Factors influencing treatment decisions in patients with pulmonary arterial hypertension

Abstract

Background

A large proportion of patients with pulmonary arterial hypertension (PAH) is treated with monotherapy although current treatment guidelines emphasize the importance of combination therapies to achieve the treatment goals. Because the reasons for physicians’ treatment decisions in routine clinical practice are not well understood, factors influencing these decisions were investigated.

Methods

In this multicentre, non-interventional study, 79 patients who started PAH therapy ≤12 months prior to study inclusion were enrolled. Data available per routine clinical practice were collected. Furthermore, physician’s rationale for treatment decision was assessed. All analyses were descriptive.

Results

Patients’ mean age was 64 years. Most patients were female (57.0%) with idiopathic PAH (76.0%) and had ≥5 comorbidities (64.6%). At therapy start the significant reasons for choosing combination therapy or monotherapy were patient’s risk (81.5%; Odds ratio, OR: 12.38, p=0.0227) and comorbidity status (56.7%; OR: 0.07, p=0.0004), respectively. The proportion of patients receiving combination therapy increased from 45.6% at therapy start to 78.4% at month 24. Concomitantly, the percentage of low-risk patients increased from 14.5% to 35.1%. A significant greater percentage of patients on initial combination therapy achieved an improvement of World Health Organization functional class (85.2% and 50.0%, respectively; OR: 5.75, p=0.0357) between therapy start and end of observation. A low-risk status was achieved by 27.3% and 50.0% of patients on monotherapy and combination therapy, respectively.

Discussion

Risk and comorbidity status are the key factors for physicians’ choice of treatment regimen. Findings from the study suggest that patients on initial combination therapy could potentially improve their clinical status more effectively, even when they have comorbidities.

Introduction

Pulmonary arterial hypertension (PAH) is a rare, progressive and chronic disease defined by high blood pressure in the arteries of the lung ¹ . It is characterized by pathologic vascular remodelling leading to right heart failure and death ² . Up to now 6 classes of drugs are approved for targeted PAH treatment which are used in monotherapy or in combination therapy. However, despite treatment advances PAH is still an incurable disease with a 5-year survival of about 50% ³ .

Assessment of patient’s risk status has become an essential tool to guide PAH treatment decisions at time of diagnosis and follow-up ^{2 4} . Several validated risk assessment tools such as the Comparative, Prospective Registry of Newly Initiated Therapies for Pulmonary Hypertension (COMPERA) method ⁵ , the French pulmonary hypertension registry method (French methodology) ⁶ , and the Registry to Evaluate Early and Long-term Pulmonary Arterial Hypertension Disease Management (REVEAL) method have been established ⁷ . Using these tools, patients are classified as having a low-, intermediate-, or high-risk status corresponding to estimated 1-year mortality rates of <5%, 5–20%, and >20%, respectively ¹ .

Although current treatment guidelines emphasize the importance of upfront combination therapies to reach the treatment goal of achieving and maintaining a low-risk status ^{1 8} , real-world data reveal that around 50% of patients is permanently treated with monotherapy ⁹ . In contrast to former knowledge about PAH which was considered to predominantly be a disease of younger people ¹⁰ , registry data also show that idiopathic PAH is contemporary more frequently diagnosed in elderly patients (>60 years) who often display multiple comorbidities ^{2 3 9 11 12 13} . As those patients are often excluded from clinical trials data on these patients are lacking ^{14 15} . Hence, real-world data from observational studies could help to close this gap of knowledge and give further insights into reasons for physicians’ treatment decision in routine clinical practice and the role of combination therapies in elderly comorbid patients ¹ . Therefore, the main objective of this non-interventional study was to assess factors influencing physician’s choice of treatment regimen (monotherapy vs. combination therapy) and associated implications on clinical outcome parameters in PAH patients in routine clinical practice in Germany.

Material and Methods

Study subjects

Incident (patients who started initial therapy ≤3 months before study inclusion) and prevalent (patients who started initial therapy >3 and ≤12 months before study inclusion) patients (≥18 years) with confirmed diagnosis of PAH (independent of aetiology) were eligible for this study. Patients who were vaso-reactive, had other forms of pulmonary hypertension than PAH, or were listed for lung transplantation were excluded. In addition, patients who were currently participating in an investigational study or for whom participation was planned, as well as patients with (limited) legal incapacity, were also excluded. The study was approved by the ethics committee of the Hannover Medical School and written informed consent was obtained from all patients.

Study design

This was a national, multicentre non-interventional study conducted between February 2021 and December 2023 in Germany – Pathway study ( Figure S1 ). The main objective of this study was to assess the reasons for physicians´ choice of treatment regimen (monotherapy vs. combination therapy) and associated implications on clinical outcome parameters and patient’s health-related quality of life (HQoL) in PAH patients in routine clinical practice. In total 17 active sites ( Table S1 ), specialized for care of patients with pulmonary hypertension, participated in this study. No formal sample size calculation was performed since this was an exploratory study.

Methods

Enrolled patients were documented prospectively for a maximum of 30 months or until withdrawal of consent, lost to follow-up, planned or performed lung transplantation, or death whatever occurred first. All assessments and treatment decisions including prescribed drugs and (change of) treatment regimen (monotherapy or combination therapy) were at the discretion of the treating physician. Only data available per routine clinical practice were collected in 3–6 monthly intervals, if applicable. The investigators were asked to complete a special designed questionnaire addressing the rationale for treatment decision (Supplementary methods). In addition, patient’s HQoL was assessed using the PAH specific emPHasis-10 questionnaire ¹⁶ .

Analysis

All statistical analyses were descriptive and were performed using SAS statistical software (version 9.4 or higher). Categorical data are presented as numbers and percentages, and continuous data are given as mean ± standard deviation. Missing data were not replaced. Details of main outcome measures are provided in the supplementary methods. Impact of different factors on physician’s treatment decision were analysed by univariate logistic regression analysis for the dependent variable physician’s treatment decision (monotherapy vs. combination therapy) in patients without change of treatment regimen between start of therapy and month 6. For clinical outcome parameters (risk status improvement (yes/no), World Health Organization functional class (WHO-FC) improvement (yes/no), hospitalisation due to PAH (yes/no), and clinical worsening (yes/no)) univariate logistic regression analyses were performed in patients without change of treatment regimen between start of therapy and end of observation.

The following analysis sets were defined: The full analysis set (FAS) comprised all patients with at least one evaluable post baseline risk assessment and documented treatment regime. The primary endpoint analysis set (PES) comprised all patients, with an available risk assessment and a completed investigator’s questionnaires at start of therapy and 6 months thereafter. All primary endpoint analyses were performed using the PES and all secondary analyses were performed using the FAS.

Results

Patient disposition and baseline characteristics

A flow diagram showing patient disposition is depicted in Fig. 1 . Of 91 screened patients 9 patients (9.9%) interfere with at least one inclusion criterion resulting in 82 (90.1%) enrolled patients. Of these patients, 3 patients had no baseline visit so that 79 (86.8%) patients were included in the FAS. For 22 patients (24.2%) no investigator questionnaire or risk assessment was completed at therapy start or at month 6 resulting in 57 patients (62.7%) in the primary endpoint analysis set (PES).

Fig. 1.

Flow diagram of patient disposition. FAS: full analysis set, IC: inclusion criterion; PES: primary endpoint analysis set.

A larger proportion of patients were female (57.0%). The mean age of the entire study population was 64 ± 16 years. Initially, many patients (76.0%) were diagnosed with idiopathic PAH, followed by PAH associated with connective tissue disease (13.9%). Most patients (>90%) had at least one comorbidity and about 2/3 of patients had ≥5 comorbidities, mainly hypertension, atrial fibrillation, and chronic obstructive pulmonary disease. There were 43.0% former smoker and 7.6% current smoker in the patient group. Detailed patients’ demographics and clinical characteristics are summarized in Table 1 .

Table 1 Patient disposition, as well as demographic and clinical characteristics.

Disposition	n (%)
# relevant PAH therapies taken since initial diagnosis. CHD, congenital heart disease, CTD, connective tissue disease; HIV, human immunodeficiency virus; SD, standard deviation.
Number of enrolled patients	82 (100.0)
Prevalent patients	39 (47.6)
Incident patients	43 (52.4)
Early study termination	30 (36.3)
Premature discontinuation	2 (2.4)
Withdrawal of informed consent	8 (9.8)
Death	12 (14.6)
Lost to follow-up	7 (8.5)
Other	1 (1.2)
Demographic and clinical data (FAS)
Female	45 (57.0)
Age , mean (±SD) [years]	64.3 (15.8)
BMI , mean (±SD) [kg/m²]	28.1 (6.6)
PAH diagnosis
Idiopathic PAH	60 (76.0)
Drug/Toxin abuse induced PAH	3 (3.8)
PAH associated with CTD	11 (13.9)
PAH associated with HIV	1 (1.3)
PAH associated with portal hypertension	2 (2.5)
PAH associated with CHD	2 (2.5)
Smoking status
Never	34 (43.0)
Former	34 (43.0)
Current	6 (7.6)
Comorbidities
no Comorbidities	2 (2.5)
1–2 Comorbidities	8 (10.1)
3–4 Comorbidities	15 (19.0)
≥5 Comorbidities	51 (64.6)
Treatment regimen (FAS) #
Monotherapy
Tadalafil	20 (25.3)
Sildenafil	15 (19.0)
Macitentan	11 (13.9)
Riociguat	4 (5.1)
Combination therapy
Macitentan + Tadalafil	38 (48.1)
Macitentan + Sildenafil	16 (20.3)
Ambrisentan + Tadalafil	7 (8.9)
Ambrisentan + Sildenafil	2 (2.5)
Macitentan + Riociguat	2 (2.5)
Macitentan + Tadalafil+Selexipag	8 (10.1)
Macitentan + Sildenafil+Selexipag	3 (3.8)
Macitentan + Tadalafil+ Epoprostenol or Iloprost	3 (3.8)
Other	8 (10.2)

Primary endpoints

At start of therapy and at months 6 most patients in the primary endpoint analysis set (PES) had an intermediate-risk status (61.4 % and 57.9 %, respectively). The percentage of patients with low-risk status increased from 14.0% at start of therapy to 28.1% at month 6 ( Fig. 2 a). Regarding patients without change of treatment regimen between start of therapy and month 6, 33.3% of patients on initial combination therapy but no patient on initial monotherapy achieved a low-risk status during the first 6 months ( Figure S2 ).

Fig. 2.

Risk status ( a ) and method of risk assessment ( b ) at start of therapy and at month 6 (PES). #Multiple answers possible. COMPERA: Comparative, Prospective Registry of Newly Initiated Therapies for Pulmonary Hypertension; FM: French methodology; POCJ: Physician’s own clinical judgement; REVEAL: Registry to Evaluate Early and Long-term Pulmonary Arterial Hypertension Disease Management.

The COMPERA method was the most common method to assess patient’s risk status at start of therapy (64.9%) and at month 6 (56.1%). However, at both time points for more than 20% of patients no validated risk assessment tool was used, and the risk status was assessed according to physician’s own clinical judgement ( Fig. 2 b).

Regarding therapy regimen, most patients (52.6%) were initially treated with monotherapy. However, after start of therapy the proportion of patients receiving combination therapy increased to 66.7% at month 6 ( Fig. 3 a), especially in patients with intermediate- or low-risk status ( Fig. 3 b).

Fig. 3.

Treatment regimen ( a ) and treatment regimen stratified by risk status ( b ) at start of therapy and at month 6 (PES). n: total number of patients.

At start of therapy and at month 6 patient’s risk status (66.7% and 73.7% respectively), age (36.8% and 22.8%, respectively), comorbidities (35.1% and 22.8%, respectively) and safety/tolerability (35.1% and 36.8%, respectively) were the most given reasons for physicians’ choice of treatment regimen ( Fig. 4 a).

Fig. 4.

Reasons for physician’s treatment decision ( a ) and relevant comorbidities ( b ) at start of therapy and at month 6 (PES). Multiple answers possible.

Univariate logistic regression analyses for the dependent variable physician’s treatment decision revealed that patient’s risk status (Odds ratio, OR: 12.38, p=0.0227) and the presence of comorbidities (OR: 0.07, p=0.0004) were the main significant decision factors at start of therapy, with ORs >1 implying a greater chance for patients to be treated with combination therapy and ORs <1 implying a greater chance for patients to be treated with monotherapy. At month 6, presence of comorbidities (OR: 0.21, p=0,0189) and safety/tolerability (OR: 0.26, p=0.0230) were revealed as significant factors influencing physician’s treatment decision towards monotherapy ( Table 2 ). Most relevant comorbidities influencing physician’s treatment decision at start of therapy and at month 6 were arterial hypertension (50.0% and 38.5%, respectively), relevant pulmonary diseases (25.0% and 38.5%, respectively) and adipositas (35.0% and 30.8%, respectively) ( Fig. 4 b).

Table 2 Factors influencing treatment decision at start of therapy and at month 6 (PES).

† Odds ratios (OR) >1 imply a greater chance for patients to be treated with combination therapy and <1 imply a greater chance for patients to be treated with monotherapy.
Treatment decision at start of therapy	Variable (yes vs. no)	OR †	p -value
Initial combination therapy vs. initial monotherapy	Risk status	12.38	0.0227
	Age	0.49	0.2323
	Comorbidities	0.07	0.0004
	Safety/Tolerability	1.15	0.8071
	Aetiology of PAH	0.93	0.9070
Treatment decision at month 6	Variable (yes vs. no)	OR	p -value
Initial combination therapy vs. initial monotherapy	Risk status	2.19	0.2068
	Age	0.32	0.0815
	Comorbidities	0.21	0.0189
	Safety/Tolerability	0.26	0.0230
	Convenience of treatment	1.16	0.8235

Secondary endpoints

Similarly to the PES, most patients of the FAS had an intermediate-risk status at each time point (>45.0%, each) and the proportion of patients with low-risk status increased continuously from start of therapy (14.5%) until month 24 (35.1%) ( Fig. 5 a). At each time point, the COMPERA method was the most utilized risk classification method and more than 20% of patients were stratified according to physician’s own clinical judgement ( Table S2 ).

Fig. 5.

Risk status ( a ) and treatment regimen ( b ) from start of therapy until month 24 (FAS). M: month; n: total number of patients; TS: therapy start.

Concomitantly to the observed increase of low-risk patients during the observational period, the percentage of patients receiving combination therapy increased from 45.6% at start of therapy to 78.4% at month 24 ( Fig. 5 b). Only one patient changed from combination therapy to monotherapy. In addition, the proportion of patients with a change in treatment regimen increased successively from start of therapy until month 12 whereas the treatment regimen remained almost unchanged during the further observational period ( Figure S3 ). Similarly to the PES, at each time point patient’s risk status was the main reason for the choice of treatment regimen in the FAS (>65.0%, each) ( Fig. 6 and Figure S4 ).

Fig. 6.

Reasons for physician’s treatment decision at month 12 ( a ) and month 24 ( b ) (FAS). total n=53 ( a ) and total n=37 ( b ), respectively; multiple answers possible.

Regarding important clinical outcomes, the results of the Pathway study show that between start of therapy and end of observation a numerical greater percentage of patients on initial combination therapy had an improved risk status to those initially treated with monotherapy (74.1% and 45.5%, respectively). A low-risk status was achieved by 27.3% and 50.0% of patients on initial monotherapy and initial combination therapy, respectively. In addition, a greater percentage of patients on initial combination therapy had an improved WHO-FC compared to those treated with initial monotherapy (85.2% and 50.0%, respectively). Univariate regression analysis revealed that initial combination therapy led to statistically higher probability for WHO-FC improvement within the observational period (OR: 5.75, p=0.0357) ( Table S3 ).

Regarding patient-reported outcomes, at start of therapy HQoL was comparable between patients treated with monotherapy and combination therapy (25.2 and 26.0 points, respectively). However, HQoL improved to a greater extent, as shown by a mean negative change, in patients on combination therapy than in those on monotherapy between start of therapy and end of observation ( Figure S5 ).

Discussion

This non-interventional study provides further insights into the current management of PAH patients and physicians’ reasons for treatment decision in routine clinical practice in Germany. In total, 79 incident and prevalent patients who started PAH treatment within 12 months prior to study inclusion were enrolled. A larger proportion of patients were female (57%), and patients’ mean age was 64 years. The majority of patients (76%) was diagnosed with idiopathic PAH and about 2/3 of patients had ≥5 comorbidities, mainly hypertension, arterial fibrillation, and chronic obstructive pulmonary disease. Hence, patients’ demographics and clinical characteristics were consistent with PAH registry data which show that idiopathic PAH is contemporary more frequently diagnosed in elderly comorbid patients ^{2 3 9 11 12 13} .

The primary objective of the Pathway study was to investigate physicians’ reasons for the choice of treatment regimen in PAH patients. As the participating sites were specialized for the care of PAH patients, reasons for therapy decision, as well as used risk assessment methods, reflect the general procedures in routine clinical practice in Germany. At therapy start, the main significant reason for choosing monotherapy was the presence of comorbidities, while for choosing combination therapy patient’s risk status was the primary reason. In addition, patient’s risk status was still the most given reason for choosing combination therapy six months after start of therapy, while comorbidities and safety/tolerability were the main significant reasons for continuation of monotherapy. Similarly, a retrospective analysis of PAH patients treated with monotherapy found that the main reasons for using monotherapy were PAH with comorbidities, mild PAH at diagnosis, and tolerability of other added drugs ¹⁷ .

As underlined by the results of this study, assessment of patient’s risk status has become an important tool to guide PAH therapy decision ² . The COMPERA method was as expected the most utilized method for risk classification at each time point. However, for more than 20% of patients no validated risk assessment tool was used. Instead, risk status was determined according to physician’s own clinical judgement. Similarly, a survey study conducted among PAH experts showed that in routine clinical practice more than 20% of physicians did not use validated risk assessment tools ⁴ . The relatively high use of own judgement methods in the Pathway study may be due to the fact that physicians, particularly those with more experience, adapt methods to suit their own preferences and individual patients. This appears to be the case especially in patients with many comorbidities, as seen in the study population. Consequently, patients’ risk status may be potentially underestimated ¹⁸ which may lead to undertreatment and impair clinical outcome. In this context it should be mentioned that the European Society of Cardiology/European Respiratory Society 4-strata model predicts patient’s mortality risk regardless of comorbidity burden, as recently demonstrated by a post hoc analysis of data from the COMPERA registry ² . This suggests that the use of validated risk assessment tools is essential for optimal treatment decision-making, even in patients with multiple comorbidities. However, clinical guidelines do not explicitly recommend risk status assessment for comorbid patients so far ^{1 8}

Consistent with registry data in this study most patients were assigned as having an intermediate- or high-risk status at therapy start ^{2 5} . Moreover, the proportion of patients with low-risk status remained relatively low even 24 months after start of therapy, reflecting that the main treatment goal was not achieved by most patients. This may be partly explained by the high number of elderly comorbid patients who are treated later, less frequently receive combination therapy, and are less likely to reach a low-risk status than younger or less comorbid patients ^{2 9 15} . However, it is not well understood to what extent the prevalence of comorbidities and/or potential undertreatment of those patients contribute to their worse clinical outcome. According to current guidelines, for patients with cardiopulmonary comorbidities initial monotherapy is recommended which should be individually escalated to combination therapy in case of an inadequate clinical response ⁸ . This underlines the reluctance regarding the use of upfront combination therapy in older patients with comorbidities. As shown in this study, more than 50% of patients were on initial monotherapy, whereas the number of patients receiving combination therapy increased during the observational period indicating an inadequate clinical response to monotherapy. Most therapy adjustments were made in the first 12 months after therapy start, comparable with data from the COMPERA registry ⁹ . In addition, first interim data of an ongoing, international, observational study show that within the first months of therapy >1/3 of incident patients on initial monotherapy were escalated to double therapy ¹⁹ .

Furthermore, there is emerging evidence from post hoc analyses of registry data and randomized clinical trials that at least a subset of older comorbid patients has a clinical benefit of receiving upfront combination therapy, albeit to a lesser extent than patients without comorbidities ^{2 20 21} . In this context, data from the COMPERA registry show that treatment naïve patients with newly diagnosed idiopathic PAH and comorbidities also benefit from PAH targeted-therapy with improvements in WHO-FC, 6-minute walking distance, brain natriuretic peptide (BNP)/N-terminal fragment of pro-brain natriuretic peptide (NT-proBNP), and mortality risk, although treatment response was less pronounced than in patients without comorbidities ² . A matched-pair analysis of patients treated with monotherapy versus combination therapy from the COMPERA registry also indicates that, in PAH patients with cardiovascular comorbidities, initial combination therapy may provide clinically meaningful advantages in early disease control, as reflected by greater improvements in WHO functional class, NT-proBNP levels, and overall risk status compared with monotherapy. Importantly, these benefits were achieved without compromising tolerability or increasing hospitalization rates, suggesting that combination therapy can be a feasible option in carefully selected patients ²² . Similarly, a subgroup analysis of the AMBITION trial also indicates that cardiovascular risk factors modify, but do not necessarily abolish, the treatment benefit of upfront combination therapy ²⁰ . These data were in line with those of a retrospective analysis of PAH patients from the Italian Pulmonary Hypertension Network (iPHNET) database which shows that treatment response to initial combination therapy is less effective in patients with cardiovascular comorbidities than in those without comorbidities, whereas non-cardiac comorbidities were not associated with a reduced treatment effect ²¹ . In this study a greater percentage of patients treated with initial combination therapy than with monotherapy had an improved WHO-FC and risk status between start of therapy and end of observation. Furthermore, compared to patients on initial monotherapy a greater proportion of patients initially treated with combination therapy reached the main treatment goal of achieving a low-risk status. These results may support the use of (initial) combinations therapies in patients with comorbidities. However, since combination therapies are less likely to be prescribed in patients with comorbidities these data are difficult to interpret ¹⁵ .

In addition to the observed clinical improvements, in this study patient-reported HQoL increased to a greater extent in patients on combination therapy compared to those on monotherapy. However, as prevalent patients did not complete the patient questionnaires at start of therapy, only incident FAS patients without change of treatment regimen between the start of therapy and the end of observation were included in the analysis.

This study has several strengths and limitations. One of the greatest strengths of this study was the prospective assessment of physicians’ treatment decisions. In addition, elderly patients with multiple comorbidities are often excluded from randomized clinical trials resulting in a highly selected study population ^{14 15} . Therefore, generalization of results from clinical trials to a larger, divers population which is seen in routine clinical practice is limited ²³ . In contrast, in this non-interventional study no strict inclusion criteria were applied and enrolled patients reflect a real-world PAH population. However, patients were recruited at 17 specialized pulmonary hypertension centres, and patients participating in or planned for investigational studies were excluded. This may have led to an underrepresentation of PAH patients eligible for medication trials, since such patients are often preferentially included in interventional studies, and conversely to an enrichment of older comorbid trial-ineligible patients. As this study was conducted under routine clinical practice the method of risk assessment was not pre-defined due to the non-interventional design. Therefore, the documented risk status may not be quite comparable between patients assessed with different methods. In addition, more than 20% of physicians did not use validated risk assessment tools which may lead to misjudgement of patient’s risk status. One significant limitation of this observational study is the lack of assessment and documentation of the clinical phenotypes of the enrolled patients. At the time of the protocol development, phenotyping of PAH patients was not yet established, and robust data on this topic was not available. Without this critical information, it becomes challenging to determine the impact of different phenotypes on clinical decision-making regarding treatment options.

Consequently, the study cannot elucidate how the phenotypic characteristics of patients may influence the choice between monotherapy and combination therapy. This gap limits the interpretation of results, as it is imperative to understand how phenotypic variability may affect patient responses to different treatments in pulmonary arterial hypertension (PAH). This limitation underscores the need for future studies to include comprehensive phenotypic profiling to enhance the understanding of tailored therapeutic approaches in PAH management.

Furthermore, the investigator questionnaire addressing physician’s rationale for treatment decision was newly created and not validated. However, the list of predefined reasons was very comprehensive, and additionally other reasons could be given.

In conclusion, this study demonstrated for the first time prospectively that risk and comorbidity status are the key factors for physician’s choice of treatment regimen. Furthermore, findings from the study suggest that patients on initial combination therapy could potentially improve their clinical status more effectively, even when they have comorbidities.

Key messages.

• Patient’s risk status and comorbidities are the key factors for physician’s choice of treatment regimen.

• Presence of comorbidities was the main significant reason for choosing monotherapy.

• Patient’s risk status was the primary reason for choosing combination therapy.

• The COMPERA method was the most common method to assess patient’s risk status.

• In more than 20% of patient, the risk status was stratified according to physician’s own clinical judgement.

• About half of patients were initially treated with monotherapy, whereas most patients were on combination therapy at month 6.

• Most therapy adjustments occurred within the first 12 months.

• Patients on initial combination therapy were more likely to achieve a low-risk status or an improved risk status than patients on initial monotherapy.

Kernaussagen.

• Der Risikostatus des Patienten und vorhandene Komorbiditäten sind die entscheidenden Faktoren für die Wahl des Behandlungsregimes durch den Arzt.

• Das Vorhandensein von Komorbiditäten war der wichtigste Grund für die Wahl einer Monotherapie.

• Der Risikostatus des Patienten war der Hauptgrund für die Entscheidung zugunsten einer Kombinationstherapie.

• Die COMPERA‑Methode war die am häufigsten verwendete Methode zur Bestimmung des Risikostatus der Patienten.

• Bei mehr als 20 % der Patienten wurde der Risikostatus nach der eigenen klinischen Einschätzung des Arztes eingestuft.

• Etwa die Hälfte der Patienten wurden initial mit einer Monotherapie behandelt, während nach 6 Monaten die meisten Patienten eine Kombinationstherapie erhielten.

• Die meisten Anpassungen des Behandlungsregimes erfolgten innerhalb der ersten 12 Monaten.

• Die Wahrscheinlichkeit einen niedrigen Risikostatus zu erreichen war bei Patienten, die bereits initial eine Kombinationstherapie erhielten, größer als bei Patienten, die zunächst eine Monotherapie erhielten.