanzapine was associated with a significant increase in mean HbA1c. Similar to weight gain, olanzapine and clozapine appear to have the greatest risk for diabetes. A significant association between olanzapine and diabetes mellitus and insulin resistance in olanzapine subjects has also been observed. (24-26)

De Hert et al (14) in a meta-analysis haveobserved significant changes in glucose levels during shortterm treatment with iloperidone (+ 6.90 mg/dl; 95% CI 2.4,11.8, p< 0.01). Hochfeld et al (17) observed fasting mean (SD) glucose changes with iloperidone 6.6 (24.0) from baseline to end of study, while Cutler et al (15) in a 25-week clinical trial with iloperidone noted that levels of serum glucose, lipids and prolactin were essentially unchanged or decreased during the treatment. Our observations in respect to FBS are in conformity with these authors.

Atypical antipsychotics have been shown to cause dyslipidemia (27-28) . These changes are largely related to concomitant weight gain; therefore, agents associated with the greatest weight gain may have the greatest propensity to cause dyslipidemia (28) . In our study, changes in lipid metabolism were observed in both olanzapine and iloperidone groups. Olanzapine significantly altered lipid parameters (TC, TG, LDL and HDL). TC levels significantly increased from baseline to endpoint (p<0.0001). Initially TG levels did not change till one month but rose significantly after three months (p<0.0001) and six months (p<0.0001). LDL values also increased significantly after each follow up. Cardioprotective HDL levels significantly decreased after three months (p<0.05) and six months (p<0.0001): these findings are similar to those of other workers who have also documented similar change in lipid metabolism with olanzapine. Lindenmayer et al (21) observed significant increase in mean TC at 14 weeks of 20.1mg/dl (p<0.002) in patients taking olanzapine. Atmaca et al (12) observed that olanzapine produced more changes in TC than risperidone, aripiprazole and ziprasidone besides there beinga marked increase in serum TG and leptin levels. Previous studies have documented a relation between atypical antipsychotics clozapine and olanzapine and serum leptin levels. Leptin has been associated with atypical antipsychotic induced weight gain. Besides, atypical antipsychotics especially clozapine and olanzapine are associated with higher risk of metabolic syndrome. (28)

Iloperidone however, showed no significant changes in TC, LDL, HDL levels from baseline to endpoint of therapy. An interesting result observed in this study was that TG levels were significantly decreased with iloperidone after one (P<0.05), three (P=0.001) and six months (P<0.05). Hochfeld et al (17) observed that non-fasting cholesterol showed decrease from baseline to time points after 4 weeks and neither short term nor long term treatment with iloperidone led to development of high or borderline high cholesterol in the overall study population. Fasting mean (SD) triglycerides changes were -0.83(82.3) mg/dl. Thus, iloperidone showed small changes in lipids that are unlikely to be of clinical concern. A decrease in TG levels is in line with our observations.

Limitations of the present study include the following: First, as the duration of the present study was relatively short, it was not possible to elicit further changes in bodyweight, BMI, glucose levels and lipid profile. Second, the number of patients included was small.

CONCLUSION

Comparative data are still too sparse to evaluate the metabolic safety profile of the two drugs used. Thus, there is a clear need for further controlled studies to comparatively evaluate which of the two agents is less problematic for short term safety and tolerability for treatment, with respect to weight gain and metabolic disturbances. Our study supports the safety and tolerability of iloperidone over olanzapine for the treatment of psychosis.

REFERENCES

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(14.) DeHert M, Yu W, Detraux J, Sweers K, et al. Body weight and metabolic adverse effects of asenapine, iloperidone, lurasidone and paliperidone in the treatment of schizophrenia and bipolar disorder: a systematic review and exploratory meta-analysis. CNS drugs. 2012;26(9):733-59.

(15.) Cutler AJ, Kalali AH, Mattingly GW, Kunovac J, et al.Long-term safety and tolerability of iloperidone: results from a 25-week, open-label extension trial. CNS Spectr. 2013;18(1):43-54.

(16.) Weiden PJ, Cutler AJ, Polymeropoulous MH, Wolfgang CD. Safety profile of iloperidone: a pooled analysis of 6-week acute phase pivotal trials. J Clin Psychopharmacol. 2008;28(2):12-9.

(17.) Hochfeld M, Ahmed S, Meng X, Winseck A. Changes in weight and metabolic parameters following long term iloperidone use: a metaanalysis of data from 9 phase II and III trials of iloperidone. Open J Psychiatry. 2012;2:414-22.

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(20.) Ingole S, Belorkar NR, Waradkar P, Shrivastava M. Comparison of effects of olanzapine and risperidone on body mass index and blood sugar level in schizophrenic patients.Indian J Physiol Pharmacol. 2009;53(1):47-54.

(21.) Lindenmayer JP, Czobor P, Volavka J, Citrome L, et al, Changes in glucose and cholesterol levels in patients with schizophrenia treated with typical or atypical antipsychotics. Am J Psychiatry. 2003;160(2):290-6.

(22.) Fuller MA, Shermock KM, Secic M, Grogg AL. Comparative study of development of diabetes mellitus in patients taking risperidone and olanzapine. Pharmacotherapy. 2003;23(8): 1037-43.

(23.) Farewell WR, Stump TE, Wang J, Tafesse E, et al. Weight gain and new onset diabetes associated with olanzapine and risperidone. J Gen Intern Med. 2004;19:1200-5.

(24.) Sernyak MJ, Leslie DL, Alarcon RD, Losonezy MF, et al. An association of diabetes mellitus with use of atypical neuroleptics in the treatment of schizophrenia. Am J Psychiatry. 2002;159:561-6.

(25.) Henderson DC, Copeland PM, Borba CP, Daley TB, et al. Glucose metabolism in patients with schizophrenia treated with olanzapine or quetiapine: a frequently sampled intravenous glucose tolerance test and minimal model analysis. J Clin Psychiatry. 2006;67(5):789-97.

(26.) Chaggar PS, Shaw SM, Williams SG. Effect of antipsychotic medications on glucose and lipid levels. J Clin Pharmacol. 2011;51(5):631-8.

(27.) Kroeze WK, Hufeisen SJ, Popadak BA, Renock SM, et al. H1- Histamine receptor affinity predicts short-term weight gain for typical and atypical antipsychotic drugs. Neuropsychopharmacol. 2012;28:519-26.

(28.) Chadda RK, Ramshankar P, Deb KS, Sood M. Metabolic syndrome in schizophrenia: differences between antipsychotic-naive and treated patients. J Pharmacol Pharmacother. 2013;4:176-86.

Shivangna Singh, Shalini Chandra, A K Kapoor ([PSI]), H K Singh, Rohit Kant

Rohilkhand Medical College and Hospital, Bareilly, Uttar Pradesh, India

(Received 12 September 2015 and accepted 22 November 2015)

([PSI]) Correspondence at: Department of

Pharmacology, Rohilkhand Medical College and Hospital, Bareilly 243006, Uttar Pradesh, India; Mobile: +919415373166; Email:

drakkapoor@rediffmail.com

DOI: http://dx.doi.org/10.4314/ijmu.v11i2.5
Table 1:Distribution of demographic parameters

S.N.  PARAMETERS            OLZ                  ILO

1     Male                  24                   21
2     Female                 7                   10
3     Mean age [+ or -] SD  29.42 [+ or -] 9.55  30.81 [+ or -] 11.62

4     Rural                 25                   25
5     Urban                  6                    6
6     Literate              13                   15
7     Illiterate            18                   16
8     Low Socio-economic    15                   17
      status
9     Middle Class          16                   14

S.N.  TOTAL NO.             Test           P-Value
      (%)                   Value

1     45 (72.58%)           [X.sup.2] =    0.3930
2     17 (27.41%)            0.7294
3     30.11 [+ or -] 10.57  t =
                             0.5145        0.6088
4     50 (80.64%)           [X.sup.2] = 0  1
5     12 (19.35%)
6     28 (45.16%)           [X.sup.2] =    0.6097
7     32 (51.61%)            0.2605
8     32 (51.61%)           [X.sup.2] =
                             0.2583        0.6112
9     30 (48.38%)

OLZ - Olanzapine; ILO - Iloperidone; p> 0.05 = not significant

Table 2:Effect of olanzapine on BW, BMI, FBS and lipid profile

                Baseline          1 month              t       p
Parameters      Mean[+ or -]S.D.  Mean [+ or -]        value   value
                                  S.D.

Bodyweight       55.17 [+ or -]    57.03               6.0293  <
(kg)              6.12             [+ or -]7.09                0.0001
BMI              20.80 [+ or -]    21.4 [+ or -] 1.57  4.5556  <
(kg/[m.sup.2])    1.20                                         0.0001
FBS              84.72             85.83[+ or -]5.84   3.016   =
(mg/dl)         [+ or -]6.11                                   0.0054
TC              140.9 [+ or -]    142.03[+ or -]       2.491   =
(mg/dl)          22.53             23.24                       0.0169
TG              125.52            126.07[+ or -]       1.978   =
(mg/dl)         [+ or -]14.10      14.74                       0.0576
LDL              95.69 [+ or -]    96.97 [+ or -]      2.3593  =
(mg/dl)          16.88             17.44                       0.0162
HDL              45.86             45.62 [+ or -]      0.8262  =
(mg/dl)         [+ or -]4.94        5.32                       0.4157

                3 months         t                6 months
Parameters      Mean             value   p value  Mean[+ or -]S.D.
                [+ or -] S.D.

Bodyweight       59.10           9.3392  <         62.10
(kg)            [+ or -]7.60              0.0001   [+ or -]6.12
BMI              22.17           8.7066  <0.0001   23.29 [+ or -]
(kg/[m.sup.2])  [+ or -]1.76                        2.37
FBS              88.72           4.7742  <         92.90 [+ or -]
(mg/dl)         [+ or -]7.41              0.0001    9.24
TC              146.17           6.1592  <        150.76[+ or -]
(mg/dl)         [+ or -] 23.93            0.0001   24.68
TG              130.93           6.2718  <        134.41[+ or -]
(mg/dl)         [+ or -] 15.68            0.0001   16.66
LDL              99.07 [+ or -]  5.7463  <        101.17 [+ or -]
(mg/dl)          17.94                    0.0001   18.02
HDL              44.83           3.198   =         43.76[+ or -]5.49
(mg/dl)         [+ or -]5.16              0.0034

                t       p
Parameters      value   value

Bodyweight      9.7084  <
(kg)                    0.0001
BMI             9.0664  <
(kg/[m.sup.2])          0.0001
FBS             6.296   <
(mg/dl)                 0.0001
TC              6.9195  <
(mg/dl)                 0.0001
TG              7.8434  <
(mg/dl)                 0.0001
LDL             6.8829  <
(mg/dl)                 0.0001
HDL             4.9155  <
(mg/dl)                 0.0001

p< 0.05 = significant; p> 0.05 = not significant

Table 3:Effect of iloperidone on BW, BMI, FBS and lipid profile

             Baseline                1 month                   p
Parameters   Mean [+ or -]           Mean             t value  value
             S.D.                    [+ or -]S.D.

Bodyweight           54.13 [+ or -]   54.58 [+ or -]           =
(kg)                  5.08             5.27           2.4762   0.0019
                                                               1
BMI (kg/m )          21.19 [+ or -]   21.42           1.9757   =
                      1.29           [+ or -]1.44              0.0575
                     83.74 [+ or -]   83.87                    =
FBS (mg/dl)           5.74           [+ or -]5.41     0.7247   0.4743
TC                  138.35[+ or -]   138.13[+ or -]2  0.8787   =
(mg/dl)              22.45             2.47                    0.3866
TG                  125.52           124.72 [+ or -]  2.7864   =
(mg/dl)      [+ or -]13.81            13.68                    0.0092
LDL (mg/dl)          92.23            95.16           0.2732   =
             [+ or -]16.65           [+ or -]16.45             0.7866
HDL                  43.74            43.61[+ or -]   0.8915   =
(mg/dl)       [+ or -]4.26             4.06                    0.3798

             3
Parameters   months                   t value  p value
             Mean [+ or -]
             S.D.

Bodyweight           54.58                     =
(kg)          [+ or -]5.61            1.7259   0.0947

BMI (kg/m )          21.48 [+ or -]   1.7585   =
                      1.58                     0.0089
                     83.77                     =
FBS (mg/dl)   [+ or -]5.60            0.1576   0.8758
TC                  138.23[+ or -]    0.4027   =
(mg/dl)              21.37                     0.6900
TG                  124.32            3.6612   =
(mg/dl)      [+ or -]13.76                     0.0010
LDL (mg/dl)          95.32[+ or -]1   0.4414   =
                      6.07                     0.6621
HDL                  43.87[+ or -]3.  0.5967   =
(mg/dl)              95                        0.5552

             6                                p
Parameters   months                  t value  value
             Mean

             [+ or -]S.D.
Bodyweight           55.00 [+ or -]           =
(kg)                  5.08           2.6366   0.0131

BMI (kg/m )          21.62 [+ or -]  2.398    =
                      1.67                    0.0229
                     83.90 [+ or -]           =
FBS (mg/dl)           5.34           0.6139   0.5439
TC                  138.16           0.733    =
(mg/dl)      [+ or -]21.98                    0.4692
TG                  124.84           2.2437   =
(mg/dl)      [+ or -]13.52                    0.0324
LDL (mg/dl)          95.19           0.1121   =
             [+ or -]15.68                    0.9115
HDL                  43.81 [+ or -]  0.2632   =
(mg/dl)               3.81                    0.3794

p< 0.05 = significant; p> 0.05 = not significant

Table 4:Comparative evaluation of olanzapine and iloperidone on body
weight and BMI

                    WEIGHT (kg)
OLZ (Mean           ILO(Mean [+ or -]    t       p

[+ or -]S.D.)       S.D.)                value   value
Baseline            Baseline                     =
55.17[+ or -] 6.12  54.12[+ or -] 5.08   0.7199  0.4745
1 month             1 month              1.587   =
57.03 [+ or -]7.09  54.48 [+ or -]5.27           0.1179
3 months            3 months             2.6319  =
59.10 [+ or -]7.60  54.58 [+ or -] 5.61          0.0109
6 months            6 months             3.6133  =
62.10 [+ or -]9.07  55.00 [+ or -]5.92           0.0006

                    BODY MASS INDEX (kg/[m.sup.2])
OLZ (Mean           OLZ (Mean [+ or -]   ILO(Mean [+ or -]
[+ or -]S.D.)       S.D.)                S.D.)

Baseline            Baseline             Baseline
55.17[+ or -] 6.12  20.80 [+ or -]1.20   21.19 [+ or -] 1.29
1 month             1 month              1 month
57.03 [+ or -]7.09  21.40 [+ or -]1.57   21.42 [+ or -]1.44
3 months            3 months             3 m onths
59.10 [+ or -]7.60  22.17 [+ or -] 1.76  21.48 [+ or -] 1.58
6 months            6 month              6 months 21.62
62.10 [+ or -]9.07  23.29 [+ or -] 2.37  [+ or -]1.67

OLZ (Mean           t value  p value
[+ or -]S.D.)

Baseline                     =
55.17[+ or -] 6.12  1.1966   0.2363
1 month             0.0527   =
57.03 [+ or -]7.09           0.9581
3 months            1.6163   =
59.10 [+ or -]7.60           0.1115
6 months            3.1646   =
62.10 [+ or -]9.07           0.0025

p< 0.05 = significant; p> 0.05 = not significant

Table 5:Comparative effects of olanzapine and iloperidone on fasting
blood sugar

                        FASTING BLOOD SUGAR (mg/dl)
OLZ (Mean [+ or -] S.D.)  ILO (Mean [+ or -] S.D.)  t - Value  p value

Baseline                  Baseline
84.72[+ or -] 6.11        83.74[+ or -] 5.74        0.6424     = 0.5232
1 month                   1 month                   1.3463     = 0.1835
85.83 [+ or -] 5.84       83.87 [+ or -] 5.41
3 months 88.72            3 months                  2.9318     = 0.0048
[+ or -]7.41              83.77 [+ or -] 5.60
6 months                  6 months
92.90 [+ or -]1.72        83.90 [+ or -]5.34        4.6438     < 0.0001

p< 0.05 = significant; p> 0.05 = not significant

Table 6:Comparative evaluation of lipid profile with olanzapine and
iloperidone

                       TOTAL CHOLESTEROL (mg/dl)
OLZ (Mean [+ or -]     ILO (Mean [+ or -]     t value  p value
S.D.)                  S.D.)
Baseline               Baseline               0.4369   =
140.9[+ or -]22.53     138.35[+ or -]22.45             0.6638
1 month                1 month                0.6617   =
142.03 [+ or -] 23.24  138.13 [+ or -]22.47            0.5108
3 months               3 months               1.3585   =
146.17 [+ or -] 23.93  138.23 [+ or -] 21.37           0.1796
6 months               6 months               2.0908   =
150.76 [+ or -] 24.68  138.16 [+ or -] 21.98           0.0409
                     TRIGLYCERIDES (mg/dl)
Baseline               Baseline               0.0003   =
125.52[+ or -] 14.10   125.52[+ or -] 13.81            0.9998
1 month                1 month                0.353    =
126.07 [+ or -] 14.74  124.72 [+ or -] 13.68           0.7254
3 months               3 months               1.7381   =
130.93 [+ or -] 15.68  124.32 [+ or -] 13.76           0.0875
6 months               6 months               2.4515   =
134.41 [+ or -]16.66   124.84 [+ or -] 13.52           0.0173

TOTAL CHOLESTEROL (mg/dl)  LOW DENSITY LIPOPROTEIN (mg/dl)
OLZ (Mean [+ or -]         OLZ (Mean              ILO (Mean [+ or -]
S.D.)                      [+ or -]S.D.)          S.D.)
Baseline                   Baseline               Baseline
140.9[+ or -]22.53          95.69 [+ or -] 16.88  92.23 [+ or -] 16.65
1 month                    1 month                1 month
142.03 [+ or -] 23.24       96.97 [+ or -] 17.44  95.16 [+ or -]16.45
3 months                   3 months               3 months
146.17 [+ or -] 23.93       99.07 [+ or -] 17.94  95.32 [+ or -] 16.07
6 months                   6 months               6 months
150.76 [+ or -] 24.68      101.17 [+ or -] 18.02  95.19 [+ or -] 15.68
TRIGLYCERIDES (mg/dl)      HIGH DENSITY LIPOPROTEIN (mg/dl)
Baseline                   Baseline              Baseline
125.52[+ or -] 14.10        45.86 [+ or -]4.94   43.74 [+ or -] 4.26
1 month                    1 month               1 month
126.07 [+ or -] 14.74       45.62 [+ or -] 5.32  43.61 [+ or -] 4.06
3 months                   3 months              3 month
130.93 [+ or -] 15.68       44.83 [+ or -] 5.16  43.87 [+ or -] 3.95
6 months                   6 months              6 months
134.41 [+ or -]16.66        43.76 [+ or -] 5.49  43.81 [+ or -] 4.37

TOTAL CHOLESTEROL (mg/dl)
OLZ (Mean [+ or -]     t Value  p value

S.D.)
Baseline               0.1071   = 0.9151
140.9[+ or -]22.53
1 month                0.4049   = 0.6870
142.03 [+ or -] 23.24
3 months               0.8531   = 0.3971
146.17 [+ or -] 23.93
6 months               1.3737   = 0.1748
150.76 [+ or -] 24.68
TRIGLYCERIDES (mg/dl)
Baseline               1.784   = 0.0797
125.52[+ or -] 14.10   0
1 month                1.6491  = 0.1045
126.07 [+ or -] 14.74
3 months               0.8102  = 0.4212
130.93 [+ or -] 15.68
6 months               0.0394  = 0.9687
134.41 [+ or -]16.66

p< 0.05 = significant; p> 0.05 = not significant
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Title Annotation:Original Work
Author:Singh, Shivangna; Chandra, Shalini; Kapoor, A.K.; Singh, H.K.; Kant, Rohit
Publication:Internet Journal of Medical Update
Article Type:Clinical report
Geographic Code:9INDI
Date:Jul 1, 2016
Words:5353
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